When will companies stop babysitting the nannis they hired for their clinical trials?

Date: 02. 27. 2020


SCOPE continues to be a central location for industry colleagues to meet and exchange ideas around clinical development. We had a great time at the 2020 meeting catching up with friends, clients and colleagues, as well as co-moderating a roundtable on protocol design and chairing a main session on site selection with esteemed industry practitioners.

It was a whirlwind of activity as we spoke at length with dozens of company representatives, and we thought it would be of interest to share the top 5 key takeaways we heard from these conversations loud and clear:

  • Stop the madness of using linear extrapolations to design/plan/implement trials. This type of thinking simply doesn’t work. For example – if a Phase 2 trial was positive, then why not recreate the same exact design for Phase 3 with more patients? Or if investigator sites were productive for one trial in a specific disease area, why not use them again for a new trial? But most industry specialists know that this mindset leads to flawed protocols and the need for sudden amendments or trial rescues (for more on this specific topic, see our recent article “Clinical Trial SOS” in the Feb. 2020 issue of Life Science Leader). We heard that it’s of utmost importance to know which types of trial amendments are avoidable or non-avoidable from the get-go. And why wouldn’t it be? Trial rescues are costly and messy.
  • Vendor partners must bring their own data to the table. Clients don’t want to sit down with a vendor and have them just cull through the company’s information. Companies want external experts to bring in tools and insights they can’t glean on their own, with an objective purview, such as: How do I do in comparing to competitors? How do I predict the future? How to be successful in a disease unfamiliar to me?
  • No more NANNIs (non-active, non-enrolling) trial sites! This is a top cause of significant trial delays and inflated costs. There is simply no reason to have smart people chasing down and babysitting sites or specific investigators that are never going to perform. This is not a new idea, yet industry continues to spin its wheels in this area, largely due to the limitations of common tools used to select sites and individual investigators. Companies long for disruptive technology but also want to be reassured by long-term experience.
    Clients want well-planned trials enabled by digital and AI solutions, not digital or AI-driven trials. As we’ve said before, big data is just data unless you can funnel and mine it appropriately to glean insights that drive decisions. Similarly, AI and digital technology are powerful technology advancements, but unless we identify the root causes to clinical development challenges and apply these technologies as solutions, these phenomena will remain mostly as a fad to talk about at meetings.
  • Trial planners need to proactively identify and address protocol challenges. So often, protocol challenges are identified through protocol implementation rather than before, during the planning process. With all of the data and technology available – per the previous points above – this should not be the case.
    We definitely felt a buzz around these topics and are excited to be continuing these conversations that started at SCOPE 2020.

Next stop for us is the DIA Digital Technology in Clinical Trials conference, March 30-31st at the Westin Boston Waterfront. If you plan to be there please stop by. You can’t miss us, at Booth #1. Find out how we are indeed #1 for enabling well-planned trials using our digital, integrated tools.

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