Hong Kong’s Hospital Authority will shorten the ethics review period for clinical trial applications from six months to 30 days next year, with the research and pharmaceutical industry saying the move can help convince companies to carry out studies in the city.
Dr Michael Wong Lap-gate, the authority’s director of quality and safety, made the pledge on Thursday as Hong Kong aimed to develop into a health and medical innovation hub.
Speaking at the launch of an Our Hong Kong Foundation policy report on the city’s strategies for developing into a clinical innovation hub, Wong said the authority was planning to further streamline the application process for ethics reviews for lower-risk clinical trials.
“Now we need to have three different applications if you want to perform clinical research in the Hospital Authority,” Wong said. “We are planning to merge them. By next year, you only need to submit one application. We will have a performance pledge. We will clear the review within 30 days.”
Lower-risk clinical trials refer to studies that do not involve offering treatment or medication to patients, such as those that review data, according to Wong.
He told the Post that efficiency could be improved with a streamlined process requiring just one application for an ethics review, saying he hoped doing so would put the city on par with other developed jurisdictions.
He said that currently it could take as many as six months just to process an ethics review. With the new mechanism in place, the procedure could be compressed to 30 days.
But for higher-risk clinical trials that involved treating patients, the process could still take as many as 60 working days, Wong said.
He also said the new arrangement was expected to take effect in the first quarter of 2024.
In his October policy address, Chief Executive John Lee Ka-chiu said that turning Hong Kong into a health and medical innovation hub would be one of his administration’s major initiatives.
A Cluster Clinical Research Support Office, to be set up by the authority, will provide advice and support for frontline staff taking part in clinical research, as well as expedite ethics reviews of clinical research.
Professor Ivan Hung Fan-ngai, a top infectious diseases expert at the University of Hong Kong, said that the new move could make the city more competitive in conducting clinical trials.
“[The new arrangement] will be more attractive to multi-centre trials,” Hung said.
He said some major pharmaceutical trials shunned Hong Kong over its lengthy ethics review process.
The Our Hong Kong Foundation report said that the number of clinical trials conducted in the city had declined by 22 per cent between 2015 and 2021, compared with an average 48 per cent increase in major economies and 285 per cent growth in mainland China.
Sabrina Chan So-kuen, senior executive director of the Hong Kong Association of the Pharmaceutical Industry, welcomed the latest move and said it was a “big improvement”.
But she also wondered whether the benchmark of 30 days could be applied to all clinical trials, without differentiating lower- or higher-risk ones.
She said that in many countries, including Singapore and Australia, an ethics review for all types of clinical trials took about 30 days, and she hoped that Hong Kong could take the same step.
Highlighting the importance of speed in conducting clinical trials, Chan said that shortening the processing time could raise Hong Kong’s competitiveness in attracting research and the number of companies conducting trials in the city.
“We need to compete with the others in the global environment, and speed is one of the criteria,” she said.