Since the pandemic there is an increasing number of clinical trials being initiated, outpacing the capacity of available study sites. In Europe, there have been reports of challenges in finding suitable study sites for clinical trials, particularly in certain therapeutic areas and for specific patient populations.

Spotlighting on the European market, some countries have a higher concentration of active study sites, whilst others may have fewer. Factors such as, staffing shortages, healthcare system capabilities, and research infrastructure can influence the suitability of sites.

With stresses faced by trial sponsors when identifying, assessing feasibility and collaborating with sites, I spoke with Philipp Badorrek, Head of Clinical Airway Research at the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, one of 76 research institutes of the Fraunhofer-Gesellschaft group. Philipp’s department operates a respiratory research site in Hanover, Germany.

David (PBC Group): What are some common challenges faced by clinical trial sites during the recruitment and enrolment phase, and how do you propose addressing them effectively?

Philipp (Fraunhofer Institute for Toxicology and Experimental Medicine ITEM): In respiratory research, specific patient populations are often included in clinical trials like asthma or COPD patients with a very specific phenotype or disease stage. Sometimes it is very difficult to find these patients and the most important aspect is to have a transparent communication about this with the Sponsor. Raising expectations that cannot be met is a sure way to jeopardize a trusting relationship.

One solution is study independent pre-screenings to line up subjects for a clinical trial. This helps to ensure a timely recruitment and it also helps to manage expectations about a realistic recruitment forecast.

David: Clinical trial sites often encounter logistical hurdles in coordinating study visits and managing participant schedules. Can you provide examples of strategies or technologies you would implement to streamline these processes and ensure efficient trial operations?

Philipp: In our clinical trial site we have one responsible study coordinator for each clinical trial. I would highly recommend this to non-professional sites such as doctor's offices. A dedicated study coordinator who knows the trial protocol by heart and has the time and resources to look after the trial can make a huge difference. It not only improves the operational aspects, but also the quality of the trial performance at the site.

David: Communication and collaboration between different stakeholders, such as principal investigators, and sponsors are vital for successful clinical trial execution. How would you foster effective communication and teamwork among these groups to overcome potential challenges and ensure timely study completion?

Philipp: More and more sponsors and CROs are conducting weekly or bi-weekly operational TCs with the sites.

Even though this is one more fixed time slot in everyone's calendar it definitely helps to establish and maintain a transparent and trusting relationship. Many hurdles, problems and issues can be discussed and addressed early on before they become major problems.

David: Participant retention and compliance can be challenging throughout the duration of a clinical trial. How would you develop strategies to enhance participant engagement, address non-adherence, and minimize dropouts, ultimately ensuring the collection of reliable and complete data?

Philipp: Patients participating in clinical trials give a lot and this should be appreciated. At my trial site we do not do normal patient care, but only treat patients in the context of clinical trials. This means it is even more important for us to invest in participant engagement. We make sure that every study participant feels special, appreciated, and gets a maximum of hospitality from us. All our study physicians have the time and are prepared to have lengthy talks with each study participant about their disease, treatment options, or any other medical topic the participant is interested in. Any feedback the participant gives us is appreciated and we invest time and effort to improve.

As soon as the information is available, we inform the participants about the treatment arm (usually verum or placebo) they have participated in. Most participants want to know this, and it is a good opportunity to thank them once again for their participation.

In conclusion, Philipp proposes the need for transparent communication about specific patient populations and study-independent pre-screenings for recruitment. He recommends dedicated study coordinators, celebrating regular operational teleconferences for effective communication, and highlights participant engagement, appreciation, and informative feedback to ensure reliable data collection.

Philipp Badorrek will be presenting on Sites as Partners: The Question of Feasibility at COG Europe, taking place on the 10th & 11th October 2023, in Milan, Italy. More information can be found here: https://www.thepbcgroup.com/cog-europe

** Disclaimer: the views shared here are the author’s alone, and not of the Pharmaceutical Business Conference Group, Fraunhofer Institute for Toxicology and Experimental Medicine ITEM or any other organisations **