Taiwan Urged To Speed Up Clinical Trial Administrative Process
This article was originally published in PharmAsia News
Executive Summary
Taiwan’s institutional review board process is putting the brakes on the country’s competitive advantage, with some trial sites taking up to six months to grant approval for clinical trials.
TAIPEI – Speeding up the laborious institutional review process necessary to grant contracts is becoming a key challenge for Taiwan’s clinical trial development, according to global pharma companies.
Taiwanese trial sites have to find a way to accelerate lengthy administrative procedures or they may lose their competitive edge to other Asian countries, speakers said during the Taiwan Trials 2013 conference Feb. 26 in Taipei.
The conference brought together pharma, biotechs, contract research organizations, regulators and hospitals from home and abroad to explore the potentials of offshoring and outsourcing clinical trials to the island of 23 million people.
Although Taiwan is a favorable destination for trial studies, the administrative process is a big turn off, said Roche’s Rosalind Lu, Asia Pacific regional head of product development operations and country clinical operations in Taiwan.
“From the sponsor’s [perspective] it’s almost unacceptable, if I may say,” she said, noting that in some extreme cases, it takes up to six months to get a contract approval. The wait not only pushes away potential sponsors but also puts a strain on existing sponsors.
Novartis AG, Pfizer Inc. and CROs shared similar concerns. Shirley Pea, regional director of clinical operations at Novartis Taiwan, said she is worried that if the situation continues, Taiwan will slowly lose its appeal to other emerging clinical sites.
“In terms of start-up time, there is no significant difference between Taiwan and the Philippines,” she said.
Delays in clinical trial approval in Taiwan also puts at risk the position the country touted that it could serve as a gateway to China’s large market.
For example, Taiwanese biotech TaiGen Biotechnology Co. Ltd. announced it would file NDAs in both China and Taiwan, relying on a cross-Straits clinical data agreement meant to improve clinical data exchanges between Taiwan FDA and China’s State FDA.
Similarly, Medigen Biotechnology Corp. received approval for a Phase III trial in China without in-country Phase I-II work, instead submitting clinical data from Taiwan (Also see "Case Study: Cross-Strait Agreement Could Shorten IND Timeframe For Products Entering China (Part 2 of 2)" - Scrip, 22 Jun, 2012.).
Lawyers To Blame?
The contributing reasons for the prolonged review process appear multi-fold. Some believe that legal departments in hospital centers are under-educated about trial regulations, while others suspect a growing conservative trend in attitudes toward clinical studies.
“When the institutes carry out clinical trials, they are more concerned about legal issues and patient safety. That’s why it takes them a long time to go over the contracts,” Churn Shiouh Gau said.
Gau is the executive director of the Center for Drug Evaluation, a non-government organization in Taiwan that evaluates new drugs and provides health technology assessments for regulatory requirements commissioned by the Department of Health. The organization was established by DOH in 1998.
In light of mounting pressure from the pharma industry and a drop in multinational clinical trials conducted in Taiwan, Gau revealed that DOH senior officials are planning to issue a contract template that would hopefully ease concerns of less experienced clinical trial institutions.
“I cannot promise the approval time will be cut in half, but I think there will be improvement on this issue, definitely [this year],” she said.
Unsuitable Partners?
“Templates are really for hospitals that don’t know what to do,” said Wing-kai Chan, head of the National Center of Excellence for Clinical Trials and Research. The center helps international pharmaceutical companies conduct trials at National Taiwan University Hospital.
He emphasized the importance of finding the right partner. A well-driven trial site has to be willing to put itself in the sponsor’s position and solve problems, rather than creating inconveniences. Through close interaction with sponsors, Chan said his center is able to issue IRB approval in 50 days and contract approval in 14, compared with 100-plus days for other local sites.
“If it’s a two-year Phase III clinical study, an extra couple of months to get the contract signed is frustrating but not a disaster. If it’s a one-month Phase I study, then an extra two months would be a problem,” said James Garner, vice president and general manager of Takeda Pharmaceutical Co. Ltd.’s Global Research and Development (Asia).
Garner pointed out that since Taiwan is unlikely to compete with some emerging populous countries like Indonesia in terms of recruitment rates, it needs to start thinking about how to position itself in the fast-changing clinical trials landscape, like providing faster, smoother administrative services.
Otherwise, change may be too late, if “movement really doesn’t start to come until the research starts going away,” he said.