Lisa Henderson

, “Technological Impact on Accelerating Vaccine Trials, Development and Delivery.” With panel members from the leading vaccine manufacturers, it offered interesting behind-the-scenes insights into how these vaccines went through the development process with flying colors.

Marie-Perre Hellio Le Graverand, SVP, head of clinical development and operations from Pfizer, brought the numbers—266 days from the announcement of the pandemic to first EUA; 44,000 enrolled participants; four months to enroll; and 150 sites in six countries; with over 50 million electronic diaries; 7.5 million data management records and 34 million total data points.

To paraphrase Hellio Le Graverand, this was only possible because of digital technologies. The volume and speed of data they managed in real time, all the while maintaining quality, was totally unprecedented.

Similarly, Janssen’s trial included 45,000 participants. Terry Murphy, the company’s COVID-19 clinical development relaunch leader, said they recruited 3,000 patients in one day alone.

Again, unprecedented. But not unpredictable. The two core technologies that pharma and CROs used were predictive analytics and dashboards.

Rachel Berria, VP and medical head of AstraZeneca (US), said that predictive analytics and data from a variety of sources to heat-map where COVID was going, to open up sites in those areas and enroll patients accordingly, was key to the speed.

All of the participants noted that the immediacy and transparency of the dashboards coming from internal and external data sources, allowed for quick decisions, fostering improved trial conduct and data quality. These examples included: applying new strategies to enrollment; shifting focus for diverse populations; and providing site support.

Tal Zaks, chief medical officer for Moderna, concedes that while the company is built from the ground with a digital infrastructure, the tools for collaboration that exist today would have been challenging five to 10 years ago. “As a small biotechnology company that is highly leveraging CRO partners, that was really a key enabler. Where we lack the infrastructure, technology has enabled us to tap into the infrastructure of our CROs partners to achieve what we have.”

But outside of technology, the one factor that helped the unprecedented speed is what Berria pointed to, the rolling regulatory review process...which wouldn’t have been possible without data provided to regulators on an ongoing basis. Technology and science for the win.

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

Articles

Behind-the-scenes look at vaccine development.

How Did Clinical Trials Move at the Speed of COVID?

As I mentioned last month, we debuted our first ever 

. And because of our speakers (side note, they were all women!) and our audience involvement, it was a success. We had over 1,300 registrants over the two-day event, and you can still register to watch on-demand. “Clinical Trials Operational Successes Post COVID-19” focused on two topic areas: Patient Participation and Technology. And each of the speakers brought their expertise to their topic, and that experience over COVID. The intention, to apply what was learned to next generation clinical trials. Some of those highlights are listed below.

This has been on the radar for clinical trials for some time, but clearly a necessary solution for COVID. There remains a lot of questions around what you can and can’t do according to local regulatory or governments, as well as how it works operationally. Dig in, plan ahead, and work through the issues with both the home nursing provider and the sites.

Clinical trial participation and diversity.

 With underrepresented populations an ongoing industry topic, COVID brought the specter of health inequities, as well as the need for what patients want in clinical trials. Joan Chambers, Senior Director, Marketing & Outreach, Center for Information & Study on Clinical Research Participation (CISCRP), brought research and insights from CISCRP, which based on audience comments, should be largely shared in the industry.

Pivoting and implementing new processes. 

From Honor Health Research, the speakers described how they worked to advance COVID-19 research quickly in their local hospital community. Try new things, communicate constantly and implement eConsent were keys to their success.

We’ve talked about these before, but NORD described the use of patient communities to inform and educate patients during COVID, as well as patient registries as a source for RWE.

Takeaways from technology day…decentralized trials and direct-to-patient (or family) trials are the way to the future, important for patients, as well as data integration. Remote monitoring and its possibilities made many sponsors and sites unaware at the beginning of the pandemic. Now, more than ever, the industry needs to look at building these capabilities into their protocol designs as back up or because it works well. And finally, Kimberly Ray presented ACRP data and support that technology is not going to replace anyone’s job at the site. Comforting data for everyone in the midst of change.

Applying a year's worth of lessons to next generation clinical trials.

A Bevy of COVID-Tested Successes

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.

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.

Lisa Henderson

Articles

How Did Clinical Trials Move at the Speed of COVID?

A Bevy of COVID-Tested Successes

2021 Promises for Clinical Trials

Decentralized Trials, Pros and Cons