Background

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, which can lead to wasted money and time. The TPoP tool was developed to address this common and critical issue. The TPoP tool can be used prior to research to identify key evidence needed to support policy decisions and/or at the point of evidence generation and dissemination. 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 also aims to facilitate early and ongoing communication between researchers, policymakers, and other global health stakeholders, such as manufacturers and regulators, to name just two. 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.

Research shows that inclusion of policymakers in the journey toward research—such as participating in the TPoP process before the TPoP format is settled on and populated—is the factor most associated with a change in policy.^[1]

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 the TPoP include;

    a) Creates next-steps to move research to a policy;
    b) Identifies stakeholder 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, who wish to engage the owners of the policy to understand what evidence a policymaker or policymaking organization needs in order to act.

When should one be completed and how is it kept up to date?

It is envisaged that 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 policy on how to address a health condition. It is recognized that 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 could 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. These stakeholders could include research funders, other researchers, global standard organizations, organizations manufacturing, subsidizing or distributing interventions involved in the new policy, as well as technical experts that a policymaker relies on to compile evidence and make recommendations. The purpose of the TPoP document is to facilitate a discussion with all relevant stakeholders.