Clinical Trials in 2021 – Planning for Uncertainty

In October, we hosted the first-ever C3 Summit – a virtual event featuring a series of industry expert-led webinars focused on remote trial management and TMF insights. In this blog post, we share a recap of the session Looking Ahead to 2021 - Planning for Uncertainty.

This includes a discussion about what sponsors and CROs anticipate for clinical trials in 2021 after a paradigm shifting year for clinical research

This blog refers to a session at the recent C3 Summit. Visit the C3 Summit virtual session here for more details on planning for 2021.

To say this has been a transformative year for clinical trials would be an understatement. The pandemic has forced investigator sites to shut down and collaboration between sponsors, CROs, and study teams to go remote, among other complications. Critical steps in the clinical trial journey that have traditionally been in-person processes—from site monitoring to investigator meetings and regulatory inspections—are going virtual.

What have we learned from adapting to the changes and challenges encountered in 2020? How do we approach 2021 with so much uncertainty still ahead? We asked a team of industry experts to share their advice and insights on how to best approach the coming year. Here is a summary of their commentary in response to some of the biggest questions facing sponsors, CROs, and sites going into 2021.

What do you perceive as the biggest challenge regarding the uncertainty of the year ahead?

Listen from 4:53–9:13 in the webinar to hear detailed responses from panelists LaRae Bennett, Senior Director, Data & Analytics, Premier Research; Bruno Gagnon, Senior Vice President, Development Operations, Eidos Therapeutics; Penelope Manasco, MD, CEO, MANA RBM; and Earl St. Rose, Co-founder & COO, DevPro BioPharma.

One of the biggest challenges in conducting clinical trials remotely is that investigators and patients are physically unable to go to the sites. If patients can’t get to sites, clinical trial planning and execution needs to account for remote or hybrid capabilities. Helping sites equip with the technology and processes needed to facilitate a remote trial is key. Sponsors also need a clear understanding of how to execute remote trials and virtual visits going into 2021, and should ensure they have the expertise available to do so.

Another major challenge is the lack of predictability tied to study start-up times. This year, sites stopped initiating studies for six months in some places. This new consideration has made it hard to set a reliable timetable.

In our current environment, we need more resourceful, transformative ways to accomplish clinical research. Now is the time for looking at new, creative ways to conduct clinical trials versus doing things the way they have always been done. For example, are there better ways to access information and data? We need to reevaluate the whole infrastructure of clinical trials to become more operationally nimble by taking advantage of new opportunities afforded by technology.

As we approach next year, are staff returning to the workplace, remaining remote, or a hybrid of the two? How are you communicating with personnel and setting expectations? 

Listen from 9:14–15:14 in the webinar to hear detailed responses from panelists LaRae Bennett, Penelope Manasco, and Earl St. Rose.

The question of whether to remain remote or return to the workplace depends on how you can best adapt to your own organization's needs. While working virtually is great, there is often unique value in bringing people together in person to communicate, share ideas, and build trust. Obviously, circumstances may not allow for in-person gatherings of any sort, so while it is important to acknowledge the benefits of being face-to-face, as clinical professionals we also have to acknowledge that it simply may incur too much risk. People first!

For hybrid organizations where some staff typically works in the office while others work remotely, going back to the office will be different. Office spaces will be configured differently. Teams will need to schedule time in advance for visits to the office. As we get back to connecting in person and having face-to-face conversations, we’ll have to implement clear protocols to help keep everyone safe and prevent increased risk of exposure to COVID-19.

For virtual organizations where everyone has always worked remotely, the environment will not change. Teams have continued to be highly productive during the pandemic. Virtual organizations also actually lower their carbon footprint by not taking up any office space. As for finding ways to be face-to-face with each other, teams in virtual organizations can conduct short-term, online interactive sessions to promote connectivity.

As organizations make decisions about whether to return to the office, it’s important to think about the intangible value of being together. In a remote environment, it’s sometimes more challenging to build trust and share knowledge than when people are in person. However, online sessions that promote effective communication and knowledge sharing can be solutions to these challenges. Whether you choose a hybrid approach or stay remote, develop innovative ways to bring people together and establish effective channels for interaction.

The true goal is finding a balance that works best for your teams based on your environment.

Have you had to reprioritize your clinical development programs and locations/regions of studies?

Listen from 15:15-22:35 in the webinar to hear detailed responses from panelists Bruno Gagnon, LaRae Bennett, Penelope Manasco, and Earl St. Rose.

Right now, it’s nearly impossible to keep studies moving at the same pace as before the pandemic. The cadence of patient enrollment changed a lot in different countries, so study teams needed to do a lot of observing to see where we could have success. In Europe, countries that were hit hard in the spring saw patients able to reenroll in studies by the summer. July and August were the best months for enrollment in Europe this year, which is usually a slow time. Canada and Australia also picked up, but the US did not.

If you’re a sponsor, be sure to understand what’s happening in each country for your study and work with your CRO partners to know the situation. If your study is not for COVID, you may have to wait longer in regions where only COVID-focused studies are able to move forward.

Leverage real-world data to look at where countries and states are no longer seeing patients and closing down sites, as well as those that are still seeing patients but don’t allow cross-border monitoring. Look at where your staff is located, their skillsets, and whether you can change monitors on studies to keep them going.

Keep in mind that the number one thing in clinical trials is the data. Stay on top of that and continue looking at the data even when you can’t be in person. It’s also important to think about how you can get patient data without on-site visits. For which visits do patients need to come on site? Which visits can patients do remotely to lower risk?

You have to change the frame of how you’re conducting trials, whether it involves applying new technologies, changing processes, or leveraging real-world data.

Have you incorporated remote monitoring and will that become the norm in 2021, if it isn’t already?

Listen from 22:37–39:25 in the webinar to hear responses from panelists Bruno Gagnon, LaRae Bennett, Penelope Manasco, and Earl St. Rose.

We need to do more remote monitoring, risk-based monitoring, and centralized monitoring to be more effective in clinical trials. It’s time to look at technologies that can help us enable simplified monitoring. Doing source document review (SDR) and direct data capture instead of integrations into EMRs will be key to successful remote monitoring as well.

Think of remote monitoring as part of your toolkit, as a way of embedding quality, and as a proactive way to control your data from the very beginning. It should be part of the suite of monitoring activities for every study you do, and not something you do simply because you want to go to sites less. The strategy behind remote monitoring should not be moving away from on-site visits completely but a matter of defining the purpose of on-site visits. Redefine the site interactions. Rethink site management as site partnership. What kinds of site collaboration, training, and more can make your study most successful?

What technologies/services do you think companies will use more that may have been less leveraged pre-pandemic?

Listen from 39:36–47:48 in the webinar to hear responses from panelists LaRae Bennett, Penelope Manasco, and Earl St. Rose.

It would be great to see eISF and eConsent open up more globally. eISF can do much more than just be a site binder; it can collect your subject’s source that comes in a paper format, and it can also be a place to do a real-time review of informed consent. Direct data capture instead of integrations on electronic medical records (EMRs) would be more efficient, since EMRs are so different around the world.

We also need to look at the power of machine learning (ML) and artificial intelligence (AI) for clinical trials. Real-world data and real-world evidence for clinical trial designs can be very powerful, especially when it comes to data strategy.

It’s important to think about how technology can optimize how we acquire data. How can we better access the data that patients create in their lives naturally? How do we do a better job of procuring the data that already exists? How do we use it and share it?

It’s not necessarily about the quantity of data but the quality—if we can collect data more directly, we get better quality. We need to focus on the data that needs attention, and not just the data in general.

We also need to move to a concept of data analytics from the concept of data collection. We should not just analyze whether the trial was effective, but how we actually ran the trial. How are you going to analyze the data and present it to allow people to do efficient, high-quality oversight?

How are you planning to engage with sites and patients? How are you maintaining communication and will it change?

Listen from 47:56–52:46 in the webinar to hear responses from panelists Bruno Gagnon and Earl St. Rose.

Active engagement with sites and patients is very important, and we have to be creative in our approach to communication. We do a lot more webinars and panels, but with investigators and patient groups. We’ve done virtual investigator meetings, virtual patient advisory boards, newsletters, and videos. We’ve increased our frequency with these touchpoints. As you’re planning your strategies for site and patient engagement in the coming year, don’t forget about your key audience, be they patients or investigators.

How has your collaboration changed?

Listen from 53:14–59:20 in the webinar to hear responses from panelists LaRae Bennett, Penelope Manasco, and Earl St. Rose.

We thought about how to design clinical trials differently so effective collaboration happens between the sponsor, the CRO, and the site. Relieving site burden is very important right now—we need to make sure we’re not asking sites to do more and pay less, or not pay them for the tasks they need to do, especially during the pandemic. We also don’t want to go back to sponsors and say we have a new line item in the budget to pay for. We can’t go through clinical trials and create line item budgets anymore. Costs have to change, and they have to be outcome-driven. To do this, we need an understanding of the expectations that sponsors will help sites do things more efficiently without adding more burden on them. The role of the CRO needs to change, too. CROs have to be willing to do things differently, including putting different monitoring plans in place and discussing why and when you need to go on site. Everything needs to be an open collaboration between these three parties.

It’s worth it to think about how you’ll create a new type of connectivity or incentive structure that bonds the sponsor, sites, and CRO around a shared goal. How do you shift what feels transactional to a mission we’re completing together? Are there constructs that don’t lend themselves well to supporting collaboration around a mission? If so, how do we find other constructs?

We also should not forget about vendor collaboration and be visionary about how well we connect the technology side of the business as an enabler. Find vendors that really understand where you want to go and will help you develop technologies that support your vision.

What’s your vision for 2021?

Listen from 59:21–1:01:15 in the webinar to hear responses from panelists Bruno Gagnon, LaRae Bennett, Penelope Manasco, and Earl St. Rose.

We need to imagine that everything that can go wrong will go wrong. Looking at contingency planning will be critical. We’ll also look to technologies like AI and machine learning to leverage data differently. This time also presents a great opportunity to be creative and find new solutions to shape the way we conduct clinical trials. In the midst of all this uncertainty is tremendous opportunity.

Wrap-Up

The above are just some of the thoughts from a very thorough and engaging session on the complexity of planning for the upcoming year. We encourage sponsors, sites, and CROs to listen to the panel discussion for some perspective from those who share your challenges. At this crossroads in clinical operations, we must trust the technology and strive for as much flexibility as can be achieved. This forward-thinking is how study teams will fortify against external influences.

For help onboarding clinical technology like eTMF, eISF, remote monitoring, LMS, content management, CTMS, and more, contact us at info@trialinteractive.com.