Neuroprotection
After more than a decade of developing a class of drugs called postsynaptic density-95 (PSD-95) protein inhibitors, the ENACT trial recently provided a positive signal that neuroprotection is achievable, said study coauthor Michael Tymianski, MD, PhD, a neurosurgeon at the University of Toronto.
Similar to reperfusion therapies, however, neuroprotectants are emergency drugs that need to be administered in a prehospital setting. Only two trials, ENACT and the ongoing FAST-MAG, have recruited stroke patients in less than four hours. Thus, any new clinical trial design that waits three to four hours before administering neuroprotective agents is unlikely to detect the small effect size of delayed neuroprotection, he noted.
Researchers now have an effective drug and a feasible trial design, and planning is under way for a study that, if successful, may provide the necessary signal needed to determine whether neuroprotection is practical, Dr. Tymianski said.
Garbage in, Garbage Out
Steven Warach, MD, PhD, Executive Director of the Seton/University of Texas Southwestern Clinical Research Institute in Austin, made a plea for scientific rigor in future clinical trials to avoid the “garbage in, garbage out” type of research.
During the next 10 years, clinical trial enrollment and assessment will move away from the individual investigator. Instead, a “handful of on-call central adjudicators” will decide which patients get into trials based on clinical and biologic case definitions and will assess outcomes, noted Dr. Warach. “Whatever advances we talk about in clinical science, it’s about reducing bias, reducing variance, and increasing the power of the trials.”
—Patrice Wendling
IMNG Medical News