*** Apologies for cross-posting.******
What do you want to know about clinical trial results?
The Canadian Women’s Health Network (CWHN) would like your opinion
CWHN will attend consultations on this topic in March 2008 and we are looking
for your input through the following patient/consumer survey
****Deadline March 16, 2008****
Background
Everyday we read in the paper or hear on the radio about a new medical study
that shows the benefits of a drug, medical device, test, and treatment or
preventative action. Many of these stories are based on a company press release
or medical journal report of a clinical trial, a research study designed to test
the safety and/or effectiveness of drugs, devices, treatments, or preventive
measures in humans.
But how much do we really know about all these drugs, devices, treatments and
preventative measures when companies and researchers are not obliged to make
the detailed results available for public scrutiny and evaluation? While some
companies and research centers do make such results available, others do not.
Many people in Canada agree that the results of all clinical trials should be
publicly available on the Web, but how should they be reported and presented?
The Ottawa Group recommends that detailed results, including raw data (i.e.,
individual participant datasets) should be posted to the Web, while journal
editors suggest that only a 500-word summary of the trial results should be
posted.
Please take a few minutes to complete the following survey...
Instructions: Copy these questions and paste them with your answers into an
e-mail to [log in to unmask] or simply send a message to [log in to unmask] and we will
send you the survey in the body of the e-mail.
1. In your opinion, who are clinical trial results reports for? (List up to
three groups of people you think should have access to clinical trial
results)
2. Why do you want access to clinical trial information? (i.e., how would you
use the information?)
3. What kind of information do you want? (e.g., how to become a trial
participant; whether or not the drug is available in Canada, or in other
jurisdictions; how effective it is compared with other similar drugs; what the
possible adverse effects are; what the impacts are specifically for women, for
children.)
4. What kind of detail do you want? (e.g., brief summary; journal article;
analyzed data tables, including sex- and gender-based analysis; anonymized
individual participant data).
5. What format would work best for you (what should the report look like)?
6. Which trials should be publicly reported? (e.g., all clinical trials; only
pre-market or post-market trials[link to definition]; controlled trials that
compare drugs with placebo; trials for serious and life-threatening
conditions).
7. When should results be reported? (e.g., within a certain time after the study
ends; after publication in a peer-reviewed journal; as soon as a drug is
licensed)
8. How should results websites be checked / monitored? (e.g., do they need peer
review? can they be self-correcting? should they be audited?)
9. What are the essential features of a results website? (e.g., free access,
language preference, should advertising be permitted?)
10. Who should administer reporting websites? (e.g., consumer groups, government
agencies, charities, NGOs, drug companies)
11. Who should fund reporting websites? (e.g., consumer groups, government
agencies, charities, NGOs, drug companies)
Any other comments (please add below)?
Thank you very much for your time and your feedback!
For more information, visit:
http://www.cwhn.ca/resources/kickers/clinical_trial_suvey.htm
--
Mona Dupré-Ollinik
Coordonnatrice de liaison/Outreach Coordinator
203-419 avenue Graham Ave
Winnipeg MB R2J 1W6
Tel: 204-942-5500 ext. 13
TTY: 1-866-694-6437 Local: 204-942-2806
Courriel/e-mail: [log in to unmask]
Website/site web: www.cwhn.ca
SUPPORT CWHN. BECOME A MEMBER. http://www.cwhn.ca/infoform.
APPUYEZ LE RCSF. DEVENEZ MEMBRE. http://www.cwhn.ca/infoform_f.
This e-mail may be privileged and/or confidential from the Canadian Women's
Health Network (CWHN). If you received this e-mail in error, please advise (by
return e-mail or otherwise) immediately.
-----------------------
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femmes (RCSF). Si vous recevez ce courriel par erreur, veuillez en aviser
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