Inspector Morse there would be many more.’ The student had had to promise his grandmother that he would never be out on the streets after 9pm. The greatest pleasure for anyone who has taught Oxford’s medical students is to meet those students again, years after they have qualified. There is such variety and richness in the lives and careers of our medical alumni that I find it inspiring, even in retirement. I recently met with Mehrunisha Suleman whom I remember as a lively contributor to the seminars in ethics when she was a student. She had just been appointed as the Research and Public Engagement Lead at Ethox. When I was an undergraduate, Henry Harris, later Regius Professor of Medicine, told me that the hallmark of Oxford was that most
of our teachers were also world-class researchers. Thirty years ago, when the first course in ethics for clinical students was delivered, there was little medical ethics research. The course will now be led by Suleman, a world-class researcher, with support from others in the Ethox Centre. Ethics in Oxford medicine is now mature: teaching and research are firmly integrated, together, hand-in-hand. The Ethox Centre: www.ethox.ox.ac.uk The Uehiro Centre: www.practicalethics.ox.ac.uk The Wellcome Centre for Ethics and Humanities: www.weh.ox.ac.uk GLIDE: www.oxjhubioethics.org
Staff of the Uehiro Centre. © Rocci Wilkinson
The Dark Art of Monitoring Clinical Trials Professor Tim Peto (1968 Brasenose College), Professor of Medicine and Co-Leader for the Infection Theme of the Oxford Biomedical Research Centre My Introductions into Clinical Trials My first exposure to clinical trials was in the early days of AIDS. I was a clinical lecturer to David Weatherall. In 1987, David Warrell was asked to chair an MRC Committee to advise on undertaking clinical trials on AIDS and he in turn asked me to be the ‘scientific secretary’ to the Committee. This was a role that he made up without a clear job description. I took it to mean that I could say whatever I felt like at the Committee and do nothing. Two hundred and eighty-two patients were randomised: half were given AZT and half placebo. Although only 27 patients completed the 24-week planned follow, the Data and Safety Monitoring Committee (DSMC) stopped the trial early because 19 patients had died in the placebo arm and only one in the active arm. Amidst major publicity, the world considered that AIDS was now treatable. I rang up my namesake, Richard Peto (the world’s leading clinical trialist, also in the NDM), to discuss the early stopping and he endorsed the results saying that the results were so extreme they could not have occurred by chance. As we now all know, AZT monotherapy stopped working because of the development of resistance. We in the MRC,
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together with French colleagues, undertook a trial (Concorde) to determine whether starting AZT in early disease would work better. In parallel, our US cousins undertook a similar trial. After a year, the US again stopped the trial early because of efficacy whilst our DSMC continued our trial. This difference of opinion between DSMCs triggered huge controversy, especially when two years later the final results from Concorde showed no benefit from early treatment. Five years later, triple therapy became available, providing long term benefit. My First DSMC Experience In 1990, Nick White (now Professor Sir Nick White) asked me to be the ‘WHO monitor’ of a blinded trial he was conducting in Vietnam comparing a new drug artemether with quinine (AQ study) for the treatment of severe malaria. I was delighted. I was given no instructions but was given the randomization code and asked to do the analysis myself and to advise the trialists whether to stop the study. I visited Ho Chi Minh City and checked the randomization procedure. I entered a darkened room to find an Oxford medical student crouched on the floor putting active drug into one set of boxes and placebo into another set. He assured me he was keeping careful records and not getting the boxes mixed up. He convinced me that he was the man for the job. His name was Chris Whitty. When this small study ended, there was only marginal evidence that artemether was better than quinine.
