The randomised controlled clinical trial (RCT) is hailed as one of the most revolutionary medical innovations this century. It is a method for determining the therapeutic efficacy of medicines. This thesis is a sociocultural history of how the clinical trial was made in Britain during the first half of this century. Previous histories have argued either that the RCT is simply the culmination of a very ancient history of therapeutic testing, or that it is the product of the rise of medical statistics this century. Both kinds of history focus on the medical statistician Austin Bradford Hill, who imported randomisation into the streptomycin trials of 1946-48.
This thesis, in contrast, shows what has been taken as a strictly medical methodology as part of other developments and contests in medicine and in British society. Not only does it show that all the procedural elements of the RCT were put into place before 1946, but that the stakes for defining therapeutic value were high for medical authorities such as the British Medical Association and the Ministry of Health and state bodies like the Medical Research Council. One layman, Major Chas Stevens, who took these authorities on year after year, for some thirty years, forced authorities to show what was at stake in creating a ‘standard’ system for defining the therapeutic value of medicines. This was the Dreyfus Case of the making of the clinical trial in Britain. What was at stake for these authorities was nothing short of the future of the nation. I focus on this extreme case, and I analyse three additional clinical trials in detail (ranging from the 1920s to the 1940s) to examine the moral management of
pharmaceutical companies, physicians and patients in defining expertise for therapeutic testing. These cases also show the role of state institutions in legitimising this system.
The thesis is divided into three parts. Part I, entitled Therapeutic Values, is about the battles of Major Chas Stevens with medical and state authorities in his attempts to have his tuberculosis remedy legitimated by these authorities. The case, which runs from the turn of the century to the 1940s, introduces the central figures and institutions, particularly the Medical Research Council (MRC), involved in making the clinical trial. I demonstrate that ‘character’, ‘trust’, and ‘standards’ were crucial in determining who were excluded from the MRC’s trial machinery as well as in defining expertise for determining efficacy. The themes of expertise and efficacy are developed further in Part II, Standards, Moral Management and the State, which connects them with state authority and public interest, through appeals to efficiency and standardisation on the part of an influential group of medical scientists and administrators within the MRC. I show how, in the 1920s, the highly publicised insulin trials were used to facilitate the MRC’s becoming the legal authority in the biological standardisation of therapeutic substances.
Part III of the thesis is entitled Human Machines, and shows how clinical trials were standardised and managed by the MRC’s Therapeutic Trials Committee, and how contests regarding the serum pneumococcal trials in the 1930s were crucial in defining standard trial procedure. Through a detailed examination of the 1940s mass trial of the drug Patulin for the common cold, I show how, in the context of wartime mobilisation, the system of clinical trials was mechanised. The large scale of this trial provided the statistician Major Greenwood with a unique opportunity to justify the essential role of statistical tools in managing and mechanising clinical trials. I conclude the thesis with discussion about the moral and cultural meanings of defining expertise for determining the therapeutic value of drugs within the state. I comment on the ways in which the ‘public’ had to be created in order to make a standard system for generating verdicts about the efficacy of medicines. Finally, I examine the implications of opening up this medical methodology as a cultural critique of twentieth century Britain. The Epilogue about postwar streptomycin trials connects this cultural history with the medical statistician Austin Bradford Hill’s use of ‘randomisation’ as a specifically statistical tool of mechanisation. It also points to the way in which this now famous RCT was made a monumental success in the wake of, and perhaps in part because of, the highly public failure of the mass Patulin trials. Overall, the thesis offers a novel perspective on how and why medical authorities, driven by and appealing to major national concerns, used particularly British cultural values to define a methodology for defining therapeutic efficacy, for the public good.