Clinical research represents the tools to explore and, more importantly, to validate the utility of medical treatments and strategies. Clinical trials include very different designs and require very different levels of infrastructure depending on the question they address. For example, trials testing new drugs or new devices usually require a high level of infrastructure and, therefore, present a high cost per patient. Nevertheless, trials testing strategies and treatment combinations of already approved drugs require a low level of infrastructure and data collection.
These late trials, could be called « real life trials » as they:
- Test questions related to daily practices in oncology
- Do not require specific infrastructure
- Require a minimal amount of data collection
- Impact millions of patients worldwide
Candidates must:
- Be specialist clinicians currently working at France or Spain
- Accreditate proven experience in clinical research
- Have the potential to develop transformative clinical trials.
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.
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 2022 programme.
All applications must provide two blocks of documentation, which must be completed entirely in English
The Clinical Trial proposal form, available at the website https://www.gustaveroussy.fr/en/clinical-research and at www.criscancer.org/programascris,
includes the following elements:
- General information about the candidates and institutions
- Spanish PI: First and last name, institution, and contact details
- French PI: First and last name, institution, and contact details
- Information of the Clinical Trial
- General information of the trial: Title, code/acronym, keywords, design of the Clinical Trial...
- Background, hypothesis, objectives, endpoints, methodology, project description, duration, and work plan
- Project resources and budget detailing foreseen annual costs and payment schedule by study milestones
- Expected impact of the proposed research.
- Project schedule.
Candidates should also include at the application their Curriculum Vitae, using a standardised summarised format (for example https:/cvn.fecyt.es/) following an abbreviated template of standard forms for public calls for applications (for example CVA). This document must be provided in English.
- Spanish PI’s abbreviated CV (maximum 5 pages)
- French PI’s abbreviated CV (maximum 5 pages)
The requested documents must be submitted in PDF format (no more than 4Mb). These documents may be provided in English language.