Medical Directors, Medical Monitors, Clinical Research Scientists, Clinical Project Directors
Doctors play important roles in the design, implementation, monitoring, analysis, and reporting of clinical studies. MDs PhDs,and PharmDs design and monitor Phase 1-4 clinical studies for drugs and biologics; veterinarians supervise studies for drugs for animal use; and dentists, podiatrists, and optometrists may guide drug or device trials in their specialties. These doctors may have titles such as Medical Director, Clinical Project Director, or Clinical Research Scientist.
Each company is different and actual study procedures are influenced by the phase of the study, prior experience with the drug or device, the clinical indication, and the number and location of investigative sites. Nevertheless, the Medical Monitor or Clinical Research Scientist usually participates in most, if not all, of the following activities:
Some of these activities, such as reviewing the literature, planning patient evaluations, working with investigators, and safety monitoring come relatively easy to physicians since they are similar to the activities learned in clinical practice. Other activities, such as regulatory interactions, writing or amending a protocol or Investigator Brochure, and AE reporting, require knowledge of procedures unique to industry.
Teamwork is key for the design, implementation, and successful completing of clinical trials. Not every study will give the desired results, but the monitor and the entire study team must always insure that the safety of participants is protected and that the study procedures have been followed with care and integrity.
Each company is different and actual study procedures are influenced by the phase of the study, prior experience with the drug or device, the clinical indication, and the number and location of investigative sites. Nevertheless, the Medical Monitor or Clinical Research Scientist usually participates in most, if not all, of the following activities:
- Review scientific and medical literature to prepare the product development plan
- Study design -- this may include discussions with a multidisciplinary clinical/regulatory/commercial product development team to be sure important product and labeling variables will be assessed and discussions with potential investigators and knowledge leaders in the field to be sure the study design is clinically appropriate
- Work with the biostatistician to provide medical/scientific input for sample size calculations, randomization, and the draft analysis plan
- Protocol writing, including identification of primary and secondary study endpoints and suitable assessment scales
- Design timetables for safety and efficacy measurements during the study
- Prepare or review and update the Investigator Brochure (IB)
- Interact with Regulatory Affairs to prepare study plans and protocols for submission to regulatory agencies and assist in discussions and negotiations
- Work with data management to identify data points to be collected, to design case report forms or data screens, and to plan coding and data quality checks
- Train study monitors about the disease under study and current treatments
- Estimate study drug and packaging needs or plan the distribution of investigational devices
- Choose study sites and recruit and train clinical investigators
- Supervise study conduct, including subject recruitment and enrollment decisions
- Monitor study progress
- Medical Monitoring which requires review of Inclusion/Exclusion Criteria for all subjects, reviewing laboratory tests, reviewing adverse events and concomitant medications, discussing Serious Adverse Events (SAEs) with investigators, and reporting SAEs to regulatory agencies. Medical Monitoring roles are usually restricted to physicians.
- Assist Regulatory Affairs with interim regulatory filings that require clinical information
- Review CRAs monitoring reports, take action with sites if needed
- Plan design of tables, listings, and figures for the clinical study report
- Work with study team on study closeout
- Review coding of concomitant medications and adverse events, review protocol deviations or violations
- Sign off on database lock
- Complete study analysis
- Prepare or review Clinical Study Report
- Other activities as needed or assigned
Some of these activities, such as reviewing the literature, planning patient evaluations, working with investigators, and safety monitoring come relatively easy to physicians since they are similar to the activities learned in clinical practice. Other activities, such as regulatory interactions, writing or amending a protocol or Investigator Brochure, and AE reporting, require knowledge of procedures unique to industry.
Teamwork is key for the design, implementation, and successful completing of clinical trials. Not every study will give the desired results, but the monitor and the entire study team must always insure that the safety of participants is protected and that the study procedures have been followed with care and integrity.
Several of the Guidance Documents in the Resource Section for Guidance Document give details about the Good Clinical Practices (GCPs) that guide clinical trials.
To Learn More
There is an on-line course for Clinical Research Training sponsored by the US National Institutes of Health. It is focused on ethical and regulatory issues related to clinical research. It was designed for NIH Investigators but is available to others at no cost, or I should say paid for by US taxpayers. It takes several hours to complete so I would not suggest that you register unless you as sure you have a real interest. But, if you are new to clinical research it is a good, somewhat advanced, place to start.