November 2006 – The CenterWatch Monthly : Volume 13, Issue 11, November 2006

Investigator Certification Catching On

A recent Thomson CenterWatch survey underscores the importance of training investigators to encourage trial participation. Of the more than 7,300 physicians surveyed, only 25% had undergone any formal training in clinical trials. Of the roughly half of physicians surveyed who had not participated, 92% had not received any training, while the number drops to 57% for those who had participated. A trend is building toward increased investigator education. The certification programs of the Drug Information Association (DIA), the Association of Clinical Research Professionals (ACRP) and the Academy of Pharmaceutical Physicians and Investigators (APPI) are now consolidated under the ACRP name and aligned with ACRP's well-established certifications for coordinators and monitors. ACRP's goal is to become the industry standard for investigator certification.

Back to the Future for CRAs

Some industry observers have long predicted that technology will ultimately replace the role of the study monitor. That has yet to happen. Instead, technology has helped expand and change the CRA’s role in clinical research for both regional and central monitors. CRAs have seen their role shift due to the nearly universal adoption of the regional field monitor structure among major pharmaceutical companies. Investigative sites consistently have rated the quality of CRAs as one of the top five most essential factors contributing to study success, according to Thomson CenterWatch data.

Europe Firms Up Flexible Trial Guidance

Interest in adaptive clinical trials is gathering pace as the pharmaceutical industry recognizes their potential. University researchers first suggested ways to change study protocols—yet without compromising a trial's validity—in the mid-1990s. Such schemes, it was claimed, could streamline an unwieldy drug development process, weeding out under-performing drugs at a far earlier stage, and funneling patients into more promising treatment arms.

Eye On: Bipolar Disorder

Bipolar disorder, sometimes referred to as manic-depressive illness, is characterized by dramatic fluctuations in mood, emotional state and behavior. During the episodes of mania, or less extreme hypomania, there is a general feeling of elation, high energy, sleeplessness, and impulsive behavior such as sexual promiscuity or excessive spending. During the episodes of depression, which are usually more frequent than the manic episodes, mood is depressed and even suicidal, vegetative signs and symptoms of depression predominate, and behavior becomes subdued and withdrawn.

• Month in Review
• In the Pipeline
• Opportunities Underway
• TrialWatch