[e-drug] Clinical trials and ethics (9)

E-DRUG: Clinical trials and ethics (9)
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Dear all,

For those promoting more ethical clinical trials in developing
countries, the following SOMO reports may be useful as background
material.

- An overview of controversial clinical trials, updated in February
2008:
http://somo.nl/publications-en/Publication_2534/view.

- A research on European Union regulations requiring that drug
authorities pay attention for clinical trial ethics when assessing
applications for approval of new drugs:
http://somo.nl/publications-en/Publication_2472/view.

Both publications refer to the Declaration of Helsinki, which provides a
global framework for clinical trial ethics and has recently been
strengthened.

In addition, for advocacy purposes, the following brochure from Wemos
Foundation may be useful:
http://www.wemos.nl/Documents/a_bitter_pill.pdf.

Best regards,

Francis Weyzig - SOMO
F.Weyzig@somo.nl

E-DRUG: Clinical trials and ethics (10)
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Dear Francis, and E-drug users,

Thank you for this.

Of what value is spending resources on poorly designed studies?
Of what value is quality data analysed by a wrong statistical test?
Of what value are conclusions arrived at by statistical tests we don't understand?

It would also be good if your organisation looked at need to examine study methods, and statistics which are used. This will be helpful.

The goal here, would be to show researchers' flaws in their proposed studies in order that appropriate ways are used. Not, neither to throw out nor condemn upcoming research. We need to encourage the researchers to spend time on developing quality work.

Then, the methods are often inappropriate.

Researchers often come to conclusions by statistical methods, which are inappropriate as well. So, we need to always remember, understand, that many statistical tests have assumptions. These are often unconsidered. Yet, when the appropriate test were to be used, there would be no significance.

And then there is this statistical test called relative risk. It is causing many to see things as if they are really big, when they aren't. We need to always ask for the absolute risk (also called attributable risk) because it expresses things the way they really are. And if there are compelling life issues to deem a low absolute risk worthy the need for intervention, so be it.

Having said this, absolute risk is causing many Ministries of Health to fund interventions which are costly. They then leave more serious problems like malaria, tuberculosis, meningitis, typhoid fever, etc. for petty issues presented as relative risk by strategic University dons as well as pharmaceutical companies.

regards,

George Kibumba Tebigwayo Kaizzi, M.Sc.
Pharmaceutical Services and Medicines Control,
Lecturer, Clinical Pharmacy Unit,
School of Health Sciences
College of Health Sciences,
Depart. of Pharmacy,
Makerere University,
P.O BOX 33543,
Kampala, Uganda.
E-mail: kibumba@yahoo.com
Mob: 256-774-110295

E-DRUG: Clinical trials and ethics (11)
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Dear E-drugers,

George Kibumba mentioned that misleading communication about evidence can
lead people, including Health Ministries, to make bad decisions. There is an excellent article about this available free:

Gerd Gigerenzer, Wolfgang Gaissmaier, Elke Kurz-Milcke, Lisa M. Schwartz,
and Steven Woloshin
Helping Doctors and Patients Make Sense of Health Statistics. Psychological
Science in the Public Interest, Volume 8, Number 2, November 2007

You may need to repair the URL:
www.psychologicalscience.org/journals/index.cfm?journal=pspi&content=pspi/8_2

--
regards,

Peter

Dr Peter R Mansfield OAM BMBS
GP
Director, Healthy Skepticism Inc
www.healthyskepticism.org
Visiting Research Fellow, University of Adelaide
www.adelaide.edu.au/directory/peter.mansfield