We have entered a “golden age” of innovation in clinical trial operations. New solutions are flooding the space to address the rapid growth in trials, intense competition for trial participants, slow and cumbersome protocols, myriad setbacks from the pandemic, and the promise of decentralized and digital trials. With this innovation comes significant complexity, but sponsors are in a unique position to mitigate it.
The clinical trial landscape is increasingly competitive (see Figure 1). While the number of industry-sponsored trials in the US has stagnated in the past decade, there has been an increased focus on rare disease or specific biomarkers with inherently smaller patient populations. For example, drugs that target orphan diseases, or those that affect fewer than 200,000 people in the US, have almost tripled between 2000 and 2020. As a result, there is fierce competition for an already limited pool of patients and sites. For instance, oncology trials for pancreatic cancer need to capture 21% of all patient cases in order to fill all trial slots, meaning there are only around five potential patients per trial slot.
The competition for clinical trials is increasing
And delays are becoming commonplace, especially as the Covid-19 pandemic and other geopolitical events have exacerbated the issue. These delays and disruptions do not bode well for pharma companies’ bottom line, as getting to market ahead of competitors provides tangible value.
We have seen an explosion of new tools, capabilities, and vendors that aim to harness digital capabilities and new methodologies to address these challenges and, ultimately, deliver better, faster trial outcomes. The e-clinical solutions market has grown around 17% per year since 2016. In the next five years, it is expected to double in size, becoming an $18 billion market.
While these digital tools have advantages, such as the enhanced ability to find new and more diverse trial participants, the emergence of this new ecosystem has also contributed to trial complexity. And it has not automatically translated to a better customer experience.
How can sponsors navigate this landscape of long delays, higher costs, tight resources, and new players? Leading sponsors are doubling down on the physician investigator experience—a powerful differentiator that can help recruit more patients and reduce delays in trials.
The customer experience imperative
Bain research shows that a better investigator experience leads to loyalty and, ultimately, faster trial recruitment and completion. In fact, investigators who have a superior experience with a sponsor enroll twice as many patients (see Figure 2). This holds true across disease areas, from oncology to musculoskeletal to central nervous system.