FDA Seeks Input on New Technology for Conducting Clinical Trials

Last October saw the publication of a request for comments from the FDA on new technologies and methods for conducting clinical trials.

As clinical trials continue to evolve, the FDA wishes to identify new opportunities to study investigational products and to gain insight into barriers, challenges, and other relevant considerations that may affect the clinical investigation of drugs using such technologies and methods. On the technology front, mobile technology and remote data capture seems to be an area of specific interest.
To pick an example – today subject recruitment still remains a bottle neck in clinical trials. Recruitment windows remain open for long periods (generally in the order of months) and most trial sites fail to recruit target numbers on time.

The irony of the situation is that out there in the community, there are more than enough patients willing to join a clinical trial, and the chasm is simply finding and connecting with these patients. A glimpse of the future perhaps, was seen with Apple’s ResearchKit studying a variety of indications, with blistering recruitment rates. Other players are getting in on the action including the recent announcement from ICON plc on their collaboration with IBM Watson which will enable matching of suitable patients for oncology trials.

In the past few decades, various ‘add-on’ features have been incorporated into classical clinical trials. In the near future however, we expect to see non-incremental advances in this space, perhaps even with the emergence of a radically new approach taking over from the current broken business model.
What the FDA will do with the feedback remains to be seen. Regulators do however have a challenge ahead to enable this emerging technology to be adopted and result in tangible advances in clinical trials. The FDA docket can be accessed here.

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About the Author
Gemma Robinson, PhD
Managing Director
As Managing Director of Acorn Regulatory, Gemma Robinson is actively involved on client projects on a day to day basis and she leads a team of respected pharmaceutical, medical device, pharmacovigilance and clinical trial experts.  Gemma is also an active contributor to developing and promoting standards in the regulatory affairs profession and she has worked with a number of academic and not for profit organisations to encourage individuals to pursue a career in regulatory affairs and the broader STEM subjects. You can read more articles by Gemma by clicking the link below.
Other articles by Gemma Robinson PhD