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Reporting Local Trials to WP8/ELN RLTWP8 Project

Reporting Local Trials to WP8/ELN RLTWP8 Project. Moshe Mittelman Tel Aviv Sourasky Medical Center Sackler School of Medicine – TA University For: WP8 / ELN Mannheim, Feb 1, 2011. RLTWP8: Background / Problem. Most clinical trials are company-driven

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Reporting Local Trials to WP8/ELN RLTWP8 Project

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  1. Reporting Local Trials to WP8/ELNRLTWP8 Project Moshe Mittelman Tel Aviv Sourasky Medical Center Sackler School of Medicine – TA University For: WP8 / ELN Mannheim, Feb 1, 2011

  2. RLTWP8: Background / Problem • Most clinical trials are company-driven • Very few IIT, usually small scale • Difficult to draw conclusions: • Heterogeneity of trials • Small number of patients • Methods of reporting so far - failed

  3. RLTWP8: Aim A simple method / system of communication between the centers Exchange of relevant information regarding designed / planned / ongoing clinical trials This would stimulate using similar parameters (method, dose, regimen…) Would allow data combination from trials May lead to conclusions as if it had been a larger clinical trial (not meta analysis)

  4. RLTWP8: The Proposed Method • A standard simple report form (see below) • An international committee (of WP8) • Chair: A leading person from a large group • The committee will receive information on each local / national clinical trial • The committee will review the protocol • Suggestions will be made • A voluntary process

  5. A Proposed Report Form (draft) (I) • Trial name / title • PI / contact person • Aim of the study • Primary endpoint (s) • Secondary endpoint (s) • Regimens / medications • Dose (s) • Duration of the trial

  6. A Proposed Report Form (draft) (II) • Other features related to the medications • Study type • Number of patients to be recruited • Study duration • Expected results • Any other relevant trial’s features

  7. RLTWP8: Expected Results • A unification or close to standardization of most national/local clinical trials • The possibility of comparing, unification and possible combination of data from various trials • A possible more meaningful clinically relevant conclusions

  8. RLTWP8: Example (?) • ViLen-01: A phase 2, single-arm study to determine the safety and efficacy of azacitidine and lenalidomide in higher risk MDS – A national Israeli trial • A similar GFM trial ? • Can we try to co-operate ?

  9. From The Tel Aviv Sourasky Medical Center

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