The second in our series of insights from the 2023 WCG Clinical Research Trends and Insights report focuses on predictions for quality, technology and diversity in clinical trials.

Diversifying Clinical Research by Providing Research Participants Payments

Kelly Fitzgerald, PhD, IRB Executive Chair and Vice President, IBC Affairs, WCG IRB

Payment to research participants is a critical aspect of diversifying clinical research participation. There will be a continued increase in awareness of this issue in 2023. IRBs are often seen as a barrier to paying participants, and that may have been true in the past, but the thinking on this topic has evolved significantly in the past few years, informed in part by the recognition of the importance of research participants as partners rather than as research “subjects.”

IRBs are tasked with ensuring that recruiting and consenting processes do not exert undue influence on participants, and high payments may be seen by IRB members as unduly influential. Some people believe that payments could incentivize someone to participate in activities they would otherwise choose not to do, particularly people with low incomes. However, when an IRB insists on lower payments, participants who have less free time, less available income or more burdensome lives are less likely to participate and the study ends up with a participant population that does not match society because those people who can bear the financial burdens of research participation will participate.

The clinical research world now recognizes that payments can incentivize without being unduly influential. While there is a perception that IRBs will not approve high payments for participants, this is changing. During the past 24 months, out of approximately 10,000 IRB reviews, only 13 reviews resulted in the IRB specifically requiring modifications to the payment plan and no records included a request to decrease the proposed payments to participants.

IRB members reflect the values and norms of their communities, and the events of the past few years have led to the awareness of the importance, both scientifically and ethically, of diverse representation in clinical trials. To improve in this area, there must be support for higher payments for research participation and a reliance on mechanisms other than limiting payment to ensure participants are recruited ethically. In 2023, there need to be more discussions around accurately assessing participant costs for research participation and providing just compensation for their service.

Clinical Trial Technology Integration Now and Into the Future

Sonia Abrol, Senior Vice President, Product and Strategy, WCG Velos

The COVID-19 pandemic made many stakeholders in clinical research reassess their technology infrastructure. To sustain and accelerate research, they prioritized taking various research management workflows online to vendor-managed systems, ensuring centralized, easy and secure access to data. As sites and sponsors expand their technology portfolio, sites are carrying a bigger technology burden. They are supporting the costs of multiple site technologies and then putting additional time and effort into entering data in both site and sponsor systems.

Approximately 90 percent of data needed by sponsors now lives in one or more site systems, according to the WCG Knowledge Base.

Additionally, the uptick in adoption of innovative technologies for helping with decentralized trials, patient recruitment, patient retention and engagement has produced new data silos for sites and sponsors. As a result, clinical research stakeholders are recognizing the need for more interoperability and workflow-driven integrations.

In 2023, sites and sponsors will continue to make technology integration one of their top priorities as they select the right solutions, enhance their technology infrastructure and budget for such investments. Sites starting their journeys toward integrated ecosystems may begin with key multilevel integrations between their e-regulatory/e-Binder, EHR/EMR, CTMS, IRB and financial systems. Those that are already ahead of the curve will continue to expand and develop new integration workflows by connecting one silo at a time.

In parallel, technology vendors will continue to work toward offering more open systems and actively defining their own integration roadmaps to help sites and sponsors gain operational efficiencies and reduce the technology burden on users.

Also, it will be interesting to see what the gained momentum in collaboration among sites, sponsors, and vendors will bring in 2023. As these consortia and partnerships come together to help define data exchange standards, map best workflows among site systems and site-sponsor systems and prioritize implementation of cost-effective and standard technology integrations, we will see remarkable growth and acceleration in conducting clinical research and drug development.

Interoperability Required for the Future of Clinical Trials

Rahul Bafna, Chief Product Officer, WCG

The use of healthcare technology at the consumer level has exploded over the past decade. This started with the broad availability and adoption of wearable devices, taking advantage of smaller sensors, better batteries and always-on connectivity. Many of these advancements in technology have the potential to be transformative in the realm of clinical trials, which for decades have suffered from low patient participation, unrepresentative study populations, heavy operational burden and long timelines. The key to making these advancements work in real-world settings is the seamless interoperability of patient data.

As an example, patient-trial matching is one of the most time-consuming operations of running a trial. Multiple software platforms exist that can match eligible patients — based on the clinical record stored in one or more electronic health record (EHR) and lab systems — to the various inclusion and exclusion criteria of trials. But for this matching to happen, these solutions need access to those clinical records in a standardized format. Once found, matches need to be pushed back into the physician’s daily workflow — often the EHR — to drive patient conversations, consent and enrollment. Once enrolled, technology can simplify or even automate the data collection necessary for some types of studies. This will be critical for enabling decentralized trials (DCT).

DCTs will allow more patients to participate, potentially from underserved communities who would benefit from trial designs that require fewer or no site visits. The use of technology can also enable more frequent collection of study data and any data collected in novel systems will need to be pushed back to a unified source, such as an EHR or electronic data collection system.

Making sense of clinical data from multiple sources — whether for clinical trials or routine care — requires that data to be collected, retained, transformed, transmitted, standardized and made available to researchers and clinicians at the right time and in the correct format.

Interoperability between all these systems is critical to driving innovation and bringing new treatments to patients. For several years, the Office of the National Coordinator for Health Information Technology has been leading the charge to improve the interoperability of patient clinical data through regulation — mandating specific data standards that enable data to be exported in standardized formats. The 21st Century Cures Act, which includes interoperability standards not only for accessing clinical data but also for enabling new workflows and within platforms like EHRs, will continue to drive advancement in 2023.

Quality by Design and Slowing Down to Speed Up

Cristin MacDonald, PhD, VP Client Delivery, WCG Avoca

The year 2023 should be seen as an opportunity for everyone in the clinical research industry to embrace the concept of “slowing down to speed up.” While the concept of quality by design is not new, the newly finalized International Council for Harmonization (ICH) E8 guidance and the EU Clinical Trials Regulation, along with the upcoming revision of ICH’s good clinical practice guideline (ICH E6) and the FDA’s diversity guidance, are all examples of the regulators prioritizing efficiency in clinical trial execution by forcing quality into the forefront of study design.

Whether it is by requiring that sponsors show their diversity strategies in advance of launching a pivotal trial, or by subjecting sponsors to regulatory holds for failed submissions, it is time to spend more resources early in study planning. It is time to slow down, think ahead and ensure quality is built in study design.

Gone are the days of rushing to a first subject in timeframe and reactive protocol amendments that have negative time and budget impacts. Entirely new benchmarks need to be established that encourage study teams to invest the appropriate time and effort in study planning and reward those who demonstrate rapid study completion with minimal amendments by leveraging the proper resourcing up front.

Read the full WCG 2023 Trends and Insights report here: https://bit.ly/3XmcKC6.

Join WCG experts in a panel discussion of 2023 trends and insights in a Jan. 24 webinar. Register for the free webinar here: https://bit.ly/3GFXU2u.