WEBVTT 00:00:01.577 --> 00:00:03.573 I'd like to share with you 00:00:03.573 --> 00:00:07.410 the story of one of my patients called Celine. NOTE Paragraph 00:00:07.410 --> 00:00:10.563 Celine is a housewife and lives in a rural district 00:00:10.563 --> 00:00:13.635 of Cameroon in west Central Africa. 00:00:13.635 --> 00:00:17.322 Six years ago, at the time of her HIV diagnosis, 00:00:17.322 --> 00:00:20.323 she was recruited to participate in the clinical trial 00:00:20.323 --> 00:00:23.394 which was running in her health district at the time. 00:00:23.394 --> 00:00:27.098 When I first met Celine, a little over a year ago, 00:00:27.098 --> 00:00:28.782 she had gone for 18 months 00:00:28.782 --> 00:00:31.069 without any antiretroviral therapy, 00:00:31.069 --> 00:00:33.806 and she was very ill. 00:00:33.806 --> 00:00:36.204 She told me that she stopped coming to the clinic 00:00:36.204 --> 00:00:37.755 when the trial ended 00:00:37.755 --> 00:00:40.466 because she had no money for the bus fare 00:00:40.466 --> 00:00:44.194 and was too ill to walk the 35-kilometer distance. 00:00:44.194 --> 00:00:45.938 Now during the clinical trial, 00:00:45.938 --> 00:00:50.323 she'd been given all her antiretroviral drugs free of charge, 00:00:50.323 --> 00:00:52.354 and her transportation costs 00:00:52.354 --> 00:00:54.961 had been covered by the research funds. 00:00:54.961 --> 00:00:58.315 All of these ended once the trial was completed, 00:00:58.315 --> 00:01:01.307 leaving Celine with no alternatives. 00:01:01.307 --> 00:01:03.983 She was unable to tell me the names of the drugs 00:01:03.983 --> 00:01:06.010 she'd received during the trial, 00:01:06.010 --> 00:01:08.767 or even what the trial had been about. 00:01:08.767 --> 00:01:12.316 I didn't bother to ask her what the results of the trial were 00:01:12.316 --> 00:01:16.723 because it seemed obvious to me that she would have no clue. 00:01:16.723 --> 00:01:18.992 Yet what puzzled me most 00:01:18.992 --> 00:01:22.099 was Celine had given her informed consent 00:01:22.099 --> 00:01:25.931 to be a part of this trial, yet she clearly did not understand 00:01:25.931 --> 00:01:28.401 the implications of being a participant 00:01:28.401 --> 00:01:32.810 or what would happen to her once the trial had been completed. NOTE Paragraph 00:01:32.810 --> 00:01:36.205 Now, I have shared this story with you as an example 00:01:36.205 --> 00:01:39.134 of what can happen to participants in the clinical trial 00:01:39.134 --> 00:01:41.593 when it is poorly conducted. 00:01:41.593 --> 00:01:45.458 Maybe this particular trial yielded exciting results. 00:01:45.458 --> 00:01:49.147 Maybe it even got published in a high-profile scientific journal. 00:01:49.147 --> 00:01:51.954 Maybe it would inform clinicians around the world 00:01:51.954 --> 00:01:57.489 on how to improve on the clinical management of HIV patients. 00:01:57.489 --> 00:02:00.275 But it would have done so at a price 00:02:00.275 --> 00:02:03.222 to hundreds of patients who, like Celine, 00:02:03.222 --> 00:02:05.466 were left to their own devices 00:02:05.466 --> 00:02:08.537 once the research had been completed. NOTE Paragraph 00:02:08.537 --> 00:02:11.875 I do not stand here today to suggest in any way 00:02:11.875 --> 00:02:13.888 that conducting HIV clinical trials 00:02:13.888 --> 00:02:16.103 in developing countries is bad. 00:02:16.103 --> 00:02:20.470 On the contrary, clinical trials are extremely useful tools, 00:02:20.470 --> 00:02:22.768 and are much needed to address the burden 00:02:22.768 --> 00:02:25.239 of disease in developing countries. 00:02:25.239 --> 00:02:28.098 However, the inequalities that exist between 00:02:28.098 --> 00:02:31.800 richer countries and developing countries in terms of funding 00:02:31.800 --> 00:02:34.957 pose a real risk for exploitation, 00:02:34.957 --> 00:02:38.842 especially in the context of externally-funded research. 00:02:38.842 --> 00:02:41.448 Sadly enough, the fact remains that 00:02:41.448 --> 00:02:45.432 a lot of the studies that are conducted in developing countries 00:02:45.432 --> 00:02:48.008 could never be authorized in the richer countries 00:02:48.008 --> 00:02:50.256 which fund the research. NOTE Paragraph 00:02:50.256 --> 00:02:52.503 I'm sure you must be asking yourselves 00:02:52.503 --> 00:02:54.419 what makes developing countries, 00:02:54.419 --> 00:02:56.963 especially those in sub-Saharan Africa, 00:02:56.963 --> 00:03:00.530 so attractive for these HIV clinical trials? 00:03:00.530 --> 00:03:03.802 Well, in order for a clinical trial to generate 00:03:03.802 --> 00:03:06.918 valid and widely applicable results, 00:03:06.918 --> 00:03:10.918 they need to be conducted with large numbers of study participants 00:03:10.918 --> 00:03:13.561 and preferably on a population 00:03:13.561 --> 00:03:17.342 with a high incidence of new HIV infections. 00:03:17.342 --> 00:03:20.813 Sub-Saharan Africa largely fits this description, 00:03:20.813 --> 00:03:24.015 with 22 million people living with HIV, 00:03:24.015 --> 00:03:27.655 an estimated 70 percent of the 30 million people 00:03:27.655 --> 00:03:30.136 who are infected worldwide. 00:03:30.136 --> 00:03:32.566 Also, research within the continent 00:03:32.566 --> 00:03:36.678 is a lot easier to conduct due to widespread poverty, 00:03:36.678 --> 00:03:40.529 endemic diseases and inadequate health care systems. 00:03:40.529 --> 00:03:43.318 A clinical trial that is considered to be 00:03:43.318 --> 00:03:46.068 potentially beneficial to the population 00:03:46.068 --> 00:03:48.375 is more likely to be authorized, 00:03:48.375 --> 00:03:51.175 and in the absence of good health care systems, 00:03:51.175 --> 00:03:54.129 almost any offer of medical assistance 00:03:54.129 --> 00:03:57.047 is accepted as better than nothing. 00:03:57.047 --> 00:03:59.633 Even more problematic reasons include 00:03:59.633 --> 00:04:01.920 lower risk of litigation, 00:04:01.920 --> 00:04:04.387 less rigorous ethical reviews, 00:04:04.387 --> 00:04:06.943 and populations that are willing to participate 00:04:06.943 --> 00:04:11.607 in almost any study that hints at a cure. 00:04:11.607 --> 00:04:15.232 As funding for HIV research 00:04:15.232 --> 00:04:17.488 increases in developing countries 00:04:17.488 --> 00:04:21.495 and ethical review in richer countries become more strict, 00:04:21.495 --> 00:04:23.580 you can see why this context becomes 00:04:23.580 --> 00:04:26.141 very, very attractive. NOTE Paragraph 00:04:26.141 --> 00:04:29.821 The high prevalence of HIV drives researchers 00:04:29.821 --> 00:04:34.305 to conduct research that is sometimes scientifically acceptable 00:04:34.305 --> 00:04:37.584 but on many levels ethically questionable. 00:04:37.584 --> 00:04:41.023 How then can we ensure that, in our search for the cure, 00:04:41.023 --> 00:04:43.343 we do not take an unfair advantage 00:04:43.343 --> 00:04:46.847 of those who are already most affected by the pandemic? 00:04:46.847 --> 00:04:50.703 I invite you to consider four areas I think we can focus on 00:04:50.703 --> 00:04:54.278 in order to improve the way in which things are done. NOTE Paragraph 00:04:54.278 --> 00:04:57.105 The first of these is informed consent. 00:04:57.105 --> 00:04:59.473 Now, in order for a clinical trial to be 00:04:59.473 --> 00:05:03.154 considered ethically acceptable, 00:05:03.154 --> 00:05:05.978 participants must be given the relevant information 00:05:05.978 --> 00:05:08.413 in a way in which they can understand, 00:05:08.413 --> 00:05:12.630 and must freely consent to participate in the trial. 00:05:12.630 --> 00:05:15.308 This is especially important in developing countries, 00:05:15.308 --> 00:05:18.210 where a lot of participants consent to research 00:05:18.210 --> 00:05:20.898 because they believe it is the only way in which 00:05:20.898 --> 00:05:24.468 they can receive medical care or other benefits. 00:05:24.468 --> 00:05:27.435 Consent procedures that are used in richer countries 00:05:27.435 --> 00:05:30.237 are often inappropriate or ineffective 00:05:30.237 --> 00:05:32.590 in a lot of developing countries. 00:05:32.590 --> 00:05:35.563 For example, it is counterintuitive to have 00:05:35.563 --> 00:05:38.562 an illiterate study participant, like Celine, 00:05:38.562 --> 00:05:41.889 sign a lengthy consent form that they are unable to read, 00:05:41.889 --> 00:05:43.996 let alone understand. 00:05:43.996 --> 00:05:47.076 Local communities need to be more involved 00:05:47.076 --> 00:05:50.349 in establishing the criteria for recruiting participants 00:05:50.349 --> 00:05:55.050 in clinical trials, as well as the incentives for participation. 00:05:55.050 --> 00:05:56.866 The information in these trials 00:05:56.866 --> 00:05:59.817 needs to be given to the potential participants 00:05:59.817 --> 00:06:04.245 in linguistically and culturally acceptable formats. NOTE Paragraph 00:06:04.245 --> 00:06:07.066 The second point I would like for you to consider 00:06:07.066 --> 00:06:09.504 is the standard of care that is provided 00:06:09.504 --> 00:06:12.450 to participants within any clinical trial. 00:06:12.450 --> 00:06:16.147 Now, this is subject to a lot of debate and controversy. 00:06:16.147 --> 00:06:19.128 Should the control group in the clinical trial 00:06:19.128 --> 00:06:22.401 be given the best current treatment which is available 00:06:22.401 --> 00:06:24.481 anywhere in the world? 00:06:24.481 --> 00:06:27.449 Or should they be given an alternative standard of care, 00:06:27.449 --> 00:06:30.337 such as the best current treatment available 00:06:30.337 --> 00:06:33.649 in the country in which the research is being conducted? 00:06:33.649 --> 00:06:36.989 Is it fair to evaluate a treatment regimen 00:06:36.989 --> 00:06:40.065 which may not be affordable or accessible 00:06:40.065 --> 00:06:44.035 to the study participants once the research has been completed? 00:06:44.035 --> 00:06:47.776 Now, in a situation where the best current treatment 00:06:47.776 --> 00:06:50.415 is inexpensive and simple to deliver, 00:06:50.415 --> 00:06:52.443 the answer is straightforward. 00:06:52.443 --> 00:06:55.593 However, the best current treatment available 00:06:55.593 --> 00:06:58.480 anywhere in the world is often very difficult 00:06:58.480 --> 00:07:01.167 to provide in developing countries. 00:07:01.167 --> 00:07:04.719 It is important to assess the potential risks and benefits 00:07:04.719 --> 00:07:07.496 of the standard of care which is to be provided 00:07:07.496 --> 00:07:09.977 to participants in any clinical trial, 00:07:09.977 --> 00:07:15.425 and establish one which is relevant for the context of the study 00:07:15.425 --> 00:07:18.922 and most beneficial for the participants within the study. NOTE Paragraph 00:07:18.922 --> 00:07:22.173 That brings us to the third point I want you think about: 00:07:22.173 --> 00:07:25.024 the ethical review of research. 00:07:25.024 --> 00:07:28.823 An effective system for reviewing the ethical suitability 00:07:28.823 --> 00:07:32.951 of clinical trials is primordial to safeguard participants 00:07:32.951 --> 00:07:35.064 within any clinical trial. 00:07:35.064 --> 00:07:37.976 Unfortunately, this is often lacking 00:07:37.976 --> 00:07:41.504 or inefficient in a lot of developing countries. 00:07:41.504 --> 00:07:45.867 Local governments need to set up effective systems 00:07:45.867 --> 00:07:48.744 for reviewing the ethical issues around the clinical trials 00:07:48.744 --> 00:07:52.661 which are authorized in different developing countries, 00:07:52.661 --> 00:07:54.935 and they need to do this by setting up 00:07:54.935 --> 00:07:57.445 ethical review committees that are independent 00:07:57.445 --> 00:08:00.830 of the government and research sponsors. 00:08:00.830 --> 00:08:03.240 Public accountability needs to be promoted 00:08:03.240 --> 00:08:06.473 through transparency and independent review 00:08:06.473 --> 00:08:09.512 by nongovernmental and international organizations 00:08:09.512 --> 00:08:11.083 as appropriate. NOTE Paragraph 00:08:11.083 --> 00:08:14.593 The final point I would like for you to consider tonight 00:08:14.593 --> 00:08:17.816 is what happens to participants in the clinical trial 00:08:17.816 --> 00:08:20.591 once the research has been completed. 00:08:20.591 --> 00:08:24.065 I think it is absolutely wrong for research to begin 00:08:24.065 --> 00:08:26.577 in the first place without a clear plan 00:08:26.577 --> 00:08:28.656 for what would happen to the participants 00:08:28.656 --> 00:08:31.096 once the trial has ended. 00:08:31.096 --> 00:08:36.224 Now, researchers need to make every effort to ensure that 00:08:36.224 --> 00:08:39.208 an intervention that has been shown to be beneficial 00:08:39.208 --> 00:08:40.940 during a clinical trial 00:08:40.940 --> 00:08:44.552 is accessible to the participants of the trial 00:08:44.552 --> 00:08:47.100 once the trial has been completed. 00:08:47.100 --> 00:08:50.624 In addition, they should be able to consider the possibility 00:08:50.624 --> 00:08:54.225 of introducing and maintaining effective treatments 00:08:54.225 --> 00:08:58.066 in the wider community once the trial ends. 00:08:58.066 --> 00:09:01.489 If, for any reason, they feel that this might not be possible, 00:09:01.489 --> 00:09:04.456 then I think they should have to ethically justify 00:09:04.456 --> 00:09:08.483 why the clinical trial should be conducted in the first place. NOTE Paragraph 00:09:08.483 --> 00:09:10.799 Now, fortunately for Celine, 00:09:10.799 --> 00:09:13.474 our meeting did not end in my office. 00:09:13.474 --> 00:09:17.848 I was able to get her enrolled into a free HIV treatment program 00:09:17.848 --> 00:09:19.236 closer to her home, 00:09:19.236 --> 00:09:23.010 and with a support group to help her cope. 00:09:23.010 --> 00:09:25.344 Her story has a positive ending, 00:09:25.344 --> 00:09:29.047 but there are thousands of others in similar situations 00:09:29.047 --> 00:09:31.344 who are much less fortunate. NOTE Paragraph 00:09:31.344 --> 00:09:33.768 Although she may not know this, 00:09:33.768 --> 00:09:37.633 my encounter with Celine has completely changed the way 00:09:37.633 --> 00:09:41.904 in which I view HIV clinical trials in developing countries, 00:09:41.904 --> 00:09:45.624 and made me even more determined to be part of the movement 00:09:45.624 --> 00:09:48.481 to change the way in which things are done. NOTE Paragraph 00:09:48.481 --> 00:09:50.849 I believe that every single person 00:09:50.849 --> 00:09:55.224 listening to me tonight can be part of that change. 00:09:55.224 --> 00:09:57.821 If you are a researcher, I hold you 00:09:57.821 --> 00:10:00.391 to a higher standard of moral conscience, 00:10:00.391 --> 00:10:02.818 to remain ethical in your research, 00:10:02.818 --> 00:10:06.306 and not compromise human welfare in your search for answers. 00:10:06.306 --> 00:10:09.984 If you work for a funding agency or pharmaceutical company, 00:10:09.984 --> 00:10:13.014 I challenge you to hold your employers 00:10:13.014 --> 00:10:16.189 to fund research that is ethically sound. 00:10:16.189 --> 00:10:19.375 If you come from a developing country like myself, 00:10:19.375 --> 00:10:22.447 I urge you to hold your government 00:10:22.447 --> 00:10:25.063 to a more thorough review of the clinical trials 00:10:25.063 --> 00:10:27.976 which are authorized in your country. 00:10:27.976 --> 00:10:31.644 Yes, there is a need for us to find a cure for HIV, 00:10:31.644 --> 00:10:34.296 to find an effective vaccine for malaria, 00:10:34.296 --> 00:10:38.138 to find a diagnostic tool that works for T.B., 00:10:38.138 --> 00:10:41.713 but I believe that we owe it to those who willingly 00:10:41.713 --> 00:10:45.768 and selflessly consent to participate in these clinical trials 00:10:45.768 --> 00:10:47.994 to do this in a humane way. NOTE Paragraph 00:10:47.994 --> 00:10:50.321 Thank you.