Comparator Sourcing in Clinical Studies (Part One of Two)

Choosing the right comparator supplier is becoming increasingly important to sponsor companies conducting clinical trials; drug development companies are constantly having to jump through narrower hoops, held higher each year by regulators. Costs to maintain drug integrity throughout the supply chain have risen exponentially over the last decade, and R&D budgets are being slashed like sacrificial lambs in homage to the great God: shareholder value. Mergers and acquisitions, and their resulting layoffs, combined with an ever-increasing number of eager, educated young professionals entering the life science employment sector has created a culture of fear in existing pharmaceutical employees who know that theirs is most definitely not a ‘job for life’. Clinical teams are under constant pressure to execute trials faster, compliantly, more effectively, with greater efficiency and transparency, with minimal risk, and for less money. Oh, and did I mention they have to plan everything at least 18 months in advance, be ready to adapt to any disaster on the turn of a dime, navigate an ever-changing regulatory landscape, but plan and manage any change before it happens? Trust me when I tell you that Ethan Hunt had it easy compared to the trials and tribulations of the average clinical trial supply chain manager. I am sure that countless numbers of these unsung heroes and heroines dream of one day running off to the circus to engage in the slightly less challenging career of juggling chainsaws. Pharma has evolved into a fast-changing environment that has typically feared change of all kinds, regardless of how much money it pumps into change management training for its people. The problem we are facing is that clinical supply chains and comparator drug distribution channels are changing dramatically and, therefore, so must our sourcing models to ensure that study drugs are accessible to patients enrolling in modern day clinical trials.