RESEARCH TRIANGLE PARK, N.C.--(EON: Enhanced Online News)--Phase 2 trials almost always see an increase in patient enrollment over Phase 1 trials, found a recent Cutting Edge Information study.
“Patient recruitment has always been, and may always be, a key struggle for clinical teams.”
The study “Oncology Clinical Trials: Drug Development Resources and Case Studies” discovered that while not nearly as large as Phase 3 enrollment, Phase 2 trials often require more than 100 patients — and sometimes many more — to complete.
Surveyed pharmaceutical companies revealed that the Phase 2 trials’ actual enrollments average 121 patients. “Not surprisingly, the actual number of patients enrolled does not equate to the number of planned enrollments,” said Ryan McGuire, research team leader at Cutting Edge Information. “Patient recruitment has always been, and may always be, a key struggle for clinical teams.”
The planned and actual enrollment levels studied range from limited (10 patients) to large (300 patients) for Phase 2 trials. Interestingly, only 43% of pharmaceutical companies that provided data hit their goals — demonstrating the difficulties associated with patient enrollment. The data show that a relationship certainly exists between enrollment and costs. Costs steadily increase as the number of patients needed rises (with only a few exceptions). In fact, the correlation coefficient of .86 indicates that patient enrollment is a very strong predictor of Phase 2 total trial costs.
Further breakdowns of this data show that Phase 2 trials with 100 or fewer patients cost an average of $4.9 million. Trials with 101 to 199 patients cost an average of $7 million. Finally, trials with more than 200 patients increase in cost tremendously — with an average of $25.7 million.
“Oncology Clinical Trials: Drug Development Resources and Case Studies” (http://www.cuttingedgeinfo.com/research/clinical-development/oncology-clinical-trials/) details oncology clinical development data, including specific best practices and strategies for allocating Phase 3 clinical development resources. Drug companies that manufacture oncology medicines can use this report to:
- Explore areas of higher activity for different types of cancer drug development.
- Determine the per-patient cost and other critical cost drivers for different types of oncology clinical trials.
- Compare the predicted and actual patient enrollment metrics of 30 oncology clinical trials from Phase 1 to Phase 3.
For more information about clinical research associate benchmarks, contact Cassie Demeter at 919-403-6583.