Longer cycle times, complex protocols and CRA inexperience and turnover are cited as factors
At the same time as a global shortage of inexperienced Clinical Research Associates (CRAs) is projected, the demand for these professionals, who monitor clinical trials, is expected to grow 1.52 percent annually by 2018. According to Craig Morgan, writing in Center Watch News Online, one reason for the disparity is the lack of training opportunities. Instead of providing in-house training for new CRAs, many pharmaceutical companies have simply required that contract research organizations (CROs) have experienced CRAs on staff.
Thus, CROs are having trouble providing the training to keep up with the demand. Still, CNNMoney listed Clinical Research Associate at #4 on its list of the “Best Jobs in America” in 2012, with a median salary of $90,700.
Because sponsors want CRAs with extensive trial monitoring experience performing their projects, the sponsors specify preferred qualifications for CRAs assigned to their studies — usually a minimum of two to four years of monitoring experience, sometimes with expertise in specific therapeutic areas — as part of their service contracts with CROs. In reality, those qualifications may not be met.
As Christine Pierre, president of the Society for Clinical Research Sites (SCRS), explained, “The CRA shortage means that sites are sometimes faced with absent or under-qualified CRAs. Consequences of this reality are that sites report negative impact on study operations, timelines and even quality. Collectively, this reality ultimately impacts all stakeholders.”
Morgan raised the question of a correlation between the CRA shortage and delays in clinical trials but concluded that “bottlenecks in starting clinical trials, such as protocol amendments, IRB approvals and contract and budget negotiations contribute to significant trial delays, and these are not the primary responsibility of the CRA.” The Tufts Center for the Study of Drug Development (CSDD) found that 57 percent of protocols are subject to significant amendments, which brings about much longer clinical trial cycle times and higher costs. Using different local institutional review boards (IRBs) to review each research site for a multicenter trial can be both inefficient and costly, adding further delays.
While the Federal Demonstration Partnership (FDP) found that principal investigators on federal grants spend around 42 percent of their time on “administrative burden,” with IRB-related burdens ranking highest, many U.S. research sites will not use a single, centralized IRB. KMR Group, analyzed 20,000 contracts and revealed that contract cycle times have doubled over a four-year period.
Morgan recommends using purpose-built Study Startup (SSU) technology to create an intelligent workflow management system that walks clinical operations teams through the clinical trials process “with alerts to ensure compliance with country-specific regulations and organizational SOPs.” These programs offer role management for workflow continuity and analytics based on operational metrics to mitigate risks by identifying process bottlenecks and enabling teams to address them.
More than 70 percent of clinical trials will be conducted by CROs by 2020. The CRA shortage is only part of the pharmaceutical industry’s concern, but there are several organizations focused on training people to assume these vital roles.
The Society of Clinical Research Associates (SOCRA) has developed an International Certification Program to create an internationally-accepted standard of knowledge, education and experience by which CRPs will be recognized as Certified Clinical Research Professionals (CCRP®s) in the clinical research community. Standards are designed “to promote recognition and continuing excellence in the ethical conduct of clinical trials.” SOCRA offers training, continuing education and a certification program. A CRA who is certified through SOCRA’s certification program receives the designation of a Certified Clinical Research Professional (CCRP).
The Association of Clinical Research Professionals (ACRP) grants a certification for CRAs, specific to the job function performed — the designation of Certified Clinical Research Associate (CCRA®). To receive it, the CRA must pass a CCRA® examination and demonstrate the ability to “work independently of the investigative staff conducting the research at the site or institution.” The applicant must work a certain number of hours in accordance with study protocols and Good Clinical Practices. The program is accredited by the National Commission for Certifying Agencies (NCCA), the accrediting body of the Institute for Credentialing Excellence.
To learn more about getting a jumpstart on your CRA career, check out my CRA Academy website.
