Rules on reporting trials must be better enforced, say health integrity groups

Unregulated reporting of clinical trials opens the door to fraud and corruption, undermining medical advances and public health objectives, a report has warned.

The report,1 by a consortium of “health integrity organisations,” urges governments to enforce current rules to ensure that patients, doctors, and scientists can access the full results of all clinical trials.

The consortium includes Transparency International Pharmaceuticals & Healthcare, TranspariMED, Cochrane, and the Collaboration for Research Integrity and Transparency at Yale University.

Till Bruckner, lead author of the study and founder of TranspariMED, told The BMJ that the report explains the problem of hidden and misreported trials in a language that policy makers can understand and, crucially, provides concrete recommendations that they can act on.

He said, “It translates the concerns of the medical research community into the language of policy and politics. TranspariMED plans to use the standards identified in the report as benchmarks to compare, rate, and rank national legal and regulatory systems to encourage political action to get all trials registered and fully reported.”

The consortium warned that the current lack of access to complete, unbiased, and undistorted evidence of the benefits and harms of drugs, medical devices, and treatments is harmful to patients, prevents public health agencies from making informed decisions, wastes public health funds, slows down medical progress, and exposes shareholders to substantial risks. The United Nations has recently urged governments to act to resolve this “pressing public health issue.”

Making clinical trials more transparent would be cheap and highly cost effective, the report says, adding that “many significant transparency gains can be achieved within current legal frameworks through administrative action alone.”

It 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.”2

The report highlights three concrete steps that governments should take to increase clinical trial transparency and “make the sector more accountable to citizens, patients, taxpayers, and investors.”1

Firstly, it says, political decision makers should require all public research funding bodies in their jurisdiction to adopt and expand on WHO transparency standards for disclosure of clinical trial findings and to ensure that these are fully implemented. “Taking this simple first step would deliver significant gains at minimal cost,” it says.

Decision makers should bring existing laws, rules, and regulations into line with global best practice standards and ensure that they cover all clinical trials, past and present, across five pillars of clinical trial transparency:

• Trial registration

• Publication of summary results within 12 months

• Proactive disclosure of full trial reports

• Publication of trial results in academic journals (or free access through appropriate trial registries or databases), and

• Frameworks that enable effective, vigilant, individual participant data sharing.

Decision makers should then support government agencies in setting up “effective monitoring and sanctions mechanisms to enforce existing laws, rules and regulations, which at present are often not consistently implemented” to bring greater accountability into the sector, the report advises.

Bruckner commented, “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 healthcare. Governments must take action now to ensure that all clinical trials are registered and fully reported.”