Innovative approaches to collaboration, making more use of big data and mobile apps and increasing transparency for clinical trial data. Those are some of the 10 trends highlighted by the Drug Information Association that will play a big role this year across the pharmaceutical, biotechnology and medical device industries.
Pharmaceutical companies have been showing an interest in more creative collaboration models, not just with universities such as University of Pennsylvania, Vanderbilt University and the University of California, San Francisco, but also with each other that’s different than the typical strategic partnerships. The launch of Transcelerate Biopharma in September last year was something altogether new. Based in Philadelphia, it includes at least 10 Big Pharma companies collaborating on research and development with a goal of bringing down drug development costs. Each member contributes funding and staff from their research and development divisions. The idea for the nonprofit originated from the Hever Group, a forum for pharmaceutical executive R&D leadership to talk about issues facing the industry.
There’s also public-private partnerships like the Target Validation Consortium between the National Institutes of Health and the pharmaceutical industry. It was developed in 2011 in response to the high attrition rate in late-phase clinical trials. It focuses on collaboration at the “precompetitive stage” to improve the ability to translate new discoveries into clinically useful products, according to the NIH’s website.
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Mobile applications to improve patient recruitment for clinical trials can be facilitated and has been a growing area of interest for drug developers and medical device companies. It can also help with remote monitoring as participants would not necessarily be restricted by geography. The U.S. Food and Drug Administration’s green light for Transparency Life Sciences to use remote monitoring in a clinical trial was a significant development that showed regulators are accepting these tools.
DIA believes this will be the year that clinical trial data will get greater transparency. Why? GlaxoSmithKline has said that it will share its clinical trial data publicly in an effort to restore public trust following its costly $3 billion settlement for promoting two antidepressant drugs — Paxil and Wellbutrin — for unapproved uses, and withholding safety data for its diabetes drug, Avandia, from the FDA. Last year, the European Medicines Agency said it wanted to create a plan to release clinical trial data. In April, it is scheduled to get feedback on issues that could affect that decision such as protecting patient confidentiality, clinical trial data formats, rules of engagement and legal considerations. It plans to initiate a policy of proactively publishing clinical trial data at the start of 2014, according to its website.
Here’s the complete top 10 list:
- New Models of Innovation
- The Continued Rise of Patient/Consumer Empowerment
- Learning How to Utilize Big Data
- Achieving Market Access is the New Goal
- Regulatory Cooperation and Convergence
- Personalized Medicine/Tailored Therapies and Companion Diagnostics
- An Explosion of Mobile Health Applications
- Continued Importance of Global Markets
- Clinical Trial Data Transparency
- Growing Ability to Make Meaningful Benefit-Risk Assessments
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