Data Safety Monitoring Board. A Data Safety Monitoring Board (DSMB) will be formed according to Omnicare CR’s operating procedures and will be solely responsible for evaluating the interim results of the study. One (1) organizational meeting and one (1) interim analysis evaluation meeting are planned. Omnicare CR and Sponsor will jointly develop guidelines for membership of the DSMB, and for conduct of DSMB meeting to be documented in the DSMB Charter. The DSMB members will be recruited by Omnicare/Sponsor. Members of the DSMB will neither have previous involvement with Sponsor’s studies in this area, nor be currently involved in clinical trials of competing therapies. The DSMB will have a written charter that will be produced by a Project Director which will define the responsibilities and will maintain records of all meetings. The written charter will also include a statistical appendix that will document the requirements and guidelines for analyzing and interpreting the interim safety results. Omnicare CR’s biometrics team will prepare mock data displays specific to the DSMB charter. A senior statistician, otherwise unrelated to the study, will be responsible for the development of the data displays defined by the DSMB to ensure interim data accuracy and summaries are produced. These data displays will be programmed and validated by biometrics staff. The validation will be performed through a combination of individual patient data review and independent programming. When the blind is ready to be broken, the DSMB statistician will perform the final run of the DSMB data displays and prepare for the DSMB. For each DSMB meeting, the database will be extracted and the data listings and summary tables will be rerun. If the DSMB requests data clarification or further information, Omnicare CR will re-extract the data and rerun the listings and tables on the new data. **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Data Safety Monitoring Board. An independent DSMB will be established and will review the safety of study treatment and any SAEs that occur during the study. Details on how the DSMB will review safety and response data are provided in the DSMB Charter. The DSMB will be composed of at least 2 oncologists (at least one of whom specializes in CRC) and a statistician. Following their initial meeting, the DSMB will meet approximately every 6 months to review clinical data and provide recommendations to the Sponsor on whether the study should continue. The DSMB may also meet more frequently, if needed.
Data Safety Monitoring Board. A Data Safety Monitoring Board (DSMB) will monitor the progress of the PGP-UK, including the risks to study participants. Although the PGP-UK will attempt to inform you of additional risks identified by the DSMB, including through updates to the study website, the DSMB will not be able to monitor all of the risks of participation in this study, and it may not be able to advise you or the PGP-UK of those risks that it monitors or identifies.
Data Safety Monitoring Board. An independent Data Safety Monitoring Board (DSMB) will monitor the trial. The DSMB will comprise of medical professionals with expertise in XXXX and clinical trials and are external to the Sponsor. The DSMB will meet periodically or as needed to review accumulating safety data and any available PK data collected throughout the trial. Safety and available PK data will be reviewed by the DSMB prior to proceeding with the next higher dose cohort. The DSMB will review safety data when at least six (6) subjects in Cohort A (CRV431 75 mg) and at least three (3) subjects in Cohort B (matching placebo) have reached 28 days of dosing, as described in Section 12.3.1. The DSMB will also review the Day 28 safety data from the remaining subjects to confirm there are no changes to the prior safety assessment. The roles and responsibilities will be further defined in a Charter.
Data Safety Monitoring Board. An independent Data Safety Monitoring Board (DSMB) will review unblinded safety data throughout the study and make recommendations as appropriate. The DSMB will begin quarterly data reviews approximately 3 months after the first patient is enrolled and continue through the last dose of the last patient enrolled. The DSMB will consist of external experts supported by an independent statistical group. The independent statistical group will prepare unblinded analyses for the DSMB and will not have a role in the statistical analysis plan (SAP) after the study has started enrolling patients. A separate, blinded statistical group (i.e., not associated with the DSMB) will be responsible for producing and finalizing the SAP and executing final data analysis of the study. The DSMB will be governed by a charter that will describe the following: • Roles and responsibilities of the DSMB members and the independent statistical group • Meeting format and frequency • Communication channels between the DSMB, the independent statistical group, the Sponsor, and the blinded study statisticians • Voting process and requirements (e.g., requirement of consensus for issuance of a termination recommendation) • Provisions governing conflict of interest and confidentiality • Process for interim analysis of efficacy, including the alpha spending function Briefly, the DSMB will review the progress of the study and the accumulating unblinded data while the study is ongoing. The DSMB will make recommendations to Sponsor representatives following each meeting. The DSMB may recommend that the study continue as is, be modified to protect patient safety, or be terminated. However, investigators, and not the DSMB, will make intra-patient dose-escalation decisions at the Week 4 visit for each patient and may choose to decrease the patient’s dose (to one-half of the prior dose).
Data Safety Monitoring Board. Sponsor understands that the Data Safety Monitoring is a requirement of this study and the Data Safety Monitoring Board (DSMB) services provided by Sponsor must meet the requirements of the FDA policy (reference: xxxxx://xxx.xxx.xxx/OHRMS/DOCKETS/98fr/01d-0489-gdl0003.pdf). DSMB Members will not be Staff of the Sponsor or Institution. Additionally, Sponsor will allow Institution's Principal Investigator to review and approve DSMB Committee Members prior to their appointment to the Committee."
Data Safety Monitoring Board. An independent Data Safety Monitoring Board (DSMB) will be chartered to review safety data to make trial conduct recommendations. The DSMB will review safety data in an interim analysis during the Phase 2 portion of the study. For this interim analysis, the DSMB will review safety data after 20 Phase 2 subjects have been treated with KTE-X19 and had the opportunity to be followed for 30 days after the KTE-X19 infusion. During Phase 2, Kite Pharma or delegate will submit SAEs or suspected unexpected serious adverse reactions (SUSARs) to the DSMB chair for risk benefit analysis. The DSMB Chair will review reported SAEs at least monthly and SUSARs as soon as received. .
Data Safety Monitoring Board. An independent DSMB will review safety and/or efficacy data 4 times during this study. The DSMB will first meet to review safety data when 10 subjects in Cohort 1 have been enrolled and treated with anti-CD19 CAR T cells and followed for 30 days. The DSMB will meet for the second time to review both safety and efficacy data after 20 subjects in Cohort 1 have been treated with anti-CD19 CAR T cells and have had the opportunity to complete the 3-month disease assessment. The DSMB will meet for the third time to review both safety and efficacy data after 10 subjects in Cohort 2 have been treated with KTE-X19 and have had the opportunity to be followed for 30 days. The DSMB will meet for the fourth time after 44 subjects in Cohort 1 have been treated with anti‑CD19 CAR T cells and have had opportunity to be followed for 30 days after the IP infusion. The DSMB will be chartered to make trial conduct recommendations based on an analysis of risk vs benefit. The DSMB may meet more often as needed. At the time of expedited reporting of suspected unexpected serious adverse reactions (SUSARs) to health authorities, Kite (or designee) will concurrently submit these reports to the DSMB chair. The DSMB chair will also review SAE narrative reports monthly. Finally, the DSMB or Kite may request additional analyses of safety data if a safety concern arises during the course of the trial.
Data Safety Monitoring Board. (DSMB) The DSMB consists of an independent group of experts who monitor patient safety and treatment efficacy data while a Clinical Trial is ongoing. The Board should comprise electrophysiologists experts in atrial fibrillation, and at least one methodologist (trial expert) and one biostatistician with particular expertise in interim analyses and sequential designs. The DSMB composition will be defined at the Project start. It will be responsible for the development of strict procedures for the monitoring of study findings and the detection of adverse events. The DSMB physically convenes prior to initiation of the study. Thereafter, the frequency of scheduled meetings depends on patient enrolment and safety event rates. However, a yearly scheduled meeting, face to face or through vision conference will be organised. If necessary, additional meetings may be held by conference calls if the DSMB so decides.
