Stay the Virtualized Course: 4 Key Considerations for Planning and Sustaining the Transition
It comes as no surprise that the impacts of COVID-19 have led the biopharma industry to rapidly adjust its approach to conducting clinical trials. The pandemic has presented unforeseen obstacles, leaving many organizations flat-footed and in need of an adjusted mindset. More specifically, we have seen a clear business case for building resiliency into virtualized clinical trial design. The road to virtualization can be a bumpy one, resulting in unforeseen challenges along the way. These challenges often cause organizations to abandon the pains associated with this change and revert to more familiar, comfortable practices, even if those practices were not always productive and effective.
So how can we strategically navigate this new virtual landscape, lean into the challenges, and stay the course to set ourselves up for success?
During a recent Halloran Speaker Series, “The Reimagined Clinical Trial: Are You Prepared?” Halloran panelists shared their experiences and considerations when moving to virtualized clinical trials.
- Educate yourself (and others) to prepare your business case
First and foremost, it’s important to have a fundamental understanding of what the transition to virtualized trials will entail. While it may sound rudimentary, this foundation is a critical component for long-term success. Take the time to engage experts in this space or other industry colleagues who have implemented a virtualized trial and ask the tough questions early on. It will also be to your benefit to evaluate virtual trials that are similar to what you envision your trial design to look like. No two trials will ever look the exact same, but similarly structured designs will give you more specific insight and thus a more directed vision as you strategize your virtualization plans. Virtualization will likely be a new concept to many in your organization, so establishing a shared knowledge of how virtualized components can or will work for your trial in similar case studies will be critical during the planning stages.
Having more information upfront better informs strategic decisions for rolling out the virtual trial. In addition, you’ll be able to see if this new tailored approach truly fits your specific business case (e.g., does this make sense for your organization now or will it in the future?) Think operationally – does your organization currently have the risk tolerance to be able to support and implement virtualization? You really need to do your research from the beginning to enable smarter decision making as you move through this process.
Understanding virtualization, and how it could look for your organization, will also be important when engaging internal stakeholders (e.g., BOD, C-Suite) for their buy-in. Your ability to break down vague concerns about virtualizing clinical trials will aid in moving the needle forward. You should be prepared that there will be individuals in your organization resistant to making change and it will be your job to prove the value. Take the time to understand and tease out the potential key areas of resistance within your organization so that you can tailor your vision towards mitigating those concerns.
Because therapeutic areas are one of the most critical factors in evaluating virtualized potential, engage therapeutic area experts in your field early on to help build your case that virtualization can be done. Strategize with internal champions or engaged stakeholders so that when you do present your virtualized trial plan you are able to speak to priorities, risks, time, money, and potential pitfalls. Articulate your vision but have the evidence to support the execution of that vision.
- Don’t underestimate the value of up-front planning
As with any larger scale change, strong up-front planning is necessary for success. Taking the opportunity to evaluate all the virtualized options for your trial is a necessary step in securing strong execution. You will need to know the type of trial you are looking to run (e.g., totally virtual (site-less), hybrid, “pandemic-proofing,” etc.).
You will need to have a high-level understanding of your trial design (e.g., geography, objectives and endpoints, study plans, and procedures) to understand what aspects of the trial can and should be virtualized. Spend the time to get cross-functional stakeholders (investigators, study coordinators, patient advocacy groups, caregivers, etc.) in the room to vet the protocol design and start building the schedule of assessments to dive deep into what is truly required in person.
Use this opportunity to engage therapeutic area experts to better understand how your study procedures can be enabled virtually – their input will be invaluable during this process. Keeping an open mind will be key as nothing is off-limits at this stage. Be open to what is possible and not constrained operationally. This is the only way you will be able to move forward with identifying the “right solutions” instead of trying to “fit” solutions into your trial design.
Once you have mapped out what is possible you can start to get a more concrete handle on what type of technology you are interested in utilizing in your virtual trial (e.g., e-source, e-consent, telehealth, etc.). The planning phase is the opportunity to set the strategy that is right sized for your organization. All aspects of your trial must be considered to ensure your approach aligns with your needs and expectations. This will also be your opportunity to conduct thorough risk assessments to think through potential risks and put contingency and backup plans in place to mitigate potential issues. You don’t want to get caught flat footed, so take the time to work through your virtual trial design to enable more resiliency if something doesn’t go exactly as planned.
As you plan for virtualization, you will also need to understand what changes are required within your organization. Specifically, consider any procedural changes needed to enable virtualization and how this will impact your team’s defined processes. Think about the flexibility of your study plans and whether they can be applied both virtually and non-virtually. These are important considerations to factor in to ensure that you can operate effectively while maintaining compliance with this virtual model.
- Pressure test your potential vendors – trust but verify
Pressure testing your potential virtual vendors must be a top priority, especially if you are leveraging a Clinical Research Organization (CRO) to support most of your trial activities. The appetite for virtual trials has skyrocketed due to the pandemic, positioning vendors to push virtualization as a service offering. Assessing and selecting the right vendor is always an important aspect of any clinical trial design, but that assessment must now incorporate a virtual perspective, impacting your approach.
Be creative with how you structure your bid defense meetings – think outside of the traditional box. Consider asking your potential vendors to simulate a kickoff meeting so you can see how they work together as a team and present their technology, focusing on the unique aspects of your trial. You will need to come prepared to ask the right questions to pressure test their aptitude for virtualization and proven ability to operationalize virtual trials.
More importantly, you will need an understanding of how they propose to operationalize your trial specifically. Asses their plans for your study and how they will be able to integrate their technologies. Confirm that their technologies will work across different geographies specific to your trial. Understand what the vendor can do in house vs. what they are planning on outsourcing to avoid those additional layers of oversight for your organization to manage.
Be proactive – request system demonstrations to better assess the technology in real time to give you a clearer picture of how these systems will work together during the conduct of your study. Walk through the data flow between systems upfront to prevent unwanted headaches in the future (e.g., duplication of data, inability to receive data in real time, etc.). Do your homework- ask around your network and learn other’s experiences with different vendors. Strategic, up-front due diligence can mitigate a lot of unnecessary missteps down the road.
- Recognize that issues are inevitable – be flexible and stay the course
Stories of clinical trials conducted without any issues are few and far between. With virtualized trials, a similar trend can be expected. Conducting virtual trials will be new to your organization so you can expect to face new challenges throughout the course of your study. The distinguishing factor in ultimate success or failure is an organization’s ability to remain flexible and work through those unforeseen (or predicted) issues that will inevitably arise.
While issues may be discouraging, especially during your pilot virtual trial, you need to press forward and keep an open mind. If you have done a thorough risk assessment upfront you may have some contingency planning in place to course correct quickly. However, we can’t anticipate every risk, and issues that have not previously been considered may arise. For most, the initial response to mitigating issues is to revert to non-virtual practices. Don’t regress to that mindset!
Take the time to investigate and identify the true root cause of your issues. It is more likely than not that you will be able to identify the appropriate mitigation without derailing your progress. If we think about the transition from paper to electronic Case Report Forms (CRFs) there is no shortage of challenging experiences, but ultimately, we persevered through that change and have greatly benefited. You will not be able to prevent all issues from occurring, but you do have the ability to use the nature of a virtual trial to quickly identify issues through real-time data review that will enable you to react quickly and put the right mitigations in place to move forward.
As you progress and continue your transition to virtual trials, ensure you are keeping your lessons learned – there will be many. This will enable you to make smarter decisions in the future with a better understanding of where things went wrong but also where things went right.
Virtualizing clinical trials is a large undertaking requiring a significant amount of planning, flexibility, and persistence. The growing pains associated with a change of this magnitude are to be expected, but there are several steps you can take to make the process more manageable and successful for your organization. Before diving into a virtualization project, you need to do your homework and prioritize education. Generate a fundamental knowledge of your virtual trial model and its requirements to better understand and articulate the implications specific to your organization. Share this information with your colleagues and engage internal stakeholders to reach alignment.
As you advance to the planning stage, it is important to be proactive and consider all aspects of your trial to inform your strategy. Consider the impact to your current procedures and study plans and determine a path forward. When considering vendors for your outsourced activities, due diligence is key. Be prepared, ask thoughtful questions, and really pressure test potential vendors in real time. Critically evaluate their experience and their ability to provide you with the specific services that align with your specific needs.
Throughout your journey to virtualization, keep in mind that the changes you are striving towards will be achieved outside of your comfort zone. Don’t let issues along the way deter you from your end goal. Face them head-on, mitigate accordingly, and file in your lessons learned for the future.