A new initiative designed to identify more targeted cohorts of patients for clinical trials has been launched with investment of more than £6 million (€8.34 million) by the UK’s Medical Research Council (MRC), the National Institute for Health Research (NIHR) and the respective health research departments in Northern Ireland, Scotland and Wales.

The Patient Research Cohort Initiative forms a key part of the overall strategy for translational research being pursued under the auspices of the new Office for Strategic Coordination of Health Research (OSCHR), the MRC noted. The programme, which will be tested in a three-year pilot phase, will seek to identify small, carefully defined groups of patients to help researchers in their efforts to detect, prevent and treat diseases – in particular, by illuminating aspects of disease that have so far been poorly understood.

The MRC and the NIHR plan to target areas of both high disease burden and unmet clinical need. The aim is to bring together groups of individuals who have been defined in terms of their health characteristics and medical history, then – subject to the normal regulatory conditions, such as approval from a research ethics committee – encourage their participation in studies conducted by industry and academia. The Patient Research Cohort Initiative will foster collaborative relationships between industry, academia, charities, the National Health Service (NHS) and patients, as well as enabling approved studies to get up and running more quickly.

The MRC has put out a call for proposals that “support the creation or further development of small cohorts of individuals who have been precisely defined in terms of their phenotype and medical history. A key aim is to enable novel interventions to be tested more swiftly through exploratory trials in small groups of carefully characterised patients, using relevant clinical endpoints or well-validated proxy measures for those endpoints.” Partnerships between industry, academia, the NHS, charities and patients are “strongly encouraged”.

A minimum of £6m over three years will be made available initially to support the eligible projects. This funding will include £3 million from the NIHR, a minimum of £3 million from the MRC, and contributions from the devolved UK administrations. Cohorts may be drawn from a wider pool of patients who already have a particular disease or subset of a disease, or from individuals who are at high risk of developing the disease.

There are a number of conditions attached to the funding: for example, all proposals must target an area of particular health need; address current or foreseen research bottlenecks; enable new interventions to be tested more quickly and support observational studies; use well-validated and robust phenotyping/characterisation methods; involve investigators with a track record in management and/or phenotyping of cohorts; and have clear plans for ensuring equity of access to industry and academia, as well as engaging with cohort participants.

More personal
“This new arrangement offers the potential to develop our knowledge of different diseases in an efficient and methodical manner,” commented MRC chief executive Sir Leszek Borysiewicz. “And as we move to an era when more and more people will have medical treatment that is targeted to their personal needs, this will help us work out how specific diseases evolve and how the spectrum of needs of different patient groups can best be addressed.”

The initiative was also welcomed by industry. “Exploratory research is an essential element of developing innovative medicines and enhanced understanding of the natural history of disease will improve clinical trial design,” noted Dr Philip Wright, director of science and technology for the Association of the British Pharmaceutical Industry (ABPI). “Together with better insight into the differences in patient response, this will enable us to predict the outcome of diseases better, and help provide the development of more effective treatments and the right medicine for the right patient at the right time.”

Aisling Burnand, chief executive of the BioIndustry Association (BIA), said the pilot scheme “sets out to speed the translation of innovative bioscience into treatments for patients. In addition to the potential patient benefits, the BIA looks forward to assessing how this initiative will benefit the UK’s bioscience sector.”