Expert Interviews
Insights from Dr. Martin Mayrleitner: Key Factors in Site Selection, GCP Training, and the Future of Clinical Research
This interview with Dr. Martin Mayrleitner highlights his extensive experience in managing clinical studies and training teams in clinical research. Dr. Mayrleitner shares his insights on site selection, GCP training, and the challenges in clinical research.
ABRS: Based on your experience in site selection and evaluation, what key criteria do you consider essential to ensure that a site is suitable for a specific clinical trial?
Dr. Martin Mayrleitner: Based on my experience, the selection of a suitable site for a specific study is crucial for its success. Some key factors are:
• Evaluating the availability of the target patient population that meets the inclusion/exclusion criteria.
• Assessing the recruitment strategies at the potential site, because it is important to enroll participants within the required timeline.
• Ensuring the site has the infrastructure and necessary facilities, and equipment to conduct the trial.
• Ensuring the site has access to specialists or resources required for a specific trial.
• Checking the site’s previous experience with clinical trials, as experienced sites are more likely to adhere to protocols and timelines.
• The site should be compliant with local, national, and international regulations, including GCP guidelines, and have a good relationship with local ethics committees.
• Confirming Investigator and site personnel qualifications and assessing the site’s ability to conduct training on study-specific protocols required for the trial.
ABRS: In your role as a trainer for investigators and monitors, what strategies do you use to ensure that teams fully understand and correctly apply GCP-ICH guidelines in their daily activities?
Dr. Martin Mayrleitner: As a trainer, I offer comprehensive ICH GCP Training Programs and Interactive Learning sessions (online courses or workshops that use quizzes and assessments). Additionally, I encourage investigators and monitors to apply GCP principles to their current projects and share their experiences and challenges. I also organize periodic refresher courses and updates on GCP-ICH guidelines.
ABRS: During your experience managing clinical studies across different regions in Europe, how have you addressed regulatory and cultural differences to ensure project success?
Dr. Martin Mayrleitner: Regulatory and cultural differences: Each European country may have specific regulatory requirements for clinical trials. Collaborating closely with local regulatory bodies, such as the EMA and national health authorities, is crucial for understanding and adhering to these regulations. I recommend maintaining detailed records to ensure that all documentation meets both local and EU-wide requirements and collaborating with local CROs or freelancers who understand the regulatory and cultural differences and nuances of each country or region.
ABRS: What have been the biggest challenges when coordinating multicultural teams in Phase II and Phase III studies?
Dr.Martin Mayrleitner: Ensuring compliance with local laws while maintaining consistency across sites can be challenging. Time zone differences in coordinating meetings may lead to delays in decision-making. Access to resources, including technology and infrastructure, can vary significantly between countries, affecting the implementation of study protocols.
ABRS: From your perspective, how has clinical research changed in recent years, and what trends do you think will be key for the future?
Dr. Martin Mayrleitner: Clinical research has undergone many significant changes in recent years. COVID-19 accelerated the adoption of telemedicine, which allows for remote patient monitoring. This trend is likely to continue and makes clinical trials more accessible. Wearable devices and mobile health applications enable real-time data collection, improving data accuracy. There is more flexibility through adaptive trial designs, which allow for modifications to the trial protocol based on interim results. Decentralized trials, utilizing remote monitoring and local healthcare providers, improve recruitment and retention rates. Regulatory bodies, such as the EMA, have adapted their guidelines to facilitate faster approval processes. Future trends include personalized medicine (with a focus on genomics, biomarkers, etc.) and the integration of Real-World Evidence (data collected outside of traditional clinical trials), as well as the trend to include diverse patient populations in clinical research.
We deeply appreciate Dr. Martin Mayrleitner for taking the time to share his valuable experience and perspectives on the challenges and opportunities in clinical research. His knowledge and approach to site selection, team training, and managing clinical studies across different regions are crucial for the success of modern clinical trials.