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Quantifying the magnitude and cost of collecting nice-to-have clinical trial data


*Corresponding author
1. Tufts University, 75 Kneeland Street Ste 1100, 2111, Boston, USA
2. Medidata Solutions, 748 Irving Terrace, Orange NJ 07050, USA


In 2013, Getz et al demonstrated that biopharmaceutical companies are implementing protocol procedures that do not support the primary and key secondary endpoints of the clinical study.  The research results indicated that between 18% and 24% of all procedures supported supplemental secondary, tertiary, exploratory or no (i.e. non-core) endpoints.  More granular information about non-core procedures, however, was not collected in the 2013 study.  That study also did not assess whether those procedures supporting primary endpoints were collected excessively.  As a follow-up, between June and October 2013, the Tufts Center for the Study of Drug Development conducted a study among a working group of eight pharmaceutical companies in which a total of 11,923 individual protocol procedures were analyzed. Results indicate that 36.0% (standard error 5.1%) of all procedures supporting non-core endpoints cannot be tied to a specific reason for being in the protocol.  1.4% of all procedures collected to support core endpoints are collected in excess.


In the last five years, the biopharmaceutical industry has adopted a more patient-centric approach to drug development (1).  Many proposed initiatives supporting patient centricity involve streamlining the clinical trial protocol to include only those procedures essential to the successful completion of the trial(2).  Companies are assessing new methods to create more streamlined and patient-friendly clinical trials.  One such approach includes reaching out to patients and patient-advocacy groups to help design the clinical trial protocol. Other approaches include employing adaptive trial and pragmatic trial designs (3) and conducting facilitated clinical trial protocol reviews (i.e., cross-functional department representatives vetting the clinical trial protocol, to improve executional feasibility)(4).

Currently, studies suggest that protocol complexity is not improving.  In 2015, Getz et al demonstrated that although 57% of clinical trial protocols have one substantial amendment, as compared to 69% in 2010, the number of avoidable amendments was greater in 2015 (5).  Addition ...

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