Protocol Complexity and Patient Enrollment Intensify Challenges in Oncology Trials, Says Tufts


Increasing complexity of clinical trials targeting cancer—including use of more sophisticated scientific designs, larger global scope, and greater focus on highly targeted patient subpopulations—have intensified the challenges in executing those trials, a newly completed analysis by the Tufts Center for the Study of Drug Development concludes.

From 2000 to 2020, the number of investigational treatments targeting cancer has nearly quadrupled, from 421 to 1,489, according to Tufts CSDD. At the same time, Phase II-III oncology trials, compared to trials for other drugs, makes it more difficult to find, compete for, and enroll patients.

Study results, highlighted in the May/June Tufts CSDD Impact Report, recently released, included the following:

  • Clinical trial durations of oncology drugs are 30%-40% longer than other drug trials, due to more complex designs and difficulty finding, enrolling, and retaining study volunteers.
  • Screening and treatment durations are much longer in Phase II and III oncology trials, compared to other drug trials, but mean study start-up times are shorter in Phase III.
  • Oncology trials generate a much higher volume of data, particularly in Phase II protocols, compared to other drug trials.
  • Phase II-III oncology trials, compared to trials for other drugs, have more protocol deviations and generate more substantial protocol amendments.

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