The FDA has issued new guidelines designed to help researchers navigate sometimes conflicting regional requirements and differences in global clinical trials in an effort to pave the way for better cooperation and faster international drug development.
There currently is no single set of rules governing how multiregional clinical trials (MRCTs) should be crafted. But the FDA is hoping to help make the road less bumpy with this fresh ICH E17 addendum.
Among its key recommendations: Plan ahead to make sure an international study is the best route to take. That is, assess potential challenges and regional differences — like environment, diet, cultural twists — to make sure they’re not too great to overcome or skew findings.
Consider all potential factors —and ways to account or adjust for them (by doing genetic testing, for example), the FDA advises, noting that “even in the case of expected major differences ... it may still be possible to conduct MRCTs by excluding some regions or a defined subgroup within a region.”
Your best bet for smooth sailing if you do opt for international probes?
Design them with seven principles in mind, the FDA suggests:
Multiregional trials have historically been used as a quick way to recruit participants with rare diseases or in special populations (like children or the elderly) or for large-scale studies (such as vaccine safety and effectiveness). But sponsors increasingly have found they’re an efficient way to get more drugs to more people — and they’re fast becoming the preferred choice for investigating new meds in today’s global market.
The difficulty is that disease definitions, diagnostic methods, medical practices, diet and other factors may vary from region to region, complicating global trials. Given all the potential differences at play, it’s vital to create an ongoing system of quality checks.
“Centralized and risk-based monitoring may be particularly useful for MRCTs to monitor and mitigate the impact of emerging regional difference in, for example, trial subject retention or adverse event reporting,” the FDA says. “Timely and accurate flow of information should occur between the sponsor, the trial management team and the participating sites.”
If investigators take the recommended steps and still notice different regional effects, the FDA suggests conducting “a structured exploration” to try to pin down potential culprits.
During their probe, researchers should consider the usual suspects first – things like disease severity and participants’ race, weight and lifestyle (smoker/nonsmoker, for instance). If that fails to turn up answers, the FDA says, they may need to dig deeper —and perhaps cull data from other clinical trials and sources.
Read the FDA’s guidance here: www.fdanews.com/07-18-18-ClinicalTrials.pdf.
-By Bill Myers