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  • Translator: Joseph Geni Reviewer: Morton Bast

  • I'd like to share with you

  • the story of one of my patients called Celine.

  • Celine 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 Celine, a 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

  • she'd received during the trial,

  • or even what the trial had been about.

  • I didn't bother to ask her what the results of the trial were

  • because it seemed obvious to me that she would have no clue.

  • Yet what puzzled me most

  • was Celine 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 it even got published in a high-profile scientific journal.

  • Maybe it would inform clinicians around the world

  • on how to improve 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 are much needed to address the burden

  • of disease in developing countries.

  • However, the inequalities that exist 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

  • a 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 percent of the 30 million people

  • who are infected worldwide.

  • Also, research within the continent

  • is 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

  • and 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 are already most affected by the pandemic?

  • I invite you to consider four areas I think we can focus on

  • in order 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

  • 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,

  • where a 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 straightforward.

  • 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 risks and benefits

  • of the standard of care which is to be provided

  • to participants in any clinical trial,

  • and establish one which is relevant 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 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 and independent review

  • by nongovernmental 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 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 are a 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, there is a 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 these clinical trials

  • to do this in a humane way.

  • Thank you.

Translator: Joseph Geni Reviewer: Morton Bast

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B1 US TED clinical trial clinical trial hiv celine

【TED】Boghuma Kabisen Titanji: Ethical riddles in HIV research (Boghuma Kabisen Titanji: Ethical riddles in HIV research)

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    Zenn posted on 2017/01/03
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