We must confront the workforce shortage in the clinical research enterprise. There are simply not enough study coordinators, site monitors, and principal investigators to do the work that needs to be done.
We've got to have a way to bring people into the workforce more effectively. ACRP and others are working together to develop standards addressing how we identify people to bring into the workforce, develop them, and assess them. We believe it needs to be based on the Joint Task Force for Clinical Trial Competency’s professional competency framework.
The pressure to grow the workforce is likely to continue. For example, the number of registered clinical trials continues its climb, to 261,940 as of Dec. 20, 2017, up from 231,208 just over a year ago, according to ClinicalTrials.gov.
While some of that uptick can be explained by new reporting mechanisms and policies, the bulk of it reflects a booming industry with a workforce that may not be able to keep up in the coming years. One solution: Standardizing the way we onboard, develop, and assess clinical research professionals.
We need to set a standard methodology and competency level for clinical researchers who come into the industry. Doing this properly will reduce the variance we struggle with today, improve the quality of the workforce, and consequently, improve the quality of research.
We understand this is no small task, but it needs to be done. Frankly, it worries me when people say it’s too big a challenge. If we are going to improve the quality of research, we need to come together and address this critical issue.
If you look at the training programs within sponsors and contract research organizations (CROs), there’s a wide variance. Result? There is simply no way to know who is doing a good job and who is not. At the site level, the variance is even wider. Variance is the enemy of quality.
You don’t need to look far to see the consequences of not addressing these variances. Warning Letters from the US Food and Drug Administration (FDA) cite the same shortcomings repeatedly. Those include failure to follow the investigational plan and/or regulations, product deviations, inadequate recordkeeping, failure to report adverse events, and informed consent issues.
The root cause of these consistent deficiencies is a lack of standardization of training and development of our workforce.
If you get a haircut or have your nails done, the barber or manicurist doing that work must be licensed. Amazingly, if you join a clinical trial, the study coordinator isn’t required to have a license or even to be credentialed. I’m not advocating licenses for clinical researchers, but regulators just might if we don’t step forward and take these important steps to improve the quality of research.
As an industry, we are in the best position to assess and implement these standards—to police ourselves, if you will. Coming together as an industry, we can determine the best way to improve quality. I believe we need to do this before regulatory bodies step in and take the process over.
Change management is fueled in part by new processes and tools. However, the most important ingredient is the workforce. Along with those processes and tools, the workforce serves as the third leg of the stool. Arguably, it’s the most important leg, too. We must have all three supporting any initiative for it to be successful. We all understand that efficiency and productivity levels in the research environment need to change, it's just a question of identifying new ways of doing things, and implementing those changes across the industry.
There are any number of benefits, including getting products to market faster and with fewer errors. Patient safety is a key consideration. As we continue to spread the word to the general public about the value of clinical research, we need to know that the people conducting the research are protecting patients with a demonstrated level of competency. Unfortunately, that’s not always the case today.
Industry would be wise, from a public perception standpoint, if patients knew that the investigator is not only a physician and the coordinator is not only a nurse. It’s of paramount importance that patients see the professionals conducting their clinical trial have met rigorous standards and know how to make sure that trial participants are safe. In some cases, they are putting their lives in our hands.
I’m encouraged by a number of initiatives underway. The aforementioned Joint Task Force for Clinical Trial Competency, organized under the sponsorship of the Multi-Regional Clinical Trials Center at Harvard University, and the Alliance for Clinical Research Excellence and Safety are two examples.
Another workgroup, ACRP’s Workforce Innovation Steering Committee (WISC), which includes several sponsors, CROs, and investigator sites, used the Joint Task Force framework to map competencies for the clinical research associate role, from entry-level to advanced positions.
I’m optimistic 2018 is going to be a turning point. We’re excited to be part of the effort to examine the workforce and how we use a competency-based model to standardize how we identify, onboard, develop, and assess clinical research workforce personnel.