By Alethea Wieland, founder and president, Clinical Research Strategies, LLC
The #1 and #2 complaints I hear consistently from peers and partners in life sciences companies are the inability to hold third-party partners and CROs accountable for quality performance and to have a consistent experienced team over the life of their clinical trial. The two are inextricably linked. A recent BDO report describes a new all-time high turnover rate of clinical research associates (CRAs) in the U.S. of nearly 30 percent, with slightly higher rates in Ireland (33 percent), China (32 percent), and Sweden (30 percent) – while other industries are around 19 percent.1
There is no perfect resourcing model. Some functional service provider (FSP) or hybrid models can work as well as a full-service model, when the number of vendors is kept to a minimum. Breakdowns and failures happen all the time and sometimes this is a result of unreasonable expectations of sponsors, sponsor disorganization, or poorly developed assumptions translated into contracts and statements of work.
Performance can suffer no matter how detailed the vendor qualification and bid process is. Third-party partners and CROs describe their company culture as one that creates an environment for staff to thrive, innovate, collaborate, and grow within. Yet these top two problems persist. In defense of service providers, it’s difficult to ignore the usual 18- to 24-month-long sales cycle, hurry up and wait syndrome, fundraising delays, or other reasons for sponsors’ lack of preparedness to start a clinical trial (e.g., IND or IDE letter to proceed, manufacturing hiccups, late decisions to shelve investigational products, etc.) that contribute to the revolving doors on all sides and cripple any efficiency in the industry. There is no question the demand is on the rise. By 2027, the clinical trials market is reported to be worth $69.8B.2
The Talent Game
For third-party partners and CROs, cost-effective talent is scarce, so much so that hiring students or postdocs fresh out of college, or young coordinators from research sites, is common. Scanning the job boards at any time over the year reveals that the recruitment period for rookie talent is a never-ending endeavor.
Younger employees recognize how quickly their value increases in the short time frame following their initial training period and are seduced by higher salaries at the two- to five-year experience mark. Mid-career level staff have upward movement in title, but usually the salaries plateau.
Finally, there are research professionals who have one to three decades under their belts. They choose either full-time work in a traditional CRO for steady income or consult for sponsors and CROs, either directly as independent contractors or indirectly through recruiting and temporary placement firms. The decision to consult is often related to reasons of job dissatisfaction, burnout, termination, or a desire for more control over work-life balance.
What Does “Experience” Mean And How Do We Get It?
Competition is fierce for business wins and for cheaper talent in a marketplace that is saturated with service providers of all sizes. Your clinical trial may or may not be conducted by team members with the most experience, and yet the rigorous requirements to understand the complexities, good clinical practices, and the ever-evolving regulations take years to comprehend, let alone apply to the full life cycle of a clinical trial. It can take approximately eight years for a research professional to be completely self-directed and autonomous and reliably contribute with few questions or mistakes.
- From E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1), Section 2.8: “Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).”
- From ISO14155, Section 4(h) (not yet released changes in 2018 draft): “Each individual involved in designing, conducting, recording and reporting a clinical investigation shall be qualified by education, training and experience to perform his or her respective task(s).”
- From 21 CFR Subpart D, 312.53 Selecting investigators and monitors, 4(d): “A sponsor shall select a monitor qualified by training and experience to monitor the progress of the investigation.”
- From ICH General Considerations for Clinical Studies E8 (R1) Step 2b Draft version, Section 3.3.1 devoted to Quality by Design. “Create a culture that values and rewards critical thinking and open dialogue about quality and that goes beyond sole reliance on tools and checklists.”
The standard requirement for training and experience, present in the earlier versions of the guidances, is especially important today in risk-based monitoring methods, quality by design and risk management mandates in drug and device guidances, and in innovative trial designs (e.g., with adaptive/Bayesian design, master protocols, platform, basket, or in silico trials, digital therapeutics, surrogate endpoints, real-world evidence, and virtual approaches). Moreover, with the passage of legislation in the United States such as the 21st Century Cures Act, and in the European Union (EU) for Medical Device Regulation (MDR) and General Data Protection Regulation (GDPR), new additional costs to train a workforce and add conformance measurements across a business need to be accounted for somewhere in budgets. All of these newer regulations and methodologies require significant know-how that elicits serious debate about what training and experience actually means.
Most training of staff is on standard operating procedures (SOPs) – checklists, processes, work instructions, and toolkits, developed for separate departments like project management, clinical monitoring, data management, statistics, pharmacovigilance, and so forth. Staff are required to follow SOPs and study-specific plans with little variance. But the real lessons can get lost if staff aren’t incentivized to read the updated guidances or regulations and are trained, instead, on summary points.
The additive nuance of thinking critically outside the check-the-box mentality is fraught with bottle-necking decision points because few people in these organizations are authorized to resolve questions or issues that are escalated. Although Quality Assurance has an independent seat in the house, most staff on the frontlines are required to stay within their lanes and not stray from their role.
Who is responsible for quality by design and risk management in your CRO? Who is experienced to handle complex problems? The real answer is that all parties — both sponsor and CRO — have a collaborative stake in these ongoing activities that involve layers of checks and balances. The decision-making is anything but quick or proactive. It is usually overly bureaucratic and reactive.
Opportunity Costs: The Trade-offs To Train Or Work
We probably agree that all companies deal with opportunity costs, but for third-party partners and CROs, certain resources are scarce and choices must be made in how to allocate those scarce resources. Time is limited. We can either work or train.
Think of all the human resourcing needs such as job postings, screening, testing or qualifying talent, making an offer, and then onboarding that talent in the rookie recruitment model. The opportunity costs to train, review, and reteach the rookies are traded off by a reduction of work output by more experienced managers, who are largely responsible for their team’s total work performance. Managers and trainers also fill roles as cheerleaders and morale-building coaches to their team members.
This rookie-in-training process doesn’t go on for only six or 12 months. Instead, it can go on for several years because mistakes, misjudgments, and misinterpretations continue to occur.
Two key pain points emerge: the training period for less experienced staff and the manager’s potential for exhaustion. Even higher performers are dramatically impacted when workload volume reaches unreasonable levels. The vicious cycle continues when the younger staffer leaves for a better job elsewhere.
Work Volume And Metrics Drive Away The Passionate And The Experienced
Some research professionals shared the following negative anecdotal accounts of their careers:
“Harder, faster, farther, more trials, more visits, fill-in for colleague who leaves or is out sick. I gained a lot of weight and never felt good. Los Angeles and Boston in the same week. That’s why I left and am a contractor. I can pick my own projects and in between, take some time off to recharge. I will never go back.” (15-year sr. CRA/PM independent consultant)
“Our BD team is very good at winning projects, but there are never enough CRAs for the projects. I am constantly dancing around the fact that I don’t have CRAs, and especially anyone who understands how to monitor difficult oncology trials. I can’t do this anymore.” (13-year project director in Phase 1 oncology at a large CRO)
“Everything in our system measures our speed or some other type of key performance metric. There are no human sensibilities. There is too much turnover. Two new trials were added to my plate, for a total of six different protocols. I know I am not giving my best performance to learn and know all six. Sponsors don’t see the volume of work we are given.” (18-year sr. CRA, moving back to independent contractor status from working full time for a midsize CRO)
The root causes of poor performance, quality issues, and team turnover include a variety of factors and can be summarized as follows:
- High (and growing) demand for services
- Scarcity of certain resources on the front line, like experienced and qualified CRAs and project managers
- Bias for cheapest labor
- Promotion incentives and competition for younger talent between the one- and five-year mark, including for retention programs before they meet developmental milestones
- Volume of workload in short bursts of time
- Complexity of newer regulations, trial designs, and methods
The Society for Clinical Data Management just recently (March 5, 2020) released a paper on enabling better technology for the field of clinical data science.3 Accelerating the use of interoperable application programming interfaces (APIs), automation, and technological advances for more virtual monitoring in exchange for travel and on-site visits will certainly ease some of these problems, as will more reasonable and more even distribution of the training and workload burden. We cannot afford to continue to shrug our shoulders and accept the status quo, especially if demand is expected to increase in the future.
- BDO, 2019/2020 INSIGHTS REPORT: CRO INDUSTRY. Turnover Escalates While Compensation Levels and Practices Remain Status Quo. https://www.bdo.com/getattachment/Thank-You-Pages/CRO-Insights-Report-Thank-you/2019_CRO-Insights-Report_FINAL.pdf.aspx?lang=en-US
- Grand View Research. Clinical Trials Market Size Worth $69.8 Billion By 2027 | CAGR: 5.1%. February 2020. https://www.grandviewresearch.com/press-release/clinical-trials-market
- Society for Clinical Data Management. The Evolution of Clinical Data Management to Clinical Data Science (Part 2: The technology enablers), March 5, 2020. https://scdm.org/6588/
About The Author:
Alethea Wieland is founder and president of Clinical Research Strategies, LLC, an executive-level management consulting firm and boutique, functional service provider for the life sciences industry. Her firm’s solutions include analyzing the intersection of healthcare innovation and policy; providing flexible clinical trial resourcing; developing sustainable corporate affairs programs and policies; training and managing resilient, high-performing clinical operations teams; mitigating risks of clinical trials; and facilitating transparent, accountable sponsor-CRO partnerships. Learn more by connecting with her on LinkedIn, and by visiting her website, www.clinicalresearchstrategies.com.