Clinical Researcher—August 2022 (Volume 36, Issue 4)

TRIALS & TECHNOLOGY

Mary Costello; Brad Hightower, CCRC

 

Talk to nearly any clinical research site professional today and you’ll likely hear their mounting struggles adopting and managing new technology. Site staff are treading water as wave after wave of technology complexity crash over their heads. They need a life raft before they drown.

While many professionals working in drug development were fortunate to have the option of working remotely during the height of the pandemic, clinical site staff such as healthcare workers were on the front lines. They were the unsung heroes of COVID-19. The unprecedented speed with which COVID vaccines were developed was thanks to the incredible commitment of clinical site teams worldwide—that, and the sudden adoption of a modern clinical research model called decentralized clinical trials (DCTs).

Hybrid (onsite/offsite) and fully remote DCTs have proven to provide reliable options for trials during unprecedented events like a pandemic lockdown, as well as the potential to solve some of the industry’s most deep-seated problems. For instance, DCT-related technology can add flexibility, expand access, and even improve population representation. However, as with all major innovations, the industry now faces the challenges of implementation at scale—and clinical research sites are shouldering a disproportionate burden.

The most recent Society for Clinical Research Sites (SCRS) annual survey reveals that technology is adding an average of 17.5 hours in training per study per site per month among the nearly 500 respondents—one principal investigator (PI) reported having more than 300 unique passwords and logins.{1} Further, PIs aren’t the only ones facing tech-related overload—Hightower Clinical’s clinical research coordinators (CRCs), for example, often must use eight or more systems for each study assigned.

On top of this heavy burden, sites are experiencing a concomitant set of challenges not unlike the rest of the industry. The backdrop of rapid DCT adoption comes at a time when turnover rates for clinical research professionals now hover around 30% amidst America’s “great resignation.”{2} If the 1.7 million healthcare workers who quit their jobs already in 2022 is any indication, clinical research is also experiencing higher-than-normal turnover as site staff suffer from burnout.{3} Not to mention, sites are operating at ever thinning margins—higher costs coupled with stagnant study budgets are resulting in less revenue and profit.{4}

All in all, sites are underwater. The DCT model has provided a blueprint for the future, but even as the industry makes progress following that blueprint, it’s time to take a scrupulous look at whether technology is reducing burden or adding to it along the way. As an industry, we must re-assess the current state of deployment and intervene to ensure that there is a clear path for sites and all stakeholders to deliver on the promise of modern technology. Here are six ways to buoy sites up, while at the same time improve trials.

1. Take time to understand the site perspective.

Sites have been struggling for years, but these struggles have not resulted in any wholescale change. Tufts Center for the Study of Drug Development has tracked the rise in trial complexity, which translates into a rise in procedures heaped onto site staff, with Phase II and III protocols now involving an average of 263 procedures per patient supporting approximately 20 endpoints.{5} At the same time, study budgets have largely remained flat. While the industry has invested in capturing the patient perspective, there has been little focus on understanding the potential problems being inadvertently created for sites.

Paradoxically, as the patient’s voice has been amplified, the site’s voice was muted—in the same SCRS survey, one-third (32%) of sites report being treated as “less than a partner” by sponsors and contract research organizations (CROs) over the last two years.{1}

One step industry can take to prevent sites from sinking under this heavy weight is to invest more time to listen carefully to the site leaders and staff who are largely responsible for implementing the technology. They are at the center of the action and have valuable feedback to provide that can help ease technology implementation and speed adoption with less friction for all stakeholders.

Even governing bodies have awoken to this problem, addressing it directly in the first revision of ICH E8 from the International Council for Harmonization since it was adopted in 1997 (in effect as of April 2022). It now encourages engaging with all the stakeholders, including PIs, CRCs, other site staff, and patients/patient organizations.{6}

While gathering this experiential information, sponsors and CROs should look back in history to understand how sites have gotten to this point. For instance, the site community has been rewarded for pinpoint consistency for decades. Suddenly, they are being told to do things in a new way, often without receiving proper education as to how. We need to listen and learn—then re-invent how we support sites’ needs.

2. Start, and end, with a site focus group.

Research needs to be consistent, iterative, and reproducible. In contrast, the varied interpretations of ICH guidelines by sponsors and CROs over-complicate the process that sites must follow.

Sites know their patient populations better than anyone, but are rarely consulted about them before starting a trial. Most sponsors and CROs dictate the patient engagement strategy without ever seeking insights from other sources, even from the professionals who have the greatest knowledge of their patients. Are sponsors and CROs asking sites what flexibility options for patients will have the biggest impact?

Take the time to ask sites what will be most effective. This small, simple step can speed a trial and prevent misstarts. Not only will sites appreciate being asked and treated as a true partner in the trial, but they will also provide sponsors and CROs with valuable information—something everyone needs as we continue learning about the DCT model and its many facets.

3. Provide the right training at the right time in the right format. Hint: it’s unlikely to be “one size fits all.”

With increasing amounts of new technology added to studies, sponsors require extra technology training, and that means a bigger time commitment for site personnel. Worse, sites selected for a trial may not discover the extent of the required technical training until it’s too late to account for this extra effort in their contract.

An additional challenge is the quality of the required training. Many sponsors and CROs have not taken an inventory of their training modules in years, and often default to online PowerPoint templates. Not only are most training programs limited, but they are also poorly administered online. For instance, a common complaint is for a training course to prematurely “time out” and reset to the beginning if the trainee steps away momentarily. It sounds minor, but it can waste hours of valuable time and frustrate already overwhelmed staff who would better serve the protocol if they were spending that time with patients.

One way to help alleviate this pervasive issue is to provide sites with an overview of all the technologies up front. Clearly outline all the systems that will be (or could be) involved in the trial, when they will be used, and how they all fit together in alignment with the protocol. Provide a concise, flow chart–style resource so site managers can budget the time and costs for the extra training from the start—preventing underestimations of timelines and ensuring they are rightfully compensated.

This “tech cheat sheet” could be made available in any number of formats—from a one-page printed piece to an interactive webpage that also includes a one-click “help” button and diagrams. Providing sites with an informative resource that offers both a holistic view and a drilled down explanation not only lessens the training burden, but also reduces the number of calls back to the sponsor’s help desk.

4. Provide a single sign-on.

Sponsors need to find a way to seamlessly integrate platforms on the back end so that users like CRCs can simply log in to their desktops or devices with a single sign-on and access all the information they need via one interface. Enough said.

5. Invest in a trial site liaison.

One of the more interesting approaches some sponsors have taken to improve site partnerships has been to provide a bonus resource—a personal site liaison—to site staff in addition to the standard clinical research associate (CRA). This liaison is deeply trained in the individual protocol, and therefore can provide reliable, full-bodied answers to more specific questions both technology-related and protocol-related. Rather than being a third party tied to specific sites, liaisons can be implemented with a broader regional responsibility. Early reviews from sites of this investment have been very positive.

While CRAs also act as internal problem solvers, they don’t always have a holistic view of trial execution or know how all the technologies connect. A site liaison could augment the role of the CRA and personally partner with site staff as a respected colleague, checking in weekly to provide more collaborative support. Technology providers, too, could work closely with a site liaison to help facilitate change management and user adoption of new systems.

Hightower Clinical, for instance, worked with a small sponsor that supplemented its CRA with a dedicated liaison who understood every aspect of the trial, including the technologies, and was very effective. In turn, the liaison listened to the site’s ongoing feedback leading to a high-performance trial.

Alternatively, sponsors could provide extra technology training to CRAs, or even a select subset of technology specialist CRAs, so they are well versed in the technology included in a study and can provide faster and more comprehensive site support. CRAs are often the first point of help for sites, so creating a reliable framework within which site teams can consolidate their questions and funnel them to a single point of contact is extremely efficient, when it works.

6. Offer optionality for sites as well as patients.

When designing the study itself, consider how much can be performed by the site. Often, sponsors work with the same site for multiple trials and have come to trust and rely on them for their high-quality work. Out of respect for that relationship, consider the damage that could be done by outsourcing a part of the trial to a third party and diverting funds from your long-time site partner.

Before implementing a study-wide solution using a third-party provider, ask whether the site would be willing to undertake responsibility for some of the challenges at hand, such as home healthcare and direct-to-patient drug deliveries, and if standard operating procedures already exist to support those tasks. If sponsors or CROs are concerned that the necessary skill sets do not exist uniformly across sites, would they be willing to give support or an upskilling program for key sites to allow them the chance to retain revenue, gain new capabilities, and retain tighter oversight? What, too, are the legal, insurance, and oversight considerations with a third-party vendor? How can sites be expected to retain control?

Remember if the site isn’t doing a task, it isn’t getting paid. Asking sites to handle trials with shifting parameters is not only disrespectful, but also cuts the sites out of the equation. Many clinical sites function on 90 days of operating cash or less. Consider the impact of moving the tasks to a separate organization—not just on the patient, but also on the site.

Show Respect, Offer a Life Raft…and Reap DCTs’ Great Promise

Drug development is part of a complex ecosystem; consequently, implementing any major innovation industrywide will take time and creative execution to perfect. Open dialogue and ongoing feedback are crucial to ensuring the innovation reaches its potential.

DCTs hold great promise, but to maximize their benefits the industry must identify its pain points for all stakeholders, especially sites that are on the front lines of research and working directly with patients. Sponsors, technology providers, and patients most of all have the most to gain from DCTs, so it behooves us to formalize tactics for helping sites evolve in a way that honors their efforts both financially and intellectually.

We cannot let sites drown under each wave of new technology. The organizations that invest the time and resources to ease this transition to the modern clinical trial model will see the greatest success.

References

1. Society for Clinical Research Sites. “The 2021 Site Landscape,” as presented at the Site Solutions Summit by Jimmy Bechtel, Casey Orvin, Laura Falcone, and Karri Venn (October 2, 2021).
2. MedCity News. “What the Great Resignation Means for Clinical Research,” by Andrea Bastek (May 1, 2022). See resource here.
3. Forbes. “Amid Healthcare’s Great Resignation, Burned Out Workers Are Pursuing Flexibility,” by Deb Gordon (May 17, 2022). See resource here.
4. Clinical Leader. “2021 Clinical Research Site Survey Findings: A Year in Flux,” by Jimmy Bechtel (March 24, 2022). See resource here.
5. Tufts Center for the Study of Drug Development. “Rising Protocol Design Complexity is Driving Rapid Growth in Clinical Trial Data Volume” (January 12, 2021). See resource here.
6. International Council for Harmonization and U.S. Food and Drug Administration. E8(R1) General Considerations for Clinical Studies—Guidance for Industry (April 2022). https://www.fda.gov/media/157560/download

Mary Costello (mary.costello@medable.com) spent more than 30 years in leadership roles in the healthcare and clinical research fields with large organizations such as Covance and Thermo Fisher, and, more recently, with eClinical Solutions and Elligo Health Research. Costello is a founder and board member of BioAustin. At Medable, she serves as Head of the Site and Investigator Network.

Brad Hightower, CCRC, has worked with clinical research sites for almost 15 years and is the former Executive Director of the Oklahoma Heart Hospital Research Foundation. Most recently, he founded the integrated site network, Hightower Clinical, and hosts the Note to File podcast on clinical research site topics.