Evidence in interdisciplinary contexts: the value and ethics of randomised controlled trials

Randomised controlled trials (RCTs) are tests that aim to determine the effectiveness of a wide range of things that play an important role in social life, from the safety of new pharmaceutical drugs, to the benefits of economic policies geared at reducing unemployment rates. Government bodies spend considerable financial resources trying to measure the outcomes of the policies that they fund. Despite this investment, it is often hard to determine the benefit of a specific policy, as many environmental, political or social factors external to the policy itself might have contributed to a policy's outcomes. The unique benefit of RCTs is that they use control groups and techniques of randomisation in order to scientifically determine whether or not a policy has produced a specific outcome or not.

Since the 1940s, RCTs have revolutionized the way we test and regulate new pharmaceutical drugs. More recently, a second major shift has taken place: academic experts in fields beyond medicine have adopted RCT methodologies in order to evaluate different policies in law, justice services and social welfare. In development economics, there has been a growing use of 'field trials' which use principles of randomisation to appraise the effectiveness of policies in, first example, alleviating poverty, curbing discrimination, or empowering local decision-making.

Government practitioners have also embraced RCTs. A 2012 report published by the UK Cabinet Office's Behavioural Insights Team laid out nine steps towards establishing and carrying out more RCTs to inform and formulate domestic policy. It is a similar story at the international level, where standard-setting bodies such as the World Health Organization are becoming increasingly reliant on RCT evidence in order to gauge the effectiveness of different policy approaches to healthcare delivery.

Although much research within anthropology, sociology, public health, philosophy and economics has investigated these challenges, to date there has been very little inter-disciplinary discussion between fields. This series of seminars will enable cross-disciplinary engagement with the various economic, political and ethical questions that are raised by the application of RCTs in different fields of knowledge and practice. For example, in medicine and public health, multiple concerns have been raised in relation to the ethics of withholding a needed drug from a control group on trials; whether the results from one study can apply to patients beyond the participants in a trial; and how best to encourage or to legally force private companies to publically disclose all trial results. The growing uptake of RCTs in economics and public policy both reiterates these challenges and introduces new ones. This series would launch the first major investigation into the different disciplinary uses and challenges raised by RCTs in policy-making.

Planned outputs include several academic articles, two edited journal collections (with both academic and practitioner contributors); practitioner-focused pieces, an interactive website to promote the seminars and upload papers and outputs, Twitter feed and regular blog.

The seminar series will benefit a wide range of audiences, including government policy-makers, charitable organizations, UK and international funding organizations and think tanks. During the design of this research application, we have communicated closely with staff members and expert advisors at the WHO, Nuffield Council on Bioethics, Medical Research Council, each of whom has welcomed the initiative and agreed to attend and contribute to stakeholders events (see Case for Support).

The following is an indicative list of audiences and stakeholders who will be invited. Some, such as the U.S. National Committee for Responsive Philanthropy, are based outside the UK. These international groups will be kept informed of seminars outputs and discussion through regular online briefings on the seminar series' website. Travel costs have been requested to fund international collaboration and participation at targeted seminars (see Justification of Resources).

Government: David Halpern, advisor, UK Cabinet Office; Sue Kinn; Team Leader and Research Manager, Dfid, Kent Woods, CEO, Medicines and Healthcare Products Regulatory Agency (MHRA); Tim Kendall, Director, National Collaborating Centre for Mental Health; Catherine Elliot, Head of Clinical Research Support and Ethics, MRC

Charities and think-tanks: Annie Duflo, executive director, Innovations for Poverty Action (IPA); Caroline Fiennes, director, Giving Evidence; Aaron Dorfmann, executive director, U.S. National Committee for Responsive Philanthropy; Sue Daniels, executive director, European Association for Philanthropy and Giving; Julian MaCrae, director of research, Institute for Government; Wim Leereveld, CEO, Access to Medicine Foundation.

Funding Organizations: Kevin Moses, Director of Science Funding, Wellcome Trust; Hugh Whittall, director; Nuffield Council for Bioethics; Martin Hynes, Chief Executive, European Science Foundation.

Business community / representatives from academic-private partnerships: Nick Cammack, Head, Medicines Development Campus for Diseases of the Developing World, GSK; Ken Getz, senior fellow, Tufts Center for the Study of Drug Development (CSDD); John Orloff, senior VP, Global Development, Novartis; Amer Alghabban, director, global good clinical practice quality auditing, Merck Serono; Carolyn Garrood, manager, European R&D Outsourcing, Mundipharma Research Limited.

In addition to benefitting from participation in the seminars, practitioners will be catered for via the outputs and impact activities which will include special editions of journals, a dedicated website, a blog, Executive Report and several other items during and after the seminar series (see Pathways to Impact).