The importance of hiring dedicated Medical Monitors to conduct clinical trials lies in the fact that they provide safety oversight to scientific research studies to ensure the well-being of study participants and the quality of the data collected during the study.
In other words, medical monitoring implies supervising that a clinical investigation is carried out correctly, that is to say, protecting the rights of patients and verifying the reliability of analytic data.
The aim of this article is to define what a Medical Monitor is, explain the main responsibilities and professional profile required for this position, as well as to provide guidance on how to hire a Medical Monitor in Europe.
What Is a Medical Monitor in Clinical Research?
A Medical Monitor is the physician and spokesperson of a sponsor responsible for examining the safety aspects of a clinical trial. [1] The need for a medically qualified individual to be involved in a clinical study will depend on the indications of the risk or resource assessment.
This physician, who has broad medical experience, is in charge of advising on the protocol standards that must be complied with during the trial as defined by applicable regulations.
Therefore, the main role of a Medical Monitor is to provide clinical knowledge and expertise, and oversee the evaluation for a successful development of the analysis.
In some cases, the sponsors of a study or the Clinical Research Organization (CRO) require a professional expert in certain medical areas, which will be discussed later in this article.
What Does a Medical Monitor Do?
A Medical Monitor is the advisor to a research team in terms of medical matters. Along with a proven professional expertise and in-depth command of the test drug, this physician must have the ability to provide medical insight to the particular medical specialty required during the conduct of the clinical study.
In short, the Medical Monitor is expected to oversee the protocol, communicate with all study parties —including the sponsor, study site, and CRO—, answering their medical questions and explaining medical concepts that are unfamiliar to other members of the study team.
The following are the main areas in which Medical Monitors are involved.
Protocol Design and Reviews
During a clinical trial, the Medical Monitor is frequently asked to modify the study protocol for certain situations and review interruption rules.
For instance, a patient has to leave a sample in the laboratory or must be checked on a certain day after finishing the doses. If that person cannot attend due to scheduling issues, the monitoring physician should analyze whether the protocol allows the test to be performed a day earlier or a day later without interfering with the results.
As mentioned above, a high degree of knowledge of the drug being tested is absolutely required.
These are further activities corresponding to the Medical Monitor: reviewing the study data to distinguish trends, ensuring that the clinical data have been entered correctly into the database, making Excel checklists, and getting involved in the patient eligibility forms for a study.
In this sense, the Medical Monitor must be ready for quick plan changes, for instance, if a sponsor asks to change the design of a study or rework the data review process. [2]
Safety Data Reviews
One of the essential tasks carried out by this professional is offering advice to the protocol team on welfare monitoring. A clinical trial involves human beings who may experience adverse reactions when receiving the medical treatment under study.
As an example, if the study drug causes an adverse effect in a particular patient, the team should observe whether other patients have the same reaction, if doses should be reduced, or, more importantly, the treatment interrupted.
Certainly, there might be other patients who have a particular health history that makes them not viable candidates for the study or to take other medications, which should not be combined with the test drug.
In fact, all these questions can only be answered by an experienced physician.
Provide Support for Medical Questions
As a result, the Medical Monitor’s job consists mostly of answering questions and providing advice to both the internal team and the study site.
But what questions can Medical Monitors answer? For instance, the study site may ask for more details about how the study drug works and its most common adverse effects when the site is writing the Informed Consent Form (ICF).
However, the mission of a Medical Monitor in clinical research entails a number of further tasks.
What Are the Tasks and Responsibilities of Medical Monitors in a CRO Managing Clinical Trials?
In this section, the tasks and responsibilities of a Medical Monitor will be presented in more detail through the case of a CRO specialized in oncology and cell therapy looking for a Medical Monitor for a study. [3]
As mentioned above, the Medical Monitor is responsible for the medical supervision of clinical trials. In the specific case of this CRO, the Medical Monitor has to perform a wide variety of tasks for different studies in the area of oncology and rare diseases.
The candidate should serve as a support from the start to the end of various studies, communicating and working together, and also autonomously, with the Medical Services team, as well as Drug Safety and Pharmacovigilance teams, to organize the planning and management of the assigned clinical evaluations.
The main responsibilities of the Medical Monitor required by this CRO are as follows:
Within the scope of medical monitoring of various studies, the first responsibility is to provide assistance in study design, protocol and regulatory approval strategy.
Additionally, the Medical Monitor should be the contact person to answer medical queries that sites, regulatory authorities and the Institutional Review Boards (IRBs) may have.
Apart from resolving and managing all medical queries during the study, the physician in charge is required to attend investigators’ meetings and safety review committees, and make presentations, if required.
Moreover, the Medical Monitor is expected to draft the study’s Medical Monitoring Plan (MMP) in mutual agreement with the Safety Monitoring Plan (SMP), which includes reviewing patient data and profiles from a medical perspective during the study period, and providing the information in the study reports.
After supervising each of the assigned studies, the Medical Monitor is the one responsible for doing the medical follow-up, as well as evaluating and managing the eligibility of patients.
On the basis of that assessment, this candidate must watch out for adverse effects and report on patient well-being data throughout the course of the study according to Good Clinical Practice (ICH), applicable regulatory guidelines, and the standard operating procedures of the CRO in question.
In reference to the patient’s safety, if adverse events of special interest (AESIs) occur or dangerous issues are detected, the Medical Monitor has to seek a resolution accordingly.
In addition, some Business Development activities are also under his/her responsibility, such as making proposals of medical protocols and feasibility of the study development by reviewing contracts for medical services, in order to justify these contracts at investigators’ meetings.
This task also includes verifying the ongoing budget and scope of work of the assigned studies, advising of a necessary change and attending meetings with clients.
Ultimately, this position requires availability throughout the week for emergencies or serious consultations.
Without doubt, a Medical Monitor has a lot of duties and responsibilities to accomplish. For this reason, the selection of a Medical Monitor in clinical research should be accurate, depending on the type of study that the CRO wishes to run.
What Are the Qualifications and Experience that Medical Monitors Have?
The job of a Medical Monitor is known as a non-clinical job that some doctors decide to pursue after several years of experience. This professional must have a Medical Degree (MD). A Bachelor of Medicine and a Bachelor of Surgery (MBBS), or equivalent, may also be required.
Medical Monitors may be specialized in different therapeutic areas, such as oncology, cardiology, neurology, urology, and other branches of medicine.
As an illustration, in the case discussed above, the Medical Monitor is required to have analytic research experience in oncology, as well as “scientific training and knowledge of clinical development, experience and ability to interpret patient data in the clinical trial setting, including safety signs and signals.” [4]
Here is a list of the experience and skills that are often required for a Medical Monitor position in Europe:
- Experience in the pharmaceutical industry, monitoring in clinical studies and pharmacovigilance, as well as in drug safety.
- Understanding of local regulatory requirements, local Good Clinical Practice (GCPs) and the International Conference on Harmonization (ICH).
- Ability to lead, communicate, convert information into regulatory documents, write and present, as well as to be assertive in decision making.
- Expertise in clinical research and trials. [5]
Furthermore, fluency in English is a must, while the ability to deal with professionals, teams and participants, building up a trusting environment, is essential.
How Can Clinical Trial Sponsors and CROs Hire Medical Monitors in Europe?
Sofpromed can provide Medical Monitors in Europe who perform specific tasks on a contract basis, working under the sponsor and/or CRO procedures, through a Functional Service Provider (FSP) personnel sourcing model. We provide Medical Monitors who are experts in specific therapeutic areas like oncology and neurology, among others.
References:
[2] https://doctorscrossing.com/what-exactly-does-a-medical-monitor-do/
