How Practice and Science Are Balanced and Blended in the NIDA Clinical Trials Network: The Bidirectional Process in the Development of the STAGE-12 Protocol as an Example

Abstract

Background: Bidirectional, collaborative partnerships between academic researchers and practitioners have been a fundamental vehicle to achieve the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) goal of improving outcomes of community-based drug treatment. These partnerships blend clinical perspectives of practitioners and methodological expertise of researchers working together to address clinically meaningful issues through randomized clinical trials conducted in community treatment settings. Objectives: Bidirectionality is a guiding principle of the CTN, but its operationlization at the practical level in protocol development and implementation has not been articulated. This descriptive article presents the development of one protocol as an example and model of this bidirectional, collaborative, iterative partnership between researchers and practitioners. Methods: This article illuminates several specific issues encountered while developing STAGE-12, a behavioral intervention to facilitate 12-step mutual support group involvement, as well as the rationale for decisions taken to resolve each. Results: The STAGE-12 protocol was successfully developed through a series of decisions taking into account both design factors and clinical practice needs and realities, thus maintaining a balance between methodological rigor and generalizability. Conclusion: The review demonstrates the process by which research and practice have been blended in protocol development, exemplifying the underlying principle of bidirectionality, a key element in the success of the NIDA CTN. Scientific Significance: Bidirectional partnerships as derived in the CTN, employing a hybrid model of efficacy-effectiveness research, are capable of designing and implementing protocols that are both methodologically rigorous and clinically meaningful, thus increasing likelihood of adoption and eventual improvement in public health.

• bidirectionality
• research
• clinical practice
• internal validity
• external validity
• clinical trials network
• protocol development

ACKNOWLEDGMENTS

This study was supported by NIDA CTN grants: U10 DA13714 (Dennis Donovan, PI), 5U10DA020036 (Dennis Daley, PI), U10 DA13732 (Eugene Somoza, PI), and 5U10DA013720 (Jose Szapocznik, PI).

The authors thank the members of the STAGE-12 protocol development team, the Clinical Coordinating Center (the EMMES Corporation), the Data Management and Statistics Center (Duke Clinical Research Institute), the representatives from CTPs that responded to surveys about design elements during the development process, the research staff, counselors, supervisors, and the 471 participants from the 10 CTPs that participated in the protocol.

The opinions are those of the authors and do not represent the official position of the National Institute on Drug Abuse or the US Government.

Declaration of Interest

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of this paper.