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Case Study # 4: Competing Enrollment

As the criteria for patient enrollment in a clinical trial become more stringent, patient pool becomes limited. Consequently, companies are coping by ensuring that the number of participating sites increase – sometimes through increasing the number of participating countries. This leads to a scenario of competing enrollment. TMI has participated in both, international competing requirements (where TMI manages the Indian sites competing with the International sites) as well as within country competing requirements (where more than one Indian CRO is contracted).

In our experiences, clients that follow this strategy have often not included India in their early clinical development plans. After worldwide recruitment has become a limitation, the client has though of India as a rescue mechanism. Although we see an increasing number of clients including India in their clinical development plans, we strongly advocate that at least a few Indian sites be opened as early on in the trial as is possible. Whenever TMI has participated in a competing study, our recruitment rates have been the highest. More importantly, our projected rates have always been achieved, allowing clients to develop a very realistic clinical development plan in India.