Int'l Network & Developing Nations

Network Will Monitor Research in Developing World

By Emily Hayes

LONDON May 30, 2002 (Reuters Health)

An international network aimed at raising ethical standards for clinical trials in developing countries is set to be formally established next month with the backing of the pharmaceutical industry.

The organisation, called SIDCER (Strategic Initiative for Developing Capacity in Ethical Review), is to be officially set up at a meeting scheduled for June 17-18 in the United States. It will act as a central fund-raising and communications body for regional forums seeking to implement new ethical standards.

SIDCER has existed on an informal basis for about 2 years. It began as part of the World Health Organisation's Tropical Disease Research (TDR) department, and led to the development of several regional ethical and educational forums covering Africa, Asia Pacific and Latin America.

Until now, organisers have devoted their spare time to the project on an ad hoc basis when their schedules permitted and there have been no full-time staff to raise the profile of the organisation and to assume responsibility for its progress. So far, SIDCER has had no fund-raising efforts and has been run on a shoe-string budget.

The new central coordinating organisation will have a full-time secretariat to run operations and for the first time will be applying for grants from non-governmental organisations, according to Juntra Karbwang, SIDCER project manager and clinical coordinator at the TDR. The change is significant because it will allow SIDCER to influence change in developing countries at a much faster pace, she said.

Initially it will be based alongside the TDR, with involvement from member groups. A business plan and budget will be created in the coming weeks and a management team will be selected at the formation meeting in mid-June. Participating organisations must approve the business plan for the official launch to go ahead, but members are in agreement about SIDCER's future and are likely to approve, Karbwang said.

In coming months, SIDCER meetings are planned in a number of countries, including Thailand and Kenya, offering health officials the opportunity to explore means of tightening their review regimes.

Industry leaders hope the network will help them avoid repeats of past media and activist claims of unethical practices in third world countries, particularly with respect to AIDS (news - web sites) drug trials in Africa.

Dr. Harvey Bale, director general of the International Federation of Pharmaceutical Manufacturers Associations, which has been closely involved with SIDCER, said the absence of national programs to monitor ethical practices means drug companies are easy targets for criticism. The issue is becoming crucial as manufacturers perform more trials in developing countries.

"No company wants to be exposed to criticism. Ethics are subjective, and there is a need in the developing world to create more comprehensive ethical review committees," he said. "We would like to avoid future problems by establishing proper reporting procedures for the conduct of clinical trials."

There are already global guidelines and national regulations to rein in manufacturers but there is a dearth of formal ethical review bodies in much of the developing world.

Aside from the risk of public relations disasters, the lack of ethical standards also has commercial ramifications. According to Bale, one drug company recently tested an important antiviral drug in a developing country, but was unable to get it approved in a developed nation because the trial standards were considered lacking.

"Industry is not interested in what one would call a free market in clinical trials. That concept is not appropriate," Bale said.

It is also in the developing world's interest to host trials, said Dr. Francis Crawley, head of the European Forum for Good Clinical Practice and SIDCER project coordinator.

"Research is very important for building healthcare systems in developing countries, but at the same time you need to ensure it is not done in a way that is disrespectful of people," he said.

Regional forums have already made headway, said Karbwang. For example, the Asia group has been instrumental in changing policy in Thailand.

Two years ago, there was no compulsory ethical review system in place in that country, Karbwang said. Pharmaceutical companies were regulated, but were providing drugs to physicians involved in unmonitored trials. Now, all investigators must submit research plans to an ethical review committee before commencing a trial.

In the past week, public health leaders in Thailand have been finalising proposals for national ethical review standards and similar reforms throughout Asia are likely, she said.

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