Principle 3 addresses the practices and behaviors that help develop trust between all those involved in a trial and contribute to generalized confidence in the clinical trials ecosystem.
All those involved in RCTs share responsibility for building and sustaining the trust of collaborating partner organizations and clinical communities, participants, and the wider public. Trust is undermined when RCTs are not sufficiently relevant, fair, transparent, and respectful of the rights, interests, concerns and values of all involved (especially those people who participate in them or whose care will be influenced by the results).
Key message: Potential participants and/or members of the relevant community provide valuable contributions to the design, execution and interpretation of RCTs.
Why this is important: The involvement of patients and relevant members of the public can play a key role in refining and prioritizing research questions; assessing RCT acceptability and feasibility; selecting outcomes that are relevant and meaningful to the intended population; developing the RCT design and procedures; optimizing the nature and delivery of information; and encouraging dialogue about access to health interventions that prove effective. Working in partnership with people and communities is likely to increase trust and confidence, while decreasing the risk of important groups being excluded or the needs of local populations or sectors being overlooked or misunderstood.
Key Message: It is important that interactions between individuals in different organizations, including those in resource-rich and resource-poor settings and among commercial, academic and healthcare sectors, are fair and respectful of the interests, concerns and values of all involved, including trial participants and their communities. Working collaboratively with partners to consider which features of a RCT are critical to its quality, and supporting a delivery approach that is appropriate to the setting and context of a RCT, can enhance its resilience and efficiency.
Why this is important: Collaborative working shares ideas and expertise, helps avoid misaligned approaches or substantially different priorities, and can maximise use of resources and increase efficiency.
Key Message: Clinical trials should be registered from the outset on a publicly available trials database. Making other trial information (including the trial protocol and other trial documentation) public is strongly encouraged. Once the RCT is completed, trial reports should be publicly available in a timely manner (typically within 12 months) and should describe the study design, methods, and results in a clear and transparent manner. It can be helpful for such reports to be available in formats that permit both professional and lay readers to understand and interpret the results. Reporting results to participants and to the public requires different approaches to reporting results to the clinical and scientific community. Data sharing should be enabled at a suitable time if ethical, feasible and scientifically appropriate.
Why this is important: Transparency and sharing of knowledge about health interventions helps generate further knowledge, builds and maintains trust, and gives confidence both to those involved in the RCT and to those who are not. Timely communication of trial results (regardless of the findings) is vital to guide future research, reduce unnecessary duplication of effort which wastes resources, and enable care to be guided by an up-to-date evidence base. Good communication can also support wider efforts to foster potential collaborations and increase informed participation in RCTs.