Data Monitoring Committee (DMC) Registry Overview & Guide

Transcription

1 Data Monitoring Committee Initiative Data Monitoring Committee (DMC) Registry Overview & Guide

2 Why prototype a DMC Registry? The role of a DMC member is quite unique. You must be skilled in evaluation and interpretation of emerging clinical trial data. However, the deliberate identification and cultivation of new DMC members has not kept pace with the growing needs of the clinical trial community. Currently, there is no centralized source that clinical trial sponsors can access to identify potential DMC members. At the same time, there is a lack of sufficient training opportunities for candidates wishing to serve on a DMC, but requiring additional experience. In an effort to solve these challenges, TransCelerate s Data Monitoring Committee initiative has developed a prototype for a DMC Registry that could serve as a central repository of information pertaining to existing or new DMC candidates. The Registry would also be a resource hub for educational materials to further knowledge sharing. 2

3 THE DMC REGISTRY WOULD BE This Registry would be a publicly available resource that collects relevant data on clinical research professionals who either have previously been a committee member or have no experience but wish to join a DMC. INFORMATIVE UP-TO-DATE EASY-TO-USE The Registry would allow clinical trial sponsors to access information about potential DMC candidates professional credentials, affiliations, therapeutic alignment, clinical experience, prior DMC service and more. Registry participants could edit their profiles at any time and are encouraged to keep them as up-to-date as possible. Periodic system-generated prompts to participants would be integrated into the platform to ensure the most recent information is presented. The Registry data input process, site navigation capabilities and search functionalities would all be developed to be simple and as userfriendly as possible. When joining this Registry, users would create an account and personal profile to inform DMC organizers (sponsors) about their skills, interests and experience. Clinical trial sponsors could also create accounts on the Registry to gain access to candidates information during their search for prospective committee members. Ultimately, the Registry would help connect trial sponsors with prospective DMC members to ensure effective staffing for DMCs. 3

4 WHO COULD JOIN THE DMC REGISTRY? The DMC Registry would serve two users: Clinical Research Professionals The Registry would serve clinicians, statisticians, and other clinical research professionals with a variety of levels of experience on DMCs, by increasing their visibility to clinical trial sponsors. Those with less experience would have the opportunity to indicate interest in an Apprenticeship, mediated by clinical trial sponsors with the ability to connect apprentice-mentor pairs when convening DMCs. In addition, prospective DMC members could find value in the Registry's hub of educational resources on interim data monitoring and the DMC process. DMC Organizers The Registry would serve clinical trial sponsors looking to convene a DMC of members independent of their organization. Easy navigation and querying capabilities would make the Registry an especially useful resource for situations in which identifying suitable DMC candidates is challenging. Pharmaceutical sponsors, as well as academic or government institutions, would be encouraged to use this Registry to facilitate the staffing of their DMCs. 4

5 WHAT FUNCTIONALITY WOULD THE DMC REGISTRY OFFER? Creating a user account would be easy. All relevant data could be added directly into the DMC Registry. 5

6 THE INFORMATION COLLECTED WOULD FALL UNDER FOUR MAIN CATEGORIES: Personal Information Professional Information General Experience DMC Experience Name Address Phone Number Geographic Region Profile Picture Credentials Institution Website Publication Links Short Biography Resume Therapeutic Area Clinical Trial Experience Adaptive Design Experience Anticipated Role on a DMC Number of Prior DMCs Served Number of Prior DMCs Chaired Interest in Being an Apprentice Interest in Being a Mentor Accounts could be updated at any time. Automatic reminders would be sent annually to individuals who have not updated their profile in the previous year. This could ensure that only the most recent and relevant information is included. The Registry would also comply with all applicable laws and regulations pertaining to the collection, storage, and use of personal data, including the General Data Protection Regulation (GDPR). 6

7 JUST FOLLOW THESE EASY STEPS TO BUILD YOUR PROFILE Step 1: Personal Information Step 2: Professional Information 7

8 JUST FOLLOW THESE EASY STEPS TO BUILD YOUR PROFILE (cont.) Step 3: General Experience Step 4: DMC Experience 8

9 THE RESULT WOULD BE A SEARCHABLE DATABASE OF CANDIDATES For DMC organizers, the Registry would incorporate standard database searching and filtering capabilities. Filters could be applied to various Registry data fields via dropdown menus and selection functions. Search summaries would be displayed in a succinct format, summarizing the set of candidates that meet the desired criteria. 9

10 By clicking on the link to a particular candidate, you could quickly call up the complete profile, all relevant links and uploaded documents. Search criteria could also incorporate ancillary features, such as setting restrictions to recall profiles with matching criteria. 10

11 The DMC Registry would contain a resource section with an annotated bibliography of materials relevant to the interim data monitoring process and the roles and responsibilities of DMC members. This would include fundamental introductory resources, operational highlights (e.g., components of the DMC Charter), regulatory guidelines, case studies and more. The materials would be arranged by topic area and all resource links would have a brief content description. This would help the reader peruse the library of content quickly and efficiently. ADDITIONAL RESOURCES TRIAL CONDUCT RECOMMENDATIONS DMC CHARTER CLINICAL & STATISTICAL PRINCIPLES REGULATORY CONSIDERATIONS 11

12 INTRODUCING THE APPRENTICESHIP MODEL The Apprenticeship model would be an additional resource to aid individuals with less experience. The model would give individuals with no or little prior DMC experience, who are interested in serving on a DMC (the Apprentice ), the opportunity to experience the interim data monitoring process firsthand. They would also have the chance to discuss this experience and the questions arising from it with a more experienced DMC member (the Mentor ). This experiential learning opportunity would complement other self-study or instructor-led training material related to DMCs, in order to accelerate a candidate s readiness to competently serve on a DMC. Individuals signed up on the DMC Registry and who are interested in either an Apprenticeship or in serving as a Mentor could flag that intent in their personal profiles. Clinical trial sponsors convening a DMC could identify an individual with the appropriate clinical background interested in an Apprenticeship. Clinical trial sponsors could pair that individual with a Mentor. The specific scope of an Apprenticeship would not be prescribed and would be left for the Mentor and the Apprentice to determine and agree upon. The education obtained through the Apprenticeship would come primarily through regular conversations between the Mentor and Apprentice and through shared experiences on a DMC. Both Mentors and Apprentices could anticipate that at least several DMC meetings would be required in order to deliver a sufficiently comprehensive experience before calling the Apprenticeship complete. 12

13 HOW WILL THE DMC REGISTRY SUPPORT THE GROWTH OF DMC PARTICIPANTS MORE BROADLY? The DMC Registry would serve as a repository for information on individuals interested in DMC service, offering benefits to all stakeholders. The value of the Registry would increase in proportion to the number of participants whose information it contains. Thus, the value proposition of the Registry would be intrinsically tied to outreach efforts that advertise its existence, explain its benefits and promote its use. A strong push in terms of socializing the Registry to the greater clinical trial community would be required to initially populate and increase the tool s awareness and popularity. Through organic sharing of the Registry by Registry participants and support from sponsors, we could expect the larger clinical trials ecosystem to realize the value of the DMC Registry. 13

14 FAQs Question What is a Data Monitoring Committee (DMC)? Answer A DMC is an independent body that evaluates accumulating clinical trial data, monitors patient safety and efficacy, and ensures the trial s validity and integrity. Want to learn more? Visit iopharmainc.com/initiative s/data-monitoringcommitee/initiativeassets to provide your feedback on this proposed solution. How would an Apprentice be defined within the Apprenticeship Model? How would a Mentor be defined within the Apprenticeship Model? Would an Apprentice get paid? Would an Apprentice be a voting member? An Apprentice is a clinical research professional with little or no experience serving on a DMC, who agrees to be part of a mentoring relationship with an experienced DMC member. A Mentor is an individual with prior DMC experience and a solid understanding of the unique interpretive challenges in evaluating accruing clinical trial data who is willing to work with an Apprentice to build that individual s capability to serve independently on a DMC. Individuals are usually compensated for their participation in DMCs. Whether to compensate for an Apprenticeship is left up to the discretion of the sponsor. The Apprentice may be asked to serve in the capacity of voting or non-voting member, at the discretion of the sponsor. The Apprentice will agree to required terms and conditions that allow him/her to participate on the DMC. Would this be a formal program/training? The intention is to provide a framework model that can help train clinical research professionals with little or no prior DMC experience, by affording them the opportunity to experience the DMC process firsthand. This experiential learning opportunity is intended to complement other self-study material or instructor-led training related to DMCs, in order to accelerate a candidate s readiness to competently serve as a DMC member. Would an Apprenticeship be guaranteed to any candidate who indicates interest within the DMC Registry? No, it is not guaranteed, nor does flagging this interest in the DMC Registry preclude the candidate from being asked to serve as a voting member on a DMC. 14