Principles and approaches for research methods to Design, Analyze, Communicate (DAC) clinical studies.
General aspects
1. What is/are the scientific question(s) to be answered by the study? Explain how the study will clearly answer or better inform the scientific question(s).
2. Outline how the proposed study fits into the overall development or life cycle strategy for the product or intervention. How will this build on the existing knowledge base and what new information will this provide?
3. What is the purpose of the study (e.g., regulatory pathway/approval, new application or extension of existing license, non-regulatory product intervention, health technology assessment (HTA), policy change, health system strengthening)? What decision, clinical program advancement, policy or policy change, would a positive outcome in your study help to support?
4. Please detail the external (to your organization) advice you have received or plan to seek in the design of this study, including regulatory authority/scientific, ethical, and implementation aspects. If the study is aimed towards a change in health policy, have you engaged with policymakers to understand their requirements, concerns around implementation, costs, politics, and acceptability early enough to have those questions factored into or answered in the study? Have you solicited or received advice from local experts regarding epidemiology, existing interventions, standards of care relevant to the health system or population of interest, and conduct of studies in the setting you propose? If so, please describe the findings.
5. What, if any, disease-specific or clinical study guidelines are you consulting and proposing to follow (e.g., FDA/EMA/WHO/ICH/HTA) in the design of this trial?
6. Please describe the study governance that is proposed for this study (e.g., appropriately constituted Study Steering Group, Scientific Review Committee, Data Monitoring Committee, and associated Charters). What is the focus of each group and what decisions will each be responsible for making?
7. Describe what you or others see as the limitations, challenges, and risks of this proposed study. Please summarize your mitigation plans for each.
8. Describe your rationale and site selections (number of sites, number of countries, and country names). How will the results be generalizable to multiple countries or regions?
9. Describe your plans for study monitoring, ensuring data integrity and quality management. Please also describe your data collection
DAC Assessment Tool: Principles and approaches for research methods to Design, Analyze, Communicate (DAC) clinical studies | Download DAC Assessment Tool
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.
