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Give staff comprehensive training in good clinical practice and ethics
Begin by defining GCP
Here's a good question for stumping clinical trial staff and investigators: How do you define GCP?
Everyone knows it stands for good clinical practice, and everyone says it's what they practice at their research sites. But beyond that, true descriptions are hard to come by from the people directly involved in clinical research, an expert says.
Protect subjects and produce accurate data
"GCP is a set of standards that exist to do two things: One is to protect the rights, safety, and welfare of subjects participating in research, and, two, is to ensure the accuracy of data coming out of the trial," explains Brian Bennett, BA, CCRA, CCRT, senior director of corporate communications and knowledge management at i3 of Little Rock, AR. A global Ingenix company, i3 provides support for drug development, including research, drug safety, data services, staffing, and science. Bennett is a speaker and instructor about research ethics, GCP, and other topics.
True understanding of GCP requires in-depth knowledge about the history of research ethics. In other words, the first place to start is with answering the "why" questions, Bennett says.
Clinical trial investigators and staff often receive GCP training through industry-sponsored sessions or professional advancement courses or investigator meetings, he notes.
Large research institutions dedicate infrastructure to training staff on GCP, often through computer-based education programs, he says.
"You're told very often what you're supposed to do and what can be done in the course of the standard operating procedures (SOPs)," Bennett says. "But in none of this did I find that anyone told me why we do what we do."
Certainly, there are regulations to follow, and there are industry standards, but these do not answer the "why" question, Bennett says.
Here is how Bennett answers the ''why' question and teaches clinical trial coordinators and others about GCP:
• Everything goes back to the big three: The Nuremberg Code of 1948, the Declaration of Helsinki in 1964, and the Belmont Report.
Everyone has heard of these, but they typically can't tell you very much about them or why they even exist," Bennett says.
For example, the informed consent form was developed as a result of these three ethical doctrines.
From an ethical standpoint, a lot of what we do is rooted in those three doctrines," Bennett says. "We're all working to bring better medicines to market."
To do so requires relying on volunteer participants, he adds.
The Nuremberg Code was the result of a 1946 American military tribunal that heard of war crimes by German physicians who had conducted lethal and crippling experiments on concentration camp prisoners. The Nuremberg Code declares that the voluntary consent of human subjects is essential.
The Declaration of Helsinki has recommendations by the World Medical Association, guiding medical doctors in human subjects research, including the guideline that research with humans should be based on results from laboratory and animal experimentation and that informed consent from research subjects is necessary and that risks should not exceed benefits.
The Belmont Report was prepared in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research as a way to summarize the basic ethical principles regarding human subjects research and establishing GCP.
The Belmont Report came after the medical and research community was made aware of the ethical violations that occurred in the Tuskegee Syphilis Study, Bennett says.
The U.S. Public Health Service began studying black men with untreated syphilis in 1932 and then continued to follow the men, observing illness progression and deaths, until 1972, decades after antibiotic treatment was available and consistently denied to the study's participants.
• Regulatory requirements are both necessary and not as onerous as often feared.
Bennett typically explains to clinical trials professionals the history of the current research regulations and the FDA's power, including a number of research tragedies that have led to oversight laws.
For example, more than 100 people died in 1937 due to a cough syrup that included a compound that had been shown by basic science to be toxic, but was nonetheless included in a prescription bottle for human consumption.
Although it's part of GCP to follow national and international regulations, clinical trials professionals often confuse laws with industry standards, Bennett notes.
"One of the most shocking things in delivering GCP training is when you do an in-depth analysis of the FDA regulations, and you look at what's out there, you often find that people believe the FDA requires a lot more than it actually does," Bennett says.
There are many examples of incidents where clinical trial professionals believed some practice or deadline was required by the FDA, when it actually was not, he adds.
"They're sometimes told by a colleague or a monitor or quality assurance person that the FDA requires this to be done, but when you look at the regulations, you'll find there's nothing point blank or specifically requiring that," Bennett says.
"I try to empower people by saying, 'If somebody tells you something needs to be done on your study, and they say it's because the FDA requires it, then challenge it," Bennett says. "I say, 'Ask the person where in the regulations it says I have 30 days to submit a final report to the sponsor or IRB?'"
What actually happens is many clinical trial practices are done because of industry standards, he says.
Everyone has done it this way or met a certain deadline, and many of them assume it's because of regulations, Bennett explains.
Overall, industry standards are a positive force because these fill in the blanks between the lines of regulations and guidelines, he says.
"Anytime you have consistency or standardization in the process, whether its standard operating procedures (SOPs), or meeting a timeline, then it eliminates guess work," Bennett says.
• Clinical trial data must be credible and accurate.
"So if any authority around the world looks at the data about a product, the product can be put on the market based on accurate and credible data," Bennett says. "As many people that are exposed to a product in a clinical trial setting, it is a small number compared with those who will be exposed once it's approved for marketing."
It's essential to protect both the study participant and the accuracy of the data because one day the medicine being studied will be on a pharmacy shelf and have someone's name on it, Bennett says.
"It could have the name of you, your mother, your father, your friends," he says. "At the end of the day, I want to sleep well at night."
Once clinical trial professionals know the background and why they need to follow GCP, they'll have a greater appreciation and openness to learning how to improve their trial activities, Bennett says.
• Teach GCP at the clinical trial site for most pointed impact.
Good clinical practice might best be taught at a clinical trial site, Bennett suggests.
"One of the best approaches to GCP training for research professionals, in my opinion, is to bring GCP training on site when there is no dedicated internal training capability," Bennett says. "I really like and prefer this approach over sending personnel to generally available GCP training courses because it presents the perfect opportunity to assemble not only a class of research professionals to learn about GCP, but a class of research professionals who work together at a site as a study team conducting a protocol."
Also, when clinical trial sites bring GCP training to their locations, they can instruct staff about GCP in the context of their own research operation, providing details on how the site's research team approaches and complies with GCP in a day-to-day manner, Bennett says.
"In other words, it's a great opportunity to, one, ensure the collective understanding of an immediate team of research professionals at a particular location," Bennett explains.
Secondly, this approach identifies areas of inconsistency in how staff conducts site business, and, third, it helps to identify any gaps in the current processes, Bennett adds.
These can lead to action plans and a more standardized and consistent approach to research, he notes.
"Again, it's that standardization and consistency that are critical to quality in the clinical trial process," Bennett says.