Details matter when participating in clinical trials
Click Here to Manage Email Alerts
Every detail counts when participating in clinical trials, according to one panelist at the virtual Women in Ophthalmology Summer Symposium.
Key areas that deserve scrupulous attention are obtaining consent, adhering to inclusion/exclusion criteria, appropriately randomizing patients, and correct drug distribution and documentation, Penny A. Asbell, MD, FACS, MBA, FARVO, said in the WIO’s inaugural clinical trials training program session.
“Those are things that come up in every trial, and you cannot screw them up,” Asbell said.
The institutional review board, the FDA, the sponsor, the contract research organization — all of these organizations — are concerned about the details, she said.
First, consent must be obtained and the consent form completed correctly.
“You don’t want to start doing things if you don’t have that consent done,” she said.
Second, patients need to “really” fit the inclusion/exclusion criteria.
“You can’t enter people who should not be entered in that specific trial. It’s not always intuitive; you have to read the directions very carefully,” Asbell said.
It is better to not recruit a patient at all than to recruit them incorrectly, she said.
“If they don’t [meet the criteria] or you’re not sure, stop. Always stop before you go to the next step,” she said.
Third, randomization must be done using the method that has been set forth.
“If you’ve forgotten how to do it or can’t remember the details, don’t do it until you find out how to do it,” she said.
Finally, drug distribution in the study must be correct and documented.
“From the FDA’s point of view and probably the sponsor’s, giving the wrong one is critical,” she said. “You need to really pay attention to that detail and go slow. Going slow is going faster in clinical trials.”
Collapse
Inaugural clinical trials training program. Presented at: Women in Ophthalmology Summer Symposium; Aug. 21-23, 2020 (virtual meeting).
Read more about
Click Here to Manage Email Alerts