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Cancer Centers In Clinical Trials

Cancer Centers In Clinical Trials. Sandrine Marreaud Head of Medical Department. Requirements for Cancer Centers in Clinical Trials (1). Facilities for clinical research allowing the evaluation of pharmaceuticals, medical devices and treatment outcome, with high quality.

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Cancer Centers In Clinical Trials

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  1. Cancer Centers In Clinical Trials Sandrine Marreaud Head of Medical Department

  2. Requirements for Cancer Centers in Clinical Trials (1) Facilities for clinical research allowing the evaluation of pharmaceuticals, medical devices and treatment outcome, with high quality. Scientific and Ethics Committees Experts (trained and certified) in trial management Administrative (contracts, regulatory) and clinical research services Dedicated research space 2

  3. Requirements for Cancer Centers in Clinical Trials (2) Additional criteria may be required for conducting specific trials like : Early phase studies Translational research oriented projects 3

  4. Sources of Information for Cancer Centers (1) • As promoter of trials, the EORTC has different sources of information regarding participating institutions: “Membership questionnaire” • It includes general information about qualifications of an institution • Type of institution (university, general…..) • Infrastructure of institution (oncology unit, surgery, radiotherapy, imaging, laboratories….……) • Infrastructure of clinical trial unit “Feasibility form” • It’s a form prepared by project in order to investigate: • Ability to support the conduct  of the trial (staff +local resources) • Potential accrual for a specific patient population • Ability to fulfill protocol requirements (timing of visits, specific tests, collection of samples for translational research, imaging tests (PET/CT/MRI……..), specific storage conditions for biological material or drugs, transfer of material for central review,……) 4

  5. Source of Information for Cancer Centers (2) “Case Report Forms” These forms are designed by trial in order to capture clinical data that will be used for assessing study endpoints. These forms provide information about the management of patients . 5

  6. Thank you 6

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