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GSK signs #AllTrials, commits to publishing clinical trial data for drugs

GSK signs #AllTrials, commits to publishing clinical trial data for drugs | PharmaSuccess | Scoop.it

Britain’s largest pharmaceutical company has stunned the medical world by announcing it would back a campaign to publish all clinical trial results to preserve the safety of medicines.

 

GlaxoSmithKline (GSK) announced the move eight months after it was hit with a record $3bn (£1.9bn) fine in the US last July, in part for withholding safety data about its best selling diabetes drug, Avandia.

 

In all, 26 drug companies – including eight of the 10 biggest global players – have racked up fines of more than $11bn (£7bn) in the last three years after having been found to have acted dishonestly.

 

The results of clinical trials, most of which are funded by the drug industry, are frequently withheld when they deliver disappointing results. This distorts the evidence base and raises doubts about the safety of medicines that are available on the market.

 

GSK said in a statement it would sign up to the alltrials.net campaign which is seeking the registration of all clinical trials, the reporting of all summary results and for full Clinical Study Results – the detailed findings – to be made public.

 

Campaign organisers who include Ben Goldacre, best-selling author of Bad Pharma, Fiona Godlee, editor of the British Medical Journal and Sir Iain Chalmers, co-founder of the Cochrane Library, said it was a “cartwheel moment.” Dr Goldacre said he had met Andrew Whitty, chief executive of GSK, last week.

 

“It was clear they have spent a lot of time thinking about these issues. While I will always wait for proof of the pudding I do not believe this is mere lip service,” Dr Goldacre said.

 

“There is no serious defence for withholding information about clinical trials from doctors and patients. It is simply unethical and it harms patients.”

Observers said GSK had occupied the moral high ground by its move and rival firms would likely follow suit.

 

The alltrials.net campaign has grown rapidly since publication of Bad Pharma four months ago, winning the backing of the Medical Research Council and the Wellcome Trust. The Commons Science and Technology Committee has announced an inquiry into missing trials.


Via Andrew Spong
EuroHealthNet's insight:

big step #opendata #transparency #patient level

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Andrew Spong's curator insight, February 6, 2013 1:39 AM

Evidence that GSK are indeed prepared to have their 'feet held to the fire', as they described it last year, over full disclosure of clinical trial data. I'm impressed that this will include -- as it should -- 'details of trials for all approved medicines dating back to its formation in 2000'.

PharmaSuccess
Votre salon business excellence et marketing santé. Le 19 mars 2015 au CNIT
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Appel à prévenir la probable pénurie du technétium 99, élément essentiel en médecine nucléaire

Appel à prévenir la probable pénurie du technétium 99, élément essentiel en médecine nucléaire | PharmaSuccess | Scoop.it
Le technétium 99 est une élément radioactif indispensable pour la réalisation des scintigraphies, des examens diagnostiques d'importance majeure en oncologie, cardiologie, neurologie, endocrinologie, urologie, pneumologie… et il risque de manquer drastiquement dans les années à venir.
En 2015, le réacteur Osiris de Saclay, seul producteur de technétium en France, fermera ses porte sous l'avis de l'Autorité de la Sureté Nucléaire. En attendant la mise en service du réacteur Jules Horowitz prévue pour 2018, la disponibilité de cet élément pourra subir une pénurie impo ...
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Laboratoires pharmaceutiques et transformation digitale #hcsmeufr

Laboratoires pharmaceutiques et transformation digitale #hcsmeufr | PharmaSuccess | Scoop.it
La transformation digitale vecteur de croissance et de création de valeur : web casting, web conference, serious games, apps, flashcodes, santé connectée,

Via Antoine POIGNANT, MD
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Laboratoires pharmaceutiques et transformation digitale

Laboratoires pharmaceutiques et transformation digitale | PharmaSuccess | Scoop.it
La transformation digitale vecteur de croissance et de création de valeur : web casting, web conference, serious games, apps, flashcodes, santé connectée,
EuroHealthNet's insight:

Au-delà des adaptations liées au marketing digital, c’est à une véritable rupture de business model que sont confrontés les industriels du médicament.


Les big players du web et du fitness ont tous développé des plateformes mobiles basées sur des données de santé ou de bien être : Apple HealthKit, Samsung Digital Health Initiative, Microsoft HealthVault, Google Android Wear & Google Fit, Nike+.


Les laboratoires pharmaceutiques, à l’heure de la médecine personnalisée et du Quantified Self, semblent étrangement absents de ce nouveau champ.


Adaptation des organisations, digitalisation des services, (r)évolution de la relation client : où en sont les laboratoires sur le marché français ?

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Mhealth Usage and Adoption by Physicians

Mhealth Usage and Adoption by Physicians | PharmaSuccess | Scoop.it

Olson Research recently polled physicians to understand what their current views are on mhealth, how they are using it in their practices today, and what they think the future looks like for this new technology.

 


Via Philippe Marchal/Pharma Hub, eMedToday, Michael Lucht - www.b-innovative.eu, Lionel Reichardt / le Pharmageek
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Bettina Gifford's curator insight, June 28, 3:01 PM

An interesting study showing what physicians think of myhealthshare and where it's going..

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Le mercantilisme menace les communautés de patients

Le mercantilisme menace les communautés de patients | PharmaSuccess | Scoop.it
Tribune. Un groupe de responsables d’associations de malades s’inquiète du détournement mercantile de réseaux conçus à l’origine comme des outils de démocratie sanitaire.
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Laboratoires pharmaceutiques et transformation digitale

Laboratoires pharmaceutiques et transformation digitale | PharmaSuccess | Scoop.it

“La transformation digitale vecteur de croissance et de création de valeur : web casting, web conference, serious games, apps, flashcodes, santé connectée,”

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In The Hospital Of The Future, Big Data Is One Of Your Doctors

In The Hospital Of The Future, Big Data Is One Of Your Doctors | PharmaSuccess | Scoop.it

From our genomes to Jawbones, the amount of data about health is exploding. Bringing on top Silicon Valley talent, one NYC hospital is preparing for a future where it can analyze and predict its patients' health needs--and maybe change our understanding of disease.

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The office of Jeff Hammerbacher at Mount Sinai's Icahn School of Medicine sits in the middle of one of the most stark economic divides in the nation. To Hammerbacher’s south are New York City’s posh Upper East Side townhouses. To the north, the barrios of East Harlem.

What's below in the basement may be what's most interesting: Minerva, a humming supercomputer installed last year that's named after the Roman goddess of wisdom and medicine.

It’s rare to find a supercomputer in a hospital, even a major research center and medical school like Mount Sinai. But it’s also rare to find people like Hammerbacher, a sort of human supercomputer who is best known for launching Facebook’s data science team and, later, co-founding Cloudera, a top Silicon Valley “big data” software company where he is chief scientist today. After moving to New York this year to dive into a new role as a researcher at Sinai’s medical school, he is setting up a second powerful computing cluster based on Cloudera’s software (it’s called Demeter) and building tools to better store, process, mine, and build data models. “They generate a pretty good amount of data,” he says of the hospital’s existing electronic medical record system and its data warehouse that stored 300 million new “events” last year. “But I would say they are only scratching the surface.”

Could there actually be three types of Type 2 diabetes? A look at the health data of 30,000 volunteers hints that we know less than we realize. Credit: Li Li, Mount Sinai Icahn School of Medicine, and Ayasdi

Combined, the circumstances make for one of the most interesting experiments happening in hospitals right now--one that gives a peek into the future of health care in a world where the amount of data about our own health, from our genomes to our Jawbone tracking devices, is exploding.

“What we’re trying to build is a learning health care system,” says Joel Dudley, director of biomedical informatics for the medical school. “We first need to collect the data on a large population of people and connect that to outcomes.”

To imagine what the hospital of the future could look like at Mount Sinai, picture how companies like Netflix and Amazon and even Facebook work today. These companies gather data about their users, and then run that data through predictive models and recommendation systems they’ve developed--usually taking into account a person’s past history, maybe his or her history in other places on the web, and the history of “similar” users--to make a best guess about the future--to suggest what a person wants to buy or see, or what advertisement might entice them.

What we’re trying to build is a learning health care system.

Through real-time data mining on a large scale--on massive computers like Minerva--hospitals could eventually operate in similar ways, both to improve health outcomes for individual patients who enter Mount Sinai’s doors as well as to make new discoveries about how to diagnose, treat, and prevent diseases at a broader, public health scale. “It’s almost like the Hadron Collider approach,” Dudley says. “Let’s throw in everything we think we know about biology and let’s just look at the raw measurements of how these things are moving within a large population. Eventually the data will tell us how biology is wired up.”

Dudley glances at his screen to show the very early inklings of this vision of what “big data” brought to the world of health care and medical research could mean.

On it (see the figure above) is a visualization of the health data of 30,000 Sinai patients who have volunteered to share their information with researchers. He points out, in color, three separate clusters of the people who have Type 2 diabetes. What we're looking at could be an entirely new notion of a highly scrutinized disease. “Why this is interesting is we could really be looking at Type 2, Type 3, and Type 4 diabetes,” says Dudley. “Right now, we have very coarse definitions of disease which are not very data-driven.” (Patients on the map are grouped by how closely related their health data is, based on clinical readings like blood sugar and cholesterol.)

From this map and others like it, Dudley might be able to pinpoint genes that are unique to diabetes patients in the different clusters, giving new ways to understand how our genes and environments are linked to disease, symptoms, and treatments. In another configuration of the map, Dudley shows how racial and ethnic genetic differences may define different patterns of a disease like diabetes--and ultimately, require different treatments.

These are just a handful of small examples of what could be done with more data on patients in one location, combined with the power to process it. In the same way Facebook shows the social network, this data set is the clinical network. (The eventual goal is to enroll 100,000 patients in what’s called the BioMe platform to explore the possibilities in having access to massive amounts of data.) “There’s nothing like that right now--where we have a sort of predictive modeling engine that’s built into a health care system,” Dudley says. “Those methods exist. The technology exists, and why we’re not using that for health care right now is kind of crazy.”

The methods exist. The technology exists, and why we’re not using that for health care right now is kind of crazy.

While Sinai’s goal is to use these methods to bring about more personalized diagnoses and treatments for a wide variety of diseases, such as cancer or diabetes, and improve patient care in the hospital, there are basic challenges that need to be overcome in order to making this vision achievable.

Almost every web company was born swimming in easily harvested and mined data about users, but in health care, the struggle has for a long time been more simple: get health records digitized and keep them private, but make them available to individual doctors, insurers, billing departments, and patients when they need them. There’s not even a hospital’s version of a search engine for all its data yet, says Hammerbacher, and in the state the slow-moving world of health care is in today, making predictions that would prevent disease could be just the icing on the cake. “Simply centralizing the data and making it easily available to a broad base of researchers and clinicians will be a powerful tool for developing new models that help us understand and treat disease,” he says.

Sinai is starting to put some of these ideas into clinical practice at the hospital. For example, in a hint of more personalized medicine that could come one day, the FDA is beginning to issue labels for some medicines that dictate different doses for patients who have a specific genetic variant (or perhaps explain that they should avoid the medicine altogether). The “Clipmerge” software that the hospital is beginning to now use makes it easier for doctors to quickly search and be notified of these kinds of potential interactions on an electronic medical record form.

On the prediction side, the hospital has already implemented a predictive model called PACT into its electronic medical record system. It is used to predict the likelihood that a discharged patient will come back to the hospital within 90 days (the new health care law creates financial incentives for hospitals to reduce their 90-day readmission rate). Based on the prediction, a high-risk patient at the medical center now might actually receive different care, such as being assigned post-care coordinator.

We’re going to build a health care system where complex models are firing on an almost day-to-day basis.

Eventually, there will be new kinds of data that can be put in mineable formats and linked to electronic patient records, from patient satisfaction surveys and doctors’ clinical notes to imaging data from MRI scans, Dudley says.

Right now, for example, the growing volumes of data generated from people’s fitness and health trackers is interesting on the surface, but it’s hard to glean anything meaningful for individuals. But when the data from thousands of people are mined for signals and links to health outcomes, Dudley says, it’s likely to prove valuable in understanding new ways to prevent disease or detect it at the earliest signs.

A major limitation to this vision is the hospital’s access to all of these new kinds of data. There are strict federal laws that govern patient privacy, which can make doctors loathe to experiment with ways to gather it or unleash it. And there are many hoops today to transferring patient data from one hospital or doctor to another, let alone from all the fitness trackers floating around. If patients start demanding more control over their own health data and voluntarily provide it to doctors, as Dudley believes patients will start to do, privacy could become a concern in ways people don’t expect or foresee today--just as it has on the Internet.

One thing is clear: As the health care system comes under pressure to cut costs and implement more preventative care, these ideas will become more relevant. Says Dudley: “A lot of people do research on computers, but I think what we’re hoping for is that we’re going to build a health care system where complex models ... are firing on an almost day-to-day basis. As patients are getting information about them put in the electronic medical record system there will be this engine in the background."

[Image via Shutterstock]

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Your Best Social Media Marketing Tool? Your Employees

Your Best Social Media Marketing Tool? Your Employees | PharmaSuccess | Scoop.it
“Do your employees know how to represent your company's brand on their own personal social media accounts? Here are a few tips for training your workers to be social media pros.”
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La guerre des start-up qui gèrent les RDV chez le médecin

La guerre des start-up qui gèrent les RDV chez le médecin | PharmaSuccess | Scoop.it
Elles s'appellent KelDoc ou MonDocteur et proposent des services inédits. Exemple: permettre à un malade de trouver un créneau qui se libère chez un praticien.
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Ne manquons pas le tournant de l'e-santé en France !

Ne manquons pas le tournant de l'e-santé en France ! | PharmaSuccess | Scoop.it
SANTÉ - Si nous voulons réussir le développement de l'e-santé dans notre pays, c'est un véritable tableau de bord de la santé qu'il faut savoir créer, un tableau de bord personnalisé qui rassemble toutes les données et aborde le champ de la...
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PharmaSuccess 2014 : Votez pour votre Start Up !

PharmaSuccess 2014 : Votez pour votre Start Up ! | PharmaSuccess | Scoop.it
EuroHealthNet's insight:

PharmaSuccess 2014 se déroulera le jeudi 20 mars 2014 au CNIT (Paris La Défense).

Centré sur les nouveaux enjeux, ce rendez-vous annuel des membres de l’industrie
pharmaceutique est une occasion unique d’information, de formation et d’échanges.
Cette année, plus de 500 participants sont attendus !
Lors de cette journée sera remis le Prix PharmaSuccess Start Up qui récompensera la Start Up
santé la plus innovante.
La Start Up gagnante sera sélectionnée par un jury de professionnels et par les votes des
membres de la communauté PharmaSuccess.fr.
À la clé, une grande visibilité par les acteurs de l’industrie pharmaceutique lors de l’événement
mais également sur le site internet PharmaSuccess.fr, et dans la presse spécialisée.

(fin des votes le lundi 17 mars 2014 à 17h)
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In-Depth: A brief history of digital patient engagement tools

In-Depth: A brief history of digital patient engagement tools | PharmaSuccess | Scoop.it
Without a doubt patient engagement is one of the more important trends in healthcare and health IT right now. Over the past few years the tools that look to enable patient engagement between providers and patients have changed markedly. It is important to note, however, that the tools themselves are just a small part of the story — they can go a long way toward improving patient engagement, though. The drivers of the patient engagement buzz are varied, but one big one is the federal government’s Office of the National Coordinator’s (ONC) Meaningful Use (MU) program, which is beginning to include requirements for very basic patient engagement services. ONC’s MU Stage II requirements include at least three patient engagement related deliverables of providers. To meet Stage II, providers must give patients clinical summaries after each visit. They must use electronic secure messaging to communicate with patients on relevant health information with a minimum of 5 percent of their patients during the review period. They must also provide patients with the ability to view online, download and transmit information about a hospital admission and give them access to any health information about that patient the providers receives — within four days of receiving it. Read more: http://mobihealthnews.com/29985/in-depth-a-brief-history-of-digital-patient-engagement-tools/
Via Parag Vora, Rowan Norrie, dbtmobile
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PharmaSuccess 2014 : BarCamp Club Digital Santé #hcsmeufr

PharmaSuccess 2014 : BarCamp Club Digital Santé #hcsmeufr | PharmaSuccess | Scoop.it

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Le mercantilisme menace les communautés de pati...

Le mercantilisme menace les communautés de pati... | PharmaSuccess | Scoop.it
Tribune. Un groupe de responsables d’associations de malades s’inquiète du détournement mercantile de réseaux conçus à l’origine comme des outils de démocratie sanitaire.
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mHealth apps that empower doctors | Government Health IT

mHealth apps that empower doctors | Government Health IT | PharmaSuccess | Scoop.it
  Despite the influx of apps and devices coming to market, the challenge of harnessing that data remains: Delivering information doctors want.    The developers of a new mobile testing kit for analyzing health information "at the molecular level" might be marketed to consumers, for instance, but such devices have strong val
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What Do Doctors Think Of Apple's HealthKit?

What Do Doctors Think Of Apple's HealthKit? | PharmaSuccess | Scoop.it
What do doctors think of HealthKit? This question was originally answered on Quora by Jae Won Joh, MD.
EuroHealthNet's insight:

Welcome in the era of patient centricity 

Antoine POIGNANT, MD

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Marisa Maiocchi's curator insight, July 2, 4:07 AM

Me parece una exageración solo para fanáticos del estilo de vida saludable. Una cosa es cuidar la salud y otra muy distinta es estar pendiente de parámetros vitales...  ¿Y qué de las horas que se dedican al trabajo, a la familia, a la recreación? ¿Y qué de emplear el tiempo en hacer cosas que nos gustan? ¿Vendrá con un medidor de felicidad o de alegría?

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e-Santé : évolution ou révolution ? un numéro s...

e-Santé : évolution ou révolution ? un numéro s... | PharmaSuccess | Scoop.it
e-Santé : évolution ou révolution ? un numéro spécial Egora diffusé à 100 000 professionnels de santé...
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Le contenu doit rester la priorité de votre stratégie de présence sur les médias sociaux - MediasSociaux.fr

Le contenu doit rester la priorité de votre stratégie de présence sur les médias sociaux - MediasSociaux.fr | PharmaSuccess | Scoop.it
Le contenu a toujours été une obsession, surtout dans le cadre des médias sociaux : pas de contenu, pas de conversation.
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Bilan économique des entreprises du médicament en 2013

“Bilan économique Leem 2013 - Les grands chiffres du secteur pharmaceutique (#PharmaSuccess Buzz : Bilan économique des entreprises du médicament en 2013 - … http://t.co/J8ruVyVEgY,...”;
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PharmaSuccess 2014 : 16h-18h > MeetUp #QuantifiedSelf Santé et données personnelles

PharmaSuccess 2014 : 16h-18h > MeetUp #QuantifiedSelf Santé et données personnelles | PharmaSuccess | Scoop.it
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BarCamp Club Digital Santé #hcsmeufr

BarCamp Club Digital Santé #hcsmeufr | PharmaSuccess | Scoop.it
EuroHealthNet's insight:

Durant PharmaSuccess 2014 aura lieu un

BarCamp Club Digital Santé sur les
10 commandements des réalisations en Santé Digitale

ce document sera disponible sur le site du Club et sur PharmaSuccess, à l'issue de l'événement.
L'avancement des travaux sera disponible sur cette page.

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Le vivant, nouveau matériel de l’innovation

Le vivant, nouveau matériel de l’innovation | PharmaSuccess | Scoop.it
Le vivant, nouveau matériel de l’innovation (#PharmaSuccess Buzz : Le vivant, nouveau matériel de l’innovation | InternetActu http://t.co/dMLuBsxWaw, see more
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PharmaVision 2014 Gagnez un iPAD mini et un an d'abonnement aux Echos ;-)

PharmaVision 2014 Gagnez un iPAD mini et un an d'abonnement aux Echos ;-) | PharmaSuccess | Scoop.it

Via Antoine POIGNANT, MD
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Antoine POIGNANT, MD's curator insight, March 8, 10:14 AM
Gagnez un iPad Mini
& 1 an d'abonnement aux Echos

#PharmaSuccess présente #ParmaVision l'enquête annuelle baromètre de la Pharma par ses propres acteurs.

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La #santé #connectée, une profonde mutation de la pratique médicale, n° spécial TLMFC

La #santé #connectée, une profonde mutation de la pratique médicale, n° spécial TLMFC | PharmaSuccess | Scoop.it

Via catherine cerisey, dbtmobile
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EuroHealthNet's curator insight, July 12, 7:17 AM

Au-delà des adaptations liées au marketing digital, c’est à une véritable rupture de business model que sont confrontés les industriels du médicament.


Les big players du web et du fitness ont tous développé des plateformes mobiles basées sur des données de santé ou de bien être : Apple HealthKitSamsung Digital Health InitiativeMicrosoft HealthVaultGoogle Android Wear & Google FitNike+.


Les laboratoires pharmaceutiques, à l’heure de la médecine personnalisée et du Quantified Self, semblent étrangement absents de ce nouveau champ.


Adaptation des organisations, digitalisation des services, (r)évolution de la relation client : où vont et où n'iront pas les laboratoires  ?

Rescooped by EuroHealthNet from Le monde du mobile et ses nouveaux usages : news web mobile, apps en m sante et telemedecine, m learning , e marketing , etc
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Quel bracelet connecté choisir ? | Comparatif | IoT

Quel bracelet connecté choisir ? | Comparatif | IoT | PharmaSuccess | Scoop.it
“ Le bracelet connecté est l'objet idéal à offrir ! Découvrez notre comparatif de 14 bracelets connectés pour faire votre choix.”
Via Clément Chanel, dbtmobile
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