The clinical trials landscape is undergoing significant transformations, especially following the challenges it faced throughout the Covid-19 pandemic, which accelerated technological innovation and virtual trial designs.
Our Co-founder and CEO, Sam Glasswell, spoke to Chris Baker, President at ICON, Symphony Health, former EVP at Parexel FSP and Jon Shephard, Partner at PwC, Deals & Strategy at our recent webinar and asked them to share their insights on the most significant disruptions in the clinical trials space and their implications.
3 Major Disruptions
A number of accelerators and disruptors were mentioned during the discussion, including blockchain, telemedicine and precision medicine. However, the three most significant disruptors that will have the biggest impact in 2023 were identified as decentralization, RWE and AI.
Decentralization and patient-centricity have become critical aspects of clinical trials in recent years. By going to the patients instead of bringing them to research centers, remote approaches have significantly helped with the number one issue in clinical trials: patient recruitment. Decentralized trials reduce the burden of travel for patients who are either too sick or live too far from trial sites and allow them to participate from the comfort of their own homes, which in turn also helps improve patient retention rates and reduce dropout.
Although we are seeing numerous applications of decentralized trials, the hybrid model - which combines both on-site and remote approaches - remains dominant for the foreseeable future.
2. Real-world evidence (RWE)
RWE is becoming increasingly important in clinical trials as a complementary source of evidence. It provides a more comprehensive understanding of how drugs or medical devices perform in real-world settings, as opposed to the controlled environment of clinical trials.
RWE can not only be used to support a variety of regulatory decisions or prove the value that a drug or device provides, but also help design more effective trial protocols and define trial populations by ensuring that the criteria used in the trial reflect the diversity of patients who will eventually use the drug or device.
3. Artificial Intelligence
AI and open-source data have the potential to transform the way clinical trials are conducted and speed up the development of new treatments and cures for diseases. Although we're still exploring what AI can do and how it can accelerate clinical trials, we're already seeing exciting applications around patient recruitment and engagement, enhancing data analysis, and increasing transparency and collaboration. However, when it comes to AI and machine learning, there are still many concerns about data privacy and security, which drives the need to ensure that these technologies are used ethically and responsibly.
Who will be the winners?
With so many exciting challenges and opportunities facing the industry, can we predict what type of companies are going to make the most of these trends? What the clinical trials investors should be looking out for?
Jon and Chris pointed out the following types of companies as having the most potential:
- Companies that can find innovative solutions to the main pain points in clinical trials and prove that it actually works with a strong ROI. Especially those who can come up with a value proposition in gap areas such as CNS, oncology and rare disease which are particularly complex and challenging.
- Companies that are agnostic to current trends and able to deliver high-quality solutions for the essential elements of clinical trials that remain the same. Despite all the disruptions in the industry, many key parts of clinical trials remain unchanged, and companies that can continuously deliver in these areas will be well-positioned.
- Companies that can serve under-supported customer groups, such as small biotech firms that cannot afford enterprise licenses for large integrated clinical trial platforms, have a unique opportunity to stand out. Providers who can offer affordable solutions and high-touch service will have an advantage in this space.
- From the CRO perspective, companies that are more specialized and focused on specific areas of clinical research rather than trying to cover a little bit of everything will be better placed to deliver on their promises and retain top talent, which is essential for sustained success.
The clinical trials industry is experiencing significant disruptions that are transforming the way trials are conducted. While some parts of the industry remain unchanged, embracing new technologies and approaches will be critical. Companies that can adapt effectively and come up with the right solutions at the right time will be well-positioned to be the winners in this space.