New Technology Boosts Clinical Study Design for Alcohol Medications Team
To streamline elements of its clinical trials program, the NIAAA Clinical Investigations Group (NCIG) recently turned to a technological innovation called Take Control. A sophisticated computer-based alcohol intervention, Take Control proved effective in a number of pilot tests with NCIG’s drug development trials.
Take Control was co-developed by Megan Ryan, Clinical Program Director/Technology Development Coordinator for NIAAA’s Division of Medications Development, and Dr. Eric Devine, a licensed clinical psychologist in the Psychiatry Department at Boston University School of Medicine. Ryan explained that the basis of Take Control is derived from the bibliotherapy and interactive web-based tools of Rethinking Drinking, NIAAA’s online resource for individuals seeking help to quit or cut down on problem drinking.
Ryan and Devine transformed the Rethinking Drinking content, which presents evidence-based alcohol education that includes motivational interviewing and cognitive-behavioral skills building. The result is a nine-session computer-based intervention that features animation and segments narrated by Dr. Carolina Yahne, a psychologist with expertise in motivational interviewing.
Ryan said that one of the primary reasons for developing Take Control was to achieve more scientific control in study designs where manualized therapy delivered by people can vary substantially from one clinician to the next, and from one study site to the next. This variation in how manualized therapies are delivered is a potential source of variability that can be minimized by using a computer-based intervention. Take Control has improved NCIG’s ability to deliver a standardized intervention dose across subjects and across investigator clinical sites.
In addition to achieving greater study design control, the use of Take Control has resulted in substantial costs savings for the NIAAA Clinical Investigations Group. In previous NCIG trials, a copyrighted behavioral therapy was licensed and therapists were trained and monitored for drift. This licensing, training, and monitoring was costly and time consuming.
Using Take Control has eliminated some constraints of study start-up as there is no need to train and certify clinicians in an intervention prior to starting the study. Developing take Control has also allowed the NCIG to modify the intervention to meet the demands of each study without incurring substantial costs that were required when using previous copyrighted behavioral therapies. By using the Take Control intervention, NIAAA’s NCIG program has realized a cost savings of at least $200,000 per trial. Take Control can be modified to accommodate future trials therefore the cost savings will grow with each additional trial.
New Program Aids Data Collection & Processing
In addition to Take Control, Ryan and Devine co-developed a program used for scoring drinking data collected using the Time-line Follow-back (TLFB) method. This TLFB scoring program incorporates multiple safety features to ensure drinking data quality including:
- transparency in standard drink scoring that allows for auditing of how standard drink values are derived from raw data,
- automatic data quality checks that flag incorrect data based on duplicate entry, automatic flags for data considered out of range, and automatic verification of the drinking inclusion criteria.
The TLFB scoring program greatly reduces the risk of scoring errors, entry errors, transcription errors, and eligibility determination errors. The TLFB scoring program also provides a clear record of data entry and scoring that can be easily audited by clinical monitors.