Marking International Clinical Trials Day 2016

James Lind Treatise on ScurvyInternational Clinical Trials Day takes place each year on May 20, commemorating the day in 1747 on which James Lind started his controlled trial of scurvy treatments. Health Decisions marked the day internally by celebrating our own project managers, clinical trial leads, clinical research associates, in-house clinical research associates, clinical trial assistants, biostatisticians and other clinical research professionals. These are the people whose professionalism enables us to conduct clinical trials for drug, IVD and medical device sponsors with high quality and efficiency, resulting in timely delivery of improved treatments and diagnostics to healthcare professionals and patients worldwide.

The James Lind Library

Citrus Fruit Slices US Agricultural ServiceInternational Clinical Trials Day is also an occasion to visit the James Lind Library. The libary’s online resources make it easy and enjoyable to explore the history of clinical research, which is replete with stories that not only show progress in clinical research but also failure of the healthcare establishment in many eras to accept and take full advantage of lessons learned. To take one example, imagine how the history of medicine might have changed if the medical profession had accepted al Razi’s contention in the 10th century that a control group was necessary when testing new treatments.

Looking Forward: Openness to Methodological Innovation Now

The point of this observation is to open eyes to potential methodological advances that may be underappreciated now. The leading contenders for the honor of underappreciated advances may be adaptive trial design and Bayesian statistics. In view of the increasing importance of testing treatments intended for small populations, whether patients with rare and orphan diseases or biomarker-defined subpopulations of chronic diseases, this is a time for open consideration of new methodologies and regulatory regimes.

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