The Indian overhaul of clinical trial regulations is still evolving after a year of gains and setbacks, the Parexel COO said.
Last year CROs (contract research organisations) faced inconsistent clinical trial approval timelines and concerns about new serious adverse event reporting as India worked to strengthen regulations.
Mark Goldberg, chief operating officer at Parexel, told Outsourcing-Pharma India is trying to improve regulations but at times it has been “one step forward, two steps back”. The situation is still evolving.
“It will be interesting to see what happens”, Goldberg said. Comments made by Goldberg echo what his CEO, Josef von Rickenbach, said in January. Rickenbach said India is as “a challenging regulatory geography” and, while the government is supportive, the impact of reforms on operations is unclear.
While Parexel noted a shift in demand away from Asia to the US and Western Europe in the second quarter, the potential of clinical trials in India means it remains a key market for sponsors and CROs.
Interest is driven, in part, by perceived shortcomings in traditional clinical trial markets. “The US and Western Europe are almost tapped out”, Theresa Musser, vice president of development operations at Rigel Pharmaceuticals, said at Partnerships in Clinical Trials this month.
Musser said the presence of more engaged physicians can make Asia-Pacific a better clinical research location than other regions but sponsors must be careful when choosing a CRO with which to work.
“Even within the top five CROs experience of GCP (good clinical practice) varies by geography”, Graeme Currie, head of clinical project management and operations at Regeneron Pharmaceuticals, said.
Musser said variability in capabilities from country-to-country is one downside of working with a few global CROs for all clinical research needs. Consequently, while working with a network of local and niche CROs can add to oversight costs, it can also allow sponsors to access the very best talent.
Stephen Porter, CEO of VDDI Pharmaceuticals, said local CROs in China love working with small to mid-sized biopharma companies. Also, by choosing small CROs in second and third-tier cities, firms can find partners that are excited by clinical trials and have lower staff turnover, Porter said.