Moving forward: putting research into practice

Abstract

Clinical trials are aimed at acquiring scientific knowledge and evidence to improve patients care. Clinical trials can either be run by industry, as private–public partnership in a collaboration between the pharmaceutical or medical device industry and hospitals or clinics, or it can be so called ‘investigator-driven clinical trials’ instigated by academic researchers. Investigator-driven clinical trials are typically proof-of-concept studies, studies on orphan diseases, comparison of diagnostic or therapeutic interventions, surgical therapies or novel indications for registered drugs. The investigator-driven clinical trials may have a broader scope and a larger potential impact than industry-driven clinical trials. Investigator-driven clinical trials have been under strain in Europe for a multiplicity of reasons. The most important areas to try and strengthen are the improvement of education, training and career structures, and opportunities for scientists involved in patient-orientated clinical research. This was described thoroughly in the Forward Look from the European Medical Research Council (EMRC), European Science Foundation (ESF), in 2009 [101]. The EMRC is the membership organization for all the medical research councils in Europe under the ESF. The Forward Look recommended an increased level of funding for investigator-driven clinical trials, an area where public funding has been sparse. Furthermore, it also recommended an adoption of a risk-based approach to the regulation of investigator-driven clinical trials, to ensure that these trials are carried out with an appropriate number of patients to produce statistically reliable results so that the trials are correctly designed and powered and the procedures for obtaining authorization are streamlined. Aim one is to perform the necessary clinical trials in all research areas, and to perform them with proper design and the necessary funding, infrastructure and trained scientists to perform the trials. The next important step is to implement the research results in clinical practice through so called ‘evidence-based medicine.’ The Forward Look from the EMRC in 2011, titled ‘Implementation of Medical Research in Clinical Practice’ has a series of recommendations regarding the implementation of clinical trials [102]. The Forward Look was developed by dedicated highlevel panels of experts in the field of clinical investigation, who wrote a draft report that was then debated at a Consensus Conference by the Council of Europe in Strasbourg (France) in the autumn of 2010. After a thorough revision of the document, in collaboration with all panel and Consensus Conference participants, the Forward Look was finished, approved by EMRC and launched in May 2011. The Forward Look launched in 2011 has ten recommendations: ■ Strengthen European work, collaboration on, coordination with and funding of systematic reviews of existing evidence, comparative effectiveness research, health technology assessments and clinical practice guidelines;