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Clinical Research Evolving: What’s to come for CRAs?

9 Oct 17 - 12:00AM Carl Marotta  | Skills Alliance blog

Clinical Research Evolving: What’s to come for CRAs?


In the enduring words of Heraclitis, “The only thing that is constant is change.”


This is especially true within pharmaceutical industry where discovery, change and development are the driving forces behind the industry, clinical research being the wheel from which it all churns. In asking clinical professionals how they got into research, their answers vary but the core is always the same: they wanted to change something – whether it was finding a cure for stroke, cancer, lupus or furthering research in a very rare disease. This drive, alongside incredibly hard work has led to innumerable developments within healthcare that we can see on a daily basis.


With the recent advancements in technology, change too has occurred quite significantly in the past 20 or so years with how many clinical jobs are performed. The role of CRAs for instance, has evolved quite notably and will continue to do so in the years to come.


In assessing how their role has changed, we should first clarify the question, what does a CRA do? Put simply, a CRA monitors clinical trials that are testing new or existing drugs for their effectiveness, safety and benefits. They are involved in all aspects of the clinical studies from identifying hospitals and clinics where they can run the study, to gathering all of the materials, collecting and verifying data and documents throughout the course of the study, assisting in ethics submissions and compiling regulatory documentation and finally closing it down on its completion. Monitoring the study throughout its course is traditionally considered the bulk of the role of the CRA. The monitoring visits, where the CRA physically travels to study sites, are typically planned on a set schedule (every 4 weeks, for instance) and a CRA will often be monitoring a number of different studies at once.


The most significant changes in the role of the CRA have appeared in how their studies are monitored. In the 1980s and 1990s, collecting data and paper documentation from the sites was the standard routine as it was the only option. With the development of the fax machine, CRAs could begin to collect some documentation remotely and with the whirlwind of technological advancements, complex electronic systems have been created. Electronic Case Report Forms now allow sponsors to have ‘real time’ access to site data, which has eliminated the need to send CRAs out to sites to collect paper CRFs. This change has caused CRA visits to have more of a focus on query resolution, cross-referencing data (Source Data Verification) and reviewing source documents. As sites continue to provide more remote access to medical records and site documents, remote monitoring is becoming significantly more common. This has contributed to a development of a different type of monitoring known as Risk-based Monitoring.


Risk-based Monitoring is an approach to monitoring where risk assessments aid in determining study-specific monitoring plans, which can include a mix of central, remote and on-site monitoring. This involves quality planning where study specific risks are assessed in order to determine how the study is run. In a risk-based approach, a percentage of the population is looked at rather 100% of the population and assertions are drawn based upon this assessment. The percentage of the population that is looked at is calculated to add minimal (if any) risk to how the study results are determined. In this way, the higher the risk of the study, the less you are going to do risk-based monitoring.


Risk-based Monitoring changes the role of the CRA in that more work is done remotely and study visits are determined based upon risk assessment rather than pre-set intervals. CRAs are now required to have a more in-depth understanding of their study, sites and patients in order to account for risk identification, risk management and decision making which falls outside of the remit of the traditional CRA role.


Approximately one third of clinical trials currently utilize risk-based monitoring and this figure is expected to increase drastically in the coming years. Remote monitoring is anticipated to become more prevalent and ultimately on-site visits are expected to become less and less frequent. It’s been hypothesized that because of this the industry could see a 10-20% reduction in the total number of CRAs. As the visits will be less frequent, the same CRA will be able to be assigned to other studies rather than adding an additional monitor which will account for this reduction.


In a more radicalized view, some think that the role of the CRA will become obsolete and eliminated entirely in the not-too-distant future. While this seems unlikely, perhaps in the next 20 to 30 years the role of the CRA will be unrecognizable to how we know it presently. In any event, the healthcare industry is in a constant state of development and it will be fascinating to see the advancements and changes in years to come, particular for the CRAs.

Anabel Balsebre
Clinical Research Consultant

0207 220 6200