chromosome

trends & perspectives in clinical research

goBalto Chromosome

Are Delays in Clinical Trials due to a Lack of Experienced CRAs?

by Craig Morgan
20Feb2017

CNN Money recently ranked Clinical Research Associates (CRAs), professionals whose main function is to monitor clinical trials of investigational drugs, as one of the 10 best careers in America in terms of job growth rate, worker pay, and satisfaction.

Are delays in clinical trials due to a lack of experienced CRAs?

Despite this, the clinical research industry has experienced a concerning global shortage of experienced CRAs in recent years. Currently, there are over 14,000 open positions for CRAs on Indeed.com alone. And demand for CRAs is expected to grow annually by 1.52 percent (5,590 new positions) by 2018. This shortage is having a significant impact across the pharmaceutical industry, contributing to higher costs and extending drug development timelines for sponsors. As a result of the highly competitive job market, many clinical trial sponsors and contract research organizations (CROs) are finding themselves in a never-ending recruitment cycle for qualified CRAs. Unfortunately, the current gap between supply and demand is not expected to close in the near future.

In an industry plagued by rising development costs and increasing complexities, to what extent is the CRA shortage to blame for the delays in clinical trials? With the current shortage levels, it is fair to say that it is a contributing factor, but it is equally important to point out that well documented bottlenecks in starting clinical trials, such as, protocol amendments, contract and budget negotiations, IRB approvals, and others, contribute to significant trial delays and these are not the primary responsibility of the CRA.

Maria Ladd
MARIA LADD
Senior Manager
Global Study Start Up, inVentiv Health
"The CRA/site relationship is a critical factor in the overall clinical trial process. In an industry with ever-increasing demands to 'beat the clock,' the face-to-face, human connection between the CRA and site staff can bridge the gaps in site moral potentially created by the pressures to speed activation, enroll the contracted number of appropriate subjects, and maintain complete and clean data. The right CRA can keep site staff grounded and engaged, ultimately serving to meet the goals of both the CRO and the sponsor."

Causes of CRA Workforce Shortage

One of the biggest factors contributing to the global shortage of CRAs is lack of training opportunities for clinical professionals to begin their careers as CRAs. The trend in recent years has been for pharmaceutical companies to outsource large functional relationships involving site monitoring to CROs in order to help manage costs and pipeline fluctuations. As a result, many pharmaceutical companies have tabled their new CRA training programs, requiring instead that CROs have experienced CRAs on staff. The experience requirements that sponsors are placing on CROs are in turn limiting the CROs' ability to grow new CRA talent for the industry.

The challenge is certainly not in finding eager and capable people willing to be trained as new CRAs. Rather, it's that sponsors only want CRAs that have years of trial monitoring experience assigned to their projects. As part of their service contracts with CROs, sponsors usually specify preferred qualifications for the CRAs assigned to their studies. Typically, they require that CRAs have a minimum of two to four years of monitoring experience, often with expertise in specific therapeutic areas. But how can CRAs who are just starting their careers ever become experienced enough to satisfy sponsors requirements without actually working on clinical trials? This is a classic 'catch 22' situation that also serves to discourage potential new CRAs from even pursuing employment opportunities, further exacerbating the situation.

"The CRO industry would be well-served to invest the resources needed to foster and train a progressive CRA pool with a goal of retaining that talent in one place for a reasonable length of time; CRAs leaving a project is highly disruptive to the study at large, and to the sites they leave behind," added Ladd. "Unless the CRO industry finds a way to break the cycle it had a hand in creating, it will be some time before an adequate, stable CRA workforce is realized."

The high numbers of unfulfilled CRA positions in the industry have caused a strain on the current CRA workforce with large increases in workload, responsibilities, and challenges. A 2015 CenterWatch/ACRP survey of CRAs found more than one-third reported a "significantly increased" workload over the past three to five years. This is causing strong performers to burn out. Some 60% of the survey respondents cited increased workload and increased responsibilities as two of their top three professional challenges. More than a third of respondents said taking on more responsibilities was their most significant change in their current role. A similar number said they were considering a job change in the next 12 months due to lack of a work/life balance.

Experienced CRAs that opt to move into management and leadership roles in the clinical research field are also contributing to the deepening CRA shortage.

Christine Pierre
CHRISTINE PIERRE
President
SCRS
"The CRA shortage means that sites are sometimes faced with absent or under-qualified CRAs. Consequences of this reality are sites report negative impact on study operations, timelines and even quality. Collectively, this reality ultimately impacts all stakeholders."

Consequences of CRA Workforce Shortage

The consequences of the global shortage of CRAs for clinical research are significant.

  • Rising costs: As in any market in which demand is outstripping supply, the shortage of CRAs is leading to experienced CRAs taking home larger paychecks, and forcing companies to move some studies and/or jobs to low income countries so that they can afford to pay top dollar for experienced CRAs. Given the competitiveness of the current market, CRAs turnover represents a constant brain drain for research organizations, with some CRAs reportedly being offered $15,000 sign on bonuses, a cost which CROs are likely to pass onto sponsors.
  • Limited career growth for experienced CRAs: Some CRAs who might have otherwise advanced to a more senior role have become trapped in their current role, as companies can’t afford to lose their CRAs to promotion. This leads to increased frustrations and potentially resignations, as CRAs conclude that the only way to advance their careers is to transfer to a different company.
  • Extended timelines and lost revenue for sponsors: Given the important role CRAs play in the clinical trial process, CRA shortages can impact study cycle times, increasing operational costs and lost revenue due to delayed market entry, as well as, ultimately delaying the delivery of critical therapies to patients.

Solutions

Competent CRAs can really drive the successful execution of a clinical trial, and sponsors are thus hesitant to forgo the experience requirement in their contracts with CROs. Nonetheless, a number of potential solutions to this problem are beginning to emerge.

The Association of Clinical Research Professionals (ACRP), whose mission is to promote excellence in clinical trials, is forming a multi-stakeholder task force charged with defining the core competencies required of entry-level CRAs. Convened in December 2015, the multi-stakeholder CRA Workforce Development Task Force includes representation from leading CROs, sponsors, and more.

ACRP believes the root cause of the CRA shortage is equating the 2-year experience requirement with validated competence. Instead of focusing on an applicant's skill set and core competencies, companies are judging potential applicants solely on time served. According to Jim Kremidas, ACRP Executive Director, this false equivalency is hurting the clinical trials industry by preventing talented and competent people from entering the CRA workforce, as well as by keeping incompetent CRAs from being identified. As Kremidas notes, "There is a major shortage of CRAs in the workforce. As a result, sponsors and CROs are battling CRA turnover and substantial compensation increases. At the same time, it's clear from our own data and continued FDA inspection findings that there is an insufficient level of knowledge, skills, and abilities in the CRA workforce." ACRP hopes that the conclusions of the CRA Workforce Development Task Force will prompt the clinical research industry to embrace hiring practices that favor professional competence over arbitrary experience requirements.

Another potential solution involves CROs investing in effective new CRA training programs. The current system in place to train and mentor CRAs is demonstrably inadequate to meet a growing demand for new skills and talents. Key elements of success for an effective CRA training program include rigorous screening of candidates and robust structured support from mentors, trainers, and peers. Trainees must also have the ability to gain valuable field experience at investigative sites. These "hands-on" experiences are critical in developing the right skills and knowledge to conduct independent site monitoring visits effectively.

Many CROs have offered training for newly hired CRA's, but these efforts have failed to make a significant dent in the CRA shortage, because they are usually only done in response to a particular sponsor's upcoming study needs. To begin to address the global CRA shortage, these training programs must become proactive and ongoing. They must also address the human element by promoting high levels of collaboration with peers and comradery between mentors and trainees. The benefits of this kind of holistic and comprehensive training program do more than just simply closing the demand gap. They may contribute to creating a highly engaged and productive workforce that will stay with a career path that promotes retention.

ACRP has also developed an intensive 8 week CRA Onboarding Program that is available to sponsors and CROs to rapidly develop competent entry-level Clinical Research Associates for sponsors and CROs. ACRP's CRA Onboarding Program blends online training with in-person training and exercises to ensure CRAs can immediately and effectively contribute to sponsor and CRO operations. An initial pilot of the ACRP CRA Onboarding Program was conducted in 2015 for Samumed, LLC, a biotech company headquartered in San Diego, California. Fifteen new Samumed CRAs participated in the pilot Program, and one year later 94% of those who went through the program are still on staff. A fully online CRA training program is also offered by The CRA Training Institute.

Finally, a number of universities are now offering master's programs in clinical research management, and a company called CRA Assessments is offering web-based simulations that fully reproduce the site environment, and can be used during interviews to assess CRA monitoring skills and competency.

Conclusion

There is little doubt that the field of clinical research has been hampered by the vast shortage of qualified Clinical Research Associates (CRAs) to monitor studies. Though sponsors largely outsource the CRA role to CROs, the challenge is ultimately a shared one. Shortages in pivotal roles such as CRAs inevitably lead to higher costs and delays at a time when research studies are under enormous pressure to deliver on-time and on-budget. The CRA shortage is a contributing factor to delays in clinical trials, but what is critical is that we look at the issue holistically and understand that many of the challenges the industry is facing are completely unrelated to the CRA shortage. We know that protocols are increasing in complexity, competition for patients is on the rise, and regulatory mandates continue to proliferate across the globe. These trends are in turn driving the demand for more senior CRAs with the appropriate experience to handle these uncertainties. Taken together, these issues make the CRA shortage all the more painful.

In the race to bring new therapies to market, we have to invest in innovative approaches to fill the talent gap, while finding ways to promote retention of existing CRAs, that are familiar with these issues and are on-hand to minimize execution risks and ultimately speed the delivery of new medicines to patients.

An abridged version of this article was originally published in Drug Discovery & Development, October 2016

Recent Posts