Four health integrity organisations have come together in calling for governments worldwide to ensure that patients, doctors, and scientists can access the full results of all clinical trials.
Their new study demonstrates that the results of medical research are often reported partially, incorrectly or not at all:
Scientists working for the U.S. Food and Drug Administration concluded that nearly half of clinica trials of antidepressants had not had a positive outcome. The academic literature gave doctors and patients a completely different impression: there, 49 out of 52 trials were painted in a positive light.
35% of results from all clinical trials of 15 drugs allowed onto the market remained unpublished and hence invisible (2015 study).
A 2017 study of 860 clinical trials found that less than 19% had been prospectively registered, despite this being an ethical requirement. Most trials had not been registered at all.
Only 11% of publications in journals provided a complete and consistent account of all the serious adverse events experienced by trial participants (2015 study of 300 clinical trials).
Researchers at Harvard Medical School foound that out of 455 completed trials involving children, 96 had never published results anywhere, in any form. Tens of thousands of children had participated in these trials (2016 study).
198 deaths were recorded in clinical trials of four new drugs, but in the subsequent published papers, only 29 deaths were fully reported (2016 study).
Researcher fought for four years to get detailed information on a slimming drug through freedom of information requests. They found that harms had been “systematically understated” not only in academic papers, but also in the summarised results submitted to regulators (2016 study).
An Oxford University team found that only nine trials out of 67 published in top medical journals had been accurately reported (2016 study).
Transparency International, TranspariMED, Cochrane, and CRIT, who jointly published the study, warned that the current lack of access to complete, unbiased and undistorted evidence of the benefits and harms of drugs, medical devices and treatments:
prevents public health agencies from making informed decisions
wastes public health funds
slows down medical progress
exposes shareholders to substantial risks
Governments should take the following three steps:
Step 1: Ensure that publicly funded clinical trials are transparent
As a first step, political decision-makers should require all public research funding bodies within their jurisdiction to adopt and expand on the provisions of the recent WHO-brokered ‘Joint statement’ by research funders, and ensure that they are fully implemented. In future, to help ensure that public funding for medical research actually benefits the public, government funders should only give taxpayers’ money to institutions and individuals that verifiably comply with best practices in clinical research. Taking this simple first step would deliver significant transparency gains at minimal cost.
Step 2: Enforce existing rules
Second, decision-makers should provide government agencies with the resources, powers and political support they need to enforce existing laws, rules and regulations, which at present are often not consistently implemented. Decision-makers should support government agencies in setting up effective monitoring and sanctions mechanisms to bring accountability into the sector. One promising monitoring model is to use existing Research Ethics Committee records to monitor the registration, summary results posting, and academic publication of all trials conducted within a jurisdiction.
Step 3: Strengthen legal and regulatory frameworks
Third, 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, as defined by the WHO. For example, in the European Union, current guidelines on results reporting should be extended beyond their current focus on certain drug trials, and disclosure policies for Clinical Study Reports should be extended to cover older trials.
The study will form the basis for future work by Transparency International and TranspariMED. For example, we now have a framework that enables us to start rating and ranking countries according to how well their legal and regulatory frameworks fare on each of the five pillars of trial transparency. Meanwhile, advocacy groups around the world can use the study to identify areas of their countries' legislation that could be improved.