Clinical research is a vital part of developing new treatments and cures for diseases. But it is also a complex and challenging process that faces many obstacles and inefficiencies.
Scott Schliebner is a Clinical Development Executive and advisor to early-stage biotech companies, helping them to design and execute clinical trials.
In the latest episode of the PharmaSource podcast, he shares his insights on some of the current problems and opportunities in clinical research, and how biopharmas can navigate the complex CRO industry in 2024.
The challenges of patient recruitment and retention
One of the biggest challenges in clinical research is finding and keeping enough patients to participate in clinical trials. Scott says that more than half of all clinical trials are behind schedule due to enrolment delays, and only a very small percentage of eligible patients ever find out about or join a study.
This has a negative impact on the speed and cost of clinical development, as well as the quality and diversity of the data collected.
“Patient recruitment is a huge problem. It’s delaying studies, which delays clinical development, which delays time to decisions and commercialization, and it drives up costs.” Scott says.
Another challenge is patient retention. Studies are becoming increasingly complex, meaning they collect more data and require more assessments from participants. This can make trials more burdensome and less appealing for patients, leading to higher dropout rates.
“Patient retention is also a key issue. Even when we recruit patients, because we’re putting them in studies that are challenging, we have a fair number that drop out and don’t complete.” Scott says.
The opportunities of AI and decentralised clinical trials
Scott believes that there are a lot of opportunities to improve clinical research by leveraging new technologies and approaches, such as AI and decentralised clinical trials (DCTs).
Scott says that AI has a lot of potential to help with clinical research, especially in sorting through large amounts of data and matching patients to clinical trials.
“We’ve got some pretty good traction with AI in clinical development, where it is being used to sort through lots of data and help match patients to clinical trials. There is a lot of information that AI can help process – huge datasets, whether it’s medical records, or clinical data, or real world evidence or things in wearables.” Scott says.
DCTs, or decentralised clinical trials, refer to the use of digital tools and platforms to enable patients to participate in clinical trials from their home or local setting, rather than having to travel to a clinical site. Scott says that DCTs have been accelerated by the COVID-19 pandemic, which forced the industry to adopt new ways of operating and bringing trials directly to patients.
“DCTs have real potential to solve the retention issue and make trials less burdensome and improve the diversity with a wider representation of populations.” Scott says.
However, Scott also acknowledges that DCTs are not a silver bullet, and that there are some challenges and limitations to this approach, such as quality concerns, regulatory hurdles, and technical issues.
“I feel like the pendulum is swinging back towards the middle. Some of the early ROI was not really what people wanted to see. There’s been some quality concerns. There’s been some things in the news that give people pause. While the industry seems to be hitting the brakes on the DCT approach, I think that a hybrid blend will be the natural evolution.” Scott says.
The need for streamlining legal issues
Another area that Scott thinks needs improvement is the administrative burden of running a clinical trial. He says that the industry is stuck in red tape, and that every institution or entity involved in a trial needs to have their own contracts, budgets, ethics approvals, and lawyers, which adds a lot of time and complexity to the process.
“It should be simple. I feel like we could come to some general consensus where we agree on some language, we agree on contractual and budget terms. We just have a standardised piece that could eliminate five, six months from every clinical trial. Let’s simplify and streamline that administrative step up, get studies opened and completed faster, and get drugs to market faster.” Scott says.
LIVE on June 13 2024 
