Guest column

Looking back, looking forward: The days of process driving clinical trials are just about over

(Image: Getty/francescoch)
(Image: Getty/francescoch)

Related tags Clinical trials ACRP

This time next year, I hope I can write a column with the headline “2019: The year of cooperation and communication in the clinical trial industry.” We’ve made some exciting progress toward that end in 2018. Now it’s time to take it to the next level.

It’s vitally important for us as an industry to find new ways to work together. We have a tremendous opportunity to complement each other’s work in our communities at the local level. We can attract more trial participants even as we provide improved patient care with a patient-centric experience featuring better access to care and treatments.

The days of process driving clinical trials are just about over. Instead, we’re entering a world where data and patient engagement are the king and queen of how trials are structured; in other words, moving to a data-oriented approach with the patient at the core.

I can’t tell you how many times professionals representing each part of the clinical trial process have told me they wanted to foster closer relationships with their colleagues. Better communication between sites, sponsors, and contract research organizations (CROs) can improve clinical trial quality “from start to finish,” experts at the ACRP-Avoca Quality Consortium’s Quality Congress reiterated during the ACRP 2018 meeting last April.

To say clinical research is an industry undergoing a transformation would be a vast understatement.

From privacy regulations to informed consent parameters, from the professionalization of the workforce to the adoption of skills-based competencies, we’re surfing a wave of change the likes of which we haven’t seen before.

For example, under Commissioner Scott Gottlieb, the US Food and Drug Administration (FDA) was more aggressive in 2018​ in terms of new guidances and policy direction. The agency took steps to advance the use of technology in risk-based monitoring. Look for more action from the FDA and other regulators around eData integrity, multisite trials, biomarkers, innovative trial design​, and inspection readiness, among many other topics.

As with most periods of evolution, living through it is simultaneously exciting and intimidating. We have an opportunity to harness these forces of change and use them to transform the clinical trial landscape.

In 2018, we continued to see exciting innovations in technology and great leaps forward in best practices. In 2019, it’s time to focus on the most important link in the clinical trial chain: People.

Entrants to the profession deserve state-of-the-art, codified standards and certifications​ to ensure employees hit the ground running with a good chance to thrive in their new career. Clinical trial practitioners deserve a defined career path to best harness their skills and inspire personal and professional growth.

Together, we also need to make the case to employers that quality training brings out the optimum skills in study coordinators, monitors, principal investigators, and everyone else involved in the conduct of clinical trials. This helps to attract the “best and the brightest” to join our exciting industry. Trials will become more efficient, driving down cost and waste, while promoting morale, reducing expensive and disruptive turnover, and delivering higher quality care to patients.

Looking back at 2018, we’re seeing several other trends emerging.

Competency is an idea whose time has come

Don’t get burned by relying on tenure when making new hires.

The demonstrable value of competency is obvious to the leadership at Duke University Medical Center. The innovative practice has organized some 180 formerly sprawling and sometimes vague job descriptions and honed them down to a dozen, based on professional competencies and clearly stated expectations. All told, Duke mapped more than 700 people.

On the corporate side, AstraZeneca is actively leveraging new core competencies to better train, retain, and inspire clinical trial practitioners to new levels of quality in every aspect of its clinical trials. Rejecting the current model of tenure-driven career advancement, the health care giant is giving members of its growing trial workforce new opportunities to develop career paths that will maximize their skills and professional opportunities.

Over the past year or so, AstraZeneca has been bringing its clinical research associates (CRAs) in-house, and planned to bring in nearly 20 of them in 2018. It will use standards-based competencies to assess the performance of new team members.

Practitioners are demanding career mapping and standardization of roles/onboarding/training

The lack of a standardized clinical research coordinator (CRC) job title for the study coordinator role “blurs” the equation on both sides of the interview and hiring process. In today’s clinical trial landscape, sites are often left to themselves to interpret various job titles without much confidence that the title reflects any actual skillset.

For example, while many CRCs are nurses, they often aren’t trained for their role in clinical trials. Nursing research is very different from clinical research. Unfortunately, that contributes to a lack of awareness among nurses when it comes to a clear career path in the clinical trial industry.

It’s also important for CRCs who are considering becoming monitors/CRAs to recognize the different types of monitoring being done in the drug and device development industry.

Beyond conducting traditional onsite monitoring by making visits to study sites, the nuances of risk-based and central monitoring vs. remote monitoring and in-house CRA activities can be difficult for people not already in those roles to understand.

Clinical care is beginning to drive clinical research

The time is now for the clinical research community to expand the way it thinks about the broader value of clinical research. Across the industry, we’re seeing more and more people promoting the concept of clinical trials as another way to further empower patients through the choice of clinical research as a health care option.

When we talk about clinical research as a care option​, we’re not advocating that clinical research is about treatment, but rather that it should be amongst the menu of options for both health care providers and patients.

In more and more cases, clinical trial participants receive “white-glove” health care, become more knowledgeable about the specific condition being studied, and become overall more interested and involved in their well-being.

Clinical trials are a vital catalyst for health care innovation. It’s time for health care and clinical research professionals to redouble efforts to educate potential patients on the benefits of trials as another valuable tool in the broader health regimen.

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