TL21: Practical Issues While Conducting a Clinical Trial DSMB
*Mohammad Bsharat, Vertex Pharmaceuticals 


Practical Issues While Conducting a DSMB on Some Clinical Trial: Although the FDA and the ICH provide guidelines on the use of Data Safety Monitoring Boards (DSMBs) for monitoring the conduct of clinical trials, practical issues/concerns arising from the use of DSMBs over the years seem to suggest current guidelines may not be clear enough for both DSMB members and sponsors regarding roles and responsibilities and decision-making process. Some examples of these practical issues include DSMB's role in decision making beyond what is specified in the DSMB Charter , for example, when a sponsor decides to perform an additional interim analysis which is not part of the DSMB scheduled data review meetings. To what extent should DSMB be involved? How to solve conflicts between planned decisions in protocol versus DSMB recommendations, for example, when protocol suggest a limited sponsor team will be unblinded in certain situations. This round table discussion will address these and other practical issues routinely faced by DSMBs and sponsors..