3 Steps To Getting Your First Decentralized Trial Greenlit & Executed

By John Ferraro and Meaghan Powers, Halloran Consulting Group

In addition to the innovation we have seen because of COVID-19, we’ve also been part of a new experience – biopharma companies coming together and sharing common issues and best practices to navigate decentralized trials together – that has resulted in an incredible landscape of support.

We have seen and heard a lot about the obstacles and concerns you will face when preparing for a decentralized trial, but we want to focus on the most important decentralized trial components that will contribute to your first launch success. Decentralized trials are complex, yes, but they are just a different kind of complex. So, we are going to unpack the top three strategies to consider before you begin your decentralized trial design and champion your vision to executives.

Please keep in mind that the FDA is supportive of and advocating for the decentralized model, but it just needs to know how sponsors will make their trials decentralized. With these three strategies, in order, and the support from the agency and your community, you have opportunities to harness your vision and see it through.

1. How To Handle Change Management And Pacify Executives’ Concerns

Examining how the executives in your organization are motivated will help you prepare for buy-in from the top down. Getting support from your executive team on your business case is mostly dependent on supporting data and statistics to show this model is reasonable.

More simply, they will need to understand the value for the organization and the patients, and if you have the data to support your business case, then it is more likely your mission will carry through. To get the buy-in necessary to execute on a clinical trial, do not underestimate the value of up-front due diligence while preparing for conversations with your executives. Due diligence often takes the form of engaging therapeutic experts in your field early on to build your case that virtualization for your trial is feasible. As you are talking with similar therapeutic experts, ask questions about their clinical trial operations, their successes, and their issues along the way. Go out there and engage with those that understand your trial.

Even as you engage with others in your community, keep in mind these common concerns felt by executives:

• Drug development timelines:
  • Because executives build timelines off classic timeline elements, you will need to define the elements of your decentralized approach. Because the traditional model can invite issues with travel and time requirements, which can result in patient dropout, added expenses, and significant trial delays, if you clearly define your virtual trial elements and explain the ways in which you see opportunities for expedited enrollment and patient retention, you will be able to appeal to executives’ risk aversion and show them that timelines would not change in any meaningful way.
  • Because a virtual trial typically errs on the side of convenience for the patient, you can explain the perspective that you’ll reduce the burden on the patient and, therefore, increase your likelihood of finishing your study on time.
• All-or-nothing approach:
  • Communicate with your executives that this is not an all-or-nothing approach, and you can bring decentralized elements into your study designs to de-risk approval and take small steps toward virtualization without having to virtualize every single element from the beginning. Even if you are implementing small virtual changes along the way, please do not discount that all these elements should still be planned and not implemented in an ad-hoc manner. Up-front planning is essential and, in preparing your business case, here are virtual considerations to implement:
    • Ensure virtualization is embedded in your protocol design.
    • Engage needed external vendors early enough.
    • Plan for implementation and training.

2. How To Nurture Or Find The Right Talent As Your Organization Develops

Organizations need to have a plan, clear expectations, and the educational components in place to enhance their organization’s vision. Not all current staff can possibly be at the same tech-savvy level at the outset, and it is unwise to force them to evolve into such a role, so you will need to identify your talent needs and understand the implications that will bring to your organization.

Whether you are assessing your current employees as a fit for this shift or are hiring experts, the most useful qualities we have heard from those that have been through this change are tenacity, persistence, resilience, and open-mindedness.

Regardless of your approach, you will need to do a thorough internal examination. For example:

• Conduct a gap analysis: Review the trial design to assess modifications to accommodate this model.
  • If you are pulling from internal resources, identify who is best for this task based on talent and bandwidth.
• Establish a dedicated team ready to support and integrate decentralized components into your trial. Your ideal team would consist of:
  • Trial or project manager(s) with technology expertise
  • Data analytic specialist(s)
  • Technology implementation specialist(s)
  • Vendor partners
• You will need to be prepared with a well thought out training process that would ensure study staff, site staff, as well as patients and caregivers, are properly trained and provided specific training materials, such as (but not limited to):
  • Guidelines
  • Instructions for use (IFUs)
  • Videos

Without these considerations, there can be organization pushback, inefficiency, and clunky integration.

3. How To Engage The FDA Early On With Success

As a sponsor, it is critical to work with the FDA to obtain guidance and feedback to ensure the trial is set up for success. As you interact with the FDA, you will need to assess your methodologies and operations to see if these elements are moving in the right direction.

Two solutions:

• Engage with confidence:
  • The FDA is interested in a sponsor’s tactical processes, like their consenting process. Go into the meeting confidently with a well thought out design and they will likely approve your process if you have a well-designed execution strategy.
• Engage early:
  • Engage early with the FDA to discuss your strategies. Ask specific questionsnd present your plans during FDA interactions. To aid your trial, asking the following types of questions could help:
    • Does the agency agree with the virtual/decentralized study design proposed?
    • Does the agency agree with the planned data analyses?
    • Does the agency agree that the proposed virtual endpoints/assessments are appropriate for this patient population?

Conclusion

A silver lining to this pandemic we have been experiencing is that it has given us an opportunity to explore new frontiers in virtual and decentralized clinical trials. Do not let fear, lack of insight, or hesitancy stop you and your organization from taking the next steps into the future with these new technologies.

About The Authors:

John Ferraro is west coast site head and innovation lead for Halloran Consulting Group. He has more than 28 years of experience in clinical operations/development within the biotechnology and pharmaceutical industry. During this time, he has been successful in all sizes and types of organizations as well as a myriad of therapeutic areas, most recently, oncology, hematology, immune-oncology, and rare disease. His expertise is in operational strategic planning, oversight, and delivery of clinical development programs. John earned a master’s in business administration from the University of Phoenix, a bachelor’s in science from University of Phoenix, and an associate’s in respiratory science from Pima Medical Institute.

Meaghan Powers is a senior consultant in clinical operations for Halloran Consulting Group. She is a clinical research professional with more than 15 years of experience in clinical trials, including experience in medical devices, oncology, urology, women’s health, and CNS studies. Additional experience is with phases I-IV drug trials and pre- and postmarket device trials, including execution and management of international trials.