Risk Management

Who Rescued Whom?

Post by
Denise Lacey
Who Rescued Whom?

(Word count: 620)

As a GCP QA consultant working mostly with small biotechs, I work on a fair number of rescue projects. It's a good opportunity to feel vaguely superior as I sit with a team to untangle the missteps of our predecessors. We qualify unqualified vendors, count uncounted samples, write missing SOPs, and put CAPAs in place while marveling at the incompetence of those who came before us.

As a consultant, I sometimes spend more time on a project than the people who originally hired me. I've been working on two different rescue projects for so long, I've seen the teams turn over multiple times, to the point where the new teams view those studies as THEIR rescue projects. I listen on Zoom as these new teams marvel at the incompetence of the folks who qualified vendors who subsequently underperformed, set up sample accountability schemes inadequate to the complexity of the project, wrote SOPs with gaps, and planned CAPAs that were never completed. "But..." I protest. "I was on the team that did that. We did the best we could with the resources we had!"

This uncomfortable experience led me to reflect on mistakes I've seen and made in clinical studies over the course of my career. I've seen a few cases of clear incompetence and fraud, but the majority of non-compliances are fostered by people doing the best they could with the resources they had. Here are some of the factors that lead teams to decisions that seem baffling in hindsight:

  • Money. Small biotechs don't have a lot of it, and it prompts them to use less expensive CROs and laboratories. Sometimes those vendors provide excellent service, but sometimes they lack resources, experience, and expertise, which leads to mistakes.
  • Influence. Even if a biotech is well-funded and can afford to bring on big, experienced vendors, it may not have the influence to compel them to do a good job. A sponsor placing one study at Big CRO or Big Central Lab is last in line for resources, getting either inexperienced staff or, worse, experienced staff who move on quickly to greener pastures.
  • Hats. In small companies, people wear different hats. Typically, one clinical study lead oversees monitoring, medical writing, data management, safety, biostatistics, clinical supplies, and labs. In the moment, it appears that this study lead is performing heroically, working twelve hours a day in disciplines far outside their job description. In hindsight, it's apparent that the biostats contract doesn't include conversion to SDTM, there is no documentation that the EDC system underwent UAT, and the specialty lab doesn't have any SOPs.
  • Churn. There are more open positions than people in this industry. At best, this causes turnover, which leaves gaps in knowledge and discontinuity in performance, and unfilled positions, which forces people to wear many hats. At worst, leadership changes frequently and unpredictably, with each new leader demanding a complete re-evaluation and reset, disincentivizing team members to take any action at all.
  • Baggage. No matter how far back in a project you go, you're dealing with legacy stakeholders: Academic labs that are the only source for an assay. Small CROs that were great for Phase 1 but have now rolled over into Phase 3. Non-complying clinical sites led by KOLs. Most teams know that the lab, CRO, or site needs to be replaced, but they can't do it because they lack money, influence, or resources to make the change.

Understanding how a study got to a point where it needed rescue is helpful, both in rescuing the study and in preventing future issues. We can't mitigate all the conditions that raise these risks, but in a future post we'll look at how to manage hats, churn, and baggage more effectively.

Denise DeRenzo Lacey, RQAP-GCP, has over twenty years’ experience in clinical Quality Assurance and clinical development operations.  Her practice focuses on application of quality risk management techniques for clinical studies, including risk-based approaches to auditing, data quality and integrity, and SOP development.  She has provided consulting services to a wide range of pharmaceutical, medical device, biotech and CRO clients in the US and Europe and has held senior positions at Vertex Pharmaceuticals and Radius Health.