1 – Background and objectives
The request for research proposal by the French National Cancer Institute is congruent with one of the development axes of the Plateforme d’Aide à la Recherche Clinique en Cancérologie of Auvergne and Rhône-Alpes. Since 2004, this platform, which is composed of all institutions which take part to clinical research and of a research team in the social sciences of healthcare (GRESAC), has led many research works to better understand barriers and facilitators to the development of multicentre clinical trials (a forthcoming review in the European Journal of Cancer, a qualitative study (38 interviews) and a quantitative study (250 answers)). Thanks to these results, the present project aims at improving our understanding on this subject through the comparison of three multicentre, randomized clinical trials.
2 – Research framework
Our past researches and the literature conduct us to favour three research axes which will guide our investigations:
1) Physicians’ conception(s) of their mission, perception(s) of clinical research and evaluation(s) of specific protocols. We intend to assess the differences between physicians concerning their interest for clinical research. These expectations will be compared with their implication in the specific trials under study.
2) Relationships between physicians. We intend to analyse the impact of competition and cooperation on the dynamics of the three studied trials. Two levels of relationships will be studied: i) local relationships between investigators and other physicians who refer or should refer them patients for enrolment; ii) relationships between investigators and main investigators.
3) Regulation of the healthcare system. We mean the impact of material resources at physicians’ disposal (thanks to the (local) management of hospitals, to the sponsor of the specific trials and to the general orientation of the healthcare system) on physicians’ participation.
Our preceding work and the literature encourage us to put the hypothesis forward that the organisational context and the physicians – rather than the patient – are the key-components to understand physicians’ participation in clinical trials and patients’ accrual.
3 – Fieldwork
We will compare three academic, multicentre, randomized clinical trials. For each of them, we will retrace its genesis, the way physicians were enrolled as investigators, patients’ accrual and the way data are collected. We expect to study the interdependencies between attitudes toward clinical research in general and patients’ actual accrual.
We chose to study academic trials since it will allow us to better understand why physicians’ may sometimes favour this kind of trials rather than trials sponsored by the industry. Indeed, whereas physicians are prone to consider that academic trials are fewer and are more interesting regarding their practices, they recognize that trials by the industry offer more material support, which is another important criterion.
The fact that the trials under study are multicentre will allow us to analyse, on the one hand, the impact of the local context on clinical research and, on the other hand, the difficulties for coordination.
The three trials deal with frequent cancers (breast, prostate and lung), but i) their nature is different (one is focussed on quality of life; another one is a phase III trial comparing two neoadjuvant treatments and the last one is a phase II trial) ii) as well as the characteristics of the centres which are investigators (one is mainly a regional trial; another one is a national trial with a majority of university hospitals, and the last one is a national trial for which almost half investigators are working in general hospitals). These differences, which are congruent with our research axes, should allow us to generalise and specify some analyses.
4 – Data collection
We will conduct semi-structured interviews with main participants of each trial (coordinating team, main investigators, investigators, local actors which investigators are in relation with). Investigators will be chosen to represent contrasted conditions of work and accrual rate. Between 120 and 140 interviews will be conducted.
