1. Indian CROs react to 22% drop in new clinical trials

    Last fiscal year the number of new studies in India fell by almost 22% to their lowest level since 2007. Considering all the hype, all the potential it’s a staggering statistic. By now India was supposed to be a global clinical trial juggernaut, involved in 15% of all studies. In reality India never got close. The 267 new Indian studies registered on ClinicalTrials.gov last year accounted for just one per cent of all trials submitted to the site.                 What went wrong? That’s what members of Indian CRO trade group ACRO are meeting to talk about next month. But they’re asking the right question to the wrong people. The panel is made up of industry, investigators, ethics committees, NGOs and just about any other group involved in clinical trials. Except the one that really matters. The one that is widely blamed for the decline.

    Regulators.

    ACRO acknowledges the problem in its promotional materials for the event, citing lengthening and unpredictable trial approval timelines as a factor in the fall. The unpredictability is the real kicker. China has long approval times. Everyone knows they’re long and plans accordingly. The sin of Indian regulators is the uncertainty their inconsistencies create. There are quite enough unknowns in clinical research without regulators throwing trial approval times in the mix.

    Last month John Lewis, VP for public affairs at ACRO - which, confusingly, has no affiliation to Indian ACRO - told me “the regulatory environment in India…is making it very difficult, if not impossible, to conduct any research.” The CROs Lewis represents - which are all global firms - can simply include fewer Indian sites in their clinical trials. Indian CROs lack that luxury.

    It is these CROs that face what Lewis described as “just a bad business environment.” Some will likely attend the ~$20 a head event Indian ACRO is hosting next month, arriving armed with 100s of questions about the fate of their business. Whether they get any answers is another matter. Optimism is in short supply in some quarters.

    “[There’s] very little hope of it getting better anytime soon,” Lewis said.

    August 28, 2012