0:00:01.577,0:00:03.573 I'd like to share with you 0:00:03.573,0:00:07.410 the story of one of my patients called Celine. 0:00:07.410,0:00:10.563 Celine is a housewife and lives in a rural district 0:00:10.563,0:00:13.635 of Cameroon in west Central Africa. 0:00:13.635,0:00:17.322 Six years ago, at the time of her HIV diagnosis, 0:00:17.322,0:00:20.323 she was recruited to participate in the clinical trial 0:00:20.323,0:00:23.394 which was running in her health district at the time. 0:00:23.394,0:00:27.098 When I first met Celine, a little over a year ago, 0:00:27.098,0:00:28.782 she had gone for 18 months 0:00:28.782,0:00:31.069 without any antiretroviral therapy, 0:00:31.069,0:00:33.806 and she was very ill. 0:00:33.806,0:00:36.204 She told me that she stopped coming to the clinic 0:00:36.204,0:00:37.755 when the trial ended 0:00:37.755,0:00:40.466 because she had no money for the bus fare 0:00:40.466,0:00:44.194 and was too ill to walk the 35-kilometer distance. 0:00:44.194,0:00:45.938 Now during the clinical trial, 0:00:45.938,0:00:50.323 she'd been given all her antiretroviral drugs free of charge, 0:00:50.323,0:00:52.354 and her transportation costs 0:00:52.354,0:00:54.961 had been covered by the research funds. 0:00:54.961,0:00:58.315 All of these ended once the trial was completed, 0:00:58.315,0:01:01.307 leaving Celine with no alternatives. 0:01:01.307,0:01:03.983 She was unable to tell me the names of the drugs 0:01:03.983,0:01:06.010 she'd received during the trial, 0:01:06.010,0:01:08.767 or even what the trial had been about. 0:01:08.767,0:01:12.316 I didn't bother to ask her what the results of the trial were 0:01:12.316,0:01:16.723 because it seemed obvious to me that she would have no clue. 0:01:16.723,0:01:18.992 Yet what puzzled me most 0:01:18.992,0:01:22.099 was Celine had given her informed consent 0:01:22.099,0:01:25.931 to be a part of this trial, yet she clearly did not understand 0:01:25.931,0:01:28.401 the implications of being a participant 0:01:28.401,0:01:32.810 or what would happen to her once the trial had been completed. 0:01:32.810,0:01:36.205 Now, I have shared this story with you as an example 0:01:36.205,0:01:39.134 of what can happen to participants in the clinical trial 0:01:39.134,0:01:41.593 when it is poorly conducted. 0:01:41.593,0:01:45.458 Maybe this particular trial yielded exciting results. 0:01:45.458,0:01:49.147 Maybe it even got published in a high-profile scientific journal. 0:01:49.147,0:01:51.954 Maybe it would inform clinicians around the world 0:01:51.954,0:01:57.489 on how to improve on the clinical management of HIV patients. 0:01:57.489,0:02:00.275 But it would have done so at a price 0:02:00.275,0:02:03.222 to hundreds of patients who, like Celine, 0:02:03.222,0:02:05.466 were left to their own devices 0:02:05.466,0:02:08.537 once the research had been completed. 0:02:08.537,0:02:11.875 I do not stand here today to suggest in any way 0:02:11.875,0:02:13.888 that conducting HIV clinical trials 0:02:13.888,0:02:16.103 in developing countries is bad. 0:02:16.103,0:02:20.470 On the contrary, clinical trials are extremely useful tools, 0:02:20.470,0:02:22.768 and are much needed to address the burden 0:02:22.768,0:02:25.239 of disease in developing countries. 0:02:25.239,0:02:28.098 However, the inequalities that exist between 0:02:28.098,0:02:31.800 richer countries and developing countries in terms of funding 0:02:31.800,0:02:34.957 pose a real risk for exploitation, 0:02:34.957,0:02:38.842 especially in the context of externally-funded research. 0:02:38.842,0:02:41.448 Sadly enough, the fact remains that 0:02:41.448,0:02:45.432 a lot of the studies that are conducted in developing countries 0:02:45.432,0:02:48.008 could never be authorized in the richer countries 0:02:48.008,0:02:50.256 which fund the research. 0:02:50.256,0:02:52.503 I'm sure you must be asking yourselves 0:02:52.503,0:02:54.419 what makes developing countries, 0:02:54.419,0:02:56.963 especially those in sub-Saharan Africa, 0:02:56.963,0:03:00.530 so attractive for these HIV clinical trials? 0:03:00.530,0:03:03.802 Well, in order for a clinical trial to generate 0:03:03.802,0:03:06.918 valid and widely applicable results, 0:03:06.918,0:03:10.918 they need to be conducted with large numbers of study participants 0:03:10.918,0:03:13.561 and preferably on a population 0:03:13.561,0:03:17.342 with a high incidence of new HIV infections. 0:03:17.342,0:03:20.813 Sub-Saharan Africa largely fits this description, 0:03:20.813,0:03:24.015 with 22 million people living with HIV, 0:03:24.015,0:03:27.655 an estimated 70 percent of the 30 million people 0:03:27.655,0:03:30.136 who are infected worldwide. 0:03:30.136,0:03:32.566 Also, research within the continent 0:03:32.566,0:03:36.678 is a lot easier to conduct due to widespread poverty, 0:03:36.678,0:03:40.529 endemic diseases and inadequate health care systems. 0:03:40.529,0:03:43.318 A clinical trial that is considered to be 0:03:43.318,0:03:46.068 potentially beneficial to the population 0:03:46.068,0:03:48.375 is more likely to be authorized, 0:03:48.375,0:03:51.175 and in the absence of good health care systems, 0:03:51.175,0:03:54.129 almost any offer of medical assistance 0:03:54.129,0:03:57.047 is accepted as better than nothing. 0:03:57.047,0:03:59.633 Even more problematic reasons include 0:03:59.633,0:04:01.920 lower risk of litigation, 0:04:01.920,0:04:04.387 less rigorous ethical reviews, 0:04:04.387,0:04:06.943 and populations that are willing to participate 0:04:06.943,0:04:11.607 in almost any study that hints at a cure. 0:04:11.607,0:04:15.232 As funding for HIV research 0:04:15.232,0:04:17.488 increases in developing countries 0:04:17.488,0:04:21.495 and ethical review in richer countries become more strict, 0:04:21.495,0:04:23.580 you can see why this context becomes 0:04:23.580,0:04:26.141 very, very attractive. 0:04:26.141,0:04:29.821 The high prevalence of HIV drives researchers 0:04:29.821,0:04:34.305 to conduct research that is sometimes scientifically acceptable 0:04:34.305,0:04:37.584 but on many levels ethically questionable. 0:04:37.584,0:04:41.023 How then can we ensure that, in our search for the cure, 0:04:41.023,0:04:43.343 we do not take an unfair advantage 0:04:43.343,0:04:46.847 of those who are already most affected by the pandemic? 0:04:46.847,0:04:50.703 I invite you to consider four areas I think we can focus on 0:04:50.703,0:04:54.278 in order to improve the way in which things are done. 0:04:54.278,0:04:57.105 The first of these is informed consent. 0:04:57.105,0:04:59.473 Now, in order for a clinical trial to be 0:04:59.473,0:05:03.154 considered ethically acceptable, 0:05:03.154,0:05:05.978 participants must be given the relevant information 0:05:05.978,0:05:08.413 in a way in which they can understand, 0:05:08.413,0:05:12.630 and must freely consent to participate in the trial. 0:05:12.630,0:05:15.308 This is especially important in developing countries, 0:05:15.308,0:05:18.210 where a lot of participants consent to research 0:05:18.210,0:05:20.898 because they believe it is the only way in which 0:05:20.898,0:05:24.468 they can receive medical care or other benefits. 0:05:24.468,0:05:27.435 Consent procedures that are used in richer countries 0:05:27.435,0:05:30.237 are often inappropriate or ineffective 0:05:30.237,0:05:32.590 in a lot of developing countries. 0:05:32.590,0:05:35.563 For example, it is counterintuitive to have 0:05:35.563,0:05:38.562 an illiterate study participant, like Celine, 0:05:38.562,0:05:41.889 sign a lengthy consent form that they are unable to read, 0:05:41.889,0:05:43.996 let alone understand. 0:05:43.996,0:05:47.076 Local communities need to be more involved 0:05:47.076,0:05:50.349 in establishing the criteria for recruiting participants 0:05:50.349,0:05:55.050 in clinical trials, as well as the incentives for participation. 0:05:55.050,0:05:56.866 The information in these trials 0:05:56.866,0:05:59.817 needs to be given to the potential participants 0:05:59.817,0:06:04.245 in linguistically and culturally acceptable formats. 0:06:04.245,0:06:07.066 The second point I would like for you to consider 0:06:07.066,0:06:09.504 is the standard of care that is provided 0:06:09.504,0:06:12.450 to participants within any clinical trial. 0:06:12.450,0:06:16.147 Now, this is subject to a lot of debate and controversy. 0:06:16.147,0:06:19.128 Should the control group in the clinical trial 0:06:19.128,0:06:22.401 be given the best current treatment which is available 0:06:22.401,0:06:24.481 anywhere in the world? 0:06:24.481,0:06:27.449 Or should they be given an alternative standard of care, 0:06:27.449,0:06:30.337 such as the best current treatment available 0:06:30.337,0:06:33.649 in the country in which the research is being conducted? 0:06:33.649,0:06:36.989 Is it fair to evaluate a treatment regimen 0:06:36.989,0:06:40.065 which may not be affordable or accessible 0:06:40.065,0:06:44.035 to the study participants once the research has been completed? 0:06:44.035,0:06:47.776 Now, in a situation where the best current treatment 0:06:47.776,0:06:50.415 is inexpensive and simple to deliver, 0:06:50.415,0:06:52.443 the answer is straightforward. 0:06:52.443,0:06:55.593 However, the best current treatment available 0:06:55.593,0:06:58.480 anywhere in the world is often very difficult 0:06:58.480,0:07:01.167 to provide in developing countries. 0:07:01.167,0:07:04.719 It is important to assess the potential risks and benefits 0:07:04.719,0:07:07.496 of the standard of care which is to be provided 0:07:07.496,0:07:09.977 to participants in any clinical trial, 0:07:09.977,0:07:15.425 and establish one which is relevant for the context of the study 0:07:15.425,0:07:18.922 and most beneficial for the participants within the study. 0:07:18.922,0:07:22.173 That brings us to the third point I want you think about: 0:07:22.173,0:07:25.024 the ethical review of research. 0:07:25.024,0:07:28.823 An effective system for reviewing the ethical suitability 0:07:28.823,0:07:32.951 of clinical trials is primordial to safeguard participants 0:07:32.951,0:07:35.064 within any clinical trial. 0:07:35.064,0:07:37.976 Unfortunately, this is often lacking 0:07:37.976,0:07:41.504 or inefficient in a lot of developing countries. 0:07:41.504,0:07:45.867 Local governments need to set up effective systems 0:07:45.867,0:07:48.744 for reviewing the ethical issues around the clinical trials 0:07:48.744,0:07:52.661 which are authorized in different developing countries, 0:07:52.661,0:07:54.935 and they need to do this by setting up 0:07:54.935,0:07:57.445 ethical review committees that are independent 0:07:57.445,0:08:00.830 of the government and research sponsors. 0:08:00.830,0:08:03.240 Public accountability needs to be promoted 0:08:03.240,0:08:06.473 through transparency and independent review 0:08:06.473,0:08:09.512 by nongovernmental and international organizations 0:08:09.512,0:08:11.083 as appropriate. 0:08:11.083,0:08:14.593 The final point I would like for you to consider tonight 0:08:14.593,0:08:17.816 is what happens to participants in the clinical trial 0:08:17.816,0:08:20.591 once the research has been completed. 0:08:20.591,0:08:24.065 I think it is absolutely wrong for research to begin 0:08:24.065,0:08:26.577 in the first place without a clear plan 0:08:26.577,0:08:28.656 for what would happen to the participants 0:08:28.656,0:08:31.096 once the trial has ended. 0:08:31.096,0:08:36.224 Now, researchers need to make every effort to ensure that 0:08:36.224,0:08:39.208 an intervention that has been shown to be beneficial 0:08:39.208,0:08:40.940 during a clinical trial 0:08:40.940,0:08:44.552 is accessible to the participants of the trial 0:08:44.552,0:08:47.100 once the trial has been completed. 0:08:47.100,0:08:50.624 In addition, they should be able to consider the possibility 0:08:50.624,0:08:54.225 of introducing and maintaining effective treatments 0:08:54.225,0:08:58.066 in the wider community once the trial ends. 0:08:58.066,0:09:01.489 If, for any reason, they feel that this might not be possible, 0:09:01.489,0:09:04.456 then I think they should have to ethically justify 0:09:04.456,0:09:08.483 why the clinical trial should be conducted in the first place. 0:09:08.483,0:09:10.799 Now, fortunately for Celine, 0:09:10.799,0:09:13.474 our meeting did not end in my office. 0:09:13.474,0:09:17.848 I was able to get her enrolled into a free HIV treatment program 0:09:17.848,0:09:19.236 closer to her home, 0:09:19.236,0:09:23.010 and with a support group to help her cope. 0:09:23.010,0:09:25.344 Her story has a positive ending, 0:09:25.344,0:09:29.047 but there are thousands of others in similar situations 0:09:29.047,0:09:31.344 who are much less fortunate. 0:09:31.344,0:09:33.768 Although she may not know this, 0:09:33.768,0:09:37.633 my encounter with Celine has completely changed the way 0:09:37.633,0:09:41.904 in which I view HIV clinical trials in developing countries, 0:09:41.904,0:09:45.624 and made me even more determined to be part of the movement 0:09:45.624,0:09:48.481 to change the way in which things are done. 0:09:48.481,0:09:50.849 I believe that every single person 0:09:50.849,0:09:55.224 listening to me tonight can be part of that change. 0:09:55.224,0:09:57.821 If you are a researcher, I hold you 0:09:57.821,0:10:00.391 to a higher standard of moral conscience, 0:10:00.391,0:10:02.818 to remain ethical in your research, 0:10:02.818,0:10:06.306 and not compromise human welfare in your search for answers. 0:10:06.306,0:10:09.984 If you work for a funding agency or pharmaceutical company, 0:10:09.984,0:10:13.014 I challenge you to hold your employers 0:10:13.014,0:10:16.189 to fund research that is ethically sound. 0:10:16.189,0:10:19.375 If you come from a developing country like myself, 0:10:19.375,0:10:22.447 I urge you to hold your government 0:10:22.447,0:10:25.063 to a more thorough review of the clinical trials 0:10:25.063,0:10:27.976 which are authorized in your country. 0:10:27.976,0:10:31.644 Yes, there is a need for us to find a cure for HIV, 0:10:31.644,0:10:34.296 to find an effective vaccine for malaria, 0:10:34.296,0:10:38.138 to find a diagnostic tool that works for T.B., 0:10:38.138,0:10:41.713 but I believe that we owe it to those who willingly 0:10:41.713,0:10:45.768 and selflessly consent to participate in these clinical trials 0:10:45.768,0:10:47.994 to do this in a humane way. 0:10:47.994,0:10:50.321 Thank you.