The Quest for Quality in Clinical Trials
By CINDY SANDERS
GIGO - or 'garbage in/garbage out' - was coined as a computer science term for the flawed output that comes from inputting flawed data. Over the years, the GIGO principle has been broadly applied to other areas of analysis where flawed logic impacts outcomes. Perhaps nowhere is that more evident than in a poorly designed or improperly executed clinical trial.
Earlier this year, Jody Black, deputy director of the Office of Extramural Research at the National Institutes of Health, introduced the acronym 'SCT' at the annual meeting for the Association of Clinical Research Professionals. Although the NIH has supported their fair share of 'small, crappy trials' over the years, the national funding source has spent the last decade enhancing oversight, monitoring, reporting and transparency to improve the quality of trials, which in turn improves the quality and credibility of research findings.
While some poorly designed, executed or reported trials are simply a waste of dollars, others have deadly consequences. Faulty 'research' published in 1998 linking vaccines to autism is still widely disseminated online. To this day, there are a significant number of fearful parents who refuse to vaccinate their children, which has led to the reemergence of several serious infectious diseases.
Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP) said the not-for-profit organization works to enhance and improve the grassroots implementation of clinical research by supporting the individuals involved.
"A poorly designed trial has a negative impact ... but so does a poorly executed trial," noted Kremidas. He added writing a protocol might seem simple, when in reality the wording has the potential to taint the entire process. "It's so critical that you ask the question correctly so that you get an answer that actually means something," he stressed. "We don't want spin in science."
Operational concerns and execution can also derail a clinical trial. "You could have a brilliant, scientifically designed study, but operationally you couldn't do it," he pointed out. Kremidas said he has seen trials with such narrow inclusion criteria that it becomes difficult, to the point of nearly impossible, to find patients to enroll. Even with a trial that is well designed, he continued, "If the people executing the trial aren't doing it correctly, you won't get the data needed."
Kremidas added, "I think the key to getting rid of those SCTs is we have to have the right experience and expertise in the people designing and implementing these studies."
While there have been a number of advances in technology and processes to improve the quality of trials, Kremidas said the people on the frontlines are often overlooked. Outside of major academic centers, those doing the heavy lifting on clinical research often aren't specifically trained in the exacting tasks that come with being a principal investigator or study coordinator.
"There hasn't been historically any standards set for who can be a clinical researcher," he explained. "Study coordinators ... most of them just fell into the job. It's been totally serendipity how people came into the field."
He continued, "About half of the doctors who do a clinical trial only do it once. Clinical practice is not the same as clinical research."
To drive the organization's mission of research excellence, Kremidas said much of the ACRP's focus has been on education and development. "We're trying to grow the workforce, and we're also trying to help individuals keep up with changes in the industry," he explained.
"If you're going to be a principal investigator, you need to be trained appropriately ... you need to have certain competencies," Kremidas pointed out.
To that end, the organization has created a competency framework. "We think it will help people transition into better clinical researchers if they know what they're getting into," he said. Kremidas continued, "We also do certification of clinical researchers. We're now offering subspecialty designations. We just launched one this year for project management and had more than 200 sign up for the exam already."
Available certifications include ACRP-CP (certified professional), CCRC (certified clinical research coordinator), CCRA (certified clinical research associate), and CPI (certified principal investigator).
Another area of emphasis for the ACRP is on workforce growth. As science explodes, so does the need for qualified researchers to oversee clinical trials. "We just recently announced a new initiative - Partners in Workforce Advancement (PWA)," he said of the effort to raise awareness of clinical research as a career path by reaching out to medical students and nursing students about the importance of field.
The PWA motto is: In clinical research, people are everything. The literature associated with the initiative points out that without an adequate pipeline of qualified, competent professionals, the clinical trial community will fail to both sustain the workforce and improve the efficiency and quality of medical discovery.
"Medical technology is advancing so fast," noted Kremidas. "There's an exponential growth in clinical trials, but there's only a linear growth in PIs, CRCs, and CRAs ... the people who actually do the trials."
Without a robust workforce, he continued, "That leads to slower introduction of new therapies to the market, and that ... in my opinion ... is a public health problem."
Founded in 1976, the ACRP has 13,000 members who work in clinical research in more than 70 countries. For more information on the Washington, D.C.-based organization or any of its programming initiatives, go online to acrpnet.org.