As clinical trial protocols have become more complex in recent years, institutions are facing new challenges in keeping up with the advancements. In this Q&A, Sofia Baig, president of clinical solutions at Precision for Medicine discusses the challenges these institutions are facing, how sites can keep pace with new technologies, and improving efficiency in early and later phase research.
Applied Clinical Trials: What challenges are institutions currently facing when conducting clinical research for drug development with global sites?
Sofia Baig: In my experience, there are three areas that present the greatest challenges for institutions. First, study protocols have become increasingly complex, with biopharma companies trying to essentially combine multiple studies into a single study. In the end, this not only increases the burden on the individual sites but also patients, as they may be required to undergo additional blood draws, make extra site visits, participate in additional in-home surveys to collect data, all while also dealing with the condition that they’re participating in the clinical trial to treat.
While it may seem counterintuitive, the second challenge is caused by automation and the drive to improve clinical trial efficiency. While embracing new technologies is critical, and the push to automate as many processes as possible is a logical step in the evolution of clinical research, it can create a greater burden on sites. As you know, each institution utilizes a variety of technologies. They incorporate them both at an individual project level, as well as on an institutional level. As sites are asked to incorporate additional technologies when executing on a trial, it can make the process more challenging, even though that’s certainly not the intent.
Finally, and this may be a product of the COVID-19 pandemic, is institution staff turnover. Like many other organizations, these institutions are struggling to keep their staff, and when they leave, the knowledge goes with them. What we’re seeing is that staff are not only burdened because of lack of staff but, logistically, it can make it more challenging to monitor the data, retrieve documents and beyond.
ACT: How can clinical trial sites incorporate the latest technology to ensure operational advances are keeping pace with scientific advances?
Baig: Standardization of technologies across clinical trial sites, whether it’s for site files, electronic data capture (EDC) systems, ESMO Clinical Research Observatory (ECRO) systems or any other technologies sites are using, is critical to ensure operational efficiency. In an ideal world, there would be set standards for the use of technology, and sites across the globe would adhere to them. Unfortunately, that’s not the case.
Imagine all the technologies that sites are being asked to adopt to run clinical trials. Let’s say they master one, but the technology becomes obsolete. The sites then must master a new or improved one and hope that it sticks, or the learning process starts anew. Simplifying the environment by moving to more standard, well-accepted technologies will help.
One area where we’ve seen the most advancement is in EDC. It’s probably the oldest site technology that we have, but it’s become very standardized. Now that so many studies are global, with sites operating around the world, this standardization makes the collection of data much easier.
ACT: What are some advancements biopharma companies should consider to improve efficiency in early and later phase research?
Baig: Biopharma companies could improve efficiency by simplifying their study protocols, which could have a positive impact on enrollment and on-time completion of studies. We’re seeing overly complex protocols, protocol designs, and requirements for clinical trials. Companies are requiring more and more testing, making data collection and associated logistics hard for sites and patients to manage. This has been a challenge for many years and, unfortunately, I don't think our industry is currently headed in in the right direction.
As I mentioned earlier, the biggest hurdle is that companies are increasingly trying to compress multiple studies into one study. They're trying to compress multiple phases to increase outputs using the fewest number of patients for the maximum gain. But, if your starting point is an already-dense protocol, when it evolves, every amendment to the protocol means a change that the sites have to be trained on. It’s a real dichotomy. On one hand, there are advantages to doing it this way, largely because it means fewer patients are needed to realize results. However, it makes it more difficult for teams at the site level, whose primary job is working directly with patients, with the actual research being secondary.
ACT: What are some exciting solutions and/or projects you are currently working on at Precision for Medicine as we move into 2024?
Baig: Precision for Medicine handles many complicated clinical trials. By its very nature, precision medicine requires complex trials and endpoints, and it requires a continuous collection of data.
We work closely with our clients to execute on these trials, but the added value we bring is in advising them about where it makes sense—or doesn’t make sense—in terms of reducing complexity and standardizing trials.
The nature of doing clinical trials and research is getting more intricate and more complicated than ever. But that's also the foundation that this company was formed on more than a decade ago. What we’re excited about is the operational excellence we’ve built to handle life science innovators that have multifaceted trials because we have the specialized expertise that helps compress timeframes and generate efficiencies. As medicine becomes more specialized, our goal is to better facilitate the process and help our clients get medicines to patients faster.