CR field needs better, more consistent training and education
Mistakes are made through ignorance
Clinical trial sites and institutions that want to reduce errors and undesirable audit findings need to invest more resources in educating research staff, an expert asserts.
Traditionally, clinical research professionals are thrown into the fire of research without formal education and training, says Lisa Mazurka, president and chief executive officer of Clinical Research Consulting of Boston, MA. Clinical Research Consulting is a niche clinical research organization (CRO) that provides clinical monitoring, project management, and education and training services.
When Mazurka first began working in the clinical research industry 15 years ago, she was given a verbal description of her job and one day with a mentor, who was the person she was replacing.
"In the past, it was a sink or swim education," she says.
But the climate that permitted this lackadaisical attitude toward education has changed substantially in the past decade, Mazurka says.
"People have become more accountable for research mistakes, as we read in the newspaper every day," she says.
These include headlines about deaths or major injuries in clinical trials and investigators and research institutions being suspended by the FDA from doing research, Mazurka explains.
"Many of these incidences could have been avoided if individuals had been adequately trained and educated," Mazurka says.
"We're hearing more and more, including talk at the FDA, about the need for proper education and training for individuals who are coming into this industry," she adds.
However, while improved education and training are being provided to new clinical research professionals, there is no formal requirement or mandate that would make such training consistent, Mazurka says.
"A physician has to go to medical school, and a nurse has to go to nursing school, and they both have to pass an exam to receive a license to practice clinically," she says. "But there is no such requirement for individuals who conduct clinical research."
While there's definitely interest and some movement into the direction of formal requirements, it hasn't happened yet, Mazurka adds.
It is a positive improvement that clinical research certification and accreditation are on the rise as voluntary measures to improve the industry's training and professional competency.
But this trend falls short of a standard and formal requirement.
"I think accreditation and certification are absolutely wonderful things in our industry, but the issue is that to sit for the certification exam, you need two years of experience," Mazurka says. "Where does training and educational experience come in before that happens?"
The handful of universities that have started formal programs to train clinical research professionals should be applauded for their work, but these can reach only a small number of people who are in need of such education, Mazurka says.
"Many individuals who are just starting out in the industry and who would benefit from these programs don't have time to attend an academic program," she explains.
Likewise, there are many education and training programs available through conferences and on-line curricula, but until these are formal requirements, these will not be accessed by everyone who needs them, she says.
"We're all trying to develop these wonderful programs to solve the problem, but we run into resistance due to budget and time constraints, and it's not mandated," Mazurka says.
"There is a lot of discussion within our industry to mandate some sort of formal education and training, and it is on the table," she adds. "But it's been on the table for many years, so the question is, 'When will we see action on it?'"
It's through education that many common trial mistakes can be prevented.
For instance, Mazurka has often seen examples of clinical research staff making mistakes that highlighted their lack of knowledge about human subjects research regulations.
"One common thing that happens is that a patient is being considered for participation in a clinical trial, and the site actually starts to evaluate and perform tests to determine the eligibility of that subject prior to obtaining informed consent," Mazurka says. "Some of these are routine tests, but if they're truly being used to determine eligibility for a protocol, then the patient needs to have adequate informed consent and needs to have documented informed consent before any procedures are conducted to determine the patient's eligibility."
The regulations clearly state that informed consent must be obtained before any procedure is performed, Mazurka says.
In absence of mandated education, clinical research institutions should develop their own formal education and training programs for all employees, Mazurka suggests.
"We should focus as an industry on documenting training and education for clinical research employees," she says. "They can attend classroom type education and training programs, or if they can't get away from the 40-hour work-week, then on-line education provides an added benefit."
Likewise, research institutions should provide staff with the funds and time necessary to seek certification, Mazurka says.
"We should encourage people upon their two-year anniversary of a job to pursue certification," she adds.