August 2000 – The CenterWatch Monthly : Volume 7, Issue 8, August 2000

Blowing the Whistle on Investigative Sites

The FDA reports that the number of complaints received on investigative site failure to comply with GCP has increased tenfold since 1998.

Investigations of complaints have not historically resulted in high incidences of official actions and debarment. The recent climate of whistle-blowing, however, will bring a dramatic increase in FDA audit activity and higher numbers of official actions are likely.

Accounting for Embezzlement

July marks the anniversary of the date when the director of the Clinical Trials Office at the University of Wisconsin-Madison was charged with embezzling over $600,000 in clinical grant funding and with evading taxes.

Academic and independent sites discuss current accounting practices and describe what is being done to prevent these fraudulent practices in the future.

CentreStage Europe: Profiad Progresses

Although Profiad reports growing receptivity among sponsor companies, this U.K.-based site management organization is pursuing two key strategic initiatives designed to stimulate more rapid growth and ultimately high value in its initial public offering. In July, Profiad landed a contract worth a half million sterling for the whole U.K. arm of an international study. Profiad also recruited a financial director to help the company get ready for an IPO.

Eye On: Addictions: New Treatment Frontiers

Although the FDA has yet to approve drugs for treating addiction to substances such as cocaine, marijuana, inhalants or anabolic steroids, several treatments exist or are in the pipeline for alcohol, smoking and specific drug addictions. CenterWatch has identified 12 drugs in the clinical research pipeline for drug, nicotine and alcohol addictions with others in the pre-clinical phases. Approximately $40 million is spent annually to study the effects of these treatments on addiction.

• Month in Review
• Opportunities Underway
• TrialWatch