• Results of the recent CenterWatch survey of sponsor-site relationship quality show that GlaxoSmithKline, Merck, Biogen, Pfizer and Eli Lilly are the top five companies rated by the investigative sites with which they work.
• Overall, however, the quality of sponsor relationships with investigative sites has declined since we last conducted our survey two years ago. Most sponsors appear to be failing to support those factors the sites consider to be most essential to study success.

Article 222: FDA Complaints Against Investigative Sites Still Rising

• FDA reports that the number of complaints filed against investigative sites for failure to compy with GCP in 2000 were 10% higher than the unprecedented number filed in 1999.
• Compared to routine inspections, the FDA finds more serious violations of compliance with GCP when it investigates formal complaints. As an additional quality assurance practice, the agency is increasing its inspections of CRAs.

• At the beginning of 1999, the young European site management organization (SMO) market was still hoping to prove itself to sponsors unfamiliar with or skeptical of the SMO concept. At present, some SMOs have been weeded out, others have put down roots, hardened by the difficulties that 1999 posed for the clinical trials industry, and still more have sprung up. Most SMOs can provide examples of more strategic use by sponsors. All have reached the conclusion that a Pan-European SMO is necessary. It has become apparent that alliances and acquisitions will be the way to form such an enterprise instead of the organic growth that the SMOs had previously pursued.

• Ovarian cancer is currently the fifth leading cause of new cancer cases every year. It is also the fourth leading cause of cancer-related deaths. The high mortality rate associated with the disease is in part due to the fact that detection of ovarian cancer usually occurs at an advanced stage (75% of all cases). Directions in research into ovarian cancer are largely focused on genetic modalities, since there seems to be a strong genetic component to this disease. CenterWatch Drug Intelligence identified 34 drugs currently in the clinical pipeline for ovarian cancer and estimates that between $170 million and $175 million will be spent on development.