This thesis arose from a desire to explore the reasons for two related phenomena: why randomisation wasn’t introduced into clinical trials before the 1940s, and why in 1947 it was. In seeking to answer these questions, this study focuses on the development of clinical trials in Britain from the mid-nineteenth century to the MRC streptomycin trial published in 1948.
Control groups and quasi-random allocation and were known to British clinicians in the nineteenth century, well before they became formalised in statistical theory. Chapter two argues that the collective therapeutic enquiries of the 1860s were an attempt to reform the medical profession in the light of the deficiencies of the 1858 Medical Act. Reform in this context was an attempt to create an ‘ideal practitioner’, defined here as one who used a statistical style of knowledge to guide both medical practice and medical etiquette. However, methodological elements such as control groups were largely irrelevant to this enterprise.
Collective enquiries were overshadowed by the possibility of an exact knowledge of therapeutic action. Drugs such as diphtheria anti-toxin and Salvarsan, both products of German laboratories, mark the beginning of the modern era of therapeutics. Clinical trials played a secondary role in the development and testing of such drugs. Biological standardisation offered a powerful way for drug companies, research laboratories, and state authorities to promote and regulate the new laboratory based drugs.
At the British Medical Research Council, physiological research in a laboratory was regarded as the desirable way to test new drugs. As a result, clinical trials organised by the MRC in the 1930s are historically inconsequential. Nevertheless, they played a role in consolidating the position of the MRC as the leading medical research organisation in Britain at a time when pharmaceutical companies were beginning to produce a range of new therapies.
The organisational challenges facing the MRC in the immediate post-war period were changed considerably by the coming of the NHS. Adoption of a more strictly designed form of randomised controlled trial offered the MRC some specific advantages when dealing with a drug such as streptomycin. Using unpublished archival sources, the organisation of the streptomycin trial is reconstructed, and the organisational advantages of an RCT design highlighted.