Declaration calls for all clinical studies to be registered and the results published

23 May 2017 | News
Leading funders of clinical research around the world say they will require grant holders to register trials in advance and to publish data in full, regardless of whether the results are positive or not

Some of the world’s largest funders of medical research and international non-governmental organisations have agreed on new standards that will require all clinical trials they fund or support to be registered and the results disclosed publicly.

Currently, about 50 per cent of clinical trials go unreported, often because the results are negative. These unreported trial results leave an incomplete and potentially misleading picture of the risks and benefits of vaccines, drugs and medical devices, and can lead to use of suboptimal or even harmful products.

Signatories including the Gates Foundation, the Research Council of Norway and the Wellcome Trust say the prospective registration and timely public disclosure of results from all clinical trials is of critical scientific and ethical importance. In addition, timely results disclosure reduces waste in research, increases value and efficiency in use of funds and reduces reporting bias, which should lead to better decision-making in health.

The research funders say that within the next 12 months they will develop and implement a policy with mandated timeframes for prospective registration and public disclosure of the results of clinical trials that they fund, co-fund, sponsor or support.

They also say there will be pro-active monitoring of registration and the outputs from the monitoring process will be publicly available.

The benefits of implementing and monitoring policies on public disclosure will have a number of benefits including:

  • The current bias in the reporting of results will be reduced allowing for more informed decisions in the following areas:
    • Licensing/marketing authorisation,
    • Public health policy recommendation on use (including cost-effectiveness),
    • Financing decisions by public procurement bodies,
    • Optimising implementation and delivery’
    • Individual treatment choices by doctors and patients
  • Research funding allocation will be more efficient because funds will no longer be allocated to answer scientific questions that have already been answered in unreported clinical trials, and learning from previous trials can be taken into account in design of new trials
  • The development of interventions will be more efficient
  • Ethical requirements for dissemination of information will be met, potentially increasing trust of trial participants

In the context of the overall cost of clinical research, there will be modest costs associated with public disclosure of clinical trial results.

Registration of clinical trials

Before any clinical trial is initiated (at any phase) its details must be registered in a publicly available, free to access, searchable clinical trial registry complying with the World Health Organisation’s international agreed standards (

The clinical trial registry entry must be made before the first subject receives the first medical intervention in the trial and should be updated as necessary to include final enrolment numbers achieved, and the date of primary study completion.

Summary results of clinical trials should be made publicly available in a timely manner following primary study completion. The funders say they will work towards a timeframe of 12 months from primary study completion as the global norm for summary results disclosure.

At the time of the initial grant submission, the plan for public disclosure of results should be included, including specific time commitments. Reasonable funds to enable compliance is a cost-eligible item in clinical trial budgets.

Reporting of previous trials realises the value of funding; therefore the contribution made from reporting previous trials, whatever their results, will be considered in the assessment of a funding proposal. When a researcher applies for new funding, they may be asked to provide a list of all previous trials on which they were principal investigator within a specified timeframe and their reporting status, with an explanation where trials have remained unreported.

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