Workshop presented at the CTN Steering Committee meeting, March 22, 2007.
Janet A. Levy, PhD (NIDA CCTN), James R. McKay, PhD (University of Pennsylvania, DV Node), Carl F. Pieper, Dr.Ph (Duke University Medical Center, DSC), Madhukar H. Trivedi, MD (University of Texas, TX Node).
This set of three presentations addresses the concept of "adaptive strategies" in treatment and treatment research, and provides current examples and future directions for the concept in the Clinical Trials Network. Adaptive strategies provide a framework for tailoring an individual patient's therapy to his/her responses to previous therapies, as well as for managing a patient's condition over time. The first presentation, "Workshop on Adaptive Treatment Strategies" (Levy), provides an introduction to the concept and outlines the goals for the workshop. The application of adaptive strategies in the CTN began with the development of the CTN-0030 protocol ("Prescription Opioid Addiction Treatment Study (POATS)"), in which the team decided it wanted to be able to re-randomize those who relapsed during the "detoxification" phase of the trial. The hope was that such a strategy would provide a vehicle for more integrated and "stepped" care, as well as help with adherence and drop-out in the trials.
The second presentation, "Adaptive Strategies in Drug Abuse Research" (Pieper and Levy), further defines the concept, specifically addressing the differences between "classic" research trials and research trials using a more adaptive strategy. A "classic" trial divides patients into two categories, treatment or placebo, and assesses them after a certain amount of time. In an "adaptive strategy" trial, patients in the two groups are reassessed midway through the trial and further divided into subsets of "compliant" and "non-compliant," with each group being rerandomized into new categories from there (e.g., reduce treatment, same treatment, increase treatment).
The final presentation, "Adaptive Treatment Strategies in the Addictions: Current Examples and Future Research" (McKay), provides some examples of adaptive treatment in addiction care and research, and describes some of the challenges in designing and implementing adaptive treatment protocols. It also offers an experimental design for developing an adaptive protocol, and discusses some of the pros and cons of implementing such protocols in the CTN. (Presentation, PowerPoint slides, English, 2006)
Keywords: Adaptive treatment strategies | CTN protocol development | CTN research agenda | Research design | CTN Steering Committee meeting, 2006
Document No: 186
Submitted by Janet Levy, PhD, NIDA CCTN 4/3/2007.