Principles and approaches for research methods to Design, Analyze, Communicate (DAC) clinical studies.
The purpose of this tool is to enable a rigorous and standardized review and subsequent discussion by study teams to enhance the probability of carrying out an informative study. Consider the DAC Best Practices when discussing your answers.
Best Practices
14. Engage local regulators, ethics committees and policymakers before, during, and after the study, for input on design, obtaining relevant approvals, and action at study’s end
15. Implement a communication plan and informed consent that involves participants, families, communities, and health systems
16. Publish protocol, analysis plan, and study results, including raw study data and code, in an open access resource, regardless of study outcome
Communicate aspects
35. Describe your Community Engagement Strategy and Communication Plan, including timings. How will you include local community members in your study team (i.e., to ensure robust understanding of local culture and considerations and improve communication)? What forms of communication (e.g., social media, print, webinars) are best suited to the study communities?
36. Describe your plans for study consent (or alternatively community assent), including allowing data reuse and biological sampling.
37. If a multi-site study, please describe your cross-site communication and collaboration plan that ensures alignment of study site protocols, clinical operations training, data collection, data standardization, and cross-site data sharing.
38. On which publicly accessible database will your study be registered?
39. Describe your commitment and plans to publish study results as soon as is practical, regardless of outcome, as well as your forecast of when the publication will be submitted following database lock. How will you disseminate research findings to relevant parties, including policy makers? Describe your plan to publish your raw, most granular study data and associated analysis code, such that, when the code is run by a third party on the data package provided, the third party will be able to reproduce your test statistic values. Describe your policy for reuse of your data for secondary analysis by the public, including how you will facilitate data-sharing.
33. Provide your statistical analysis plan (draft, if not finalized) for the study including the method for subject allocation, measurement methods of response variables, hypothesis to be tested, analytical approach to common problems including early study withdrawal and protocol violations. Please describe your plans to analyze and report disaggregated data by gender, including data for withdrawals or dropouts.
34. Describe your interim analysis plans including decision rules/stopping rules, possible outcomes, and statistical adjustment considerations. Will there be criteria to stop for futility or efficacy? If not, please explain the rationale. Please describe any pre-planned adjustments to the study design (e.g., adaptive designs) and operating characteristics of the decision rules related to the adaptive elements of the design.
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.
