NEW WHO STANDARDS FOR REGISTRATION OF HUMAN MEDICAL RESEARCH

The World Health Organization 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 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. 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 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.

WHO 25/2006

WORLDWIDE SHORTAGE OF DOCTORS, NURSES, AND HEALTH WORKERS - GLOBAL ALLIANCE ADDRESSES THE PROBLEM

A new global partnership that will strive to address the worldwide shortage of nurses, doctors, midwives and other health workers is launched. The Global Health Workforce Alliance will draw together and mobilize key stakeholders engaged in global health to help countries improve the way they plan for, educate and employ health workers. Its secretariat will be hosted by the World Health Organization.
Responding to the call by African Heads of State, the G-8 and the World Health Assembly for urgent solutions to the health workforce crisis, the Alliance will seek practical approaches to urgent problems such as improving working conditions for health professionals and reaching more effective agreements to manage their migration. It will also serve as an international information hub and monitoring body.
The Alliance will start an ambitious programme - the Fast Track Training Initiative - aimed at achieving a rapid increase in the number of qualified health workers in countries experiencing shortages. The initiative will work towards that goal through five strategies:

• Mobilizing direct financial support for health training institutions, through a model similar to that of the Education for All Fast Track Initiative - a global partnership between donor and developing countries to ensure accelerated progress towards the Millennium Development Goal of universal primary education;
• Training partnerships between schools in industrialized and developing countries involving exchanges of faculty and students, with the aim of improving the education of doctors, nurses, midwives, and paraprofessional health workers, and training more of them now;
• Nurturing a new generation of academic leaders in developing countries with the support of experts in the clinical, public health, and managerial sciences from around the world;
• Developing innovative approaches to teaching in developing countries with state-of-the art teaching materials and continuing education through information and communications technology;
• Assistance with the creation of planning teams in each country facing health worker shortages, drawing on the top leadership of the major schools, whose task will be to develop a comprehensive national health workforce strategy.

Fifty-seven countries, 36 of which are in sub-Saharan Africa, have severe shortages of health workers. More than four million additional doctors, nurses, midwives, managers, and public health workers are urgently needed to fill this gap. An adequate health workforce is defined by WHO as at least 2.3 well-trained health care providers available per 1000 people and balanced in such a way as to reach 80% of the population or more with skilled birth attendance and childhood immunization. The inadequacy of the health workforce in many developing countries is a major obstacle to providing essential life-saving health services to millions of people who lack access now. Coordinated action to address this crisis at the global level, in regions, and within countries must begin now.
The Alliance will seek to spur country action implementing the ten-year health workforce plan set forth in The World Health Report 2006: Working together for health. The Report calls for national leadership to urgently formulate and implement country strategies for the health workforce, with backing by international assistance. The Global Health Workforce Alliance will bring together all the stakeholders needed to move forward on this plan with a view to sharing evidence-based practices countries can follow to expand their workforces and make them more effective.
The initial partners of the Alliance include the Bill & Melinda Gates Foundation, the Canadian International Development Agency, the European Commission, the Global Alliance for Vaccines and Immunization, the Global Equity Initiative at Harvard University, the International Council of Nurses, the New Partnership for Africa’s Development, the Norwegian Agency for Development Cooperation, the Ministry of Public Health, Thailand, Physicians for Human Rights, the World Bank, and WHO. The Government of Norway has donated US$ 3.5 million towards the Alliance’s operations during its first year. Seed money for its start-up was donated by the governments of Canada, Ireland and Sweden.

WHO 26/2006