When a regulator calls to say it would like to inspect your clinical trial, gratitude is not the usual response. Health Canada is betting it can change that. Ahead of its October deadline for the revised International Council for Harmonisation’s (ICH) good clinical practice (GCP) guideline known as E6(R3), the regulator is offering sponsors a “pulse check”: a compliance readiness inspection with, in the words of its own Reza Salehzadeh-Asl, “no consequences.”
His pitch was almost plaintive. “If you receive a phone call from Health Canada,” he told sponsors, “please don’t decline.”
It’s a strange eat-your-vegetables moment. An inspection can often feel like a stick. Canada has turned it into a carrot. Participating sponsors get no rating, no formal report and no requirement to file a corrective action plan but correcting any observations is highly recommended; the findings are neither posted publicly nor used for regulatory decisions.
Companies that have not been called can invite themselves: “You can send a request,” Salehzadeh-Asl, national supervisor of Canada’s clinical trial compliance program, said. The agency has taken the most dreaded event in a trial’s life and rebranded it as a courtesy – for the next few months, at least.
The Inspection As Sales Pitch
Canada is not doing this out of pure benevolence, nor alone. It adopted E6(R3) in April with a six-month grace period before full enforcement, and its no-fault inspections focus on the two areas it considers the biggest changes: risk proportionality and data governance. The offer is real help. It is also a competitive instrument.
Countries are competing, more openly than ever, to attract clinical trials. The United Kingdom now markets faster approval timelines as national attractiveness, and the European Union has set numeric targets to win back the trials it has been losing. The United States just rolled out its pun-of-a-program-name “Operation TrialBlazer.”