Decluttering Your Protocol

Marie Kondo is a “decluttering” expert who has made cleaning out the garage the hippest thing since brewing beer in the basement. Kondo’s international bestselling book, The Life-Changing Magic of Tidying Up: The Japanese Art of Decluttering and Organizing, shows us how to simplify our lives, closets, and junk drawers by applying one basic principle: anything that doesn’t “spark joy” or isn’t absolutely necessary should be discarded (Kondo asks us to first touch and thank the items, then bid them adieu). Following the “KonMari” method, readers are taught that instead of deciding what to dispose of, focus on what to keep. Kondo likens the decluttered house or apartment to a Shinto shrine…”a place where there are no unnecessary things, and our thoughts become clear.”

Researchers at the Tufts Center for the Study of Drug Development (Tufts CSDD) were early proponents of the declutter movement. Back in 2007, I attended a presentation on behalf of the medical writing group of a mid-size pharmaceutical company where I was consulting. The speaker presented results from a Tufts CSDD study that evaluated protocol design trends over a 6-year period, which showed that sponsor companies were collecting an ever increasing amount of clinical research data. The growth and complexity of data collection resulted in more expensive clinical studies that were more burdensome on project teams, site personnel, and patients, and most importantly, did not produce better outcomes. Rather, the complexity adversely affected data reporting and collection and thus overall trial performance. I returned to work the next day and shared this information with my medical writing colleagues and we disseminated it to our project teams with evangelical zeal, envisioning the vast improvements in study design and significant cost savings our newfound information would reap. Years later, however, the unfortunate trend in cluttered protocol design continues.

A 2014 follow-up study by Tufts CSDD observed that while sponsor companies made improvements in the execution of clinical protocols and now place a greater emphasis on prospective study feasibility, they are still collecting large amounts of complex data that are associated with neither primary nor key secondary endpoints, nor are required by regulatory agencies. I was reminded of this recently when I worked on a clinical study report for a phase 3 protocol that contained more than 20 endpoints! The reasons for data hoarding are understandable: drug development is costly and companies are hard pressed to complete studies at a record pace to keep up with the competition; sponsors want to get the most out of each study and believe that when it comes to data collection, more is more. We are an industry driven by data, and when the data demonstrate that better study results can be achieved by means of streamlined study design, we need to pay attention. It’s time to make the clinical protocol a place where there are no unnecessary things, a place where our thoughts can become clear, and where life-changing therapies can develop.

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