Research and innovation
Pharmaceutical medicine is a research-based specialty concerned with innovation, research and development of medicines as well as medical devices, drug-device combinations, and diagnostic agents and systems. Most research is conducted as part of randomised controlled clinical trials in distinct ‘phases’ – from phase I clinical pharmacology to phase IV post-marketing safety studies. The FPM has a useful chart explaining the different phases of drug development. However, evidence for the effectiveness of medicines is also increasingly being sought from different clinical trial types and from ‘real world data’, in the form of meta-analyses and patient registries. The increased involvement of patient advocacy and support groups and patients themselves as stakeholders in information-sharing and decision-making in healthcare is important to help establish the benefits and risks of participating in clinical trials.
Much of the R&D conducted by the pharmaceutical industry is in collaboration or partnership with academia, charitable and government bodies (eg MRC, NIHR, AMRC), with the Health Research Authority, which now provides the National Research Ethics Service, and in NHS healthcare settings and clinical practice. Medicines R&D is regulated in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA) which is the competent authority in relation to the European Clinical Trials Directive (2001/20/EC) and Clinical Trials Regulation (EU No 536/2014), and is responsible for ensuring the safety of patients and participants in clinical trials and the safe use of medicines after approval.
Specific education and training in research and innovation in pharmaceutical medicine, which has at its heart the science and practices of drug development, is provided by the FPM through the Diploma in Pharmaceutical Medicine and Pharmaceutical Medicine Specialty Training. The FPM is part of the PharmaTrain Federation, the major education and training project of the EU Innovative Medicines Initiative. Its aim is to provide a European platform for award-bearing education and training in drug development science (pharmaceutical medicine) for all professionals, including knowledge-based and competency-based programmes, clinical investigator certification (CLIC) programmes, ethics committees training and patient information and awareness (EUPATI).