WHO announces new standards for registration of ALL human medical research

The World Health Organization (WHO) is urging research institutions and companies to register all medical studies that test treatments on human beings, including the earliest studies, whether they involve patients or healthy volunteers. As part of the International Clinical Trials Registry Platform, a major initiative aimed at standardizing the way information on medical studies is made available to the public through a process called registration, WHO is also recommending that 20 key details be disclosed at the time studies are begun. The initiative seeks to respond to growing public demands for transparency regarding all studies applying interventions to human participants, known as clinical trials. Before making the recommendations announced today, the Registry Platform initiative consulted with all concerned stakeholders, including representatives from the pharmaceutical, biotechnology and device industries, patient and consumer groups, governments, medical journal editors, ethics committees, and academia over a period of nearly two years.

"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 World Health Organization.

Although registration is voluntary, there is a groundswell of policies aimed at spurring registration of all clinical trials. In July 2005, for example, the International Committee of Medical Journal Editors, a group representing 11 prestigious medical journals, instituted a policy whereby a scientific paper on clinical trial results cannot be published unless the trial had been recorded in a publicly-accessible registry at its outset.

Some groups have raised concerns that these new requirements could jeopardize academic or commercial competitive advantage if they apply to preliminary trials of new interventions. 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.

"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," said Dr Ida Sim, Associate Director for Medical Informatics at the University of California, San Francisco and coordinator of the Registry Platform initiative.

The planned Registry Platform will not be a register itself, but rather will provide a set of standards for all registers. It has not only standardized what must be reported to register a trial but is creating a global trial identification system that will confer a unique reference number on every qualified trial.

Currently, there are several hundred registers of clinical trials around the world but little coordination among them. The Registry Platform seeks to bring participating registers together in a global network to provide a single point of access to the information stored in them.

Later this year, the WHO Registry Platform will launch a web-based search portal where scientists, patients, doctors, donors and anyone else who is interested can search among participating registers for clinical trials taking place or completed throughout the world.