The regulatory landscape in South Korea and China
My last two columns have focused on regional guidelines for clinical trial recruitment, to provide context for engaging in advanced targeting and acquisition methods—such as online advertising, search engine marketing and social media—to engage prospective participants.
This column, the last in this series, looks at two key countries in Asia Pacific: South Korea and China. Each country accounts for 3% to 4% of the total number of clinical trials currently underway outside the U.S., and each has a different level of tolerance for advanced methods of targeting and acquiring patients.
In a global survey of investigators I conducted in January, 90% of Chinese investigators said recruitment is challenging in their country and 80% cited communication with subjects and retention during a trial as challenging. All of them expressed interest in using digital media for identifying prospective patients and acquiring patients into trials. Fortunately, Chinese law does not prohibit online recruitment of patients for clinical trials. Indeed, some web sites in China already publish ads for clinical trials. China represents an excellent opportunity to leverage social and digital tactics to help investigators recruit and retain patients.
The Guidelines on Ethical Review of Clinical Trials (2010) state the recruitment materials of a clinical trial, including the recruitment strategy and methods, should be submitted to the Ethics Committees (ECs) for approval. The law, however, does not provide any detail on requirements for a trial’s recruitment materials. Therefore, ultimately the EC has discretion as to whether a particular medium, such as search engine marketing, online display ads or social media promotion should be used to recruit patients for a trial. The EC makes its decision based on the specific circumstances of a particular trial and may impose restrictions after review of the recruitment materials.
The guidelines apply equally to trials that do not use online recruitment methods, but there are no guidelines from the EC on how online recruitment is approved. Nevertheless, online recruitment is used for clinical trials in China by legitimate companies and hospitals. This indicates online recruitment methods do not prevent clinical trials from receiving EC approval.
In South Korea, guidance is provided in three categories: pre-approval trials (phases I, II and III), post-approval (phase IV) and medical device trials. Across all three categories, medical institutions are responsible for recruitment and, accordingly, are allowed to advertise for trial subjects in the media of their choice, including their own web sites. Promotions customarily share only a contact telephone number, without disclosing the name of the medical institution. Although principal investigators (PIs) are permitted to advertise on their own, in practice it is uncommon for promotions to come from an individual rather than an institution.
Three agencies operate under the Pharmaceutical Affairs Act (PAA) to provide governance: the Korea Good Clinical Practice for Pharmaceutical Products (KGCP), the Ministry of Food and Drug Safety (MFDS, formerly Korea Food Drug Administration) and the institutional review board of each medical institution participating in the clinical trial (IRB). Neither the PAA nor the KGCP explicitly states whether the sponsor of a phase I, II or III trial (either pharmaceutical company or CRO) is allowed to recruit trial subjects by itself. However, prevailing interpretation among Korean counsel is that the sponsor is prohibited from directly recruiting patients or advertising trials. The KGCP requires a PI to obtain a prior approval from the IRB regarding trial subject recruitment procedure, including advertisement of the trial. The PI must provide prospective trial subjects with information about the trial, from which the sponsor’s name is blinded.
For phase IV trials, the PAA does not explicitly state whether sponsors are allowed to recruit subjects themselves. However, the KGCP does not apply to phase IV trials, and there is no publicly available case evidence, opinion or court decision to indicate sponsors are restricted from doing so. But because the PAA prohibits direct-to-consumer advertisement, in practice sponsors are advised not to be directly involved in phase IV recruitment.
Clinical trials for pre-approved and post-approved registered medical devices must be performed pursuant to the Medical Devices Act and the Korea Good Clinical Practice for Medical Devices. The same reasoning and conclusion for phases I, II and III clinical trials may apply to trials for pre-approved/registered medical devices, unofficially confirmed by an official at the MFDS in charge of issues relating to clinical trials of medical devices.
Matthew Howes is head of strategic services at inVentiv Digital + Innovation, the digital center of excellence for inVentiv Health. A leader in digital strategy, Matthew has provided the fuel for digital businesses visited by over 100 million people every month and generate billions of dollars in revenue every year.
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