TECH OUTLOOK 8OCTOBER - 2022IN MY OPINIONBy Steven Beales, Senior Vice President, Safety Reporting at WCGDoes safety reporting get the attention it deserves?In our hearts, keeping patients safe is the number one priority of investigators, sponsors, and regulators in clinical trials. In practice, because drug safety is seen as a cost center and not a revenue generator, it doesn't always get the same attention as efficacy ­ typically less than 0.5% of pre- and post-market budgets. This budget pressure will only continue to increase as we move into increasingly sophisticated oncology and immunology trials, which experience high volume of SAEs and potential safety signals. Complicating matters, adverse reactions in these therapeutic areas are frequently caused by the underlying disease and require more expert statistical analysis to identify valid drug-related signals.Do sponsors have adequate resources to manage safety? Only a handful of the largest sponsors have the resources to assemble a global safety organization. They have the in-house scientific expertise and large pharmacovigilance departments, but still struggle with compliant safety reporting. For small and emerging biopharma organizations, building safety functions entirely in-house can be prohibitively expensive. As a result, these smaller sponsors typically turn to niche service providers to provide that expertise. Niche companies tend to respond in a narrow sense, handling just safety documentation or intake of SAEs from sites. Other models, meanwhile, provides end-to-end service, but do so by pooling offshore resources. That makes it affordable, but it doesn't ensure proper expertise.If you're working on a generic that's well understood, that may be adequate. But if you have a new potential cancer treatment, it's not. Too often, these smaller companies feel that the only options are cost-prohibitive or of dubious quality. We recently took on a small biopharma client after it had its drug kicked back by the FDA for safety concerns; their safety information didn't meet FDA standards and requirements. It had outsourced its safety function to a large organization where it was a small fish in a very large pond. That rarely works out well.Overcoming Global Drug Safety Operations and Safety Reporting ChallengesSteven Beales
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