Sense about Science

In 2013, we estimated over half of all clinical trial results were never reported. Our response was the global AllTrials campaign — an international initiative of Ben Goldacre, the BMJ, the Centre for Evidence-based Medicine, the Cochrane Collaboration, the James Lind Initiative, PLOS and Sense about Science. Our goal: for every clinical trial to be registered and their full methods and results reported – even if they are negative.

Why registration and reporting of clinical trials matters

When the results of clinical trials are not reported, the public trust in science is damaged — a loss we cannot afford in an era where mis- and disinformation run rampant.

Withheld clinical trial results threaten the public trust in science, inhibit potentially life-saving research, waste resources, prevent fully informed treatment decisions and pose an unacceptable risk to human life.

When results are cherry-picked, the evidence we have access to is distorted. We’re only able to understand the data through the lens those who handle it want us to, and this suggests that we rarely ever see the trial results that are negative. Regulatory bodies, clinicians and doctors are then unable to make effective, informed decisions about important healthcare interventions.

When members of the public know their healthcare providers are only partially informed, it creates more uneasiness in a time that’s already stressful. Many clinical trials are also publicly funded, and researcher accountability provides us answers as to how our money is spent.

Further, volunteers take part in these trials without knowing anything about the efficacy or safety of the intervention, which poses an inherent risk. Given this risk, ensuring results are reported and volunteers are aware of the intervention’s impacts is a basic moral duty as well.

Everyone feels the impact of this malpractice. Clinicians and doctors can’t fully understand the interventions they’re tasked with evaluating, patients face additional uncertainty, and volunteer subjects are left in the dark, leaving us – the group whose funding allows these trials to take place – to bear the brunt of it.

We are witnessing never-before-seen advances in healthcare, and these advances have the potential to save lives across the world. But when results are withheld from the public, scepticism arises, treatments are misjudged and our trust in scientific research is damaged.

Public and professional demand for change

While the issue with unreported medical trials was already well-recognised by medical bodies and the pharmaceutical industry, the mission needed a catalyst. AllTrials has become the public campaign to channel collective global concerns and demand change.

We must make sure governments across the world know that change is non-negotiable. The overwhelming support for the AllTrials initiative shows the global interest in research transparency and pressures policymakers all over the world to reevaluate the standards by which clinical researchers must adhere.

Stronger clinical trials regulations

Since the inception of the AllTrials initiative, tangible, enforceable amendments to research regulations have been achieved. The campaign has also received recognition from the BBC,

which shared its successes as a rare piece of good news for research, and it is cited as a movement that inspired worldwide action.

United Kingdom

New regulations developed by the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Healthcare Research Authority (HRA) will come into force on 28 April 2026. By law, all clinical trials in the UK will be required to:

• Be reported on a public registry that allows further accessibility to information

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  1. When trials are registered on a public registry, we can easily identify trials performed in the UK, and sponsors can easily disseminate their results.
  2. The HRA is partnered with a main public registry, ISRCTN, which streamlines trial registration and application, making the process seamless for researchers as well.
  3. Registration with the EU’s Clinical Trials Information System (CTIS) will be inadequate, as it does not allow us to identify trials taking place in the UK.

• Publish results within one year of completion

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  1. Sponsors must publish summaries of their protocol and results through the registry the trial is published with. It is highly encouraged for them to do so in plain language so we can all understand what they mean.
  2. Being clicks away from timely, comprehensive trial summaries means clinicians, doctors and we, the public, have access to science-based answers that can save lives (and taxpayers’ money).
  3. To ensure these summaries are clear, the qualifying registries ISRCTN and ClinicalTrials.gov are both available in Be Part of Research, which further breaks down trial summaries and their implications

• Offer to share findings with participants in a clear, understandable format

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  1. Beyond publishing results publicly, sponsors are obligated to actively offer complete summaries to volunteer subjects.
  2. They must provide these summaries to each volunteer in plain language, and the results shared must reflect the trial as a whole instead of on an individualised basis.
  3. Without the volunteers who subject themselves to unknown risks in the name of advancing healthcare for others, the introduction of tested, safe medical interventions would be stalled significantly. Answers are the least we can offer them.[

• This is a massive step in the right direction, but will we really see an improvement in research transparency?

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  We are surely closer than we were. Adherence will be monitored by the HRA and enforced by the MHRA, with punishments for offences including:

  • Fines
  • Imprisonment
  • Denial of future trial approval if a sponsor has not complied with regulations

  The amendment also acknowledges the transitional period as the amendment is introduced and explains how enforcements will be arranged during this time.

European Union

The European Union simplified the registration and reporting of clinical trials. Since 31 January 2023, all initial clinical trial applications in the EU must be submitted via the CTIS, making it the single-entry point for the submission, assessment and dissemination of clinical trial data collected in the EU.

USA

In the USA, the Food and Drug Administration Amendments Act of 2007 required sponsors running clinical trials of drugs and devices via funding from the National Institutes of Health (NIH) must register them on ClinicalTrials.gov within 21 days of enrolling the first volunteer, but this law was never effectively enforced. However, in 2023 the Government Accountability Office published a report which found that between July and November 2022, the agency brought 235 researchers into compliance with registration and reporting requirements

Global

At the 75th World Medical Association General Assembly in October 2024, we witnessed a groundbreaking update to the Declaration of Helsinki, which regulates medical practices worldwide. The amendment states that the dissemination of results is an ethical obligation, negative and inconclusive results should be published and all affiliations (e.g., funding sources, conflicts of interest) should be disclosed. Any research which does not adhere to these principles should not be accepted for publication.

All of these regulations have an impact even in jurisdictions where there are no strong laws because many big clinical trials are international. If a study has one clinic in a country with regulations – and the UK has traditionally been popular for drugs trials because of the National Health Service (NHS) infrastructure – then that applies to results from everywhere

Next steps for clinical transparency

We campaign for transparency of evidence in all areas: AllTrials is perhaps the most tangible example of the social harms that result when knowledge and data are not openly shared.

Over the past decade, there has been significant progress in clinical trial registration and reporting. We have achieved recognition of and respect for the volunteers, whose participation these trials depend completely, and we allowed clinicians, regulatory bodies and doctors access to more tools to help them better care for their communities. As the potential subjects of these interventions, we’re entitled to receive care based on fully informed decisions.

But until 100% of clinical trials are registered and 100% of their results reported, there is still work to do. We invite you to sign up for updates from us – we will keep you informed of progress and ways you can help in your area.

AllTrials partners and supporters