Role-specific and peer-reviewed training written by an expert clinical trial budget professional, this course is ideal for research site administrators, clinical trial coordinators, and other key research study staff members.
Trialists intuitively employ project management skills but lack access to rigorous research methodologies that support these approaches – presenting a serious obstacle in terms of efficient and effective trial management.
Getting Started
Clinical trial management is an integral component of developing and testing new medicines. Without proper administration, even carefully designed studies could yield unreliable results that affect researchers as well as patients. Therefore, developing effective strategies to guide trial managers and those overseeing them is of utmost importance; currently, these strategies tend to develop intuitively either on the job or through experience and lack any standardized practices; creating formal protocols could bring advantages for all involved – from funders supporting research through to patients taking part in trials.
George Washington University provides numerous educational options for those interested in clinical trial management, such as certificate and bachelor’s degree programs online in clinical research administration; with one taking 18 months and the latter two.
Are You Curious About Clinical Trial Management? A non-credit certificate program offered by the University of Delaware’s Professional and Continuing Studies offers another great opportunity for those wishing to learn more about it. Over 14 weeks, participants gain a comprehensive overview of clinical trial management concepts which aligns closely with ACRP exam content.
This course is tailored for health care professionals with some knowledge of clinical trial process who want to enhance their expertise in this area. Students learn how to initiate a research study, implement monitoring methods and comply with FDA regulations and International Conference on Harmonization guidelines.
Participants of this course not only learn the fundamentals of clinical trial management, but also build project management, communication, and leadership skills. It features a practical hands-on project which gives students an opportunity to put what they have learned into action within real life environments.
Setting Goals
Trial managers should work collaboratively with their team members to set realistic goals and objectives for every project, documenting them for presentation to funding bodies.
One key objective that must be thoroughly discussed and approved at the outset of any trial is its recruitment plan. The goal should be to attract participants who meet all criteria of the study while likely responding well to it. Promotional materials for your study must be eye-catching and include key points relevant to potential participants; working with marketing professionals or providing in-house training may help with this goal.
An additional key objective should be establishing an efficient system for tracking trial progress. A CTMS can aid this effort, by centralizing and tracking organizational data in real time; providing valuable insights while streamlining trial management operations.
Guaranteeing effective communication among trial team members is of utmost importance. Regular meetings among all collaborative team members should serve to discuss progress, resolve problems and identify any potential roadblocks before they become major roadblocks. Meetings may even take place remotely with appropriate tools available if available – effective meeting techniques may include agendas, timed targets and group discussion for maximum effectiveness.
Leveraging the experience of individuals doing well to teach others in your collaboration is an excellent way to build capacity and foster internal learning. This can be accomplished via newsletter or at meetings, and often results in increased enthusiasm about your project.
Longer-term objectives should include setting standards for managing clinical trials that provide funders and trial managers with clear guidelines as to how clinical trials should be run. To accomplish this goal, a multidisciplinary group including trialists from industry will need to come together – but their effort will pay off.
Recruiting Participants
Recruitment of potential trial participants is of critical importance in any trial’s development process, so trial managers must have an in-depth knowledge of how best to market it to potential participants and what opportunities lie within it for recruitment.
Trial teams should consist of people with clear knowledge of their responsibilities, who have received adequate training in managing trials. This ensures they can effectively deliver on required work without becoming overwhelmed with tasks they cannot manage.
Trial managers must understand how to oversee all aspects of a project and ensure that those responsible for its success receive due credit for their contributions. Collaboration trials require everyone involved to embrace their roles fully, contributing to its successful conclusion and being recognized. This may take the form of trial management roles, group authorship or being highlighted in publications.
Utilizing digital tools to assist with recruitment, retention, and other trial processes is an effective way to optimize efficiency in clinical trials. Some of the best online tools allow multiple different activities to be completed simultaneously in one place – this may reduce clicks or refreshes required from users.
Trial team members must understand how and when to use any new digital tool to ensure it delivers its desired results and works correctly; otherwise running studies without this knowledge could prove costly.
Recent research – available here – suggested that sponsors and CROs running master trials, also known as basket, umbrella, or platform studies, should dedicate substantial effort towards reevaluating, refining, and evolving their operational approaches. It examined master trials as overarching protocols that encompass multiple sub-trials.
Research concluded that master trials are complex in structure and require an intricate information flow with safety and efficacy evaluations occurring frequently and being difficult to manage. According to this research, it was recommended that digital tools be developed and deployed to help conduct such complex trials successfully.
Monitoring
Designing a clinical trial requires extensive research and consideration, from selecting participants to gathering data. Unfortunately, less care and consideration goes into running these trials than initially planned – this is why monitoring is integral in clinical trial management; monitoring ensures participants’ rights and safety are respected while quality data collection occurs as planned and within set timelines.
Monitoring can be performed by monitors, quality assurance teams or trial managers. Guidance for this activity often comes from multiple sources and often uses technical jargon that may lead to confusion and lead to safety risks for trial participants, inferior data quality and the integrity of clinical trials.
A recent reflection paper from the European Medicines Agency (EMA) on risk-based monitoring has helped refocus attention on this aspect of trial oversight, with clearer guidance for how it should be carried out. This emphasizes building relationships with sites while making certain there is clarity over what needs to be monitored (i.e. compliance with GCP or other international regulations).
One key piece of advice for monitoring is to always come prepared when visiting trial sites, making sure they have access to any necessary documents and know about any changes or amendments in trial procedures. An up-to-date clinical trial management system (CTMS) can also prove invaluable, providing all staff members with one central source for all the information they require – saving both time and resources when overseeing large programs with multiple trials.
Pharmaceutical and biotechnology companies use clinical trial management systems (CTMS) as a resource to track clinical research activities. At Fred Hutch Cancer Center and the University of Washington, OnCore is used as their daily clinical research manager; it allows them to keep tabs on all ongoing trials running, monitor progress, record and report data, and much more.