An adaptive clinical trial is a clinical trial that evaluates a medical device or treatment by observing participant outcomes (and possibly other measures, such as side-effects) on a prescribed schedule, and modifying parameters of the trial protocol in accord with those observations.
Medical Monitoring, Defined
- A Phase 3 clinical trial designed to evaluate if an investigational vaccine can prevent symptomatic coronavirus disease 2019 (COVID-19) in adults has begun. The vaccine, known as mRNA-1273, was co-developed by the Cambridge, Massachusetts-based biotechnology company Moderna, Inc., and the National Institute of Allergy and Infectious Diseases.
- A well-written monitoring report is an essential part of documenting clinical trial oversight. In addition to being required by ISO and ICH guidelines, it also tells the story of the clinical trial to the FDA, demonstrating site performance and sponsor oversight during an FDA inspection.
Medical monitoring is an essential component of the clinical research process. Medical monitors provide medical expertise and oversight for the entire clinical trial, from initial study design through final study close-out. They ensure the clinical integrity of the trial subjects and provide safety accountability across the duration of the study, while acting as expert points of reference for both investigative sites and study team members.
Unlike a Clinical Research Associate (CRA) who aid investigative sites in adhering to clinical protocols and reporting requirements, a Medical Monitor provides medical expertise for trial oversight and safety concerns. They field a wide array of study specific questions and protocol issues that relate both to subject safety and trial management, for example:
- Answering inclusion and exclusion questions from investigative sites, CRAs, and study teams.
- Answering questions specific to the protocol during the site start-up process
- Coordinating with other personnel on the study to ensure that information is consistent
- Addressing safety issues across the study from sites and the study team
- Actively interacting with investigative sites
- Acknowledging and providing guidance for when a subject needs to be unblinded due to medical emergency.
- Reviewing line listings for coded events to verify Medical Dictionary for Regulatory Activities (MedDRA) consistency
From Design to Close Out
Medical monitors support the entire clinical trial, from protocol design to study close out. During protocol design, the monitor could be called on to assess the inclusion and exclusion criteria – i.e. which factors would qualify a patient for the trial and which would disqualify a patient for the trial. They also weigh the efficacy and safety assessments of the protocol, including how the efficacy of the drug in question will be determined and how adverse events will be assessed and collected.
At the start of a trial, the medical monitor may conduct a Study Initiation Visit. The purpose of this visit is to have a detailed discussion about the study procedures and sponsor expectations for a given clinical trial, including ensuring each member of the trial is clear about their role. It is the final step in a series of preparations that should occur before a clinical study begins enrollment.
Once a study is underway, the medical monitor must be available 24/7 to field trial questions. You can’t account for every scenario in a trial ahead of time, and adverse events can occur at any time. They may be called on for medical review of safety information before reports are submitted to the FDA.
During Monitoring Visits, which are periodically occurring visits from the sponsor CRA, medical monitors are responsible for verifying/assuring the rights and well-being of human subjects are protected and the trial data is compliance with the approved protocol, good clinical practice (GCP) and other regulatory requirements. They must assure that reported trial data are accurate, complete, and verifiable from the source documents, among other things.
Medical monitoring is an essential function of the clinical trial process. If not done, or not done well, there exists the potential for huge fines and legal penalties.
A Balanced Approach to Medical Monitoring
At C3i Solutions, our Medical Monitoring staff is made up of experienced physicians, with deep and specific therapeutic expertise. Our physicians have years of hands-on experience in all sides of the research arena and they are able to apply expertise from working backgrounds in both clinical and safety. This unique combination allows for a greater depth of understanding and interaction with both investigative sites and study teams.
Free Download Program Types Of Clinical Trial Monitoring Visit Log
Tags: adverse events, clinical trials, drug safety, medical monitoring, Pharmacovigilance