How To Prepare An Informative And Thorough DSMB Report. Presenter: Amy Mhatre-Owens

Transcription

1 How To Prepare An Informative And Thorough DSMB Report Presenter: Amy Mhatre-Owens

2 Background Agenda Data and Safety Monitoring Board (DSMB) Report Structure Examples of useful charts, tables and listings 2

3 KAI Research, Inc Full service CRO Manages over 60+ DSMBs Develops and reviews data and safety reports for industry, academic institutions and multiple NIH institutes. 3

4 Purpose of a DSMB Independent group of experts Protecting participant safety Safeguarding the credibility and integrity of the trial for future subjects Ensuring the timely conclusion of a trial so its results can be disseminated 4

5 Items Reviewed by the DSMB Interim/cumulative data for evidence of: study-related adverse events efficacy according to pre-established statistical guidelines, if appropriate Site performance in recruitment and retention Adherence to the protocol Factors affecting study outcomes External factors such as scientific or therapeutic developments that may impact participant safety or the ethics of the study. 5

6 Open vs Closed Reports Open Session Report: Data is provided in aggregate. Information on study conduct such as accrual, appropriate demographic representation, baseline characteristics, protocol compliance, site performance, quality control, and frequency of follow-up. General (ungrouped) adverse events and toxicity issues. 6

7 Open vs Closed Reports Closed Session Report: Data from the Open Session presented separately for each group/study arm Study outcomes, safety data and, efficacy data coded by group (if appropriate) Interim analyses of efficacy data are presented only when planned in advance Marked Confidential 7

8 Example Reports Reference: Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Ann Int Med 2010;

9 Example Reports Enrollment: Actual vs. Expected All Sites or Site n - Aggregate 9

10 Example Reports Enrollment: Actual vs. Expected All Sites or Site n - Aggregate 10

11 Example Reports Participant Enrollment Status Site 1 Site 2 Total N %* N %* N %* Enrolled Active Completed Protocol N %** N %** N %** Discontinued from Treatment/Follow-up Ongoing Reason 1 **** Reason 2 N %*** N %*** N %*** Discontinued from Treatment/Follow-up Completed Reason 1 Reason 2 Other (specify): N %*** N %*** N %*** Discontinued from Study/Follow-up Not Ongoing Reason 1 Reason 2 Screen Failures by Site Reasons* Site 1 Site 2 Total N % N % N %** Reason 1 Reason 2 Total Screened Total Screen Failures Missed Visits Number of Completed Participants Number of Participants Missing Visits Number of Missed Visits Average Number of Missed Visits for Completed Participants Number of Active Participants Number of Participants Missing Visits Number of Missed Visits Average Number of Missed Visits for Active Participants Summary of Missed Visits by Site Site 1 Site 2 Total N (%) N (%) N (%) 11

12 Other Considerations Protocol Synopsis Summary of key events Laboratory test results Clinically Significant Abnormal Values Listing of Unanticipated Problems Listing of Protocol Violations/Deviations 12

13 Summary An effective safety report template allows the DSMBs to efficiently perform their duties. A clear and concise safety report provides transparency and credibility to the study. 13

14 References Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomized trials. Ann Int Med 2010;152. He W, Pinheiro J, Kuznetsova OM. Practical Considerations for Adaptive Trial Design and Implementation. Springer; DeMets D, Furberg CD, Friedman LM. Data Monitoring in Clinical Trials, A Case Studies Approach. Springer Science & Business Media; NIAMS Policies, Guidelines and Sample Templates for Clinical Trials lines.asp NIA Toolbox

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