Best Practices for Study Informativeness
Design, Analyze and Communicate: Working together to improve clinical study outcomes.
Background
Studies can end in a variety of ways that are insufficiently persuasive to move leaders to implement a change in policy or to initiate a subsequent study in a clinical development plan. For example, studies might end without sufficient power to answer the research question; might run at a site with inadequate disease burden and fail to meet recruitment goals or run too long and lose too many participants to follow-up or might be unclear about the optimally effective, safe and cost-effective dose.
Unfortunately, it only takes one among dozens of decisions being wrong to lead to uninformative results.
Best Practice development
In concert with Wellcome Trust and other funders, the Gates Foundation has investigated the most common design-related factors associated with studies ending successfully and informatively. These factors are presented as the “best practices” of the DAC program.
None of these best practices is new. Rather, they are well-regarded and accepted research methods, often referenced in international guidelines. They represent solid science, and global health researchers acknowledge the need to implement these practices in their research. However, some global health studies lack one or more of the best practices even though the absence of just one risks uninformative outcomes.
Please note: Implementors of studies should also always refer to relevant regulatory standards and guidelines (e.g. FDA, EMA) to assist with study/protocol design.
