On January 25, 2018 the National Institutes of Health (NIH) is implementing new policies related to clinical trials. Researchers whose proposed work meets the expanded definition of “Clinical Trials” will be required to do the following:
- Apply for funding via Funding Opportunity Announcements (FOA) specifically for clinical trials.
- Provide additional information in proposals. A “new Human Subjects and Clinical Trial Information form will be included in grant application packages and contracts for all human subjects and/or clinical trial research applications beginning for January 25, 2018 due dates”
- Register and maintain studies in ClinicalTrials.gov
- Complete Good Clinical Practices education
Registration for ClinicalTrials.gov is available by contacting ORIC at 412-268-7166 or emailing Susan Brunner at email@example.com.
Education on Good Clinical Practices is available through CMU.
Clinical Trials Definition
The definition of clinical trials encompasses a wide range of trial types: mechanistic, exploratory/developmental, pilot/feasibility, behavioral, and more. Some Human Subjects Research previously not considered to be clinical trials is now categorized as such.
NIH provides guidance and a tool to help determine whether a study is considered to be a clinical trial by NIH. See NIH’s webpage on the definition that includes case studies, FAQs and other resources that can help. ORIC is also available to assist researchers; see this guidance. Determinations need to be made prior to proposal submission so this analysis should be completed well in advance of submission deadlines.
Contact your NIH Program Manager well in advance of proposal submission for assistance in determining if your work will be categorized as a clinical trial.
Good Clinical Practices Education
Good Clinical Practices Education
NIH policy states that NIH-funded investigators and staff involved in NIH-funded clinical trials should be trained in Good Clinical Practice (GCP).
The principles of GCP help assure the safety, integrity and quality of the clinical trials by addressing elements related to the design, conduct and reporting of clinical trials. GCP training describes the responsibilities of the investigators, sponsors, monitors and IRBs in the conduct of clinical trials.
GCP education is available via CITI. Choose the most appropriate course for your research; either GCP for Social and Behavioral Research or GCP for Clinical Investigations of Devices. See CITI Login Instructions to access the courses.
See the NIH FAQ regarding GCP.
Data Safety and Monitoring Plans (DSMP)
NIH Policy for Data and Safety Monitoring of Clinical Trials
NIH policy requires that each NIH Institute and Center have a system for the appropriate oversight and monitoring of the conduct of clinical trials to ensure the safety of participants and the validity and integrity of the data for all NIH-supported clinical trials.
It is important to note that data and safety monitoring functions and oversight of such activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB).
Most NIH applications for funding for clinical trials include the requirement for inclusion of a DSMP in the proposal. NIH institutes and centers have specific policies and guidance for data safety and monitoring that should guide development of the DSMP. See the NIH site for institute specific guidance.
The principles of data and safety monitoring include:
- Monitoring that is commensurate with risks;
- Monitoring that is commensurate with size and complexity of the study;
- Monitoring activities that are conducted by experts in all scientific disciplines needed to interpret the data and ensure study participant safety; and
- Ideally, participants in monitoring outcomes of a study are not associated with the study.
The activities performed for data and safety monitoring generally include:
- Review of the research protocol and plans for data and safety monitoring;
- Evaluation of study progress including periodic assessments of data quality and timeliness, participant recruitment, accrual and retention, participant risk versus benefit, performance of study sites, and other factors that can affect study outcome;
- Consideration of factors external to the study when interpreting the data, such as scientific or therapeutic developments that may have an impact on the safety of the participants or the ethics of the study;
- Recommendations to funding institute, the IRB, and investigators concerning continuation or conclusion of the study;
- Protection of the confidentiality of the trial data and the results of monitoring.
Typical Elements of Data and Safety Monitoring Plan (DSMP)
- Description of data and safety monitoring process, frequency, reporting and responsible parties
- Description of the study including participant population and inclusion/exclusion criteria
- Risks and benefits for participants
- Plans to minimize potential risks
- Description of informed consent process
- Description of data collection, data analysis and data security
- Plan for identifying and reporting safety concerns, adverse events and unanticipated problems
- Plan for handling incidental findings
- Criteria and plan for stopping study
- Process for identifying and disclosing conflicts of interest
- Discussion of responsible parties (investigators, and DSMP participants)