The goal of health research is to find answers to important questions and ultimately improve the health of our communities. However, without rigorous attention to how research questions are posed, studies are designed, and results are analyzed, well-intentioned research can fail to have the intended impact. For more than 30 years, the CTN+, and the CTN before it, has provided methodological and statistical support to hundreds of research projects. Now, with the evolving and expanding structure of our Network, this support has grown into the newly minted Methods Think Tank.
This Think Tank is dedicated to ensuring trials use cutting-edge methodologies, addressing priority research questions, and promoting inclusivity of diverse participants. Additionally, their commitment to leveraging implementation science methods ensures that the knowledge gained from CTN+ research can more effectively move into clinical practice. It is also important to design studies that include EDI best practices, applying early input from community members to ensure that a wide range of participants are included and that results are applicable to those most in need.
In collaboration with the three other CTN+ Think Tanks, our Methods co-leads are here to support CTN+ researchers in developing the best possible research projects. Let’s meet them!
Meet your co-leads
Dr. Shirin Golchi, an Assistant Professor at McGill’s School of Population and Global Health, is a statistician with a strong passion for enhancing clinical trials through innovative methodologies. Her expertise spans multiple disease areas, and she is eager to apply her expertise in adaptive clinical trial design to STBBI research. Dr. Golchi looks forward to learning more about the unique challenges and requirements within the STBBI research field while collaborating with her fellow Methods Think Tank co-leads and the CTN+ community.
Dr. Lawrence Mbuagbaw, an Associate Professor with the Faculty of Health Sciences at McMaster University, has been an integral part of the CTN+ for over 15 years, initially joining the network as CTN’s first international postdoctoral fellow and then serving on several CTN+ committees. As a Methods Think Tank co-lead, Dr. Mbuagbaw will provide invaluable support for research design, analysis, and reporting, while also contributing to guideline development and capacity building to help drive impactful clinical study design.
Dr. Guillaume Fontaine, an Assistant Professor in McGill’s Faculty of Medicine and Health Sciences, is an implementation scientist and Director of the RISE3 Lab (Research and Implementation Science for Healthcare Effectiveness, Engagement and Equity). Dr. Fontaine’s expertise centers on developing and applying methods to support the successful implementation of novel interventions within the STBBI field. His research explores how to assess and address barriers and enablers at various levels of the health care system, ensuring that effective interventions are embedded in clinical practice, sustained, and reach targeted populations.
Dr. Serge Vicente is a Teaching Professor at the École de Technologie Supérieure and a former postdoctoral fellow with the CTN. His research focuses on innovative clinical trials, patient-reported outcomes, and statistical methods to improve HIV care. Furthermore, as a person living with HIV, Dr. Vicente integrates patient perspectives into his work and a community voice in the Methods Think Tank. Dr. Vicente is passionate about bridging the gap between scientific research and patient experiences and ensuring that clinical trial methodologies are inclusive and rigorous.
Bringing together different methodologies
Although the Methods Think Tank will be providing insight for several different types of clinical research projects, one of the key focuses novel to the CTN+ is the advancement of innovative trial designs, particularly adaptive clinical trials. These flexible trial designs allow for adjustments to be made at prespecified interim times, based on accumulating evidence, rather than waiting until the end of the trial to draw conclusions. An adaptive trial is designed so that interim analyses can be conducted throughout the study period and decisions may be made throughout the trial according to predefined decision rules. This can allow for early termination of treatments that are not having the intended effect or rapid adoption of effective interventions and more efficient use of resources.
To ensure that results from CTN+ research impact clinical practice, the Methods Think Tank will provide implementation science guidance and support, particularly for novel trial designs incorporating implementation outcomes, such as hybrid effectiveness-implementation trials and implementation trials. Implementation science focuses on methods that ensure effective interventions in care are embedded in routine clinical practice, sustained, and importantly, reach the people who will benefit the most. Applying implementation science methodology to CTN+ research can accelerate the translation of study findings into clinical practice.
Engaging community from the beginning
Community involvement is a crucial aspect of the Methods Think Tank’s approach to clinical trials and research within the CTN+ as a whole. The integration of community perspectives is seen as essential throughout the research process, from a study’s conception to the dissemination of its results. Community members play a vital role in shaping research questions to ensure they address issues important to those at the heart of it. Their input helps inform study design, including recruitment strategies and the development of inclusion and exclusion criteria that accurately reflect the target population. Community members also provide valuable insights into selecting relevant outcomes that matter to those affected by the research.
The implementation science aspect of the Methods Think Tank’s work heavily emphasizes co-design and partnership. This involves engaging community members in discussions to help identify barriers and facilitators to accessing care. This is critical in shaping how new models of care are adopted and how intervention strategies are conceptualized and developed. This approach ensures that the strategies resulting from CTN+ research are stigma-sensitive, inclusive, and grounded in the needs of community members. While the community’s primary contribution is often at the design stage, their involvement extends to other areas as well. They play a crucial role in integrated knowledge translation approaches, supporting the dissemination of study updates, recruitment information, and interim results. Additionally, the expertise behind the Methods Think Tank supports CTN+ researchers in using advanced statistical methods to integrate information from external sources and applying them across multiple trials. These newer statistical methods have the potential to increase researchers’ ability to draw robust study conclusions when data are sparse, as if often the case with underrepresented populations.
Looking forward to the future of CTN+
The Methods Think Tank plays a critical role in the restructured CTN+. Providing a centralized source for methodological input from experts in the field ensures communication and information sharing across different studies. This approach also allows for the exchange of evidence and insights, which can benefit multiple projects. It is an exciting step towards more efficient and effective research methodologies and, by providing a dedicated space for methodological discussions, the Methods Think Tank will play a critical role in enhancing the rigor and innovation of research conducted within the CTN+.