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International Clinical Trials
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Innovative health technologies are moving fast and have successfully found their way into clinical trials. Digital devices, wearables, sensors, and apps have the potential to serve multiple purposes in clinical research and, in an increasing number of cases, have become a central part of patientfocussed clinical trial development (1-11). A major part of the discussion around the appropriate use of technologies in clinical research, and the recommendations and guidances published by regulatory agencies and other organisations, have focussed on the use of mobile and other digital devices as unique or combination products throughout the duration of the clinical trial (12-15). However, not much (if any) attention has been paid to the potential use of these devices during the often long timeframe between the end of a trial, final regulatory approval, and broad market access.
The use of advanced technologies in healthcare have rapidly increased over the past few years, and, as a result, a growing number of patients are enrolled in clinical trials that use these technologies as part of the researched treatment or to track treatment progress. To stay abreast of these developments and be prepared for responsibility concerns arising down the road, sponsors will have to start considering what happens to the patient once the trial ends. Will patients be able to continue using these technologies or will their access be eliminated? How can clients be best transitioned to other support offerings post trial?
To become truly patient-centric, clinical trial development will need to increasingly incorporate post-trial plans for the continued use of devices, tracking mechanisms, and apps that are beneficial for patients.
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Dr Jennifer Riggins, a DIA Fellow, has extensive experience in the fields of medical affairs, medical information, medical communications, and digital capabilities. She currently serves as Advisor of Global Medical Digital Strategy and Capabilities at Eli Lilly. She has responsibility for global digital strategy development, creating and implementing impactful medical digital solutions, and understanding and shaping the external environment as it relates to medical affairs and digital. Jennifer graduated with her PharmD from Butler University College of Pharmacy, US, and has been at Eli Lilly for 25 years.
A biologist by training, Dr Sandra Blumenrath serves as science writer for DIA. Sandra brings extensive experience in scientific research, education, and communication to her role at DIA, where she produces scientific and healthcare-related content for a variety of audiences. She graduated from the University of Copenhagen, Denmark, and earned her PhD at the University of Maryland, College Park, US. Prior to joining DIA, Sandra worked as a scientist, educator, and content developer at the University of Maryland, the Howard Hughes Medical Institute, US, and the American Association for the Advancement of Science.
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Dr Jennifer Riggins |
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Dr Sandra Blumenrath |
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10th Annual Summit for Clinical Ops Executives
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