Medical Monitors play an important role in clinical trials as they provide the medical expertise needed to ensure patient safety and medical support both during the trial and in the use of the new drug after its approval. The Medical Monitor is a healthcare professional, a physician, who evaluates the study at every stage according to his/her medical perspective. Proper medical monitoring is essential in a clinical trial.
What Is a Medical Monitor?
A Medical Monitor essentially provides medical expertise, oversight, and consultation in a clinical trial. They are qualified, licensed physicians (in the United States, PharmaD is also an accepted qualification) involved in the trial from initial study design through final close-out. They ensure both the correct clinical evaluation of the trial and the safety of the trial subjects, and provide accountability throughout the study. At the same time, they are a point of reference and consultation for clinical site staff and sponsors. They are available 24/7 to answer questions and provide input when something unexpected happens.
Why Are Medical Monitors Important in Clinical Trials?
The companies and people developing new pharmaceuticals and therapies are not typically doctors themselves but rather experts and researchers who develop drugs and work on their efficacy. Physicians, by contrast, are specialized in the human body, disease, and the application of treatments. Drug developers and doctors need to work together to ensure that a drug is both safe and effective, and that the safety of trial participants is granted. In this context, the role of the Medical Monitor comes in.
Medical monitors provide expertise and support in three main areas that span the entirety of the clinical trial: protocol design and reviews, safety data reviews, and support for medical questions during the trial.
During protocol design, the Medical Monitor assesses the inclusion and exclusion criteria, the factors that will qualify or disqualify a patient for the trial. They also review the efficacy and safety assessments of the protocol from a clinical perspective, including how the efficacy of the drug in question will be determined and how adverse events will be evaluated and collected. In this regard, the patient care perspective is imperative for securing participant safety.
Once the trial is ready to start at the clinical sites, the Medical Monitor may conduct study protocol trainings. These staff trainings may include detailed discussions of the study procedures and sponsor expectations for a given clinical trial, ensuring each member of the trial is clear about their role. It is the last step before a clinical study begins enrollment.
Once a study is underway, the Medical Monitor is available to resolve medical questions from clinical site staff and the sponsor. Although planning and pre-clinical studies attempt to account for all possible situations, when dealing with experimental drugs, sponsors and staff need to expect the unexpected. When this happens, the Medical Monitor is there to provide consultation and input to guarantee participant safety and the integrity of the trial.
The Medical Monitor may also be involved in monitoring visits, and/or on-site inspections. During these visits, the Medical Monitor verifies that the rights and well-being of human subjects are being protected. The Medical Monitor also verifies that clinical site staff are correctly evaluating the protocol and adverse events to ensure the quality of the data and the safety of patients. They also check that good clinical practice is being followed.
One of the most significant roles of the Medical Monitor is conducting safety data reviews, which evaluate the presence or lack of safety issues with respect to the treatment the subjects receive. These reviews need to be conducted from the early stages of the study. Not only are they required by regulators, but they are necessary to ensure the safety of participants. Also, by following subjects as they progress through the study, researchers can build a picture of the safety profile of the compound under consideration.
Before the reports are submitted to the FDA, the Medical Monitor may be called to provide a medical review of the safety information.
How Is a Medical Monitor Different from Other Research Leads Such as a Principal Investigator?
Medical Monitors have a higher level of responsibility than a Clinical Research Associate (CRA) or a Principal Investigator when it comes to trial safety aspects. A Medical Monitor is both a consulting physician and spokesperson for a drug sponsor and is charged by the sponsor with the responsibility of examining the safety aspects of various clinical trials or trial sites.
In terms of safety and medical issues, the input of the Medical Monitor in a clinical trial goes beyond that of a CRA or Principal Investigator who makes sure a particular trial site follows protocols and reports adverse events properly. Based on their professional medical qualifications and experience as a physician, Medical Monitors advise and consult across various sites on how the protocol and safety events are evaluated at all stages of the trial.
The consultation offered by a Medical Monitor includes, for example, deciding whether a specific adverse event requires unblinding, mediating between the sponsor and trial sites, or reviewing in the case that an adverse event, i.e. patient symptom, is coded and reported properly. Their role implies many more aspects of the trial, all related to the evaluation of the trial in accordance with their medical perspective and expertise.
What Are the Tasks and Responsibilities of Medical Monitors in Clinical Trials?
- Acts as a medical manager for assigned clinical trials.
- Collaborates with the other staff to process Serious Adverse Events (SAEs).
- Provides therapeutic and protocol-specific training to the clinical site staff and others involved in the trial.
- Contributes to the design of study protocols by offering medical input.
- Provides around-the-clock medical support for clinical trials.
- Gives a medical review and assistance in the preparation of final study reports and other study documentation.
- Acts as a medical consultant for all parts of study.
- Identifies, documents and appropriately resolves out-of-scope work.
- Maintains working knowledge of good clinical practice and regulatory requirements related to clinical development and safety in order to ensure compliance with ethical, legal and regulatory standards.
- Mentors other medical staff as needed and consistently shows exemplary work ethics, compassion and integrity as a medical professional and clinical researcher.
- Participates in continuing education to maintain clinical acumen in his or her therapeutic speciality.
- Is competent with the processing of SAEs and related medical review via electronic safety databases.
What Qualifications and Experience Do Medical Monitors Have?
Medical Monitors have both academic training and clinical experience. They have accredited professional degrees and board certifications, and some of them are specialized in certain therapeutic areas, such as oncology, cardiology, neurology, etc. Before taking on the role of Medical Monitor for a clinical trial, the professional will have acquired significant clinical experience combined with a background in clinical research. This person may have worked in private practice, at a hospital, or both.
Additionally, the Medical Monitor will also have had other roles in clinical trials, especially with a Clinical Research Organization (CRO), or in other areas of the pharmaceutical industry. They may also have other academic research experience.
A Medical Monitor combines a passion for research and patient care, and has proven adept at both areas of medicine.
How Can Clinical Trial Sponsors and CROs Hire Medical Monitors in the United States?
Clinical trial sponsors —biotech and pharma companies— and CROs can hire Medical Monitors in the United States by contacting Sofpromed.
Sofpromed provides sponsors and CROs with Medical Monitors through a Functional Service Provider (FSP) model. FSP is a personnel sourcing model in which staff is provided to biotechnology and pharmaceutical companies in order to perform specific tasks on an independent contractor basis —but in a dedicated manner— and under the operating procedures of the sponsor.