My colleague Frances Bentley and I had the privilege of attending the 8th Annual Clinical Monitoring and Patient Recruitment Retention (CMPRR) Summit in Barcelona. Several clinical trial challenges and solutions were discussed.
I was there to present a talk titled “Exploring the Hidden Challenges to On-Time Study Startup.” I also had the honor of serving as chairperson of the entire event at the request of organizer Sachin Sharma.
A well-designed conference has or should have, topics of direct interest to all who attend. Considering the diverse backgrounds of delegates, this represented a challenge. In-person attendees were from various CROs and sponsors, plus vendors from a variety of areas, including decentralized trials, risk monitoring, and startups. All offered innovative ways to capture or manage data, site teams, physicians, and even patients. So, there were plenty of topics surrounding clinical trial issues.
A prominent theme, as expected, covered the patient and site burden and different ways these burdens could be minimized whilst not greatly affecting risk or data. From my perspective as chair, it was interesting to see how presentations aligned on this subject, which fostered fantastic discussions during networking breaks.
The topic of training came up frequently in presentations. Many sites face pressures due to too little training, rushed training, and little support, especially for complicated studies. Another critical focus of many talks (including my own) was patient training, education, and improved understanding of the different steps involved in the study.
Site Clinical Trial Challenges
Michaela Vancova, managing director of Clinical Research Center, led a panel discussion looking at the challenges from the site perspective. Studies are more complicated than ever before. Whilst there are great benefits to patients in the long term from trials that are more flexible, the strain on sites, which are often already overburdened, is immense.
One of her panelists, Eva Turpel Kantor of Octapharma, said her wish for CROs would be to think back 15 years to when trials were less complicated. Almost all trials had similar designs. Clinical research associates and site teams had more training and support for studies, and the studies were all more inherently similar than today. Today’s studies require far more tasks and steps that impact site teams.
Site personnel take on many more tasks: more reporting, more monitoring, and an ever-increasing number of systems and procedures to learn and understand. In order to keep costs down and accelerate startup, training needs to be improved. All parties need to get better at setting expectations and understanding what the study aims to achieve. And an understanding of the elements needed to ensure study success.
There were interesting and surprising challenges seen at the site level, challenges that are known but frequently not discussed or addressed. In many countries, especially in Eastern Europe, not all sites have study coordinators. During site selection, the site may claim to have these positions filled. However, in reality, the role is managed by multiple people. This has a perilous knock-on effect resulting in poor data quality and overburdened teams. This then creates the common scenario of the regional clinical research associates providing the needed additional support to boost their income. This is called double dipping. It is well known, yet hard to monitor.
Mark Bradley, founder and CEO of PeopleWith, highlighted the critical challenge surrounding electronic health data needed to undertake many trials. Of the 123 countries listed in a world health data survey, only 57 have electronic data records. As a result, we are all competing and recruiting from the same limited pool of patients. As an industry, we are missing out on billions of additional patients and trial participants who have less advanced health care and could benefit from clinical trial participation.
This was echoed in a talk by Janusz Kabata, CEO of gp4resarch. He told us that the geographical barriers on traditional site models actually exclude more than 90 percent of patients from trial participation.
Joseph Lovett of Medidata gave a similar perspective. He pointed out that the Covid pandemic has led to an 80 percent drop in new patients entering clinical trials and the following paints a disconcerting picture:
- Increasingly challenging trials and trial design
- Inadequate training and support for site teams
- Increasing costs and financial pressures
- Challenge to find patients in the right geographical region
- Patients in the right locations are apprehensive about trial participation post-Covid
Recruiting in Developing Countries
Thankfully, Day 2 of the conference gave hope, inspiration, and a glimmer of light at the end of the tunnel!
Elizabeth Barabash of GaeaOÜ started the ball rolling with a fascinating presentation looking at the challenges and benefits of recruiting in developing countries.
She said developing countries are effectively a blank canvas with the opportunity to implement best-in-class technologies. This drives significant innovation and has a hugely beneficial impact at a broader level on a country’s medical development.
She did warn, however, that it takes time and resources to get up to speed in developing countries. This can involve high costs. Yet when time is taken at the start, with an eager patient population and high interest and commitment from site teams, studies can recruit incredibly well, even ahead of time.
Oncology: Only a Fraction of Patients Participate
Selin Kurnaz, cofounder and CEO of Massive Bio, talked about a market where there is a great need for clinical trials: oncology. She shared that only six percent of oncology patients globally are offered clinical trials. In 2021, 18 million people were diagnosed with cancer, and this is a market with accelerated growth. An increase in clinical trials is beneficial to the industry and has an enormous social benefit.
She provided a statistic of great interest to me: 85 percent of cancer care in the U.S. is handled at the community level and not at the larger cancer trial specialist centers. This reveals that managing patient logistical issues, information issues, and the patient burden (especially the financial impact) is critical. This point came up several times during the summit, including in my presentation. We must, as an industry, consider and allow for the increasing patient burden when we design trials.
Engaging all Stakeholders
The last session I want to share with you was a fabulous panel discussion led by Estrella Garcia from Almirall. Her talk included three excellent panelists. The key message within the forum was the importance of developing solutions in collaboration with all stakeholders, with the end goal of making life easier for patients and sites.
The approach they discussed had a higher initial cost. However, with a willing sponsor and excellent communication among the CRO, sites, and vendors, the studies had a 30 percent higher retention rate! They closed out quicker, meaning the drug was able to reach the market sooner.
Clinical Trial Challenges are Universal and Fixable
The talks across both days were engaging. The mix of delegates worked very well, too. It’s a conference that I highly recommend. The common themes that impact studies, from study startup and delays with enrollment and retention, are universal. But they are also fixable.
Small conferences like this provide valuable opportunities for people in the industry to dig deep into an understanding of the challenges faced by other stakeholders. Shifting your angle of perception can help you see clinical trial challenges and delays from the viewpoint of others. In doing so, resolutions are more easily obtained. The networking was also just as valuable.
After the conference finished, I took a few days of vacation. I enjoyed the wonderful sights of Barcelona with my husband whilst my U.S. colleagues enjoyed their Thanksgiving holiday. A lot to be thankful for!
For more information on overcoming hidden delays in clinical study startup, check out this blog: https://www.imperialcrs.com/blog/2022/10/21/clinical-study-startup-and-execution-hidden-causes-behind-big-delays/ and contact us to find out how we can help.
Clip of Imogen Cheese speaking at the CMPRR summit