Opacity over clinical trials of medical treatments putting patients at risk

All clinical trials must be made fully transparent

12^th December 2017, London – Four health integrity organisations have come together in calling for governments to ensure that patients, doctors, and scientists can access the full results of all clinical trials.

A new publication from Transparency International Pharmaceuticals & Healthcare (PHP), TranspariMED, Cochrane, and Collaboration for Research Integrity and Transparency (CRIT) demonstrates that the results of medical research are often reported partially, incorrectly or not at all.

The groups warn that the current lack of access to complete, unbiased and undistorted evidence of the benefits and harms of drugs, medical devices and treatments harms patients, prevents public health agencies from making informed decisions, wastes public health funds, slows down medical progress, and exposes shareholders to substantial risks.

The report finds that despite strong global standards set by the World Health Organisation and positive regulatory moves at regional and national levels, in many instances rules are being ignored due to a lack of enforcement. In 2007, the US brought in a law to improve reporting transparency, but has so far failed to collect a single dollar in fines for non-compliance. Similar European Union provisions equally remain unenforced.

Rachel Cooper, Director Transparency International Pharmaceuticals & Healthcare, said:

“Anyone with a basic level of common sense can understand the high stakes involved in clinical trials for medical products, and it’s of very deep concern that their results can’t be trusted, due to a lack of transparency. Positive moves from states and international organisations are to be welcomed but can only be judged as ineffective if they fail to be properly implemented. Transparency is never about lip service but giving the public, their physicians and other related parties, the necessary information to both have confidence and make informed decisions.”

Dr. Till Bruckner, founder of TranspariMED, said:

“Even government scientists often cannot reliably determine how safe and effective a medicine is because much of the evidence remains hidden or has been distorted. This exposes patients to unnecessary risks and significantly drives up the costs of health care. Governments must take action now to ensure that all clinical trials are registered and fully reported.”

Margaret McCarthy, executive director of CRIT, said:

“Despite the public health significance of the information gathered through clinical research, much of the data is withheld, missing, or inadequately disclosed. This lack of transparency has sweeping negative consequences for medical research, regulation, clinical care, and the healthcare system. Our recommendations are designed to provide patients, clinicians, independent researchers and payers the information that they need.”

 Cochrane’s Editor in Chief, Dr David Tovey said,

“Transparency within all clinical trials is critically important if evidence-based healthcare researchers, professionals and clinicians are to make informed decisions about assessing the risks and benefits of treatment for patients. Without making available a complete picture of trial results, information is lost or misinterpreted and as a result wrong treatment decisions may be made. Cochrane supports calls for all past and present clinical trials to be registered and their results reported to avoid duplicating efforts and wasting scarce health resources.”

TI-PHP, TranspariMED, Cochrane and CRIT jointly called on governments to ensure that all clinical trials conducted in their countries fully adhere to global transparency standards:

1. Trial registration: All clinical trials must be registered before they start.

2. Summary results posting: Headline results must be made public within 12 months.

3. Full trial reports: Detailed trial findings must be proactively disclosed.

4. Academic publication: Trial results must be published in academic journals or made freely available in appropriate trials registries or databases (preferably both).

5. Individual participant data sharing: Frameworks, standards, policy and legislation that enable effective, vigilant individual participant data sharing should be established.

***ENDS***

Notes to Editor:

• Transparency International Pharmaceuticals & Healthcare Programme (TI-PHP) is a global initiative based in Transparency International UK, with the overall goal to improve global health and healthcare outcomes for the benefit of all people, of all ages. It aims to achieve this by reducing corruption and promoting transparency, integrity, and accountability within the pharmaceutical and healthcare sectors.
• TranspariMED is an initiative that works to end evidence distortion in medicine by developing and promoting policy solutions to improve clinical trial transparency.
• The Collaboration for Research Integrity and Transparency (CRIT) is an inter-disciplinary initiative launched in 2016 at Yale to enhance the quality and transparency of the research base for medical products. Through research, advocacy, and litigation, CRIT is focused on ensuring that the clinical evidence that supports and informs our understanding of the safety and effectiveness of pharmaceuticals, medical devices, and other medical products is accurate, comprehensive, accessible, and reliable.
• Cochrane is a global independent network of health practitioners, researchers, patient advocates and others, responding to the challenge of making the vast amounts of evidence generated through research useful for informing decisions about health. Cochrane is a not-for-profit organization with collaborators from over 120 countries working together to produce credible, accessible health information that is free from commercial sponsorship and other conflicts of interest.

Contact:

Dominic Kavakeb
020 3096 7695
079 6456 0340
Dominic.kavakeb@transparency.org.uk