Rescue Studies Are on the Rise - Common Pitfalls in Clinical Development Partnerships and Key Considerations for Success

August 30, 2022

How have recent changes to the clinical trial industry influenced or transformed the way you are doing business? From the volatility in the global stock markets, to the numerous layoffs in Biotechs, Pharma and CROs alike, to the inability to recruit and retain quality talent and the mass exit of talent in our industry. This is a question that is more complex than it ever has been. I hope that you will read on and weigh in on this industry dynamic.

One clear reality is rescue studies are on the rise. We have all seen the alarming data that 80% of clinical trials fail to meet enrollment timelines and up to 50% of research trial sites enroll one or no patients. 72% of studies run more than one month behind schedule, resulting in Sponsors losing between $660,000 - $8 million for each day that the trial delays a product's development and launch.

In recent months, Linical has been asked to “rescue” several studies from much larger companies. The common theme is the lack of project leadership, site engagement, overall passionate communication, and care for the Sponsor goals with a “heartbeat” for the patient. Is the industry trying too hard to replace people with technologies (decentralized trials, site recruitment platforms, artificial intelligence, etc.) and not embrace the fact that we need both? The fact is that when science and technology come together, great things happen. We can see the results with hybrid approaches, but when our industry hires less talented people to increase margins, the Sponsor, the CRO and most importantly, the Patient all lose.

This disconnect and misalignment of expectations starts at the planning stage. Too often, clients tell us they listened for what they wanted to hear during the CRO evaluation stage, which is focused on the number of related studies, indication experience, and personality alignment instead of looking for the real compliment to the Sponsor’s staff. That can be project leadership skills, industry knowledge, quality of sites, and extensive site relationship skills. The planning stage with our Sponsors is quite frankly the most important stage in any trial. It allows us to challenge and align on goals right upfront so when we get into the trial itself, our velocity is more inline with what Sponsors want to see. Without good planning, the impact for Biotechs especially can be catastrophic and derail partnerships, causing the compound to miss vital milestones that can create financial disaster.

When evaluating a CRO, try to look beyond the obvious and select a committed, passionate CRO partner that cares about the patient and can ride the waves of change in a study or program. Select a CRO that not only understands the TA (therapeutic area) and indication, but is experienced to lead, track, multitask, and communicate cross functionally and globally while having patient benefits in mind. According to Venture Capital firms, many times the “softer” and underlying reasons described below are keys reasons that cause failure and broken relationships. Look for a proactive partner, where the project management team uses real-time data to focus on issues and bottlenecks affecting the clinical study. It is critical that intervention happens early, rather than after an issue occurs, so it is not too late to avoid problems.

When selecting the right clinical development partner, put the focus where it needs to be:

  1. Planning and aligning on goals upfront
  2. Experienced and committed project leadership
  3. Passion for the patients
  4. Communication and engagement
  5. Cultural alignment
  6. Engaged executives that care

What are your current challenges? What are your thoughts on this subject?

Author:

Clareece West
Executive Vice President - Linical Americas