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I'd like to share with you the story of one of my patients called Selene.
Selena is a housewife and lives in a rural district of Cameroon in west Central Africa.
Six years ago, at the time of her HIV diagnosis, she was recruited to participate in the clinical trial, which was running in her health district at the time.
When I first met Selena little over a year ago, she had gone for 18 months without any antiretroviral therapy, and she was very ill.
She told me that she stopped coming to the clinic when the trial ended because she had no money for the bus fare and was too ill to walk the 35 kilometer distance.
Now, during the clinical trial, she'd been given all her antiretroviral drugs free of charge, and her transportation costs had been covered by the research funds.
All of these ended once the trial was completed, leaving Celine with no alternatives.
She was unable to tell me the names of the drugs should receive during the trial, or even what the trial had been about.
I didn't bother to ask her what the results of the trial, where because it seemed obvious to me that she would have no clue.
Yet.
What puzzled me most was Selene had given her informed consent to be a part of this trial.
Yet she clearly did not understand the implications of being a participant or what would happen to her once the trial had been completed.
Now I have shared this story with you as an example of what can happen to participants in the clinical trial when it is poorly conducted.
Maybe this particular trial yielded exciting results, maybe even got published in a high profile scientific journal.
Maybe it would inform clinicians around the world on how to improve on the HIV on the clinical management of HIV patients, but it would have done so at a price to hundreds of patients who, like Celine, were left to their own devices once the research had been completed.
I do not stand here today to suggest in any way that conducting HIV clinical trials in developing countries is bad.
On the contrary, clinical trials are extremely useful tools and a much needed to address the burden of disease in developing countries.
However, the inequalities that exists between richer countries and developing countries in terms of funding pose a real risk for exploitation, especially in the context of externally funded research.
Sadly enough, the fact remains that Ah, lot of the studies that are conducted in developing countries could never be authorized in the richer countries which fund the research.
I'm sure you must be asking yourselves what makes developing countries, especially those in sub Saharan Africa, so attractive for these HIV clinical trials?
Well, in order for a clinical trial to generate valid and widely applicable results, they need to be conducted with large numbers of study participants and preferably on a population with a high incidence of new HIV infections.
Sub Saharan Africa largely fits this description.
With 22 million people living with HIV.
An estimated 70% of the 30 million people who are infected worldwide also research within the continent.
It's a lot easier to conduct due to widespread poverty, endemic diseases and inadequate health care systems.
A clinical trial that is considered to be potentially beneficial to the population is more likely to be authorized, and in the absence of good health care systems, almost any offer of medical assistance is accepted as better than nothing.
Even more problematic, reasons include lower risk of litigation, less rigorous ethical reviews and populations that are willing to participate in almost any study that hints at a cure.
As funding for HIV research increases in developing countries, an ethical review in richer countries become more strict.
You can see why this context becomes very, very attractive.
The high prevalence of HIV drives researchers to conduct research that is sometimes scientifically acceptable but on many levels, ethically questionable.
How, then, can we ensure that in our search for the cure, we do not take an unfair advantage of those who already most affected by the pandemic?
I invite you to consider four areas I think we can focus on in other to improve the way in which things are done.
The first of these is informed consent.
Now, in order for a clinical trial to be ethically considered ethically acceptable, participants must be given the relevant information in a way in which they can understand and must freely consent to participate in the trial.
This is especially important in developing countries.
Well, lot of participants consent to research because they believe it is the only way in which they can receive medical care or other benefits.
Consent procedures that are used in richer countries are often inappropriate or ineffective.
In a lot of developing countries, for example, it is counterintuitive to have an illiterate study participant like Celine sign a lengthy consent form that they are unable to read, let alone understand.
Local communities need to be more involved in establishing the criteria for recruiting participants in clinical trials, as well as the incentives for participation.
The information in these trials needs to be given to the potential participants in linguistically and culturally acceptable formats.
The second point I would like for you to consider is the standard of care that is provided to participants within any clinical trial.
Now this is subject to a lot of debate and controversy.
Should the control group in the clinical trial be given the best current treatment, which is available anywhere in the world, or should they be given an alternative standard of care, such as the best current treatment available in the country in which the research is being conducted?
Is it fair to evaluate a treatment regimen which may not be affordable or accessible to the study participants?
Once the research has been completed, Now, in a situation where the best current treatment is inexpensive and simple to deliver, the answer is straight forward.
However, the best current treatment available anywhere in the world is often very difficult to provide in developing countries.
It is important to assess the potential risk and benefits off the standard of care, which is to be provided to participants in any clinical trial and establish one which is relevant for the study.
Look for the context of the study and most beneficial for the participants within the study.
That brings us to the third point.
I want you to think about the Ethical Review of Research.
An effective system for reviewing the ethical suitability of clinical trials is primordial to safeguard participants within any clinical trial.
Unfortunately, this is often lacking or inefficient in a lot of developing countries.
Local governments need to set up effective systems for reviewing the ethical issues around the clinical trials which are authorized in different developing countries, and they need to do this by setting up ethical review committees that are independent of the government and research sponsors.
Public accountability needs to be promoted through transparency.
An independent review by non governmental and international organizations as appropriate.
The final point I would like for you to consider tonight is what happens to participants in the clinical trial once the research has been completed.
I think it is absolutely wrong for research to begin in the first place without a clear plan for what would happen to the participants once the trial has ended.
Now researchers need to make every effort to ensure that an intervention that has been shown to be beneficial during a clinical trial is US accessible to the participants of the trial once the trial has been completed.
In addition, they should be able to consider the possibility of introducing and maintaining effective treatments in the wider community once the trial ends.
If for any reason they feel that this might not be possible, then I think they should have to ethically justify why the clinical trial should be conducted in the first place Now, fortunately for Celine, our meeting did not end in my office.
I was able to get her enrolled into a free HIV treatment program closer to her home and with a support group to help her cope.
Her story has a positive ending, but there are thousands of others in similar situations who are much less fortunate.
Although she may not know this, my encounter with Celine has completely changed the way in which I view HIV clinical trials in developing countries and made me even more determined to be part of the movement to change the way in which things are done.
I believe that every single person listening to me tonight can be part of that change.
If you're researcher, I hold you to a higher standard of moral conscience to remain ethical in your research and not compromise human welfare in your search for answers.
If you work for a funding agency or pharmaceutical company, I challenge you to hold your employers to fund research that is ethically sound.
If you come from a developing country like myself, I urge you to hold your government to a more thorough review of the clinical trials, which are authorized in your country.
Yes, the reason need for us to find a cure for HIV to find an effective vaccine for malaria to find a diagnostic tool that works for T.
B.
But I believe that we owe it to those who willingly and selflessly consent to participate in this clinical trials.
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Ethical riddles in HIV research - Boghuma Kabisen Titanji

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林宜悉 2020 年 7 月 3 日 に公開

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