April 2000 – The CenterWatch Monthly : Volume 7, Issue 4, April 2000

IRBs: Facing a Crackdown

OPRR and FDA scrutiny of institutional and independent IRBs has intensified and is likely to increase this year.

Nationwide, IRBs are responding by increasing headcount, resources, training and SOPs. The costs for this response likely will come from institutional overhead rates and from increased fees to industry sponsors.

Another Setback for CROs: Strained Relations with Euro Sites

Facing volatility in a maturing U.S. market, CROs look to Europe for higher levels of growth in contract clinical services.

Unfortunately, relationship quality between European sites and CROs is marginal and has declined over the past two years. Problem areas include poor levels of CRP staff professionalism and unrealistic project timelines and patient enrollment goals.

CentreStage Europe: Common Time Frames for U.S. and European Drug Approval

The European Agency for the Evaluation of medicinal Products (EMEA) has implemented a centralized drug approval process for 15 member countries. The EMEA has matched the U.S. Food and Drug Administration (FDA) average drug approval times.

Tufts Center data suggest that the EMEA has succeeded in meeting its goals in all categories except the time the Committee for Proprietary Medical Products (CPMP) takes to prepare the assessment report before sending the drug dossier to the EC for final approval.

Eye On: Leukemia

CenterWatch estimates that at least $200 million will be spent on developing leukemia drugs in 2000, with 35 drugs in the clinical pipeline. Clinical trials are being conducted on new drugs, new drug combinations and new schedules of chemotherapy. Scientists are also studying ways to improve bone marrow transplantation. There are four major types of leukemia that affect both adults and children.

• Month in Review
• Opportunities Underway
• TrialWatch