LONDON (Reuters Health) May 30 - 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 co-ordinating 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 co-ordinator at the TDR. The change is
significant because it will allow SIDCER to influence change in developing
countries at a much more rapid 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 drug trials in Africa.
Dr. Harvey Bale, director general of the International Federation of
Pharmaceutical Manufacturers Associations (IFPMA), 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...We would like to avoid future problems by establishing
proper reporting procedures for the conduct of clinical trials," he said.
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 PR 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 (EFGCP)
and SIDCER project co-ordinator.
"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.