Office of Clinical Trials Operations and Management (OCTOM), NIDCR
The purpose of this contract renewal is to continue operations and management support services for clinical research studies funded by the National Institute of Dental and Craniofacial Research (NIDCR) within both the extramural and intramural research divisions. These services provide tools essential for the effective administration and coordination of NIDCR’s clinical studies. In addition, the contract will provide adjunct expertise and resources to assure sound and efficient clinical study protocol development, study execution, clinical site monitoring, data and safety oversight, data management support, statistical support, and regulatory compliance. The Clinical Research Operations and Management Support (CROMS) contractor provides clinical research expertise, tools, and project management support to NIDCR staff and the Institute’s clinical investigative teams.
As part of its overall research mission, the NIDCR supports clinical research on the causes, incidence, prevalence, prevention, diagnosis and treatment of dental, oral and craniofacial diseases and disorders. These studies, conducted within the intramural research program and well as extramurally through the funding of research grants and cooperative agreements, include Phase I-IV clinical trials and observational population-based and natural history studies. The clinical trials NIDCR supports include studies under Investigational New Drug (IND) or Investigational Device Exemptions (IDE) applications testing drugs, biologics, devices, or a combination of products, as well as trials to test surgical, behavioral or other non-regulated interventions.
NIDCR’s extramural program has an extensive clinical research portfolio that covers a broad range of clinical efforts. Studies span small, short-term, pilot evaluations involving a single domestic site, to large, multi-year, multi-site clinical studies conducted both domestically and internationally. They include preventive, diagnostic and therapeutic interventional clinical trials as well as observational clinical studies. Intramural studies are generally performed in NIH’s Clinical Center and include both outpatient and inpatient studies, as well as partnerships with industry, academic and medical centers, and other NIH Institutes.
The current CROMS contract has centralized a number of oversight and management activities such safety event tracking, data and safety oversight and clinical site monitoring, as determined by the NIDCR. Support services are delivered in a tailored, study-specific approach, offering flexibility to meet the needs of the different studies.
Although NIDCR staff has expertise to assist with various aspects of the support provided by the contract, these resources are finite. Only limited in-house resources are currently available to bolster the clinical coordination efforts needed to establish and maintain an efficient and high-quality clinical research program. The growing complexity and size of NIDCR’s clinical research in the extramural and intramural programs supports the need for continued centralized and standardized approach for NIDCR clinical research oversight and management. Additionally, the NIDCR’s goals for this contract align with NIH’s heightened oversight and management expectations for NIH-supported clinical research. In recent years, the NIH has released a series of initiatives to enhance the accountability, efficiency and transparency of clinical research with an emphasis on clinical trials. The initiatives target key aspects throughout the lifecycle of research from concept to implementation and dissemination of results.
In summary, this contract renewal requirement will provide operations and management support for the NIDCR clinical research program. This initiative will allow NIDCR to continue to consolidate efforts and establish a more efficient and consistent approach to clinical trial implementation and oversight. In addition, the contract will support the use of tools, systems and services necessary for NIDCR staff to effectively manage its clinical research portfolio. It will provide adjunct expertise, advice and resources to the Institute and clinical investigators to assure sound and efficient clinical study design, study execution, data management and analysis, and regulatory compliance. Activities supported by this contract may include:
1) consulting/collaborating on study design and protocol development; 2) study document preparation, including designing of case report forms, procedure manuals and other study materials; 3) study-specific training and/or study initiation site visits; 4) clinical research operations support (e.g. supply management, product packaging, labeling and shipping; clinical specimen tracking and storage); 5) data management services; 6) assessing/assuring quality of study data; 7) clinical site monitoring; 8) statistical support, including plan development and analyses; 9) safety monitoring (e.g., medical monitoring of events); 10) regulatory support, including Food and Drug Administration (FDA) submission and interface coordination; 11) logistical support for Data Safety and Monitoring Boards and Medical Monitor Oversight Reports; 12) assistance with reporting and publication and 13) electronic information systems development and support to assist the Institute with its clinical research management responsibilities.
CURRENT PORTFOLIO OVERVIEW
As of April 2018, there are over 105 extramural and 19 intramural active clinical research studies that are receiving oversight and support services from CROMS. About half of the extramural studies have utilized study design, statistical, document writing, data management, project management, or other services from CROMS. Additionally, there are 26 oversight committees supported by the CROMS contract.
Study tools, tracking and reporting systems are maintained and updated by CROMS. Over 100 document templates or tools are maintained by CROMS and many publicly available on the NIDCR website. A password-protected tracking database of nearly 400 clinical studies since 2008 is maintained and contains information on over 350 grants, and over 400 clinical sites. The password-protected web-based tracking systems maintain over 5,000 study documents making the documents accessible to NIDCR program staff and investigators on a study-specific level.
It is anticipated that the area of growth in clinical research management support will be in quality management and Good Clinical Practice (GCP) training as well as regulatory support. In addition, NIDCR anticipates the need for enhancements to its existing project management systems to aid in tracking progress and providing efficient oversight to its growing clinical research portfolio and the heightened oversight of NIH-supported clinical trials. This will include development of centralized clinical research project management systems and tools to facilitate NIDCR staff workflow and oversight tracking, development of quality management and GCP training programs, expertise in regulatory support and submissions, and the training of clinical research staff and NIDCR Program staff.
ALIGNMENT WITH INSTITUTE GOALS, STRATEGIES AND IMPLEMENTATION PLAN
The CROMS contract is aligned with the NIDCR’s goals for high quality clinical research and compliance with regulations and policies. Use of the CROMS contract offers efficient strategies for study planning and implementation, effective and efficient NIDCR oversight, and providing support to maintain standards consistent with those described in the International Council on Harmonisation, NIH policy and the Code of Federal Regulation.
Clinical research operational and management support of NIDCR’s clinical studies has been established and is integrated with the processes of extramural and intramural research. Many documents, tools and processes are available publicly to potential grantees, and continuing this support assists with protecting the safety of human subjects, offers an objective process for overseeing data and safety, and provides mechanisms for improving quality conduct of NIDCR’s clinical research.
RECOMMENDATIONS FROM SCIENTIFIC EVENTS AND FROM PUBLIC INPUT
Clinical Trial Requirements for Grants and Contracts. The Office of Extramural Research (OER), the National Institutes of Health (NIH) (2017). Retrieved from https://grants.nih.gov/policy/clinical-trials.htm
Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). International Council for Harmonisation. (2016). Retrieved from http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4_2016_1109.pdf
Protection of Human Subjects. Title 45 Code of Federal Regulations (CFR) Part 46. Department of Health and Human Services (2009). Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html
Toolkit & Educational Materials, Human Subjects Research, the National Institute of Dental and Craniofacial Research (NIDCR) website. Retrieved from https://www.nidcr.nih.gov/research/human-subjects-research/toolkit-and-education-materials