The Gustave Roussy Foundation and CRIS Cancer Foundation are calling for applications to their Real-Life Trials in Oncology Programme to support the development of practice-changing clinical trials in France and Spain.

Candidates must be specialist clinicians currently working in France and/or Spain with clinical research experience and with the potential to develop transformative clinical trials. The participation of patient associations in the development of the project will be valued.

The programme invites applications from all specialist physicians who have a transformative clinical trial proposal and look for co-investigators in France or Spain to develop the trial. The trial should run for a maximum of 3 years.

In case of justifiable delay of the project, the principal investigators may ask for an extended period and the GRF-CCF Committee will evaluate to confirm or deny the extension.

Training Applications will be admitted from specialist physicians in France or Spain, who have proven experience on developing and managing independent clinical trials.

Nationality Real-Life Trials in Oncology Programme is open to clinical researchers of any nationality working at French or Spanish hospitals.

Clinical Trial Candidates must provide a proposal of the clinical trial associated with the call for applications and which will be the object of funding.

The clinical trial shall demonstrate a high level of methodology and scientific quality. The trial must be practice-changing or practice-informing and must have a measurable impact on patient outcome and patient management, whether the primary endpoint is met or not.

Principal Investigator (PI) There will be two Principal Investigators, a Spanish PI (working at a Spanish institution) and a French PI (working at a French institution)

Information about their background must be provided along with the application.

Both investigators shall show an active role in the development of the clinical trial.

Restrictions The following restrictions apply to the submission of applications: ● A researcher may only be a beneficiary of one Real-Life Trials in Oncology Programme at the same time. They may only re-apply following completion of the previous programme. ● Only Hospitals in France and/or in Spain can be the beneficiary of the Real-Life Trials in Oncology Programme. ● Members of the scientific evaluation board will not be able to apply for these programmes. ● If an applicant has been rejected previously due to a lack of scientific integrity, they may not reapply.

The maximum amount awarded will be €1.500.000, which will be divided among the awarded proposals and spread over three annual instalments according to the budget calendar description, 3 which must detail the annual breakdown of the budget, not exceeding €500.000 per year summing up all the proposals awarded.

Annual instalments may include:

a. Salary: to cover labour costs corresponding to the intensification in the working hours of subinvestigators, nursing, or study coordinators. This cost includes Social Security contributions and any other amounts payable by the institution, as well as the gross remuneration of the beneficiary. b. Costs associated to the clinical trial including:

● Fee per patient included to cover all the site costs: clinical practice, extraordinary tests, other services costs, and hospital overhead.

● Consumables for any trial related testing.

● Outsourcing of services related to the management of the trial, CRO, central pharmacy, central lab, database management, etc.

● Other expenses related to the clinical trial as the insurance policy, regulatory agencies taxes, couriers, publication costs, etc. These amounts will be subject to the corresponding legal tax retention.

Candidates or their institutions can access the Real-Life Trials in Oncology Programme call for applications, at https://www.gustaveroussy.fr/en/clinical-research and at www.criscancer.org/programascris.

All applications must be submitted by e-mail to RLtrials@gustaveroussy.fr and clinicaltrials@criscancer.org during the application submission period for the 2021 programme.