1. 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

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

4. 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)

5. 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

6. 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

7. 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

8. 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

9. 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 ?

10. From The Tel Aviv Sourasky Medical Center