As the year comes to an end, industry experts look back to discuss how the clinical research market has evolved since 2018 and prepare for the challenges to overcome in the year to come.
This year was a busy one for Signant Health, which was formed in June after the rebranding of CRF Bracket, which followed CRF Health’s acquisition by Genstar Capital, the private equity firm behind Bracket, in 2018.
Shortly after rebranding, Signant launched a partner program aiming to improve collaboration between contract research organizations (CROs) and sponsors, in order to help avoid miscommunication and “reduce scope creep that is common when vendors work together,” a spokesperson for the company told us at the time.
Collaborations with new sponsors entering the industry was one of the main factors that reshaped the clinical trial market in the past year, according to Mike Nolte, the company’s CEO.
“I think 2019 will be remembered as the year that clinical research mapped a journey towards merging with the mainstream,” Nolte told us, and continued by explaining that, due to the complexity of clinical research, technologies and solutions that seem like an ‘obvious fit’ are often a ‘mismatch’.
Nolte noted that incidents like this are also due to regulatory issues and concerns about the risks that companies are willing, or not willing, to take.
However, the executive commented that “2019 saw large, horizontal technology players emerge with an eye towards investing in this industry, and it also saw a handful of real, as opposed to speculative, connections between clinical care and clinical research using technology.”
Some of the announcements from companies in the field and the expectations placed on them “should probably be met with skepticism,'' Nolte commented; however, he expressed the opinion that the energy and focus seen in the industry is expected to create a ‘larger ecosystem’ for new solutions.
Moreover, according to Nolte, “if history repeats itself, the best answers are far more likely to come from smaller, expert vertical vendors, but the focus and attention still has the potential to move regulatory and other barriers to adoption.”
Signant’s CEO added that the ‘momentum’ to see software solutions and ‘patient connectivity’ as essential to the execution of quality research is ‘irreversible’, although it does “ebb and flow as sponsors evaluate risks and benefits to multi-billion-dollar bets.”
Nolte concluded, however, that the presence of new capital, new pressures and new ideas are a positive for patients and industry participants who “will benefit from simpler, less expensive and higher quality solutions.”
Blinded data analytics ‘the next big technology’ to adopt in 2020
Asked about the new technologies that are most expected to be adopted by the clinical trials industry in the upcoming year, Bill Byrom, VP of product strategy and innovation at Signant, pointed at sensors and wearables, of which the market will see a ‘continued increased uptake’.
According to Byrom, the focus on processes and solutions on how to acquire, manage and monitor data will be maintained in 2020, as the potential of leveraging the growing market of wearables and sensors in clinical trials is ‘well understood’, and consists of three main aspects:
“Enabling more frequent assessment in remote settings to provide a richer insight into treatment effects; measuring endpoints that have been difficult to measure previously; and measuring in free-living functioning as opposed to only in-clinic measures.”
The executive noted that tools that can be used to derive greater insights from our data to inform processes and endpoint quality will become more important in the foreseeable future.
Blinded data analytics (BDA) is going to be ‘the next big technology’ to adopt in 2020, Byrom suggested, and explained that its applicability expands across many different diseases and endpoint types – where insights on data variance, outliers, systematic issues and implausible data help to monitor and manage endpoint quality throughout the study.
“There are a number of disease states where data analysis presents challenges that are greater than usual, such as dermatology,” Byrom said, concluding: “Here, BDA can be used to triangulate the data from multiple sources, making it easier to identify outliers, identify problems, and course correct before it’s too late. As a tool, it’s invaluable.”