In April, we reflected on long term data management opportunities with Henrik Nørgaard Rasmussen, reviewed current use examples of social media in clinical trials and kicked off our exploration of the drug development landscape in China. We will be at Clinical Trials Sans Frontieres in London on May 14th - please say hello if you are attending. Got feedback on our research? Contact firstname.lastname@example.org.
The potential is huge; but until very recently, physicians have been largely unable to take full advantage of what these connections have to offer. Specifically, the Health Insurance Portability and Accountability Act (HIPAA) of 1996 prevents doctors from using email or text messaging, much less open platforms like Facebook or Twitter, to communicate about patient care without risk of being fined or fired.
Still, the potential for physician-focused, web-based networks is huge, and HIPAA-compliant tools and sites have indeed started to take shape and populate.
Healthcare itself has been (often rightly) criticized as slow to change. In fact, Dr. Leslie Saxon recently published an insightful article on why the Internet hasn’t yet had any real impact on how medicine is practiced.
But research has shown that as far as technology goes, doctors themselves have proven to be early adopters. Having seen the kinds of conversations that have already begun to take place, I strongly believe that the future of digital medicine will be anchored in these kinds of connections.
29 March 2011 – Specialist global Contract Research Organisation (CRO), Phlexglobal has today announced it has completed a private equity-backed management buyout (MBO).
The deal with mid-market private equity investor, Inflexion Private Equity, will allow the company to further expand its provision of clinical trial support, a significant part of which is the management of global trial master files (TMF), both paper and electronic. The recent launch of version 3 of PhlexEview, the company’s eTMF solution, will underpin this growth.
The Phlexglobal management team remains largely the same with Phlexglobal’s former financial director, Stella Donoghue, moving into the role of managing director and Karen Redding remaining as global business development manager. They will be joined by technical director, John Lazenby and Sarah Tucker, who has been internally appointed as director of eTMF operations.
Effectively responding to the challenge of patient recruitment and retention requires clinical trails’ teams to have a deep understanding of the issues, hurdles and opportunities facing patients considering their involvement in a trial. Social media, including YouTube, offer trial teams a means not just to raise awareness of the trials themselves but also to discover what matters most to patients as they consider joining or remaining with a trial. It offers not just a means to learn from patient preferences for trial involvement but also crucially to engage directly with them and to use this intelligence to improve the trial process.
However, a note of caution is required. The real value of content on social media is that it is created by individuals for individuals. Participation from representatives of commercial organisations can be viewed with scepticism. Trails teams will need to carefully consider their information policy, content and ‘voice’ to ensure their social media efforts are successful.
We always look forward to the publication of a new TouchBriefings. The British firm's projects delve a bit deeper. TouchBriefings addresses the knottier questions facing the industry. Visually, its articles resemble those in a peer-reviewed journal.
Late in 2011, a publication from the TouchBriefings team was dedicated to one topic, the increasingly pivotal clinical trial management system (CTMS). The TouchBriefing editorial package includes an interview with Christopher Heider, who is a director of IT for Merck's research effort.
Don't hold us to this. The details are few. But it sounds as if the new team at Merck pulled together its own people and folks from Schering and Organon, which Schering had acquired. They decided to make a gradual transition away from Parexel's Impact CTMS and toward Oracle's Siebel CTMS.
Having said that, there are no additional details on exactly how trials are migrated from two huge, customized CTMS to a third. Could Merck projects continue to use Parexel's system? When Parexel is helping on a Merck trial as a contract research organization (CRO), will its employees be obliged to use a competitor's CTMS? Did Merck consider any alternatives to Oracle and Parexel, or is it game over for small CTMS suppliers?
The article skirts the most daunting question facing big pharma's IT strategists. Are some large drug, device and biotech companies so large that it is no longer possible to merge their clinical trial systems? Combining financial and manufacturing systems is easy. Is clinical research the same? Just as some global banks are too big too fail (TBTF), are some firms running modern clinical trials simply too big to integrate (TBTI)? Who can say?
DIA 6th Annual Clinical Forum 8th – 10th October, The Hague The DIA Clinical Forum is widely recognised as the only European conference that brings together industry thought leaders across the key disciplines of data management, clinical operations, drug safety and medical communications. Professionals from pharmaceutical and biotech industry as well as CROs, clinical trial sites, health regulatory agencies and delegates from patient organisations will discuss Clinical Data Management/eClinical, Clinical Operations, Clinical Research, Clinical Safety and Pharmacovigilance among others. More info here.
Second time around.. This was the second year goBalto attended Partnerships in Clinical Trials. The event was held in sunny Orlando, Florida, and decided to walk the floor rather than have a booth.
We reconfirmed that sponsors, CROs and sites have a specific pain and the pain begins with study startup. We got great feedback and interest from professionals that have seen us and want to learn more.
Florida was great. The weather was great. Over all we consider it a great event when professionals congregate to contribute to make clinical trials better.
Come look for us at our next conference DIA 2012. We’ll have a booth there.
The current list of partners is representative of the community addressed by CALLIOPE and it comprises its constitutional membership, however the Network will continue to expand and involve more members as it is established. Although the current partnership is representative of a significant number of countries and stakeholder groups, it does not exhaust the membership of the network, which shall continue to expand and involve more members after it is established. CALLIOPE welcomes further representation from such organisations.
Index Ventures may be best known on these pages for its technology investments, but today it launched a new fund that points to how the company is willing to put its money into other examples of strong innovation. The life sciences fund will see Index put in $100 million of its own capital, and have it matched by $50 million each from big pharma leaders GlaxoSmithKline and Johnson & Johnson.
Mobility and convenience lower barriers to participation, increase ease of staying the course. Earlier we wrote about how mobile apps will drive self service. We expect this to change the way investigators and monitoring staff engage patients, and more importantly, how data collection and verification is executed.
More information to the patients and more data from patients will add pressure on data management teams. We expect the more informed and participative patient to demand seamlessness between health records and trials engagement. The data harmonisation agreement between CDISC and IMI is an important starting point to address this emerging imperative.
Drug companies world-wide are under pressure. The rise of generics, looming patent expirations and the expanding innovation gap are creating cost pressures from every direction. Could outsourcing R&D be one way to ease the pain?
In a significant report by leading advisory and consulting services firm PriceWaterhouseCoopers (PwC), the company evaluated countries in the region on cost, risk and market opportunity for the pharmaceutical industry. The resulting index placed China as the top location for outsourcing in the region followed by India, Korea, Taiwan and Singapore. The PwC report also highlights three significant developments shaping Asian pharmaceutical outsourcing and impacting the industry as a whole:
The trend towards high-end innovation – this is being driven in particular by increases in drug development investments in Asia by the large pharmaceutical firms. The rapid expansion of clinical trials in Asia — with much lower clinical trial costs, for example India is estimated to be up to 50% cheaper compared to the U.S., the volume of clinical trials conducted in Asia has grown rapidly. A scaling up of pharmaceutical manufacturing in Asia — with an increased commitment to international standards, Asian contract manufacturing organisations (CMOs) are securing more outsourcing orders from big pharmaceutical companies. Again, in India, for example, there are more than 100 FDA-approved pharmaceutical facilities; the largest number in any country outside the U.S.
14th and 15th May 2012, Grand Connaught Rooms, London Covers the practicalities of conducting clinical research in a global environment while questioning the extent to which foreign data can truly underpin local decisions on prescribing and reimbursement. Virtual research, medical devices and European collaboration plus members competing for research training fellowship and clinical research Team Challenge awards.
NEWDIGS is a unique collaboration for transforming the global healthcare innovation system to deliver greater value to all stakeholders and to ensure its sustainability.
NEWDIGS activities are structured into discrete modules, each focused on a specific area of innovation. Within each module, scalable programs are undertaken that combine real-world demonstration projects involving R&D pipeline assets from participating companies with research in science, engineering, management, and clinical medicine, led by MIT and the Harvard-MIT Division of Health Sciences and Technology. Each demonstration project is evaluated for success in terms of specific measurable improvements, while also informing the design of a future, better innovation system. The tight coordination between research and demonstration projects within NEWDIGS enables rapid cycle learning and the generation of rigorous evidence designed to provide a strong foundation for redefining the healthcare innovation system.
PR: Isn’t flexibility a good thing? HNR: Normally, yes. But there are so many downstream benefits that are being missed. Take for example pharmacovigilence practices that drive need to have control over all data throughout the life of a drug. Or breakthroughs from using previous trial findings as background for new studies. Both these examples show long term value providing the basics are in place. This is why more progressive sponsor organisations are investing to put in place better data governance, and spending time to understand sustainable metadata schemes.
PR: It does sound like the long term benefits are compelling. What is stopping more sponsor teams drive towards this? HNR: I wouldn’t say it is being stopped; rather, we are seeing a changing landscape and sponsors are responding at different paces. Those further ahead in thinking about long term needs are implementing data governance and internal standards. This is more than a technical discussion. Trials managers need to support standards and motivate trials operations teams to comply. The underlying challenge lies in incentives. Most trials teams’ performance management focuses on specific trials. The benefit of data governance goes well beyond any individual trial. This apparent conflict in priorities must be resolved.
As study sponsors and trail managers determine the role of IT in supporting their clinical trials and aim to improve on their previous study outcomes, they have to do this whilst also juggling potential recruitment and/or retention staff issues , multiple trials at different stages in trial lifecycle and management of different CRO partners, potentially under varying contract relationships. Implementation of IT in trial conduct therefore has to be flexible. One such flexible IT approach has been taken by ICON. The company is a global CRO for the pharmaceutical, biotechnology and medical devices industries and offers its clients both an ‘a la carte’ menu of technology solutions and an integrated technology solution. ICONs individual but connected product suite consists of:
ICONPhone – platform for delivery of voice and web response services (IVR and IWR) ICONPhone ePRO – application offering real-time access to and fast validation of patient data ICON MIRA – ICONs medical image review and analysis system IKE – an image based knowledge management portal providing access to study data and tools ICOSpeedRead – an independent image review system to quickly get the image review process up and running. ICON IMRA – ICONs medical review application is a web based laboratory tool providing 24/7, global access to laboratory data on a client’s study. PDxPOP – a software tool for speeding up iterative process of pharmacokinetic population modelling and analysis
Clinical trial managers continue to face pressure to dramatically reduce costs while increasing productivity. The potential to embrace transformational change requires clear understanding or options, drivers and barriers. During the Summer of 2011, we embarked on a study to examine how aspirations for the role of IT in clinical trials has changed. We wanted to also assess why the persistent a gap between aspirations and achievement prevail.
The insights that have surfaced from this study suggest several opportunities for clinical trials teams, their sponsors, data managers and IT advisors to improve. The overwhelming focus from study sponsors and trial operations teams is towards the patient eco-system, while IT and data support teams struggle with poor analytics and fragmented investments. The full report is available for download here.
An expert panel today called for creating a massive data network that would combine cutting-edge genomic and molecular data on patients' diseases with their routine medical records. Such a database would be a boon for research and help move medical care into the era of "precision medicine," the panel says.
The National Research Council panel was formed last year at the request of the National Institutes of Health (NIH) to consider how the more than 100-year-old system of disease classification should be changed to reflect insights from molecular biology. But the committee decided that "our challenge is bigger," said panel co-chair Susan Desmond-Hellmann, chancellor of the University of California, San Francisco, at a press briefing today. Instead of a new classification, the nation needs a live network of data on individuals' molecular tests and health records. This system would be used to develop a new disease taxonomy and personalize medical care, according to the 108-page report, titled Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease.
Digital patient engagement is a growing focus for many industry players. One such company is Quintiles. In January this year, Quintiles announced the formation of a new Digital Patient Unit, bringing together the company’s investment in two online communities (MediGuard.org and ClinicalResearch.com) and its growing digital expertise to directly engage patients for its clinical research trials. Recognising the dominant influence of the empowered patient and the increasingly competitive marketplace for patient recruitment services, the new Digital Patient Unit will provide both high quality content to patients and a clear channel for its customers to reach appropriate patients with highly effective and efficient research study communications. In particular, MediGuard represents a very significant asset for Quintiles with a patient database of 2.5 million users; it provides patients with a free medication monitoring service including safety alerts, drug recalls and checks for possible drug interactions.
to ensure companies can keep meaningful metrics in place, and by inference meaningful relationships in place, organisations need to evolve their FSP (Functional Service Provider) model, learning from mistakes, sharing good practice and trialling new processes. One such company that has made rigorous efforts to introduce and maintain meaningful metrics at the centre of its outsourcing relationships is Pfizer.
The Clinical Outsourcing World conference last week was a vibrant, collegiate event with frank and open discussions. Over the next few weeks, we will profile individual presentations and panels. For now, I’d like to review a few startling declarations at the opening panel.
With effective facilitation by Trevov Jones, former Director General of the Association of the British Pharmaceutical Industry (ABPI), we heard from Paula Gildert, Head Strategic Sourcing Development at Novartis Pharma AG, Finnuala Lonsdale, Global Director at AstraZeneca, David Kim, Head Vendor Strategy and Management at Merck & Company and Dr Jeffrey Kasher, Vice President at Eli Lilly