Assessments and Assistance for NIAMS Clinical Trials
Client: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), NIH
Client/study focus and needs: Since 1996, we have provided assistance and executive secretarial support to NIAMS. In this role, we support over 60 monitoring bodies including Data and Safety Monitoring Boards (DSMBs), Observational Safety Monitoring Boards (OSMBs), and independent Safety Officers (SOs). We suggest and invite members, prepare a charter, interface between the monitoring body members and the investigators, schedule meetings, and prepare action items and minutes. In addition, we provide statistical and methodological consultation to NIAMS and to investigators. We develop and update generic safety report templates for investigators, obtain liability insurance for DSMB members, review grant applications to assess study risk, and maintain a website to house study materials and reports for the investigative teams, the monitoring bodies, and the NIAMS program staff.
We also assisted NIH in the conduct of the first and second Mid-Course Review of the Patient-Reported Outcomes Measurement Information System (PROMIS) initiative, convening an expert panel, developing the conceptual framework, and preparing a final report and presentation.
Our customized approach: Our consistent team and documented standardized approach enabled us to compile knowledge, documents, and forms and develop a database of potential Board participants with expertise across therapeutic areas. We are thus able to efficiently convene new Boards and manage existing ones over time.
Services: Development and management of safety oversight and evaluation boards, database development and management, clinical study documentation development, quality assurance reviews
Results: We have successfully supported NIAMS since 1996, and our recent workload includes the following activities:
- Continuing the review of clinical research guidelines and policies to identify changing practices and the need to revise or add to the Institute guidance for investigators
- Providing executive secretarial and logistical support for over 60 DSMBs as well as SOs
- Assisting investigators in preparation for study conduct including review of protocols, manuals of operating procedures, data and safety monitoring plans, adverse event and serious adverse event reporting, and quality control procedures
- Providing biostatistical and methodological support, including review of statistical plans, analytic approaches, recruitment strategies, and data management resources and methods
- Using automated tools and web portals to track clinical trials and monitoring body meeting materials and information