1.I'd like to share with you the story of one of my patients called Celine.
我想和大家分享 關(guān)于我的病人賽琳的故事。
2.Celine is a housewife and lives in a rural district of Cameroon in west Central Africa.
賽琳是一位家庭主婦 生活在非洲中西部喀麥隆的鄉(xiāng)下。
3.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.
六年前，她被診斷患有艾滋病 她被招募參與了某個藥品的臨床實驗 實驗剛好在賽琳的圍生區(qū)進行
4.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.
一年多以前，我第一次見到賽琳 她當時已經(jīng)停止治療超過18個月了 完全停止使用抗逆轉(zhuǎn)錄病毒藥物(是一類于治療逆轉(zhuǎn)錄病毒，主要HIV感染的藥物) 她當時病的很重。
5.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.
她告訴我，自那臨床實驗結(jié)束后 就再也沒去那兒接受過治療了 因為她負擔不起巴士車費 身體也太虛弱 沒法走35公里路去診所
6.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.
在實驗進行的時候 她可以獲得免費的抗逆轉(zhuǎn)錄病毒藥物 并可以報銷交通費 這些費用統(tǒng)統(tǒng)由實驗研究承包。
7.All of these ended once the trial was completed, leaving Celine with no alternatives.
然而這一切都隨著實驗的結(jié)束而結(jié)束 只留下當時走投無路的賽琳。
8.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.
她沒法告訴我在實驗中 試過什么藥 甚至也不知道那是個什么實驗。
9.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.
我沒有再追問她實驗的結(jié)果 因為很明顯她是一頭霧水的。
10.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
然而最令我想不通的是 賽琳曾經(jīng)簽署過參與實驗的 同意書，然而她當時肯定不明白 參與臨床實驗到底意味著什么
11.or what would happen to her once the trial had been completed.
實驗結(jié)束后有會怎樣。
12.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.
現(xiàn)在，我跟你們分享的這個故事，是一個真實的 發(fā)生在參于實驗的人身上的故事 當實驗不負責任的結(jié)束之后。
13.Maybe this particular trial yielded exciting results.
也許這個實驗會獲得一些令人鼓舞的成果。
14.Maybe it even got published in a high-profile scientific journal.
也許結(jié)果會被發(fā)表在某個知名的科學期刊上。
15.Maybe it would inform clinicians around the world on how to improve on the clinical management of HIV patients.
也許它能幫助一些臨床醫(yī)生們 提升他們在艾滋病臨床管理的經(jīng)驗。
16.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.
可是這些成果都要付如此浩大的代價！ 數(shù)百名和賽琳一樣的病人 隨著實驗的結(jié)束， 他們失去了所有的幫助。
17.I do not stand here today to suggest in any way that conducting HIV clinical trials in developing countries is bad.
我今天站在這里并非要告訴大家 在發(fā)展中國家做 艾滋病臨床研究是不對的。
18.On the contrary, clinical trials are extremely useful tools, and are much needed to address the burden of disease in developing countries.
相反，要改善病人狀況，它絕對是一種行之有效的方法 而且那些發(fā)展中國家也非常需要臨床實驗來 減輕他們的醫(yī)療負擔。
19.However, the inequalities that exist between richer countries and developing countries in terms of funding pose a real risk for exploitation,
然而，我們都知道，一些存在于富國跟窮國之間 的不公平情況，尤其是資金方面 這讓研究工作帶來剝削的可能
20.especially in the context of externally-funded research.
尤其是那些來自外界投資的臨床研究。
21.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
讓人夠難過的，現(xiàn)實告訴我們 很多在發(fā)展中國家進行的研究 永遠也不會在發(fā)達國家得到授權(quán)
22.which fund the research.
并且得到投資。
23.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?
我肯定你一定會問 什么驅(qū)使這些發(fā)展中國家 特別是那些位于非洲撒哈拉沙漠的國家 被吸引去參與這些艾滋病臨床實驗？
24.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
為了讓臨床實驗獲得 人數(shù)和復蓋率過多而有令人信服的結(jié)果 大量的病人會被招募參與實驗
25.and preferably on a population with a high incidence of new HIV infections.
這些病人都優(yōu)先從 艾滋病新感染率很高的地區(qū)找來的
26.Sub-Saharan Africa largely fits this description, with 22 million people living with HIV, an estimated 70 percent of the 30 million people
非洲撒哈拉地區(qū)最能符合以上的要求 有2200萬人生活在艾滋病的陰霾中 據(jù)估算，全世界3000萬艾滋病感染人數(shù)中，
27.who are infected worldwide.
他們占70%
28.Also, research within the continent is a lot easier to conduct due to widespread poverty, endemic diseases and inadequate health care systems.
并且，在那里開展研究 還比較其他地區(qū)容易， 因為那里充斥著 貧窮，疾病以及不完善的醫(yī)療保健體系
29.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,
因此，考慮到臨床實驗 可能會給當?shù)貛韼椭?所以研究很容易就會得到授權(quán) 由于缺乏完善的醫(yī)療保健體系
30.almost any offer of medical assistance is accepted as better than nothing.
所以任何的醫(yī)療援助都很容易被接受 因為總比什么都沒有好
31.Even more problematic reasons include lower risk of litigation, less rigorous ethical reviews, and populations that are willing to participate
而且還有一些有問題的理由，像 負比較少的法律責任 比較低的道德壓力 更有大量的病人愿意加入各種類似的研究
32.in almost any study that hints at a cure.
這些臨床實驗都號稱能治好他們。
33.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
隨著越來越多的艾滋病研究 得到投資并且在發(fā)展中國家開展起來 道德審查卻在發(fā)達國家變得越來越嚴格 這就是為什么這個話題變得
34.very, very attractive.
這么的引人注目。
35.The high prevalence of HIV drives researchers to conduct research that is sometimes scientifically acceptable but on many levels ethically questionable.
艾滋病的高發(fā)病率促使研究員們 作這方面的研究，這在科學研究上是可以接受的 但在很多道德倫理方面就出現(xiàn)疑問
36.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?
我們怎么才能保證，在研究治療的過程中 不會損害那些參與實驗而 又在與疾病抗爭的病人們的利益？
37.I invite you to consider four areas I think we can focus on in order to improve the way in which things are done.
我懇請大家考慮下以下這四個方面 為了改善這個現(xiàn)狀。
38.The first of these is informed consent.
首先是要提倡參加者的知情權(quán)。
39.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,
時至今日，為了讓臨床實驗 在道德上容易被接受 參與者必須有權(quán)獲得相關(guān)的資料 而且是他們可以理解的
40.and must freely consent to participate in the trial.
必須專重參加者的參與自由。
41.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
這在發(fā)展中國家尤其重要 因為大量的參與者同意參加研究 他們相信這是他們唯一的機會
42.they can receive medical care or other benefits.
得到治療或者其他方面的幫助。
43.Consent procedures that are used in richer countries are often inappropriate or ineffective in a lot of developing countries.
然而發(fā)達國家那套用來保障知情權(quán)的方法 在很多發(fā)展中國家 基本上是形同虛設(shè)。
44.For example, it is counterintuitive to have an illiterate study participant, like Celine, sign a lengthy consent form that they are unable to read,
就拿賽琳來說吧，那簡直是荒謬的 讓一個沒受過教育的參加者 去簽一份又長又看不懂的
45.let alone understand.
同意書。
46.Local communities need to be more involved in establishing the criteria for recruiting participants in clinical trials, as well as the incentives for participation.
我們需要更多本地政府的參與 建立一套合理的參與者招募準則 須要提到臨床實驗，而不僅僅是吸引參與者。
47.The information in these trials needs to be given to the potential participants in linguistically and culturally acceptable formats.
所有跟實驗相關(guān)的信息 應該要用參加者的語言和方式 讓他們理解。
48.The second point I would like for you to consider is the standard of care that is provided to participants within any clinical trial.
我要提出的第二點是 我們應該提供治療的標準 給這些參與臨床實驗的人。
49.Now, this is subject to a lot of debate and controversy.
現(xiàn)在，這個話題帶有爭議性。
50.Should the control group in the clinical trial be given the best current treatment which is available anywhere in the world?
參與實驗的對照組病人是否也 應該得到頂級的治療 就像發(fā)達國家的病人一樣？
51.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?
或者他們應該被區(qū)別對待 只能得到進行實驗的國家的那些 所謂的頂級的治療待遇呢？
52.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?
我們是否能公正的評價一種 讓參與研究的病人們感覺遙不可及的療法 當這些療法問世的時候？
53.Now, in a situation where the best current treatment is inexpensive and simple to deliver, the answer is straightforward.
此時此刻，我們身處一個頂級醫(yī)療 觸手可及的國度 答案是明顯的。
54.However, the best current treatment available anywhere in the world is often very difficult to provide in developing countries.
然而，這些這些在發(fā)達國家 觸手可及的事情 在發(fā)展中國家卻是難如登天。
55.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,
我認為在臨床實驗中對即將提供給 臨床病人們的醫(yī)療品質(zhì) 是非常有必要進行風險評估的
56.and establish one which is relevant for the context of the study and most beneficial for the participants within the study.
這能幫助我們建立一種既不影響實驗 又能給予參與實驗的病人們最大利益的準則。
57.That brings us to the third point I want you think about: the ethical review of research.
說到準則，正好談一下我第三個觀點 希望大思考一下臨床研究的倫理審查。
58.An effective system for reviewing the ethical suitability of clinical trials is primordial to safeguard participants within any clinical trial.
一個有效的倫理審查體系 一定是以保護參與者的生命安全為出發(fā)點 在臨床實驗中。
59.Unfortunately, this is often lacking or inefficient in a lot of developing countries.
不幸的是，這在很多發(fā)展中國家 倫理審查根本就是聞所未聞的事情。
60.Local governments need to set up effective systems for reviewing the ethical issues around the clinical trials which are authorized in different developing countries,
本地政府需要建立有效的 臨床實驗倫理審查體系針對那些 在發(fā)展中國家得到授權(quán)的實驗
61.and they need to do this by setting up ethical review committees that are independent of the government and research sponsors.
并且建立起一個 獨立的倫理審查委員會 不受政府和研究贊助人的干擾。
62.Public accountability needs to be promoted through transparency and independent review by nongovernmental and international organizations
應該提倡向公眾問責的體系 通過非政府組織或國際機構(gòu)的 公開透明且獨立的
63.as appropriate.
倫理審查。
64.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.
最后我希望大家想一想 那些臨床實驗的病人 隨著實驗的結(jié)束會面對怎樣的情況。
65.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
我認為這種 一旦結(jié)束就過河拆橋的 醫(yī)學研究
66.once the trial has ended.
根本不應該開展。
67.Now, researchers need to make every effort to ensure that an intervention that has been shown to be beneficial during a clinical trial
現(xiàn)在，研究者們應該努力確保 讓那些參與實驗參的人 能夠得到妥善的安排
68.is accessible to the participants of the trial once the trial has been completed.
就像他們在參與實驗時那樣 即使在實驗完成后。
69.In addition, they should be able to consider the possibility of introducing and maintaining effective treatments in the wider community once the trial ends.
不僅如此，研究完成后，研究者們應該盡力 提供一些可行的療法 來回饋更多的病人不僅僅是曾經(jīng)參與的人。
70.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.
如果，無論什么原因，他們做不到的話 我認為他們應該從倫理上向社會交代 自己的實驗當初可以開展的理由。
71.Now, fortunately for Celine, our meeting did not end in my office.
賽琳是幸運的 我們的會面沒有在辦公室里結(jié)束。
72.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.
我?guī)退尤肓艘粋€離家很近 而是免費的艾滋病治療計劃 還有一個支持團體在幫助她對抗病魔。
73.Her story has a positive ending, but there are thousands of others in similar situations who are much less fortunate.
賽琳的故事總算有一個正面的結(jié)果 但還有成千上萬像她的病人 就沒這么幸運了。
74.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,
賽琳肯定沒想到 我們的相遇完全的改變了 我對在發(fā)展中國家進行臨床實驗的看法
75.and made me even more determined to be part of the movement to change the way in which things are done.
并且讓我下定決心，成為了改變運動的一部份 希望可以改變這些不公義的狀況。
76.I believe that every single person listening to me tonight can be part of that change.
我堅信今天晚上 在座的各位也會愿義加入成為我們的一部分。
77.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.
如果你是研究員，我請你堅持 用更高的道德標準來要求自己 摸著你的良心做研究 不要為了研究成果而犧牲他人的生命。
78.If you work for a funding agency or pharmaceutical company, I challenge you to hold your employers to fund research that is ethically sound.
如果你在資助機構(gòu)或藥品公司工作的話 我希望你建議你的老板 投資那些講良心的研究。
79.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
如果你像我一樣來自一個發(fā)展中國家 我渴望你能敦促你的政府 更加嚴謹?shù)膶彶槟切┰谀愕膰?/div>
80.which are authorized in your country.
得到授權(quán)的臨床實驗。
81.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.,
的確，我們需要可以治愈艾滋病的藥物 需要更有效的瘧疾疫苗 需要能檢測結(jié)核病菌的機器
82.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.
但是我認為我們應該更人道的 對待那些無私、自愿參與 臨床試驗的參加者。
83.Thank you.
謝謝大家。
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