Four health integrity organizations, Transparency International Pharmaceuticals & Healthcare (PHP), TranspariMED, Cochrane, and the Yale Collaboration for Research Integrity and Transparency (CRIT) have come together to call on governments to ensure that patients, doctors, and scientists can access the full results of all clinical trials. The new publication discloses that the results of medical research are often reported partially, incorrectly or not at all. The findings are summarized below.

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.

Despite strong global standards set by the World Health Organization and positive regulatory moves at regional and national levels, rules are being ignored, in many instances, due to a lack of enforcement. In 2007, the US enacted a law to require trial registration and reporting of trial results, but has so far failed to collect a single dollar in fines for non-compliance. Similar European Union provisions remain equally unenforced.

The problem

Clinical trials are a key driver of medical innovation and progress, but scientists have known for decades that the existing evidence base on drugs and medical devices is incomplete and biased due to the opacity of clinical trials. The medical community, the private sector and public bodies all lack access to reliable information on the benefits and harms of drugs, devices and treatments. The negative consequences of this lack of transparency are severe:

• Patients are harmed
• Public health agencies cannot make informed decisions
• Public health funds are wasted
• Medical progress is slowed down
• Shareholders are exposed to substantial risks

This lack of transparency in clinical trials can increase the risk for undue influence, manipulation of data and evidence distortion. It is a symptom of limited regulatory authority over the reporting process. It opens the door to fraud and corruption and undermines both medical advances and public health objectives.

The Solution

Strengthening clinical trial transparency would positively and directly benefit patient outcomes, improve the allocation of scarce medical research and healthcare resources, and facilitate and accelerate the development of new treatments and cures. Clinical trial transparency rests on five distinct pillars: trial registration; summary results posting; full trial reports; academic publication; and individual participant sharing.

Implementation

The United Nations has recently called on governments to take action to resolve this pressing public health issue. Making clinical trials more transparent would be both low-cost and highly cost-effective. Indeed, many significant transparency gains can be achieved within current legal frameworks through administrative action alone.

Concrete steps

Decision-makers should take the following three steps to increase clinical trial transparency and make the sector more accountable to citizens, patients, taxpayers, and investors:

Step 1: Ensure that publicly funded clinical trials are transparently reported
As a first step, political decision-makers should require all public research funding bodies within their jurisdiction to adopt and expand on World Health Organization transparency standards for disclosure of clinical trial findings, and ensure that they are fully implemented. Taking this simple first step would deliver significant gains at minimal cost.

Step 2: Enforce existing rules for clinical trials reporting
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 greater accountability into the sector.

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, across all five pillars of clinical trial transparency.

For more information about the study, contact lead author, Till Brucker, founder of TranspariMED, tillbruckner@gmail.com