Master Alliance Provisions Guide (MAPGuideⓇ)
Issue Introduction: Clinical Trials
This issue refers to provisions that define the roles, responsibilities and standards that apply when clinical studies involving human participants are conducted under an agreement. Clinical trial provisions are important for equitable access because they influence where and how evidence is generated, how communities are engaged, and whether results are transparent and applicable to the populations that the product is intended to serve.
Questions to consider when developing clinical trial provisions
- Which party is the clinical trial sponsor?
- Are the parties required to conduct clinical trials in accordance with a specific code of conduct or policy?
- How will safety and adverse event data be shared between the parties during clinical trials?
Example approaches found in the MAPGuide
Which party is the clinical trial sponsor?
- Funding agreements usually specify that the grantee/funding recipient will be the clinical trial sponsor for all studies conducted under the project. In some cases, clinical studies in specific countries are sponsored by local sub-grantees, with the primary grantee responsible for ensuring that local sponsors comply with the sponsor-level obligations under the main agreement.
- License, collaboration, and technology transfer agreements allocate sponsorship responsibilities depending on each party’s agreed scope of activities under the agreement. For example, different parties may be responsible for clinical trials in countries in accordance with territory definitions under the agreement.
Are the parties required to conduct clinical trials in accordance with a specific code of conduct or policy?
- Some agreements require clinical trials to be conducted in accordance with an agreement party’s clinical trials policy. Most examples of these requirements in the MAPGuide provision database reference are from funding agreements with references to a funder’s policy. Some requirements found in funder policies include:
- Compliance with ICH-GCP;
- Community consultation and engagement as part of trial design and implementation, particularly for studies conducted in low- and middle-income countries;
- Ensuring that standards of care for control groups are at least equivalent to the best locally available and affordable standard; and
- Planning for the inclusion of under-served groups in clinical trial recruitment.
- In addition to funder policy compliance, agreements sometimes require clinical trial sponsors to register the trial in a recognised clinical trials registry before enrolment begins, and for detailed protocols and statistical analysis plans to be made publicly available by specified time points.
- Some agreements also require the establishment of independent Trial Steering Committees and Data Safety Monitoring Boards, with defined charters and responsibilities for overseeing trial conduct and participant safety. Funders sometimes have the right to attend Trial Steering Committee and Data Safety Monitoring Board meetings as observers and to receive relevant papers, subject to preserving the integrity or blinded nature of ongoing trials.
- Some agreements require clinical trials to be conducted in accordance with an agreement party’s clinical trials policy. Most examples of these requirements in the MAPGuide provision database reference are from funding agreements with references to a funder’s policy. Some requirements found in funder policies include:
How will safety and adverse event data be shared between the parties during clinical trials?
- Some funding agreements set out specific timelines and formats for funded developers or manufacturers to share adverse event or other safety information, requiring notification to a steering committee or the funder immediately or within a short defined period following a safety event.
- Collaboration and license agreements may set out the specific responsibilities of each party for reporting adverse events to regulatory authorities and ethics committees, as well as sharing the information with the other agreement parties.