Spring 2011 • Issue 22


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Bridging the Gap in Drug Development

The NIAAA Clinical Investigations Group (NCIG) is an Institute-directed program created in 2007 to speed up the testing of promising medications for the treatment of alcohol dependence. The group was developed to conduct small-scale, Phase II clinical efficacy trials that bridge a gap in the drug development process between early Phase I studies and larger Phase III clinical trials.

Figure showing timeline

The NCIG program offers a rapid and efficient means for testing new medications. To be added to the program, medications must work in theory and be supported by data from human and animal models. Good candidate medications include those already marketed for the treatment of other diseases or disorders, as well as new products currently in development by pharmaceutical companies. NCIG program staff look for signs of efficacy, such as reduction in drinking, craving for alcohol, or other subjective effects. When a compound shows such signs, staff then work collaboratively with Pharma to increase the likelihood that the drug will be made available to patients.

NCIG program staff primarily are responsible for trial, design and protocol development and also oversee the conduct of the trial including analysis of the data. A Contract Research Organization (CRO) assists with logistical support, monitoring services, and data processing. Independent outside experts make up the Data Safety Monitoring Board (DSMB) that reviews trial safety data. That review is conducted at the start of the trial and at least every 6 months during the course of the study. Dr. Ted George, a Senior Scientist with NIAAA’s Division of Intramural Clinical and Biological Research, acts as a medical monitor. Dr. George reviews all trial-related unexpected adverse and/or serious side-effects. He also is the point of contact for questions regarding the risks associated with possible drug–drug interactions and the risks of potential drug–medical/psychiatric condition interactions in potential trial participants. Informed consent forms are required for each trial and must be approved by NIAAA, the CRO, and DSMB, as well as each participating site’s investigational review board before a trial starts. An investigational new drug (IND) application or an IND exemption is filed with the Food and Drug Administration for each trial. Finally, a Certificate of Confidentiality is issued for each clinical site.

The NCIG program currently is conducting a trial to assess the safety and efficacy of varenicline tartrate for alcohol dependence (currently prescribed under the trade names Champix® and Chantix® for stopping smoking).

The NCIG program is part of the Division of Treatment and Recovery Research. Team members include Drs. Raye Litten, Joanne Fertig, and Daniel Falk and Ms. Megan Ryan.