Lisa Henderson

I could promise that I’m not going to write another editor’s letter this year about decentralized trials, but I don’t make promises I can’t keep. While so many issues related to COVID’s impact on clinical trials rise to the top of the news stream, it has pulled decentralized trials along its wake since the pandemic’s start. I can promise, however, that we are encouraging contributors to rise above the urge to blanket everything under the decentralized trials-per-COVID umbrella. We are much happier to offer the readers of 

 actual, concrete solutions or dialogue that furthers the conversation. We can keep pointing to the past, but not learning from that past and putting lessons into future practice, the industry runs the risk of falling back into reactive clinical trial habits.

Because of recent sponsored projects, the editors are privy to information we can’t attribute yet on decentralized trials, but safe to say, many industry stakeholders are open to change and to further the cause. Observations include:

The pandemic has truly accelerated the adoption of patient-centric technologies, as well as expectations for accelerated timelines.

Leaders that believe in taking action and who enable adoption of technologies or practices is essential for the industry—or at least their organizations—to thrive.

When the regulatory decisions on submissions during the COVID timeframe are made, many will look to those as signals for FDA readiness.

At press time, we are putting the final touches on 

“Clinical Trials Operational Successes Post COVID-19”

. The event is live on February 11 and 12. If you can’t make it, however, the symposium will be available on-demand, and we encourage you to watch at your leisure. You can also submit questions on-demand, and they will be forwarded along to the respective presenters for their response.

For the rest of the year, any topic we write to will include a component of COVID. For example, site feasibility will include aspects of ensuring sites can recruit participants from a diverse population, as indicated by the need borne out of COVID vaccine trials. Patient centricity and diversity again would not be complete without including the natural outcome of patient-centric solutions expected to take deeper roots post-COVID.

2021 has just begun, but thankfully, it looks like a promising year.

 is Editor-in-Chief of Applied Clinical Trials. She can be reached at 

Articles

A look forward to 2021 for the clinical trials industry.

2021 Promises for Clinical Trials

As we continue to keep our eye on decentralized trials advances, a recent survey released by Oracle, and detailed in a recent 

 showed that 76% of 252 industry respondents noted that the pandemic sped their adoption of decentralized clinical trial methods. The most common decentralization steps taken were patient-facing technologies or alternatives (64%), protocol redesign (63%), and investigator-facing technologies or alternatives (53%).

However, it is data issues and regulatory concerns that held most back from adopting decentralized trial methods—specifically, ensuring data reliability and quality and data collection. Also, to wearable and remote monitoring, the respondents’ top concerns are a different approach to review, manage, and interpret data (50%), expense (46%), and complicated regulatory considerations (41%). Additionally, from the 24% of respondents who reported that the pandemic had not accelerated their adoption of decentralized clinical trials, regulatory concerns (42%) were a top reason.

During Informa’s Clinical Trials in Europe virtual event, the panel discussion “The Future of Clinical Trials” was heavily weighted toward the many advances in technology used in clinical trials during COVID, and practices such as decentralized trials. Panel members Kenneth Getz, Deputy Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine, and Kai Langel, Director, Janssen Clinical Innovation, took a moment to discuss whether industry will continue with its advances post-COVID.

Langel reiterated that as a global experiment, aspects brought forward by COVID are working out and regulators are OK with many of the changes, and, therefore, what’s successful will remain. He suggested that protocol deviations during COVID were not perfect but we can learn from that. “There will be data points that worked extremely well, and those that will show how they could improve,” Langel maintained.

Getz admittedly offered a “somewhat cynical” perspective based on historical data. “I think a lot of change in behavior in response to the pandemic may be more of a short-term or one-time occurrence, even though it has facilitated much more widespread use of many approaches supportive of the remote and virtual clinical trial activity,”
he said.

Based on an audience poll around barriers to decentralized trials, Langel expressed surprise that no one pointed out costs related to decentralized trials, saying costs will go up. “Home nursing is an expensive service as opposed to asking patients to travel to site,” he said. “But in many studies, such as rare diseases, the research gets done faster and better, so that trade-off can be worth it.”

Regulatory concerns remain despite industry's quick adaptation of decentralized trials.

Decentralized Trials, Pros and Cons

For many years, it’s been discussed that FDA is a barrier to change…mostly related to a change in process or a change of technology. Though regulators would routinely come forward to reassure the industry that their guidance documents supported change, fear and insecurities still abound. It does take time to change, but the FDA really does support advances in clinical trials. But every so often, it is reassuring to hear it in the agency’s own words, especially now with talks of decentralized trials and patient participation. Recently, FDA has been asked about ongoing changes in clinical trials from the point of decentralization and participation.

Last month, Amy Abernethy, MD, PhD, principal deputy commissioner and interim CIO for the FDA, gave the opening keynote for the Veeva Systems R&D and Quality Summit. As a hematologist/oncologist and palliative medicine physician, and internationally recognized clinical data expert and clinical researcher, she shared her compelling views on those discussions. She set the stage by saying the practical reality of clinical trials features two important responsibilities, (1) keep study participants safe and (2) generate a high-quality data set that will answer the question at hand.

For that, Abernethy stressed that the “site is critical to that entire set of activities.” And specifically for decentralized clinical trials, she said: “I think about a series of solutions that help physicians or other healthcare providers involved in the clinical trial process and keep patients safe. It also allows us to be able to have, even if it’s virtual, eyes on the person receiving care to make sure that we know how the patient is doing.”

Abernethy continued, “I think that from the perspective of the site investigator involved in decentralized clinical trials, they still are going to continue to have this incredibly important central function—even if it’s a decentralized clinical trial—of continuing to lead that focus of patient safety, and then also contributing to the clinical trial in alliance with the study protocol.”

At a closed event, a member of FDA declared that “Participating in clinical trials is an imposition on people. If we can move to trial designs that are more pragmatic, with less burden and allows for more participation…” that would be a plus.

There was also the hint that the speed with which FDA issued guidances in the early pandemic could become the norm; the process would shorten to release with a more fluid approach to alterations or changes as needed.

The FDA is moving with the times, and with speed. It will be up to some in the industry to respond in kind.

The FDA hints that their increased speed in issuing guidances during the pandemic could become the new norm.

FDA Reassurances Always Go a Long Way

Let’s take a short vocabulary quiz. Full in-person, hybrid, virtual, remote, synchronous, asynchronous are terms used for, a) descriptions of clinical trials, b) types of cars, c) descriptions of learning models for schools during COVID-19. The answer is “c,” but the comparison I was going for is clearly trial design or type of site model. I left out decentralization because that would have been a huge giveaway, and I haven’t seen that term used yet on any school K-college curriculum. While I struggled with understanding synchronous and asynchronous as the two forms of online learning in the beginning, I have it down now. There has been a lot of discussion in clinical trials about the difference between virtual and remote, and I think that has been cleared up also. So let’s dive into the future of hybrid, decentralized, and remote trials.

According to a recent report from Frost & Sullivan, 

“Hybridization of Clinical Trial Designs Reviving Global CRO Market Post-pandemic; 2019-2024,” 

hybrid trials and remote patient monitoring are key trends driving the global CRO market. While COVID-19 may in and of itself be a driving force behind the adoption of both hybrid trials and remote patient monitoring, it is also putting downward pressure on the overall CRO market. The company’s analysis suggested that the current ongoing trial disruptions are effecting revenues for the short-term. Frost & Sullivan further expects that revenue will be back to its original growth trajectory by 2024–2025, with a compound annual growth rate of 8.2% and $63.83 billion revenue by 2024, up from $43.03 billion in 2019.

The report also suggested that adoption of hybrid trials by CROs could increase their growth opportunities by enabling uninterrupted trials and cost savings of 15% to 20%; by focusing on long-term collaborations that offer substantial cost advantages with 8% to 13% savings across different trial phases; by leveraging new technologies, such as risk-based monitoring, eConsent, wearables, and telemedicine patient visits; and implementing direct-to-patient model clinical trial supplies

 has learned in discussions with clinical trials professionals, there is no shortage of innovative ideas being put forth in both the CROs and investigative sites. There are successful transitions coming from organizations including eConsent (how about virtual reality consent and consents that span clinical to research in an institutional setting?); telehealth for patients that did require a bit more convincing for physicians; launching patient recruitment websites in days down from weeks; and a survey that suggests people have the skills for these new clinical trials, they just need support in adapting to the digital world.

While I’m a supporter of remote and hybrid trials to support patients’ needs and expansion of availability of trials to more people, I have questions about the future of the same for long-time learning purposes. For the clinical research enterprise, the pandemic is bringing great innovation more quickly to an industry willing to move forward with purpose.

ACT's Editor-in-Chief, Lisa Henderson, assesses the sustainability of remote trials.

Lisa Henderson

Articles

2021 Promises for Clinical Trials

Decentralized Trials, Pros and Cons

FDA Reassurances Always Go a Long Way

The Future of Remote Trials