Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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One "Simple" Question: What Is the Future of Clinical Trials?

One "Simple" Question: What Is the Future of Clinical Trials? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Artificial Intelligence, mHealth, Internet of Things, big data, social media; there's no doubt that technology is changing clinical trials. However, everyone has different ideas about how best to use these technologies and where they are taking the trials of the future.

Additionally, with innovative trial designs, increasingly patient-centric approaches, biomarkers and personalised medicine, clinical trials could look very different in 5, 10 or 20 years.

We asked dozens of experts from every area of clinical trials one simple question: what is the future of clinical trials? Discover their answers here.

Pharma Guy's insight:

I offered an overly simple answer: mobile!

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TrialsTracker Reveals that Nearly Half of All Clinical Trials Go Unpublished

TrialsTracker Reveals that Nearly Half of All Clinical Trials Go Unpublished | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Around half of all trials run by pharma companies, universities and other major research sponsors remain unpublished, according to a tool built to promote greater trial transparency.

 

The TrialsTracker monitors ClinicalTrials.gov, the world's largest clinical trial register, for whether or not studies have been published two years after their stated end date.

 

Collecting data from January 2006 to November 2014, the tracker found that 45% of the 25,927 eligible trials had not had their results published.

 

The TrialsTracker was created by a team of academics at the University of Oxford that includes Dr Ben Goldacre, author of Bad Pharma and one of the founders of the AllTrials campaign for clinical trial transparency.

 

“Everyone has been talking about this problem for far too long. We hope that increasing accountability will help to drive change forward,” he said.

 

“The TrialsTracker helps to identify the individual universities and companies with the most overdue trials. If any institution is concerned that it is doing badly in our league tables, then there is one simple thing they can do: publish their trial results, using their trial registry number, so that this information can be accessed and read by doctors, researchers, and patients.”

Pharma Guy's insight:

You might also like to read:

 

"Ben Goldacre Says Pharma Industry Has Destroyed Its Own Reputation. Duh!"; http://sco.lt/6mneQj

 

“Scientific Community Get Poor Grades for Sharing and Reporting Results of Clinical Trials”; http://sco.lt/8p9yCH

 

“Results of Over 500 Clinical Trials Each Year Go Undisclosed to Public”; http://sco.lt/7eA89p

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One Way for #Pharma to to Use EHR Data. Will It Work?

One Way for #Pharma to to Use EHR Data. Will It Work? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Providers have sunk millions into their EHRs, and the imperative to make good on the investment has never been stronger. As the EHR continues to evolve and change the way care is delivered to patient populations, provider organizations and pharmaceutical companies alike need to increase collaboration efforts in targeted ways to see the most benefit.

 

A partnership between the two to optimize their EHRs is a proactive and practical way to achieve shared goals—providing the best possible care to patients and engaging clinicians in that work.

 

One way is for provider-pharma partners to use EHR data to quickly identify and recruit eligible patients for clinical research trials, which would enable providers to have a more direct impact on drug development and innovation. Additionally, real-time data can generate a larger pool of eligible populations more quickly, helping to fast track a new therapy through the clinical testing stage, saving time, money, and effort for both providers and pharma companies.

Pharma Guy's insight:

This is a good idea provided that patients opt-in for this. This was not mentioned in the article. Also read “EHRs Are #Pharma's Digital Marketing Tools, Say Authors of a NEJM Article”; http://sco.lt/6ebfu5

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Scientists Frustrated by the Conventional Theory of Cause of Alzheimer's Disease

Scientists Frustrated by the Conventional Theory of Cause of Alzheimer's Disease | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In the wake of disappointing results this week for yet another experimental Alzheimer’s drug (read “Another Alzheimer's Clinical Trial Failure”; http://sco.lt/4gvYGX), scientists who have toiled for decades to understand the devastating disease expressed frustration and even anger that their field has not made more progress toward a cure.

 

To a growing number of scientists, the problem isn’t that there’s been too little time to make meaningful progress against a hugely complicated disease that strikes an organ unrivaled for its complexity. It’s that the field has made many missteps, that its leaders stifled research that deviated from the dominant theory of what caused Alzheimer’s, and that it was too easy to count as progress journal papers rather than advances that help patients.

 

“People got into a certain mindset, had a certain set of expectations, and then proceeded on those expectations for 35 years,” said Dr. Daniel Alkon, a 30-year veteran of the National Institutes of Health and now scientific director of the Blanchette Rockefeller Neurosciences Institute in West Virginia. “It was the expectation that amyloid plaques and tau tangles kill brain synapses and neurons,” and that eliminating them will stop the disease, he said. “There were a lot of clues that wasn’t true, but because of their mindset, people didn’t see those clues.”

 

The idea that Alzheimer’s is caused by sticky clumps of protein called amyloid plaques, which destroy the synapses between brain neurons, dates to the 1980s, and key genetic mutations that cause early-onset forms of it were discovered in the 1980s and 1990s. The discovery that a protein called tau forms “neurofibrillary tangles” that are toxic to neurons dates to 1986, but for decades was overshadowed by the amyloid idea. The animosity between the two camps grew as bitter as a religious war, earning it the name “tauists vs. baptists” (the “ba-” stands for beta-amyloid, the formal name of the protein).

Pharma Guy's insight:

This is an example of a big idea soaking up gov't funding; i.e.,  current Alzheimer's Disease research that focuses on one big idea: clearing the sticky plaque gumming up patients' brains is the solution (read, for example, "Another Alzheimer's Clinical Trial Failure"; http://sco.lt/4gvYGX and “Can Pharma Cure Alzheimer's Disease?”; http://bit.ly/1gmpt1D)

 

Despite repeated failures like this, there is a clamor for even more funding of such blind-alley research. Read, for example, “Lack of Alzheimer's Disease Research Funding Due to #Pharma Failures”; http://sco.lt/75EmKf 

 

It's unlikely that NIH will reinvest in these efforts due to political pressure from interest groups such as patient advocates and drug company investors.

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Sacré Bleu! French Authorities, CRO & Pharma Blame Each Other for Clinical Trial Death

Four months after a clinical trial in France left one person dead and five others hospitalized, French authorities blamed the clinical research organization and drug maker for various lapses and moved to tighten procedures for testing medicines. The CRO, however, castigated authorities for their findings and blamed the medicine for causing the serious patient reactions.

 

In a 271-page report released today, France’s social affairs inspectorate, known as IGAS, concluded that Biotrial, the CRO that oversaw the early-stage study, failed to properly manage the testing. Notably, the agency found that Biotrial continued to administer the drug even after one patient was sent to the hospital, and it failed to confirm patient consent before running the trial.

 

Overall, the CRO failed to “implement the optimal level of protection for volunteers,” the report stated. Compounding matters, the drug maker, Bial, and the CRO were both accused of taking too long to inform French health authorities of the serious adverse events, although the report cleared the National Agency of Drug Safety of wrongdoing.

 

The drug maker also maintained it did not have access to the patient autopsy in order to investigate possible causes, there was no reason to modify dosing, and that trial protocol was approved and followed. “There were no alerts, or signals in any of the safety parameters collected from any of the previous cohorts that could have anticipated the tragic accident,” the company said.]

 

For its part, Biotrial issued a scathing statement, saying the company “deplores this situation,” especially since it “respected” the trial protocol that was approved by French health authorities. And the CRO blamed the drug for its “unexpected and unpredictable toxicity, which is at fault for the accident.”

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French Bial Trial Death: Regulators Release Timeline of Events

The French national drug safety agency (ANSM), released the timeline of events (downloadable in English) for the Phase I clinical trial of BIA 10-2474, and it confirms what had been speculated, that the eight healthy volunteers received the fifth of the highest dose escalation (50 mg) of the investigational drug at the same time. This goes against EMA recommendations released in 2007, to address failures of a 2006 Phase I trial conducted in the UK, that specifically stated that trials be designed with “sequence and interval between dosing of subjects within the same cohort,” among other ways to help mitigate risk.

The Phase I trial contracted by Portuguese pharma company Bial to CRO Biotrial was conducted in Rennes, France. The ANSM document outlines that after the eight received their doses, one was hospitalized that evening. The remaining seven then received the sixth dose the next morning. The eighth man succumbed to a coma that day. Biotrial and Bial then discontinued the trial and notified ANSM, three days later. In the interim, five additional participants were hospitalized and now MRIs are indicating brain injuries to four of them.

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Are Clinical Trials More Marketing Than Science?

Are Clinical Trials More Marketing Than Science? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Background
Analysis of trial documentation has revealed that some industry-funded trials may be done more for marketing purposes than scientific endeavour. We aimed to define characteristics of drug trials that appear to be influenced by marketing considerations and estimate their prevalence.


Methods
We examined reports of randomised controlled trials of drugs published in six general medical journals in 2011. Six investigators independently reviewed all publications, characterising them as YES/MAYBE/NO suspected marketing trials, and then met to reach consensus. Blinded researchers then extracted key trial characteristics. We used blinded cluster analysis to determine if key variables could characterise the categories of trials (YES/MAYBE/NO).


Results
41/194 (21 %) trials were categorised as YES, 14 (7 %) as MAYBE, 139 (72 %) as NO. All YES and MAYBE trials were funded by the manufacturer, compared with 37 % of NO trials (p < 0.001). A higher proportion of YES trials had authors or contributors from the manufacturer involved in study design (83 % vs. 19 %), data analysis (85 % vs.15 %) and reporting (81 % vs. 15 %) than NO trials (p < 0.001). There was no significant difference between groups in the median number of participants screened (p = 0.49), but the median number of centres recruiting participants was higher for YES compared with NO trials (171 vs. 13, p < 0.001). YES trials were not more likely to use a surrogate (42 % vs. 30 %; p = 0.38) or composite primary outcome measure (34 % vs. 19 %; p = 0.14) than NO trials. YES trials were often better reported in terms of blinding, safety outcomes and adverse events than NO trials. YES trials more frequently included speculation that might encourage clinicians to use the intervention outside of the study population compared to NO trials (59 % vs.37 %, p = 0.03). Cluster analysis based on study characteristics did not identify a clear variable structure that accurately characterised YES/MAYBE/NO trials.


Conclusions
We reached consensus that a fifth of drug trials published in the highest impact general medical journals in 2011 had features that were suggestive of being designed for marketing purposes. Each of the marketing trials appeared to have a unique combination of features reported in the journal publications.

SOURCES, FULL STUDY, MORE INFORMATION
  • Characterisation of trials where marketing purposes have been influential in study design: a descriptive study, trials journal, doi:10.1186/s13063-015-1107-1, 21 January 2016.
  • Are clinical drug trials more marketing than science?biomed central blog, 21 Jan 2016.
Pharma Guy's insight:

Obviously, clinical trials are designed to obtain marketing approval from the FDA. So, I would say they are pre-marketing endeavors :-) But also  read: “Warning: Government Listing Of Clinical Trials Doesn’t Disclose Costs To Patients”; http://sco.lt/9012fJ

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Top Universities Ignore Law to Publicly Report Clinical Trial Data

Top Universities Ignore Law to Publicly Report Clinical Trial Data | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Stanford University, Memorial Sloan Kettering Cancer Center, and other prestigious medical research institutions have flagrantly violated a federal law requiring public reporting of study results, depriving patients and doctors of complete data to gauge the safety and benefits of treatments, a STAT investigation has found.


The violations have left gaping holes in a federal database used by millions of patients, their relatives, and medical professionals, often to compare the effectiveness and side effects of treatments for deadly diseases such as advanced breast cancer.


The worst offenders included four of the top 10 recipients of federal medical research funding from the National Institutes of Health: Stanford, the University of Pennsylvania, the University of Pittsburgh, and the University of California, San Diego. All disclosed research results late or not at all at least 95 percent of the time since reporting became mandatory in 2008.


The federal government has the power to impose fines on institutions that fail to disclose trial results, or suspend their research funding. It could have collected a whopping $25 billion from drug companies alone in the past seven years. But it has not levied a single fine.


The STAT investigation is the first detailed review of how well individual research institutions have complied with the law.

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Victory for Open Clinical Trial Data Movement: GSK's Paroxetine Study Re-Analyzed

Victory for Open Clinical Trial Data Movement: GSK's Paroxetine Study Re-Analyzed | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Millions of young people were prescribed a common anti-depressant on the basis of a notorious medical trial that actually showed the drug was neither safe nor effective in children and adolescents, a major review has confirmed. 


The new analysis of tens of thousands of pages of GlaxoSmithKline's Study 329 starkly contradicts the original report's claims about the drug paroxetine. It is the first study to be reassessed under a pioneering initiative aimed at overturning the findings of potentially misleading studies, often funded by drug firms. 


While the dangers of paroxetine, which can lead to suicidal behaviour and aggression in children and adolescents, are now well established, the reassessment of Study 329 marks a milestone in the medical community's campaign to open up clinical trial data held by pharmaceutical companies to independent scientific scrutiny. 


The original trial report, funded by what was then SmithKline Beecham, in 2001, was not written by any of the 22 named experts but by a medical writer hired by the drug company. It concluded the drug was “generally well tolerated and effective” and led to a marketing campaign that boasted of “remarkable efficacy and safety”. In fact, according to researchers from the University of Adelaide, writing in the BMJ today, an assessment of all the data from the trial supports the opposite conclusion in young people.


he new assessment in the BMJ is the result of the Restoring Invisible and Abandoned Trials (Riat) initiative - part of a wider movement to force pharmaceutical companies to release all of their data to independent scientific scrutiny. GSK is the only pharmaceutical firm signed up to the All Trials campaign, a group co-founded by the BMJ, which is calling for all trials to be registered and all results made public. 


Despite serious questions over the influence of the drug firm on the eventual findings, Study 329 has never been withdrawn by the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) where it was first published.


More here...

Pharma Guy's insight:


You might also be interested in reading this Pharma Marketing Blog post: "Basic Science Plagued by Financial Conflicts of Interest"; http://bit.ly/1aEFsC5 

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A Patient's View on Why Many Clinical Trials Fail to Enroll Sufficient Patients

A Patient's View on Why Many Clinical Trials Fail to Enroll Sufficient Patients | Pharmaguy's Insights Into Drug Industry News | Scoop.it
A drug obtained through a clinical trial appears to have extended my life. So why do many trials fail to enroll sufficient patients?


Within trials for these sorts of drugs, therapies are free and participants who are not helped can drop out at any point. Yet according to the physician-author Wendy Harpham, only about 5 percent of adult patients receive treatment in trials and an estimated 30 percent of trials sponsored by the National Cancer Institute fail to attract the minimum number of patients needed.


The failure in enrollment can be partly attributed to the fact that trials must set scientific inquiry as their goal, not patient improvement. It is estimated that fewer than 6 percent of patients enrolled in a clinical trial will actually experience any kind of response to treatment. Of course patients who benefit from conventional interventions need not morph into guinea pigs.


But what of people who have reason to doubt the efficacy of standard protocols? And how come Phase II and III trials — where benefits are more likely to ensue — also fail to obtain the minimum number of patients needed? Are the astonishing advances that have been made in the treatment of childhood leukemia a result of the fact that more than 60 percent of children with cancer receive treatment through trials?


In any case, the barriers to participation remain legion. First of all, you need a Ph.D. to interpret the listings on the Internet. No, forget that: I have a Ph.D. and couldn’t do it.


The data on ClinicalTrials.gov are daunting. Patients coping with enervating symptoms and fears may find it impossible to search through hundreds of trials involving their disease. At many cancer centers, there is no research officer to help patients locate suitable trials. I am grateful for a savvy physician at a university hospital who could dedicate her and her staff’s time to the paperwork of consent forms and to the scheduling all trials require. Oncologists outside research networks may not be able to keep up to date in a quickly changing field. And some make their money by dispensing the usual drugs on hand.


Additionally, trials have limited openings within limited temporal frames at research centers. The calendars of the patients must match those of the researchers, and patients in rural populations confront a disadvantage, as do lower-income patients. Even though I receive some help covering travel and accommodation costs, expenses usually exceed the amount of this compensation.


Strict inclusion criteria can also pose a problem. Only people with a particular mutation or a specific number of recurrences are eligible. Early stage trials involving what patients call sugar pills seem most disconcerting. Why risk being “randomized” to the control arm of a trial in which participants do not receive the experimental drug, although they generally do receive standard care as part of the study?


For all these reasons, the premature termination problem of trials appears to be over-determined. Some of these factors need to be addressed by scientists and by regulatory as well as funding agencies, if the number of patients enrolled in trials is to increase.

Pharma Guy's insight:


Can technology such as Apple's ResearchKit help solve some of these problems? Read this: http://sco.lt/8FEbVh

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FDA's "Intentional Fogginess" Regarding Drugs Based on Faulty Clinical Trials

FDA's "Intentional Fogginess" Regarding Drugs Based on Faulty Clinical Trials | Pharmaguy's Insights Into Drug Industry News | Scoop.it
For years, the FDA has made it nearly impossible to figure out where serious lapses in medical research has contributed to faulty drugs.


This information came from the FDA, but not directly. Instead, a team of investigative journalists had to scrounge to find the missing links between bad research and the drugs it was performed on. “I look at warning letters from the FDA, and see these awful things happening in clinical trials that are rarely reported,” says Charles Seife, a journalist and professor at NYU who led the research. The 57 clinical trials listed here (there are 78 records because some clinical trials contain multiple lines of bad research) are only a fraction of what he found. In all, he published evidence of approximately 600 clinical trials with significant scientific and ethical lapses—lapses the FDA did their best to hide.


By removing the link between warning letters and the drug trials they impact, the FDA has hamstrung your doctor’s ability to make an informed decision about your health.

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Big Pharma Plays Hide-the-Ball With Data

Big Pharma Plays Hide-the-Ball With Data | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Half of all clinical trials are never published, and Big Pharma wants to keep it that way.


The revelation of hidden data bolstered a growing movement against what’s referred to within the research community as “publication bias,” in which scientists squirrel away mostly negative or inconclusive findings and broadcast only their positive ones. Concealing trial data—for which patients accept the risks of untested treatments for the greater good—is routine. As many as half of all clinical trials are never published, PLOS Medicine reported last year.


Since the Cochrane report, many groups have urged companies and regulators to open up trial data, particularly if public money is being used.  “All trials should be published or at least have their results available somewhere,” says Agnes Dechartres of Paris Descartes University, who led the PLOS Medicine study.

Pharma Guy's insight:


This article goes into some depth regarding Roche's Tamiflu clinical trials. What Cochrane uncovered was more than 70 Tamiflu trials and well over 100,000 pages of unpublished reports. Among them were many trials where the results were negative or inconclusive. With this more complete picture of the testing, Cochrane concluded the trials don’t prove that Tamiflu prevents hospitalizations, contagiousness or complications. The only thing it definitely does do, Cochrane said, is shorten the duration of symptoms, by about a day. Meanwhile, the U.S. government spent (wasted?) $1.3 billion to develop and stockpile antiviral medication, including Tamiflu.


Also read "Results of Over 500 Clinical Trials Each Year Go Undisclosed to Public."

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Pharma Physicians Overwhelmingly Favor Clinical Trial Data Transparency

Amid ongoing debate over the extent to which clinical trial data should be divulged, a new survey finds that an overwhelming majority of members of the Royal College of Physicians in the U.K. believe that such information should be disclosed and accessible.


95 percent say all trials should be registered; 89% says increased publication of results, including those that are negative, will lead to better medicines and patient healthcare; 81% agree that a “moral duty” exists for drug makers to make completed data available to trial participants, the public and the scientific community; and 87% says increased scrutiny of data will lead to better science and research.


The survey, however, indicates that, while physicians are overwhelmingly supportive of greater transparency, they are also cognizant of industry concerns. For instance, just 18% believe all trial data should be placed on a central, publicly accessible database with no limitation to access. Still, 61% says either current regulatory bodies or a newly established independent body should act as a gatekeeper.

Pharma Guy's insight:


It should be noted that these physicians are not representative of general practitioners. The majority of them work internationally as clinical pharmacologists, clinical research physicians, medical affairs physicians and regulators across a wide range of organizations - 59% of the survey respondents said they worked for a pharmaceutical company (52%) or a biotechnology company (7%). 


It should also be noted that only 10% of respondents work predominantly in the U.S. Perhaps the AMA should survey its members on this issue.

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Clinical Trial Research Funded by Pharma More More Likely to Produce Positive Results. Not Here in the UK, Says ABPI!

Clinical Trial Research Funded by Pharma More More Likely to Produce Positive Results. Not Here in the UK, Says ABPI! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A new paper published in the British Medical Journal (BMJ) has called the integrity of certain clinical trials into question by claiming that pharmaceutical companies paid researchers for consultancy and advisory work, travel expenses, speeches and stock ownership, and where these payments were made, studies were more likely to have positive outcomes, highlighting a “risk of research bias”.

 

Based on a sample of 195 drug effectiveness trials in 2013, it was found that 58% of lead authors had financial connections to the pharma industry; the US researchers concluded that, “Financial ties of principal investigators were independently associated with positive clinical trial results. These findings may be suggestive of bias in the evidence base.”

 

“The UK clinical trials environment works differently than in the US,” explained Dr Jacintha Sivarajah, head of medical affairs at the Association of the British Pharmaceutical Industry (ABPI). “In the UK, funding to run clinical studies is made available to organisations including NHS Trusts and Universities – rather than individuals. There should be no undue influence from any industry, pharmaceutical or otherwise, in the clinical and financial decisions of a NHS institution.

 

Further Reading:

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@LillyPad Commissions "The Hero's Journey" - Crowdsourced One Brick at a Time

@LillyPad Commissions "The Hero's Journey" - Crowdsourced One Brick at a Time | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Coined by scholar Joseph Campbell, “The Hero’s Journey” is a familiar trope in myths and stories – a hero sets out on an adventure, encounters setbacks, is transformed and eventually returns home.

 

“It’s a story that’s as old as humanity,” said John Magnan.

 

Using the same title, the latest project of the Mattapoisett sculptor looks at that journey through the scope of patients who undergo clinical trials and the community that surrounds them.

 

Commissioned by Eli Lilly and Company, a multinational pharmaceutical company based in Indiana, Magnan is creating three elaborate structures of wood and light that incorporate the journeys of patients and the greater clinical drug trial community to raise awareness.

 

“What’s important about clinical trials is that’s how drugs get approved. We can’t get new medicines out there healing people unless we test it on people,” Magnan said. “I knew art could inspire people to look into clinical trials and potentially take action and also be used to validate and honor the patient experience.”

 

The project also has a crowdsourcing element, something that immediately drew Magnan to the project.

 

“The art is not finished without the physical participation of the clinical trial community. That really captured my imagination,” he said.

 

Magnan created 2,000 wooden bricks that will be sent to patients, members of the medical community, caretakers and others through the One Brick, Your Voice campaign, designed by Magnan’s wife Annie Jonas. Participants who request a kit will receive a brick on which to paint, paste, draw or write something related to their experiences with drug trials. The kits will also contain a replica of one of the cairns, made by Jonas, to keep.

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Majority of U.S Adults Would Participate in a Nationwide Precision Medicine Initiative Cohort Study

Majority of U.S Adults Would Participate in a Nationwide Precision Medicine Initiative Cohort Study | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Objectives
A survey of a population-based sample of U.S adults was conducted to measure their attitudes about, and inform the design of the Precision Medicine Initiative’s planned national cohort study.

Methods
An online survey was conducted by GfK between May and June of 2015. The influence of different consent models on willingness to share data was examined by randomizing participants to one of eight consent scenarios.

Results
Of 4,777 people invited to take the survey, 2,706 responded and 2,601 (54% response rate) provided valid responses. Most respondents (79%) supported the proposed study, and 54% said they would definitely or probably participate if asked. Support for and willingness to participate in the study varied little among demographic groups; younger respondents, LGBT respondents, and those with more years of education were significantly more likely to take part if asked. The most important study incentive that the survey asked about was learning about one’s own health information. Willingness to share data and samples under broad, study-by-study, menu and dynamic consent models was similar when a statement about transparency was included in the consent scenarios. Respondents were generally interested in taking part in several governance functions of the cohort study.

Conclusions
A large majority of the U.S. adults who responded to the survey supported a large national cohort study. Levels of support for the study and willingness to participate were both consistent across most demographic groups. The opportunity to learn health information about one’s self from the study appears to be a strong motivation to participate.

Pharma Guy's insight:

Precision medicine’s implications for marketers is clear. Just as precision medicine enables clinicians to understand the complex mechanisms underlying health, disease, or a condition and target treatments, marketers will need to drill down using sophisticated data analysis to understand where their target audience is. For more, read “Precision Medicine: A Back Door to Patient Data for #Pharma Marketers”; http://sco.lt/8GRNQX

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Direct patient engagement through social media speeds recruitment to cancer research study

Direct patient engagement through social media speeds recruitment to cancer research study | Pharmaguy's Insights Into Drug Industry News | Scoop.it
A crowd-sourcing strategy aimed at accelerating research into metastatic breast cancer has registered more than 2,000 patients from all 50 states in its first seven months, report researchers from Dana-Farber Cancer Institute and the Broad Institute of MIT and Harvard at the American Society of Clinical Oncology Annual Meeting.

Via Julie O'Donnell, Lionel Reichardt / le Pharmageek
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Clinical Trials Need More Subjects

Clinical Trials Need More Subjects | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Researchers try new methods to sign up patients who are unaware or reluctant to participate, delaying new medicines’ development.
Pharma Guy's insight:

What about clinical trials for rare diseases? Difficult to find patients to enroll. Read, for example, "Scores of DMD Advocates Set to Attempt to Sway FDA To Approve Drug with Scant Evidence"; http://sco.lt/6Y28xd 

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Is #pharma at Risk from The Clinical Trial Transparency Movement?

Is #pharma at Risk from The Clinical Trial Transparency Movement? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Calls for transparency in the pharmaceutical industry have grown in recent years, focusing on issues including pricing, access to medicine and how companies report finances. While these calls for transparency have come from healthcare professionalsinvestors and regulatory bodies, the cause for clinical trial transparency has had a vocal leader in Ben Goldacre.


Based on trends in social media discussion over the last three months, alva has identified the following risks to the pharma sector where clinical trial transparency is concerned:


  1. AllTrials expansion in the US and beyond. Multiple tweets ask for AllTrials to “go global”, and recent articles in US news media signify that awareness of this issue is likely to grow
  2. Emotional campaigning linked to topics including veterinary care and prevention of patient harm. Members of the general public have shared posts using this emotional messaging to boost visibility among a patient audience
  3. Campaigns to “name and shame” universities not reporting clinical trial results as required. This poses a risk to individual pharmaceutical companies that are partnered with targeted institutions – and could augment criticism of individual firms


Though the issue of clinical trial transparency currently represents only a minor risk in relation to the general public, it is possible that increasing public awareness combined with Goldacre’s determination to “name and shame” will bring more individual companies – and their record on trial transparency – into the spotlight of public discussion.


Pharma Guy's insight:

You might also like to read: "Ben Goldacre Says Pharma Industry Has Destroyed Its Own Reputation. Duh!"; http://sco.lt/6mneQj 

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A Broken Covenant With Patients

A Broken Covenant With Patients | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In 2007, federal law mandated that all pharmaceutical companies, universities and hospitals conducting clinical trials must disclose study results and adverse events on ClinicalTrials.gov, a website used by a large percentage of doctors and patients. Mr. Piller’s evidence proves that pharmaceutical companies have often failed to follow the law while prestigious medical research institutions have routinely flouted it. Malfeasance appears to be the rule, not the exception.

An example from the pharmaceutical industry: According to Mr. Piller, in my home state, Indiana, the nonprofit Hoosier Cancer Research Network, which runs trials for drug companies, terminated a study of Avastin in 2009 because it did not help but harmed patients with metastatic breast cancer. During the next two years, the trial’s investigators neither published their results in a journal nor posted them on ClinicalTrials.gov. It was not until 2011 that the F.D.A. revoked approval of Avastin for metastatic breast cancer because of its life-threatening risks. How many sick women were unnecessarily endangered between 2009 and 2011?

An example from the prestigious medical research institutions: According to Mr. Piller, Memorial Sloan Kettering Cancer Center broke the law on 100 percent of its studies—“reporting results late or not at all.” In two trials of the experimental drug ganetespib, it failed to report adverse consequences — heart and liver disorders, bowel and colon obstructions, death — affecting “volunteers” with breast and colorectal cancers.

The word “volunteers” reminds us that the often debilitated participants in clinical cancer trials decide on their own accord to put their lives on the line, usually with no resulting personal health benefit. It also brings to my mind the first anxious days of my participation in the Phase I trial that I began in August 2012.

My husband and I undertook the one-hour drive from Bloomington to the Indianapolis cancer center at the crack of dawn. Inside a hospital room from 8 a.m. until 11 p.m., I spent a long period of that time fasting. Because the experimental drug had never been used on human beings before, I was monitored every hour with all sorts of tests that were followed by various infusions to offset potential side effects. Totally exhausted upon release, my husband and I got lost finding our way to a bleak motel, paid for by the trial because we had to return to the hospital the next morning for more testing.

The stressful and demanding start of the trial forecast its evolution. To date, I have had approximately 20 CT scans for the trial—not one of which was good for me physically or psychologically, but all of which help researchers ascertain how the drug I take works. Yet the knowledge they gain from this study remains barren, if it does not circulate among other researchers, cancer doctors, and patients. I benefit from the study drug, but no one else will be aided unless at its conclusion the results of the trial are promptly reported not just in a medical journal but on the site provided for the dissemination of information required by law.

Pharma Guy's insight:

This story suggests to me another way that can be more "patient-centric" - Publish all clinical trial results. For other suggestions for pharma to be more patient-centric, see http://sco.lt/5e6HKb 

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Meta Pharma Influence: 1/3 of Meta-Analyses Written by Industry Employees

Meta Pharma Influence: 1/3 of Meta-Analyses Written by Industry Employees | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Pharmaceutical industry influence is known to pervade scientific research, including clinical trials the U.S. Food and Drug Administration requires pharma companies to fund in order to assess their products. For that reason, people who read scientific papers as part of their jobs have come to rely on meta-analyses, supposedly thorough reviews summarizing the evidence from multiple trials, rather than trust individual studies. But a new analysis casts doubt on that practice as well, finding that the vast majority of meta-analyses of antidepressants have some industry link, with a corresponding suppression of negative results.


The latest study, published in the Journal of Clinical Epidemiology, which evaluated 185 meta-analyses, found that one third of them were written by pharma industry employees. “We knew that the industry would fund studies to promote its products, but it’s very different to fund meta-analyses,” which “have traditionally been a bulwark of evidence-based medicine,” says John Ioannidis, an epidemiologist at Stanford University School of Medicine and co-author of the study. “It’s really amazing that there is such a massive influx of influence in this field.”


Almost 80 percent of meta-analyses in the review had some sort of industry tie, either through sponsorship, which the authors defined as direct industry funding of the study, or conflicts of interest, defined as any situation in which one or more authors were either industry employees or independent researchers receiving any type of industry support (including speaking fees and research grants). Especially troubling, the study showed about 7 percent of researchers had undisclosed conflicts of interest. “There’s a certain pecking order of papers,” says Erick Turner, a professor of psychiatry at Oregon Health & Science University who was not associated with the research. “Meta-analyses are at the top of the evidence pyramid.” Turner was “very concerned” by the results but did not find them surprising. “Industry influence is just massive. What’s really new is the level of attention people are now paying to it.”

Pharma Guy's insight:


You might also be interested in reading this Pharma Marketing Blog post: "Basic Science Plagued by Financial Conflicts of Interest"; http://bit.ly/1aEFsC5

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21st Century Cures Act Could Weaken the F.D.A.’s Drug Approval Process, Says Former FDA Commish Kessler

21st Century Cures Act Could Weaken the F.D.A.’s Drug Approval Process, Says Former FDA Commish Kessler | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The 21st Century Cures Act could substantially lower the standards for approval of many medical products, potentially placing patients at unnecessary risk.


For instance, the current version of the bill would allow consideration of drug approvals based on clinical experience, replacing scientific data from large numbers of patients in well-designed and controlled clinical trials.


Other provisions could mandate the use of biomarkers to approve a wider variety of drugs, far beyond just those for serious and life-threatening conditions.


Approval standards for medical devices, already lower than those for drugs, could become even less rigorous, allowing lifesaving devices like heart valves and stents to be revamped by manufacturers without the F.D.A. even reviewing the changes (though the agency would have to be notified).

Pharma Guy's insight:


Also read: 21st Century Cures Act + Off-Label "Free Speech" = More Adverse Events, IMO http://sco.lt/8GUClV

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Patients Want Docs to Disclose Ties to #Pharma Before They Enroll in Trials

Patients Want Docs to Disclose Ties to #Pharma Before They Enroll in Trials | Pharmaguy's Insights Into Drug Industry News | Scoop.it
A new study finds that multiple sclerosis patients who have not participated in a clinical trial say disclosure is important enough to influence their participation in industry-sponsored clinical trials.


For instance, 79% of multiple sclerosis patients surveyed said it was important to know that a drug maker sponsoring a study would pay a portion of a physician’s salary before deciding whether they would participate. Nearly as many responded the same way when asked whether payments for speaking or consulting work was also important enough to influence their participation.


Among those who have never participated in a trial, 87% believe that a doctor involved in a study should disclose they or their office is paid for a patient to participate. Similarly, 75% of those who have participated in a trial hold the same view. And two-thirds of both groups says a doctor involved in a study should disclose how they or their office use money paid for patients to participate in a study.


“Potential physician conflicts can be an important piece of information for patients as they weigh the pros and cons of volunteering for a research study and can enhance or preserve trust between a subject and investigators and ensure that patients make well-informed decisions that preserve their autonomy,” the authors write in Multiple Sclerosis Journal. The study canvassed 597 people who suffer from the illness.

Pharma Guy's insight:


Interestingly, financial disclosure is NOT part of the "informed consent" documents shown to patients before they join a clinical trial.


I have a question: Do pharmaceutical companies pay physicians to recruit patients into trials that the physicians are otherwise not involved in?


It seems to me that transparency should be one of the "pillars" of patient centricity, which is a subject I will discuss in a March 20, 2105, podcast interview of Anne C. Beal, MD, MPH, Chief Patient Officer, Sanofi, and Melva T. Covington, MPH, MBA., PhD, Project Leader, Research and Develooment, Sanofi. They talk about their roles in bringing the patient perspective into Sanofi's work to advance Sanofi's ability to deliver health care solutions that matter most to patients and those who care for them. Listen here.

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The Institute of Medicine Report Suggests When to Share Clinical Trial Data

The Institute of Medicine Report Suggests When to Share Clinical Trial Data | Pharmaguy's Insights Into Drug Industry News | Scoop.it

I want to thank the Institute of Medicine (IOM) for its important and thoughtful report, Sharing Clinical Trial Data – Maximizing Benefits, Minimizing Risk , which was commissioned by NIH and a number of other sponsors.  Data sharing is fundamental to NIH’s mission, and the responsible sharing of clinical trials data in ways that protects patient privacy has many important benefits. Through responsible data sharing, participants in clinical trials are assured that their contributions to research will have maximal effect, and researchers are able to accelerate efforts to prevent, detect, and treat disease by validating and advancing results. Data sharing also improves the efficiency of clinical research and bolsters safety in clinical trials by preventing unnecessary duplication of trials, including trials of products that have already been found to be unsafe or ineffective.  NIH is committed to advancing efforts in this arena, and the IOM report presents thoughtful analysis and useful points to consider about how to promote responsible access to participant level data.


The IOM report is timely, coming on the heels of two important measurestaken by the Department of Health and Human Services and NIH to enhance transparency in clinical trials. The first is a proposed rule (PDF - 793KB)  that clarifies the requirements under the Food and Drug Administration Amendments Act of 2007 (FDAAA) for clinical trial researchers to register and to submit summary-level trial results information to ClinicalTrials.gov for specified trials of FDA-approved drugs and devices.  The proposed rule would also expand the results submission requirement to trials of unapproved products.  The second is a complementary draft NIH policy that expects all NIH-funded clinical trials, whether or not they are subject to FDAAA, to submit the same registration and summary results information as specified in the proposed rule.  We look forward to hearing from the community on these two proposals. The feedback will be critically important as we consider the IOM report and NIH’s role in enhancing the responsible sharing of data from clinical trials for the benefit of all.


Francis S. Collins, M.D., Ph.D.
Director, National Institutes of Health

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You can download the report here.

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Scientific Community Get Poor Grades for Sharing and Reporting Results of Clinical Trials

Scientific Community Get Poor Grades for Sharing and Reporting Results of Clinical Trials | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The scientific community has a disappointing track record for dissemination of clinical trial results. Numerous factors may contribute to these poor publication rates, including some that are beyond the control of researchers. Despite the best efforts of investigators, the results of some trials may never reach the threshold deemed necessary to merit the attention of journal editors and readers. Even published results may focus only on the findings of most interest to the investigators. Other means to share such data are necessary because both real and potential harm can result from failure to fully disclose the results of clinical trials. However, difficulty with achieving publication in scientific journals for negative results cannot be blamed entirely. A recent analysis of 400 clinical studies revealed that 30% had not shared results through publication or through results reporting in ClinicalTrials.gov within 4 years of completion. This is a serious issue and the proposed rule underscores the intent of NIH to take strong action to promote timely dissemination of clinical trial results.


Without access to complete information about a particular scientific question, including negative or inconclusive data, duplicative studies may be initiated that unnecessarily put patients at risk or expose them to interventions that are known to be ineffective for specific uses. If multiple related studies are conducted but only positive results are reported, publication bias can distort the evidence base. Incomplete knowledge can then be incorporated into clinical guidelines and patient care. However, one of the greatest harms from nondisclosure of results may be the erosion of the trust accorded to researchers by trial participants and, when public funds are used, by taxpayers.

Pharma Guy's insight:


Amid ongoing debate over the extent to which clinical trial data should be divulged, a new survey finds that an overwhelming majority of members of the Royal College of Physicians in the U.K. believe that such information should be disclosed and accessible.


95 percent say all trials should be registered; 89% says increased publication of results, including those that are negative, will lead to better medicines and patient healthcare; 81% agree that a “moral duty” exists for drug makers to make completed data available to trial participants, the public and the scientific community; and 87% says increased scrutiny of data will lead to better science and research.


The survey, however, indicates that, while physicians are overwhelmingly supportive of greater transparency, they are also cognizant of industry concerns. For instance, just 18% believe all trial data should be placed on a central, publicly accessible database with no limitation to access. Still, 61% says either current regulatory bodies or a newly established independent body should act as a gatekeeper.


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