[e-drug] RFI: clinical trials in India

e-drug
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E-DRUG: RFI: clinical trials in India
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I am looking for information on both the grow and actual execution of
clinical trials in India during the past five years --by both foreign and
local drug firms. I am especially interested in subject recruitment by
CRO's, scale of payment of subjects, and anyone who has any information on
challenges to conducting trials ethically.

I am writing an article on the out-sourcing of clinical trials to
developing countries as part of a Society for Medical Anthropology Task
force that is taking a balanced look at this phenomena and looking to see
how this may be done better --both locally and internationally. I want to
use India as one of our case studies. I would appreciate any information or
ideas anyone could share with me and will be in India in the spring if
anyone would like to talk further or possibly in person.

Thanks

Mark Nichter
Mnichter@u.arizona.edu

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E-DRUG: Ethics of clinical trials in developing countries
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Hi Mark

We in our organisation have a special interest in the ethics of
research in developing countries and and have been trying to develop
our policy. Ethical issues have been discussed on e-drug before too.

But one issue we have discussed is the ethics committee that OKs a
trial or research study. Is it appropriate for an ethics committee
from university or other body in a 'developed' country to make the
decision?

It has been argued that there are international standards for such
ethics committees and they are much higher than the standards in the
'developing' country. That may or may not be. However here are some
issues that might not be considered in the development of trials and
studies.

- Issues associated with consultation and collaboration
- Issues associated with data collection, ownership and access
- Methodological approaches and feasibility in the particular setting
- Strategies for dissemination of findings.

Could there be an appropriate 'partner' ethics committee in the local setting?

I would be really interested in your response, and responses from
others of course.

Beverley Snell

--
Beverley Snell
Centre for International Health
Macfarlane Burnet Institute for Medical Research & Public Health
GPO Box 2284, Melbourne 3001 Australia
http://www.burnet.internationalhealth.edu.au
Telephone 613 9282 2115 / 9282 2275
Fax 61 3 9282 2144 or 9282 2100
Time zone: 10 hours ahead of GMT.
email <bev@burnet.edu.au>
Site: Alfred Medical Research & Education Precinct (AMREP),
corner Punt & Commercial Roads, Prahran 3181

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E-DRUG: Ethics of clinical trials in developing countries (2)
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Dear Mark and Beverly,

Re:
- Issues associated with consultation and collaboration
- Issues associated with data collection, ownership and access
- Methodological approaches and feasibility in the particular setting
- Strategies for dissemination of findings.

It could well be argued, and I have heard it effectively argued by a number
of aboriginal communities/leaders here in Canada, that unless the
"community" is involved in participating in decisions related to the four
points you identified (for any kind of research including clinical trials)
the research cannot be considered "ethical".

I work next door to an interesting university-based and community-focused
organization. It is committed to fostering communication among aboriginal
communities, researchers and health professionals, increasing research
partnerships with communities, and providing examples of best research
practices and outcomes. i.e. ACADRE (Aboriginal capacity and developmental
research environments partners) http://www.acadre.ualberta.ca/ - Director
Mary Gibson.

This group recently received a major grant from a national research agency
and is now producing a low cost and interesting quarterly journal
(Pimatziwin) with input from researchers, community leaders, and health
professionals - which discusses such issues.
I am also told have have developed some new ethical frameworks reflecting
best practices for dealing with research proposals.

Personally, I find it both interesting and ironic that this cultural group
(Canadian aboriginals) which has the least clout or capacity in our society
in many ways, is the one standing up for genuine ethical research on behalf
of all potential research participants. Makes one wonder just who are the
"developed" and the "developing" groups in our society really are. . .

At the same time, one might also question the practices of research review
boards in "developed countries". Busy and hurried volunteer research ethics
boards often have their own unique problems and pressures. There have been
a number of articles in the print media in Canada during this past year by
a National Post reporter, Margaret Munroe. She has uncovered many
disturbing issues related to sloppy practices by research ethics boards and
a lack of regulatory oversight related to clinical trials in Canada.

Hope this is helpful.

Wendy Armstrong
Community-University Partnership
For the Study of Children, Youth and Families
University of Alberta
Edmonton, Alberta, Canada

Wendy Armstrong
Edmonton, Alberta
(780) 454-9450
E-mail: wlarmstr@telusplanet.net

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E-DRUG: Ethics of clinical trials in developing countries (3)
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dear E-druggers,

It seems to me that there may be a chicken and egg problem here - I would
argue that it would be very desirable for there to be "local ethics
committee" approval for wherever the study is conducted. In the USA this is
required so that both my institution's ethics committee and the ethics
committees at all of the performance sites must approve the protocol. It is
common for local committees to add additional stipulations. If the research
is supported by the NIH it is mandatory that there be local approval even if
the performance site is outside of the USA.

In developing countries how prevalent are ethics committees? What if the
study is not being conducted at a major medical institution - are there
applicable committees? In the USA there are commercial ethics committees
which will review protocols for private practitioners who may not be under
the jurisdiction of any institutional ethics committee. Are there similar
resources available in developing countries?

-phil

J. Philip Miller, Professor of Biostatistics
Washington University School of Medicine
Director of Biostatistics Core, Siteman Cancer Center
Mail: Campus Box 8067, 660 S. Euclid Ave
St. Louis, MO 63110
Physical Address: 3349 Barnard
Phone: 314-362-3617, 314-362-3728 (fax)
email: jphilipmiller@wustl.edu
web: http://www.biostat.wustl.edu/~phil