Transparency International Austria has launched the German language translation of the study "Clinical Trial Transparency: A Guide for Decision Makers" in order to put the issue onto the map of policy makers in German speaking countries.
"The guide is aimed at helping governments to fully implement the right of patients, doctors and scientists to access scientific data," TI Austria explains on its website.
The study documents the stunning human and financial costs of opacity in the sector, and sets out clear policy recommendations for resolving the issue.
Gerald Gartlehner, the director of Cochrane Austria, gave the keynote address at the launch, which was hosted by Vienna Medical University [Medizinische Universität Wien]. The launch event brought together anti-corruption experts, academic researchers, and policy experts with representatives from the pharmaceutical industry and the Organisation of Austrian Social Security.
The study recommends that 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 original English language version of the study was lead written by Till Bruckner, founder of TranspariMED, and launched by Transparency International jointly with Cochrane, CRIT and TranspariMED in London in December 2017.