Improved patient-oriented research in Europe will benefit European citizens and the European medical industry and facilitate the transfer of scientific discoveries from the laboratory bench to the bedside. For Europe and for the rest of the world this effort will be of great importance for the quality of life of individuals and the wellbeing of society as a whole.
To achieve this important objective, the European Medical Research Councils (EMRC) at the ESF mandated the undertaking of a foresight study, a so called Forward Look, on 'Investigator- Driven Clinical Trials' (IDCT). "This project marks the most comprehensive examination and analysis of the issue in Europe and proposes particular steps towards better clinical research in Europe," said Dr. Carole Moquin-Pattey, Head of EMRC and coordinator of the study. Investigator-driven clinical trials - trials instigated by academic researchers aimed at acquiring scientific knowledge and evidence to improve patient care - deal with potential diagnostic and therapeutic innovations that do not attract or could be even against commercial interest.
Rarity is part of the problem: the more patients with a chance of survival, the greater the likelihood that pharmaceutical companies will put money into clinical trials of new treatments. In the sorry economics of suffering and death, osteosarcoma and fibrous dysplasia are known as orphan diseases, partly because no wealthy pharmaceutical company wants to "adopt" them, and partly because the incidence is so rare that there are too few patients in any one country for tests that will produce statistically reliable results. So far only a few studies deal with these two rare diseases: through a collaborative programme launched by the ESF, academic, researchers from across the continent have joined forces to launch two pan-European clinical trials.
These are just examples of IDCT, other typical topics include proof of concept studies, comparison of diagnostic or therapeutic interventions, surgical therapies or novel indications for registered drugs. IDCT thus have a much broader scope and potential impact than industry-driven clinical trials.
In order to tackle these problems faced by researchers conducting IDCT a thorough analysis of the issues was carried out through a series of five workshops covering different themes and attended by active and acknowledged experts in the field. A total of 26 recommendations emerged addressing needs and solutions, the top five of which are the following:
- To improve the education, training and career structure and opportunities for scientists involved in patient-oriented clinical research.
- To increase levels of funding for IDCT.
- To adopt a 'risk-based' approach to the regulation of IDCT.
- To streamline procedures for obtaining authorization for IDCT.
- To ensure that IDCT are carried out with an appropriate number of patients to produce statistically reliable results so that the trials are 'correctly powered'.
"We hope that these outcomes will be the beginning of interactive discussions between the stakeholders and generate strategic planning and implementation of the recommendations so that better IDCT and clinical research will improve patient care and health in Europe and worldwide" said Dr. Carole Moquin-Pattey. Europe needs to listen and implement the recommendations, which are urgently required given that clinical research in Europe is under severe pressure.