The World Health Organisation (WHO) has asked pharmaceutical companies and other organisations sponsoring clinical trials to register every one – including the earliest studies - in a centralised database.
But industry groups are concerned that the move could put a brake on R&D in certain fields if companies feel they have to make public sensitive information which could help their competitors.
The WHO has drawn up a 20-point check-list of information that should be included in any registry of trials, and has developed a registry platform that would provide a web-based portal, giving a single point of access to the several hundred registers currently being operated around the world. To qualify for inclusion, those registries would have to adopt the standards asked for by the WHO.
The pharmaceutical industry has already made efforts to make its clinical research more transparent, in the wake of a high-profile case in 2004, in which GlaxoSmithKline was accused by US attorney general Eliot Spitzer of withholding the results of negative clinical trials of its Paxil (paroxetine) antidepressant in children and adolescents.
GSK eventually paid $2.5 million to settle the claims and set up a registry of its own clinical trials, as the withdrawal from the market of Merck & Co’s Vioxx (rofecoxib) increased concerns about drug safety and the pressure on companies to adopt a policy of full disclosure. Other companies followed suit, and in January 2005 the world's major pharmaceutical industry trade associations from Europe, Japan and the USA announced they were setting up registries for their members.
However, in most cases only Phase II to IV trials involving patients are included, and the WHO feels it is also important to extend these registration efforts to exploratory studies involving healthy volunteers.
"Registration of all clinical trials and full disclosure of key information at the time of registration are fundamental to ensuring transparency in medical research and fulfilling ethical responsibilities to patients and study participants," said Dr Timothy Evans, Assistant Director-General of the WHO.
Dr Evans told a press conference that if the registry had been operating ahead of Vioxx’ withdrawal from the market, it is possible that its propensity to increase the risk of heart attacks and stroke might have been identified. The initiative could also cut down on unnecessary work by avoiding duplication of studies, he suggested.
The agency claims to have the support of the drug industry for its proposals, but at least one industry body, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), has reservations about the new initiative.
While it welcomed the WHO’s actions in this area, the IFPMA said requiring registration of early exploratory trials could ‘slow development or even prevent innovation in certain cases, without providing ... benefit to doctors and patients’.
This viewpoint was echoed by Roche, which operates its own register but excludes early Phase I studies ‘to avoid confusing healthcare providers and creating false expectations for patients suffering from serious diseases’.
Most medicines tested in these first human studies never progress to marketed compounds and these exploratory clinical trials generally do not generate data which are later used to support clinical claims or recommendations for use, according to the company, which added that any relevant findings are published in peer reviewed journals.
“The industry, represented at international level by the IFPMA and at EU level by the European Federation of Pharmaceutical Industries and Associations (EFPIA), has already done much to increase clinical trials transparency and stands ready to play a full and active part in discussions with the WHO and other stakeholders,” commented IFPMA Director General Dr Harvey Bale.
The WHO check-list would cover funding and sponsorship contact information, current recruitment status, the countries participating in the study’ the health conditions, the specific name of the intervention, expected outcomes, and participation criteria.
“Some groups have raised concerns that these new requirements could jeopardise academic or commercial competitive advantage if they apply to preliminary trials of new interventions,” said the WHO in a statement.
Similar concerns have been voiced about the requirement to disclose certain items, such as the scientific title of the study, the name of the treatment being tested and the outcomes expected from the study, at the time of registration, it said.
Ida Sim, the coordinator of the Registry Platform initiative, claimed these concerns were being taken into account. "Our aim is to make clinical research transparent and enhance public trust in science, but we are engaged in a fair and open process with all stakeholders. We look forward to continued dialogue about trial registration and results reporting as we move forward with the Registry Platform," she said.
Meanwhile, Peter Pitts of the industry-backed Center for Medicines in the Public Interest, in an online blog, described the aim of registering all clinical trials "whether marketed or not; whether randomized or not; and whether early phase or late phase" as absurd. He added that the move was of "doubtful public benefit" and harmful to the intellectual property rights of drugmakers.