CRA Shortage – Part 1
A topic of current interest across the clinical research industry is the apparent shortage of entry level CRAs, in CRAs with limited experience and those deemed “qualified”. The impact has the potential to drive development costs higher and introduce delays to those development programs.
The cause of the shortage is complex, and may include:
- Changes in outsourcing strategies at pharmaceutical, biotech and med device companies
- Rebadging strategies
- Co-development deals
- Mergers and acquisitions
- Challenges in entry level talent identification and retention at CROs
- Challenges in rapid advancement for competency
- Industry requirements for >2 years’ experience
- Increase in the number of products in development
- Increase in the complexity of clinical trial design and execution
- Renewed focus on challenging therapeutic areas such as oncology and pediatrics
These are all real contributing factors to a shortage of experienced CRAs and any response to this challenge of must be multi factorial.
Many CROs are introducing new training programs and CRA universities / Academies to train those recruits who are new to the industry and the role, and those efforts should be lauded especially those that are longer in duration, more detailed, and tackle training from both a classroom and onsite/practical perspective, and those which include mentoring as a longer term support infrastructure.
It may be interesting to step sideways for one moment to think about how “qualified” may be defined for the variety of stakeholders / collaborators / clients / sponsors in this business of clinical trial execution.
- For the Sponsor: Qualified means 2 years of experience in the role of CRA, training in regulatory / health authority requirements, guidance’s and regulations ICH/GCP/Code Federal Regulations. Often this requirement for qualified will include prior exposure to and experience in the study therapeutic area.
- For the CRO: Qualified means all internal training requirements have been met which may include an overview of the clinical trial process, specifics on what the regulations require in a particular geographic area and detailed information on what monitoring visits entail. There may be specific training on electronic systems for either data collections or study documentation.Qualified also may be defined for a CRO as an interpretation of how a client defines this.
- For the CRA: Qualified may mean the number of years of experience, therapeutic area exposures, certification by industry bodies (eg ACRPI), or number and types of training taken / given.
- For the research site: Qualified is a measure that is not really applicable as sites assume that CRAs will be qualified by the sponsor and/or by the CRO, i.e. they are already fit to perform their job. What is of major importance to the site is the competency of the CRA and the interpersonal interactions and relationship they develop.
There are two further factors to consider when thinking of what it means for a CRA to be “qualified” and I’ll discuss these in the next post.
- With the implementation of risk based monitoring and the introduction of the quality system requirements in clinical research (with the release of E6 R2), how does this impact the qualifications and expectations of the CRA role?
- Irrespective of the definition of “qualified”, and the reasons for a shortage of that type of CRA, what is the actual outcome of a “qualified” status that stake holders are expecting or looking for?
I’ll leave you to ponder number 2 in particular, as the needs and definition of “qualified” will vary, and this may help in structuring the response.