Novel Methods and Technologies for 21st-Century Clinical Trials

“New technologies are rapidly reshaping health care. However, their effect on drug development to date 1459F243510565C0D9F22F2E131324C7generally has been limited.” A recent article in the Journal of the American Medical Association (JAMA) Neurology highlights a literature review completed by a  team of URMC researchers led by Dr. Ray Dorsey, including CTSI Co-Director Karl Kieburtz. Dr. Dorsey is an Associate Director of the CTSI, and was formerly a CTSI Career Development Scholar.

The objective of the review was “…to evaluate disease modeling and simulation, alternative study design, novel objective measures, virtual research visits, and enhanced participant engagement and to examine their potential effects as methods and tools on clinical trials.” The article entitled “Novel Methods and Technologies for 21st-Century Clinical Trials: A Review” appears in the May 2015 edition of JAMA Neurology. The team conducted a systematic search of relevant terms on PubMed, references of previous publications, and private files. The search encompassed articles published from January 1, 2000, through November 30, 2014, and produced 7976 articles, of which 22 were determined to be relevant and were included in this review.

The review uncovered that “Few of these new methods and technologies have been applied to neurology clinical trials. Clinical outcomes, including cognitive and stroke outcomes, increasingly are captured remotely. Other therapeutic areas have successfully implemented many of these tools and technologies, including web-enabled clinical trials.” The team concluded that “Increased use of new tools and approaches in future clinical trials can enhance the design, improve the assessment, and engage participants in the evaluation of novel therapies for neurologic disorders.” Click here to read the full article.

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