21st century drug development is a complex endeavor, driven by new clinical and scientific insights. An important manifestation of this complexity is the necessity to manage multiple obstacles along the way to successful trial execution. These challenges may be associated with the trial phase, the indication, or nature of the study treatment.
Clinical research organizations (CROs) employ teams of Medical Monitors to provide guidance and oversight that are essential components of study planning and execution. Below, we outline the role, skillset, and contributions of these essential CRO team members.
CROs provide support for all aspects of drug development. In areas of high innovation such as oncology, project teams depend on medical monitors to provide perspective on each study and specific guidance that contributes to study-specific planning, execution, and analysis.
Medical monitors serve as expert consultants to sponsors and project teams, providing safety oversight to protect study participants, delivering training and support to the project team, and helping to drive strong site performance. This last objective has an outsized impact because site performance is usually the primary determinant of study success. whether a trial succeeds in collecting high quality, analyzed data in a timely manner.
Successful medical monitors possess a necessary blend of clinical experience, scientific insight, and personality traits. They are medical doctors, some with specialty training that is relevant to the disease being studied, and others with broad therapeutic experience. Regardless of therapeutic focus, excellent communication abilities and emotional intelligence are vital.
The wide-ranging nature of their role in the CRO setting also requires efficiency at managing their time.
In terms of knowledge, successful medical monitors must have a strong grasp of pharmacology, pathophysiology, and relevant aspects of molecular biology and immune system function. This scientific background plays a key role in translating innovation to the practical reality of working with clinical trial subjects.
Expertise in every therapeutic area is not feasible; therefore, medical monitors must possess the ability to conduct the research that is necessary to understand relevant principles of disease management. They must also be able to identify nuances in disease management and aspects of the competitive environment that may have an impact on study design and site selection. These considerations must be applied based on understanding of geographic differences in disease epidemiology and clinical practice.
A strong handle on the foundational principles of drug development such as good clinical practice, ethical considerations, and bias reduction, is mandatory. Medical monitors must also have extensive experience in pharmacovigilance, and significant familiarity with biostatistics and data analysis. This experience is a key requirement for making sense of study data and providing guidance to internal teams and sponsors.
In the context of modern drug development, it is critical for medical monitors to be familiar with a range of drug classes and formulations including small molecules, biologics such as monoclonal antibodies, as well as cell and gene therapies.
Within a CRO environment, medical monitors interact regularly with project team members from a variety of functional groups, including:
These interactions allow the sharing of expertise to provide guidance while also being an important learning opportunity to build monitor knowledge over their career.
Medical monitors frequently interact with study sites as a source of guidance regarding the requirements of the study and in the context of study updates. They also support activities such as Safety Review committee meetings and Data Monitoring Committee meetings. An especially important type of interaction is the relationship with the trial sponsor’s medical experts. Given that a CRO’s medical monitor often acts on behalf of the sponsor’s medical lead, this relationship must be established early in the life of any clinical trial.
Medical experts in CROs wear many hats. In addition to serving as a project physician supporting the project team and sites, they participate in business development activities, including client meetings, proposals, bid defense meetings, and marketing activities. Their clinical and scientific knowledge makes them vital contributors to process improvement initiatives and technical training programs.
Successful integration of the medical monitor into all aspects of a project, from the planning to data analysis, is critical for optimal outcomes. Although demanding, the role allows for substantial positive impact on drug development through the unique perspective monitors provide. Their oversight, consulting, and knowledge sharing are important for ensuring site performance as manifested by the timely acquisition of the high quality of data necessary for study success and for bringing important new medicines to patients.
The medical monitoring group at Precision for Medicine is part of a team of oncology and rare disease drug development experts supporting a broad range of drugs, including cell and gene therapies.