INSERM

Inserm

INSERM-SC10 Clinical Trials Unit was created in 1990, in collaboration with the newly created National Agency for AIDS Research (ANRS), to enhance the cooperative effort between clinicians and biologists involved in HIV therapeutic trials and to develop this endeavour on a European scale. The unit has gradually extended its research to the treatment of viral hepatitis, vaccines, and several bacterial and parasitic diseases to cover more generally all infectious diseases.

Since its creation, SC10 has undertaken over 60 trials including thousands of patients from around the world. These phase I to phase IV trials, promoted by academic sponsors, evaluate new drugs for specific needs and new therapeutic strategies. All these studies have been developed at national level within the SC10 network since the first INSERM/ANRS trials were launched. Today, this network consists of around one hundred hospital sites located all over the country, including clinical services, pharmacies, and virology and immunology laboratories.

Over the years, SC10 has developed interactions with many academic HIV networks. Large international trials have been conducted with partners such as INSIGHT, CPCRA, ACTG, IMPAACT and NEAT. SC10 has been working closely with the MRC-CTU at UCL for many years. Together they have led the largest European adult academic clinical trials in HIV. Meanwhile, SC10 and Penta began their collaboration in order to launch and sustain a strategic research platform in paediatric HIV. It is worth noting that INSERM SC10 has been a key member of the Penta network since its establishment in 1991, and continues to be passionately involved in Penta clinical trial activities. It is currently the lead trial unit in the Penta sponsored SMILE study (PENTA 17).

SC10 oversees the coordination and the scientific responsibility of the ANRS centralized Biobank that consists of 1.4 million blood samples collected from thousands of patients participating in the ANRS trials and other international trials like those sponsored by Penta. SC10, whose Biobank activities are ISO 9001: 2015 certified, has equipped the Biobank with an advanced logistics organisation, and a laboratory information management system according to the standards of the domain. In addition, INSERM-SC10 is a leader in the French Biobank system, providing tools for both sites and reference laboratories within the networks, and in particular for Penta sites in order to have high-quality samples of ready for studies.

With around 40 people working on the team, SC10 brings together all the skills and resources needed for methodological design, protocol development and implementation, coordination and monitoring, data management, statistical analysis, trials reporting, quality assurance and financial management of studies.