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Challenging the Practice of Competitive Enrollment

The majority of clinical trials use competitive enrollment programs that penalize under-enrollers and offer financial bonuses to over-enrollers. There is limited proof that this strategy has improved patient recruitment effectiveness. Industry professionals are increasingly concerned that competitive enrollment practices compromise study design, pose ethical dilemmas, harm the viability of investigative sites operations, and tarnish the image of clinical research among the general population.

A Turning Point for Pharmacogenomics

An estimated 36% of all clinical trials now involve a genetic testing component and numerous industry alliances are driving adoption. Pharmacogenomic information is being used to refine study design, improve safety and data quality, and better target patient recruitment. The U.S. Food and Drug Administration last month issued a draft guidance detailing the use of pharmacogenomic data in clinical trials. This guidance is expected to accelerate the development of personalized medicine.

Also in this issue:

• Can a trans-European SMO Succeed?
• Eye on: Lung cancer