Design, Analyze, Communicate: Working together to improve clinical study outcomes.
In many cases, the end goal of clinical research is a change in policy, but there is often a gap between research design and policy needs. The Target Policy Profile (TPoP) tool was developed to address this common and critical issue. The TPoP can help researchers structure engagement with stakeholders to analyze the evidence underlying a given policy, the gaps in that evidence and the nature of additional evidence needed. The TPoP can also facilitate early and ongoing communication between researchers, policymakers and other global health stakeholders, such as manufacturers and regulators. Armed with this knowledge and these relationships, clinical researchers can maximize the likelihood that studies are informative and support the efficient generation of optimal policies.
Overview
What is the TPoP Tool and what are the benefits of using it?
The TPoP tool consists of a form for researchers to fill out, including prompts and a set of questions as a guide. The benefits of using it include:
a) Creates next steps to move research to a policy;
b) Identifies barriers to move to a new policy;
c) Shows how new evidence fits with other facts;
d) Focuses all stakeholders on the same facts for a dialogue, and;
e) Identifies missing facts that need to be researched.
Who should complete the TPoP?
The TPoP could be completed by a PI or study team. The group creating a TPoP is usually the team advocating a change in policy that wishes to engage the owners of the policy to understand what evidence they need in order to act.
When should one be completed and how is it kept up to date?
IIdeally, a TPoP would be completed whenever a change in policy is proposed and updated whenever significant new information becomes available that may affect any of the assertions within the TPoP. The TPoP should then be kept current throughout the lifecycle of the policy change.
Who is the audience for a TPoP?
The typical target audience of a TPoP is the policymaking body that decides if, when and how to change a health-related policy. It is not always possible to directly engage those responsible for a change in policy as a collective, and in these circumstances, applying a rigorous approach to reviewing the evidence and identifying the gaps will still serve the policy objectives well. The TPoP can also serve as a tool for the academic community to agree on the current state of knowledge and research gaps. Additional audiences might include various stakeholders such as research funders, other researchers, global standard organizations, technical experts and organizations manufacturing, subsidizing or distributing interventions involved in the new policy.
Complete Instructions
Engage your target audience early and often
When ready to create your TPoP, first identify the “target audience” for the information you want to communicate. Often policymakers are the target audience. An ideal approach is to engage specific members of your target audience as well as key opinion leaders (KOLs) in early dialog that is intended to draft a “case for change”. This case for change should:
- Establish arguments based on robust evidence for why the proposed policy change will save and improve lives.
- Summarize the existing approach.
- Propose the evidence requirements to justify the proposed change in policy. This will come from research and other implementations, pilots and guidelines.
- Highlight existing research and identify any gaps to be filled by further studies, serving as a tool to discuss and agree on approaches including the design of studies to address evidence gaps.
This can be done by including KOLs in a design workshop to draft the key points for your case for change and collaboratively fill in the TPoP template. The output of the initial workshop will often be required research and the planning of new studies to generate necessary evidence. The draft TPoP can be iteratively revised, based on the research and studies you complete and by working in concert with the relevant stakeholders along the way, to keep them involved in the dialog and integrate their feedback, when appropriate.
Filling out the TPoP template
The Target Policy Profile Template is a blank copy of the template for you to fill out. This template includes some questions in red (under the “Proposed Target Policy” column header) that you will need to answer to help you draft your Proposed Target Policy. These questions are for guidance only and should be removed before the template is circulated.
Once completed, the top section of the TPoP Template allows you to outline the specific “case for change story” for your proposed TPoP. If desired, this tabular structure can easily be used to draft a compelling and easy-to-read document to engage policymakers, the research community and/or other stakeholders. Such a document should include: (1) your case for change, including the list of challenges of the current policy that make the newly proposed policy attractive to public health; (2) the benefits of a new policy; (3) if it exists, an exemplar case of the how the proposed policy is performing well in current use somewhere, and (4) the proposed summary of evidence that will be presented to change the policy.
The bottom section of TPoP Template (Target Policy Profile “tool”), once completed, provides a side-by-side comparison of the new/proposed policy, the current policy and the pros/cons of the new policy. The completed table can be included in your TPoP document.
How to cite the TPoP
Any mention of the TPoP tool in publications (including reports, briefings and journal articles) must include the following citation of the source:
“Target Policy Profile (TPoP) Version 1 Design Analyze Communicate (DAC), Bill and Melinda Gates Foundation, 2020. https://doi.org/10.48060/tghn.2″.
Publications
Publications
Zarin DA, Goodman SN, Kimmelman J. Harms from uninformative clinical trials. JAMA. 2019;322(9):813-814. doi:10.1001/jama.2019.9892
Hartman D, Heaton P, Cammack N, Hudson I, Dolley S, Netsi E, Norman T, Mundel T. Clinical trials in the pandemic age: What is fit for purpose? Gates Open Research. 2020;4. https://gatesopenresearch.org/articles/4-58
Dolley, S, D Hartman, T Norman, and I Hudson. Target Policy Profile (TPoP) Version 2 Design Analyze Communicate (DAC), Bill & Melinda Gates Foundation 2020. May.https://doi.org/10.48060/tghn.2.
Bugin K, Woodcock J. Trends in COVID-19 Therapeutic Clinical Trials. Nature. 2021 Feb BioBusiness Briefs. doi: https://doi.org/10.1038/d41573-021-00037-3 Supplementary information
Hutchinson N, Moyer H, Zarin DA, Kimmelman J. The proportion of randomized controlled trials that inform clinical practice. (2022) eLife 11:e79491: https://doi.org/10.7554/eLife.79491
Uninformative Research: The global health crisis you’ve never heard of. Ideas Blog. https://www.gatesfoundation.org/ideas/articles/deworm3-clinical-trials-show-the-value-of-informed-research
Saidu Y, Ben Bachire H, Frambo A et al. Health policy making process in Cameroon: a case for the utilization of the Target Policy Profile [version 1; peer review: 2 approved with reservations]. Gates Open Res 2022, 6:68 (https://doi.org/10.12688/gatesopenres.13580.1)
Foundation, B. &. M. G. (2023, September 8). Design, Analyze, Communicate (DAC) Assessment Tool. https://doi.org/10.31219/osf.io/b8n73
Stevens G, Dolley S, Mogg R, Connor JT. A template for the authoring of statistical analysis plans. Contemp Clin Trials Commun. 2023 Jun 9;34:101100. doi: 10.1016/j.conctc.2023.101100. PMID: 37388218; PMCID: PMC10300078. https://www.sciencedirect.com/science/article/pii/S2451865423000467
Burford, Belinda & Norman, Thea & Dolley, Shawn. (2023). Scientific Review of Protocols to Enhance Informativeness of Global Health Clinical Trials. https://doi.org/10.21203/rs.3.rs-3717747/v1.
Dolley S, Norman TC, McNair D, Hartman D. A Maturity Model for the Scientific Review of Clinical Trial Designs and Their Informativeness. Trials (2024) 25: 271. https://rdcu.be/dFfsz.
Dolley, S. A Novel Feasibility Study Design Enabling Informative Clinical Trials in Low Resource Settings: the Pop-Up Prevalence study with Private Ethics (PUPPE). Preprints 2024, 2024010020. https://doi.org/10.20944/preprints202401.0020.v1
S Dolley, C Miller, P Quach, T Norman Recent cross-sectional prevalence studies in sub-Saharan Africa for communicable, maternal, neonatal, and nutritional diseases and conditions: a scoping review. medRxiv 2023.12.24.23300511;https://doi.org/10.1101/2023.12.24.23300511
Arianna Rubin , List Kellie , Roll Amy , Gwayi-Chore Marie-Claire , Dolley Shawn , Schünemann Holger J. , Norman Thea C. , Walson Judd L. Participatory development of a target policy profile to support soil-transmitted helminth elimination. Frontiers in Health Services. 2024 (3). DOI=10.3389/frhs.2023.1310694. https://www.frontiersin.org/journals/health-services/articles/10.3389/frhs.2023.1310694
Wood TA and McNair D. Clinical Trial Risk Tool: software application using natural language processing to identify the risk of trial uninformativeness [version 1; peer review: 1 approved with reservations]. Gates Open Res 2023, 7:56 (https://doi.org/10.12688/gatesopenres.14416.1)
How to cite the TPoP
How to cite the TPoP
Any mention of the TPoP tool in publications (including reports, briefings and journal articles) must include the following citation of the source:
“Target Policy Profile (TPoP) Version 1 Design Analyze Communicate (DAC), Bill and Melinda Gates Foundation, 2020. https://doi.org/10.48060/tghn.2″.
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.
