MDIC Global Clinical Trials Question Title * 1. Global clinical trials: Describe your experience with conduct of global clinical trials intended for multi-country registration purposes: a. We have conducted global clinical trials that have led to successful product registration in 3 or more target countries without having to conduct additional “local” [country specific] clinical trials; b. We have run global clinical trials which have led to successful registration in the US and Europe but which have had to be supplemented with smaller local clinical trials in countries such as Japan, Korea, etc. c. We typically run our trials in the US and possibly Europe and then use that data for global registration purposes without running local studies; d. We haven’t tried to run global trials. Question Title * 2. Barriers to multi-country studies: Please rank (number 1-4) the potential barriers to conduct of global clinical trials listed below(from (1) largest barrier to (4) smallest barrier 1 2 3 4 a. Due to differences in cultural factors, practice of medicine, patient demographics and other factors, it is often difficult to design a single study protocol that is generalizable to patient populations in multiple countries; 1 2 3 4 b. Clinical study infrastructures in some countries/facilities may be inadequate to pass muster with FDA and other regulators; 1 2 3 4 c. Intellectual property and data confidentiality concerns make running studies in some countries problematic; 1 2 3 4 d. Country specific insurance requirements in countries such as Germany greatly increase the complexity of running trials and greatly impede study start up. Question Title * 3. Benefits of multi-country studies: Please rank (number 1-5) the potential benefits to multi-country studies listed below from (1) largest benefit to (5) smallest benefit 1 2 3 4 5 a. Potentially lower cost for study conduct; 1 2 3 4 5 b. Faster enrollment due to larger available populations and lower competition for available study patients vs. the US; 1 2 3 4 5 c. The potential to offer patients in some countries with access to better, more advanced treatments than would otherwise be available, therefore improving subject willingness to participate in studies; 1 2 3 4 5 d. A lower subject ‘contamination’ level by other treatments that may impact study outcomes. 1 2 3 4 5 e. Engagement of clinicians in multiple major geographies better satisfies regulatory and reimbursement officials looking for local experience. Question Title * 4. Please select the best answer given your perspectives: a. Yes, I am in favor of an MDIC initiative aimed at achieving a mechanism for a single global trial that would result in product approval within countries that enroll patients. b. No, I do not see the value in this c. Yes, I see the value in this but I don’t think it’s an achievable goal Question Title * 5. Additional comments Next