Keywords: clinical trial; drug development; primary health care

Background:

Most clinical trials (CTs) are conducted in hospitals, although 90% of clinical consultations take place in primary care (PC). Research in PC is essential to ensuring safe and efficient patient care. Unfortunately, most of the knowledge on which we base our practice comes from studies carried out in other settings, with patients who bear little resemblance to those treated in PC.

Research questions:

Is it feasible and efficient to conduct CTs in PC sites?

Method:

After receiving an offer to participate in a multinational observational study, a multidisciplinary research team was founded, consisting of 1 family medicine resident, 2 nurses and 2 primary care pharmacists, led by a senior family physician. All members underwent formal training in Good Clinical Practices (GCP) and other skills necessary to conduct CTs with medicines. In addition, the site was registered on several “shared investigator platforms” to make sponsors aware of its availability and interest in participating in industry-sponsored CTs.

Results:

To date, the team has participated in five international studies that have already completed recruitment, three phase III trials (infectious diseases and cardiovascular diseases) and two observational studies (cardiovascular). We are currently involved in four other CTs, one phase IIb trial (infectious diseases) and three phase III trials (respiratory, cardiovascular and endocrine). As for completed studies, at the national level, our site was the one that recruited the highest number of participants in three of them and the second in the other two.

Conclusions:

Involving GPs in registration CTs would favor a more early and efficient translation of the CTs results to the care practice. A multidisciplinary team is key to success. Currently, several initiatives are ongoing to promote Spanish national networks and open collaboration between the Government and Pharma-Industry to promote the involving of GPs in clinical research (strategy “win/win”).

Points for discussion:

National/International strategies to promote the participation of primary care professionals in clinical trials. Role of EGPRN.

What minimum requirements do you think a site must meet in order to participate in clinical trials?