WHA 75: UK draft resolution on Strengthening Clinical Trials to Improve Public Health

As reported by Politico on 26 January 2022, at the 150th session of the World Health Organization’s Executive Board, the United Kingdom of Great Britain and Northern Ireland made a “surprise proposal…for a new World Health Organization resolution on clinical trials that would focus on improving standards and streamlining processes for trials.”

The Politico article recorded that the “[UK] government’s chief medical adviser Chris Whitty said that the coronavirus pandemic had exposed weaknesses in the clinical trials ecosystem. Some trials didn’t produce actionable evidence to inform interventions, Whitty said, with many COVID-19 therapeutic trials being “insufficient in size, methodology and conduct, failing to generate the robust clinical evidence needed to inform decision making and practice change…Whitty said that such a resolution would aim to improve the capability of clinical trials, strengthen international collaboration and improve standards.

On the same day, Simon Manley, Ambassador and Permanent Representative, UK Mission to the WTO, UN and Other International Organisations (Geneva), tweeted the following:

On 2 March 2022 and 16 March 2022, the United Kingdom along with Argentina co-convened informal consultations on the draft text.

On 30 March 2022, Knowledge Ecology International (KEI) published the text of the draft resolution on social media. The text of the UK draft resolution on Strengthening Clinical Trials to Improve Public Health can be found here: Strengthening Clinical Trials to Improve Public Health – zero draft

The preamble contains these key principles:

    (PP2) Recognizing the critical role of effective randomized controlled trials in appraising the efficacy of prospective healthcare interventions prior to implementing their results in practice as a cornerstone of high-quality healthcare, and the contribution of quality clinical trials in progressing universal health coverage through equitable access to healthcare interventions;

    (PP4) Noting the urgent need to enhance international clinical trial capability, collaboration and coordination, and to adopt robust clinical trial standards in routine practice, to expedite the development of effective healthcare interventions and acknowledging that current variation in clinical trial standards impacts the quality of evidence available to inform the development of healthcare interventions;

    (PP5) Recognizing the importance of collaboration and coordination between public and non-public funders of clinical trials to help ensure funding is targeted towards quality clinical trials that will produce actionable evidence, and which aim to address issues of public health importance

The operative section directed at Member States is quite meaty consisting of nine paragraphs. One public health expert disclosed to KEI the following view: “What is missing is mention of the need to make efforts to ensure inclusion across populations – pregnant women and children.”

Absent from the UK clinical trials resolution is any mention of the cost of clinical trials.

Operative paragraph 9 of the UK draft resolution urges WHO member states to:

(OP9) acknowledge the immense contributions of participants in vaccine clinical trials to the development of COVID-19 vaccines and agree to recognize participants in COVID-19 vaccine clinical trials regulated by a World Health Organization listed Stringent Regulatory Authority as fully vaccinated against COVID-19, and to introduce mechanisms to recognize their vaccination status for travel and domestic certification purpose;

Rather than fostering more democratic and decentralized clinical trials, this particular provision is more about garnering automatic authentication for vaccine status for purposes of travel and domestic certification through trials regulated by stringent regulatory authorities (SRAs). Given WHO’s recent announcement on transitional WHO Listed Authorities, it will be interesting to see how member states respond to the UK’s proposed language on SRAs. According to sources close the negotiations, the reference to SRAs in operative paragraph 9 has been struck from the text in the current negotiations (the last informal was held on 1 April 2022).

Operative paragraph 2 of the resolution signaled the intent of the UK to strengthen clinical trial capabilities in low-and-middle-income countries:

(OP2) increase clinical trial capability globally,particularly in developing and low-and-middle-income countries, including through enabling a greater number of clinical trials sites and more readily co-ordinating activity through existing and new clinical trial networks, and taking measures to enhance information sharing on innovative and efficient clinical trial design and delivery to help researchers conduct effective trials and funders to make informed decisions based on methodological rigour;

Operative paragraph 3 highlights the need to coordinate research priorities in order to avoid duplication:

    (OP3) co-ordinate research priorities in order to align and prioritise clinical trials when mutually beneficial and to avoid duplication, helping to ensure public and private resources are effectively deployed where they are needed;

Operative paragraph 5 provides a detailed prescription on clinical trial design:

    (OP5)ensure national research funding agencies prioritise and fund clinical trials that are both well designed and have adequate statistical power to generate the reliable and actionable evidence needed to inform policy and practice, including through:

    (OP5.1)encouraging investment in effective clinical trials by ensuring new trials are not duplicative, are of sufficient size and appropriate design, are developed in collaboration with affected communities, and are funded to build long-term research capacity particularly in developing and low-and-middle-income countries;

    (OP5.2)introducing grant conditions for funding clinical trials to encourage the use of standard data protocols where available and to mandate registration on a clinical trial registry within the World Health Organization’s International Clinical Trials Registry Platform (ICTRP);

    (OP5.3)establishing mechanisms to secure a commitment from researchers to share pre-publication results with regulatory bodies, the World Health Organization and national clinical guideline development bodies as appropriate, to enable rapid regulatory approvals, evidence reviews and changes to national and international clinical guidelines;

    (OP5.4)establishing mechanisms to ensure the results of clinical trials are reported ina timely manner following primary study completion, including through registering the results on a clinical trial registry within the ICTRP, and encouraging timely publication of the trial results ideally in an open-access publication;

The resolution text requests the WHO Director-General to develop a global action plan to strengthen clinical trial practice to support preparedness and response in both pandemic and non-pandemic contexts by the Seventy-Sixth World Health Assembly in 2023.

(OP11) develop a global action plan, in consultation with Member States and relevant stakeholders, to guide implementation of the principles of this resolution to strengthen clinical trial practice to support preparedness and response in both pandemic and non-pandemic contexts;

The next informal consultations hosted by Argentina and the United Kingdom on this draft text will take place on 8 April 2022 and 13 April 2022.