What Is The Role Of Medical Monitors In Clinical Trials?

Medical monitoring is essential for the progression of a clinical trial. Medical monitors are physicians who offer their medical expertise to ensure patients’ safety both during and after a clinical trial.

This article will discuss the role of medical monitors in clinical trials in detail and will cover the following topics:

  • What is a medical monitor?
  • What does a medical monitor do in clinical trials?
  • Why are medical monitors required for clinical trials?
  • Who else is involved in clinical trial monitoring?
  • Key takeaways

What is a medical monitor?

A medical monitor offers informed physician-level opinions in clinical trials and is essential in trial conduct. They are qualified and licensed medical professionals involved in clinical study design, execution, and evaluation, and they ensure the safety of the patients by analyzing adverse events and ensuring that they are reported and appropriately evaluated.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) defines the purpose of clinical trial monitoring in the following way:

The purposes of trial monitoring are to verify that:

(a) The rights and well-being of human subjects are protected.

(b) The reported trial data are accurate, complete, and verifiable from source documents.

(c) The conduct of the trial is compliant with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).

The aim of medical monitoring is to ensure patient safety and that the trial is being executed in the way in which it was planned. Medical monitors are also available as a point of reference for clinical staff and sponsors throughout the clinical trial. Generally, the medical monitor is always available to provide consultation to the clinical operations team to ensure participant safety and the continued integrity of the trial.

What does a medical monitor do in clinical trials?

Although the specific tasks involved in medical monitoring can differ based on the design, purpose, objective, endpoint(s), and complexity of a given trial, the general activities of monitoring are more or less the same.

Medical monitors are generally required before, during, and after a trial. Medical monitors usually operate on-site, but in some circumstances they operate centrally and offer written guidance to ensure that the trial runs as it should and that no problems occur in their absence. Moreover, medical monitors can also be requested during investigator’s meetings and trainings.

Here are some of the main activities a medical monitor performs for clinical trial monitoring:

Protocol design support

From protocol design to safety guidelines, medical monitors create a monitoring strategy specific to each clinical trial, holding patient safety and data integrity as top priorities. The monitoring strategy encompasses the roles and responsibilities of all the parties involved, as well as the various monitoring methods and their purposes. Medical monitors are also involved in defining how adverse events will be handled.

Study initiation visit

A study initiation visit is conducted at the start of a clinical trial. It is one of the final steps in ensuring the clinical trial follows all the standard procedures and protocols. The medical monitor extensively discusses the study procedures and sponsor expectations during this visit. Moreover, the roles and responsibilities of each individual are also clearly defined.

The medical monitor also ensures patient safety by verifying that all study participants have given written informed consent, and that the data collected is accurate and complete by checking the source documents.

Monitoring visits

There are two different types of clinical medical monitoring visits; on-site and central. On-site monitoring is recommended before, during, and after the trial procedure, whereas central monitoring is advised only in exceptional circumstances.

Since the onset of the COVID-19 pandemic, central monitoring has increased in use, seeing as regular site visits were often not possible. However, relying on central monitoring alone is often not a viable option, as many clinical trials require on-site monitoring, for example to evaluate adverse events.

Medical monitors should be able to perform the necessary clinical medical monitoring activities based on the specific nature of the study, and they should have appropriate knowledge about the product, study protocols, and safety guidelines.

Why are medical monitors required for clinical trials?

Medical monitors are required for proper trial conduct, for the safety of patients, and for reducing data integrity risk. They are an essential part of the clinical trial process and the evaluation of a drug’s safety.

Doctors and medical monitors work together with sponsors and clinical operations teams to develop a safe and effective drug. Medical monitors offer professional insight in 3 main areas: support during the trial, study design and protocol, and safety data reviews.

Who else is involved in clinical trial monitoring?

Although medical monitors are often employed in clinical trials, the monitoring responsibilities don’t lie solely on them. Monitoring responsibilities require visiting sites, interacting with patients and investigators, designing protocols, adhering to the monitoring strategy, and assessing adverse events. Some of these responsibilities may be shared amongst the team.

Here are just some of the roles involved in monitoring and how they each contribute to clinical trial monitoring:

  • Medical monitors: Licensed and certified physicians who use their medical expertise to help in study protocol design, patient safety guidelines, and collection and reporting of adverse events.
  • CRAs: Clinical research associates (CRAs) only conduct site-specific inspections and ensure that trial sites are following protocols and reporting adverse events properly.
  • Quality assurance teams: The QA team is responsible for conducting site audits and verifying that the standard protocols are followed. They also address the welfare of the patients and ensure all issues detected by medical monitors are resolved.
  • Trial investigators and managers: Clinical investigators are responsible for conducting an investigation based on the signed investigator statement, the regulatory protocols, and the investigation plan.

Main differences between a medical monitor and a principal investigator

Medical monitors and principal investigators are both physicians, but their responsibilities within a clinical trial differ. One difference is that medical monitors advise or consult on patient safety, monitoring, and data integrity across multiple study sites, whereas the principal investigator is the individual who is responsible for the conduct of a clinical study at one particular site. Medical monitors are also often the spokesperson for the drug sponsor and are required to develop a monitoring strategy and ensure the safety of the patient population across all trial sites.

Key Takeaways

Clinical trial monitoring is an important part of trial conduct, and medical monitors are responsible for this aspect of the trial. Medical monitors are licensed professionals who act as a consultant and provide their input on a trial's safety, efficiency, and protocols. They have medical and clinical experience and ensure that the trial is conducted properly by verifying adhering to SOPs, regulations, and sponsor expectations.