MAPGuideⓇ
Equitable Access Toolkit
Incorporating Equitable Access Considerations for Clinical Trials into Funding Agreement
Approaches to designing, executing, and sharing data from clinical trials can play an important role in achieving timely and equitable access to a final product. Where relevant to the scope and context of the funded project, funding agreements can include clinical trial-related requirements reflecting best practice approaches for facilitating equitable access, such as:
The registration of funded clinical trials, and the reporting of both positive and negative results, in a publicly available clinical trial registry;
Open access publication of clinical trial results;
Rapid sharing of clinical trial results during health emergencies;
Compliance with good clinical practice guidelines;
Timely and meaningful community engagement throughout the clinical trial process;
Recruitment of diverse and inclusive clinical trial populations;
Use of clinical trial sites in LMICs to support faster regulatory reviews for markets where a funded product may be most needed;
Making clinical trial results available to the Ministry of Health in the country in which a trial is conducted;
Providing a funded product to third parties at an affordable price for clinical trials; and
Planning for post-trial access to the product for patients participating in the clinical trial.
Funding agreements may address the above considerations through specific agreement provisions, through a requirement for the funded partner to conduct clinical trials in accordance with the funder’s clinical trial policy, and/or as part of a product development or access plan established under the agreement.
Clinical trial-related provisions may also provide for funder oversight of clinical trial design and execution through rights to review and comment on clinical trial protocols, and/or other governance and reporting mechanisms under the agreement.
Examples from the MAPGuide
[Developer] shall procure that the Clinical Trial which is undertaken by the [Developer], its collaborators, sub-contractors or service providers under the Project; must be conducted in accordance with [Funders]’s Clinical Trial Policy included in Schedule [x] and in accordance with good clinical practice guidelines in the countries in which the Clinical Trial takes place.
Source: taken from a USD $11.7 million convertible loan agreement between the Wellcome Trust (Funder) and Alto Neuroscience (Developer). Partner types: philanthropic funder, industry; Product type: bipolar depression therapeutic; Development stage at signature: phase 2b clinical trials. Read in context.
Awardee shall be responsible for the preparation of clinical trial protocols for the Project Clinical Trials. Awardee shall provide [Funder] and/or [Funder]’s designee with a draft of each clinical trial protocol for the Project Clinical Trials and shall consult with and consider any reasonable suggestions made by [Funder] and/or its designee regarding the clinical trial protocols reasonably in advance of finalising the relevant clinical trial protocol and submitting it to the institutional review boards, ethics committees, and/or regulatory authorities.
Source: taken from a development funding agreement for up to USD $33 million between CEPI (Funder) and Variation Biotechnologies (Developer). Partner types: non-profit funder, industry; Product type: COVID-19 vaccine; Development stage at signature: early stage development. Read in context.
With respect to publications relating to clinical trials other than the [Developer]-Funded Study, [Developer] shall credit where appropriate the country in which the clinical trials were performed and make the results of such clinical trials available to the relevant country’s Ministry of Health or equivalent.
Source: taken from a USD $23.4 million funding agreement between CEPI (Funder) and Valneva (Developer). Partner types: philanthropic funder, industry; Product type: Chikungunya vaccine; Development stage at signature: phase 3 clinical trials. Read in context.
Dissemination of Project Data to Countries Hosting Clinical Studies. Subject to reasonable protection for [Developer]’s rights under this Agreement, [Developer] shall, to the extent it has the legal right to do so, make all Project Data (excluding any chemistry, manufacturing and controls (CMC) data), such as results of disease-specific assays, animal models, correlates of protection or risk, or diagnostics and epidemic preparedness mechanisms arising from such clinical trial available to that country’s Ministry of Health or equivalent.
Clinical Trial Data. [Funder]’s Clinical Trials Policy requires that clinical data and results (including negative results) must be disclosed publicly in as close to real time as possible. Accordingly, such data must be shared through an easily discoverable existing public route (website or system) that includes a metadata description, where patient privacy is upheld, and the system follows a request-for-information approach (where requests are fulfilled subject to an independent review and approval step). Clinical trial data shall be submitted for publication within twelve (12) months after each final study report or report submitted to [Funder]. During the same time period, [Developer] shall make the results available to the relevant country’s Ministry of Health or equivalent. The clinical trial ID or registry identifier code/number shall be included in all publications of clinical trials.
Source: taken from a development funding agreement for up to USD $384 million between CEPI (Funder) and Novavax (Developer). Partner types: non-profit funder, industry; Product type: COVID-19 vaccine; Development stage at signature: phase I clinical trials. Read in context. Read in context.
Consistent with the Publication provisions of the Grant Agreement, [Developer] will use reasonable and diligent steps to publish (in a customary and reasonable manner as [Developer] sees fit) information related to the Phase 3 Clinical Trial under the Project, which shall include:
(A) prospective registration of clinical trials on a WHO compliant clinical trial registry (e.g.,www.who.int/ictrp), with final clinical trial results publicized within 12 months from the completion date of the trial in accordance with WHO reporting guidelines/recommendations;
(B) publication of status of each clinical trial conducted under the Project on clintrials.gov within the earlier of 12 months of completion of each such clinical trial or the date imposed or specified by applicable law; and
(C) publication of final results of each clinical trial under the Project in one or more applicable peer reviewed open access journals within 12 months from the last subject last visit time point of any such clinical trial, consistent with the provisions in the Grant Agreement. In the event of an inability to obtain peer reviewed publication, [Developer] agrees to publish in manner that the [Funder] determines in its reasonable discretion satisfies the requirement that such research be published in a form that is “available to the interested public” as described in Treasury Regulation 1.501(c)(3)- 1(d)(5)(iii)(c)(2) (the “Publication Requirement”).
Source: taken from a global access commitments agreement between the Gates Foundation (Funder) and Novavax (Developer) signed in relation to a USD $83 million grant from the Foundation to Novavax. Partner types: philanthropic funder, industry; Product type: RSV vaccine; Development stage at signature: late stage clinical trials. Read in context.
How will other stakeholders support clinical trial conduct to facilitate equitable access, for example by supporting clinical trial sites.
Will the clinical trial strategy be developed further as part of the access plan for the funded product?
How do clinical trial provisions align with other provisions in the agreement intended to support response to health emergencies?
How do requirements for registration and reporting of clinical trial results align with other publication obligations under the agreement?
How does the clinical trial strategy align with the funded partner’s regulatory and product registration commitments for the funded product?
How will the governance mechanisms under the agreement provide oversight over clinical trial conduct?
What clinical trial-related information will be incorporated into reporting obligations under the agreement?
This toolkit has been built based on the data in the MAPGuide and the GHIAA team’s experience of negotiating and implementing agreements. We intend that the toolkit will evolve and expand over time based on input from MAPGuide users and availability of new agreements showing examples of alternative approaches. We welcome ongoing constructive dialogue around these materials and encourage you to contact us or fill in our feedback survey to share your thoughts, questions and suggestions.