If your organization intends to develop drugs for the Asian market, you may need to repeat Phase 1 studies in regions outside of North America or Europe—or with your current CRO if they have the right participant populations. This research can help you determine whether the drug’s pharmacokinetics are the same in different ethnic groups. If your organization wants to demonstrate biosimilarity in drug products between Asian and non-Asian populations, consider performing Asian ethnobridging trials. When you decide to incorporate ethnobridging into your project during early clinical development, you can save time and help your budget. Here’s how.
What Is Ethnobridging?
Ethnobridging means using a local target population for a study during Phase 1. Instead of needing to repeat studies in the target region, your organization can recruit participants in “global” safety and efficacy trials using a Phase 1 ethnobridging strategy. The Phase 1 development won’t have to be repeated for Phases 2 and 3, making it possible to use the same Phase 1 clinical trial units without finding other units globally. This can help reduce drug development timelines, often by years.
Why Should You Perform Ethnobridging?
More than half of the world’s population is genetically Asian. Within the many Asian subgroups are known differences in pharmacogenetics and previously identified variants. These are significantly more or less prevalent in Asian populations compared to other populations. In the past, this meant timelines for drugs developed in Asia differed from Western regions. Time lag could last for years. While some of these problems have been addressed in the past few decades, it is still easier to perform ethnobridging locally as opposed to multiple studies worldwide.
Bridging Data with ICH E5 Guidance
Another strategy for addressing this lag was with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) issuing the ICH E5 guidelines. Drug development sponsors must have a complete clinical data package. This includes adequate characterization of PK/PD, safety and efficacy, and a clear definition of dose response. Authorities will also review region-specific medical and diagnostic approaches. Once it passes this step, your organization can consider a bridging strategy for implementation.
ICH E17 Guidance
ICH E17 provides further guidance, giving context for multi-regional clinical trials (MRCTs) that support global drug development. These guidelines include genomic sampling, the use of good clinical practice, and statistical principles for control groups and sample sizes. MRCTs that follow E17 allow for investigation of treatment effects, such as safety evaluations in the overall population. It can also facilitate submitting marketing authorization applications to multiple regulatory authorities in different regions simultaneously. This can provide earlier access to new drugs worldwide.
Accelerating Asian Drug Development Through Ethnobridging
Depending on the region of Asia you’ve decided to target, your drug development may only need to perform Phase 2 studies and beyond in the target regions. Phase 1 studies could be done in the U.S. with an ethnobridging strategy. FIH, SAD/MAD, and ethnobridging trials can be conducted in the U.S. if your drug is developed for all Asian markets simultaneously. Target development regions and ethnobridging strategies can be identified, with further decisions following consultations with regulatory authorities across the regions.
About Altasciences
Altasciences, a mid-sized contract research organization, understands drug development is a complex process. Their fully integrated team helps keep their sponsors’ drug development projects smooth and streamlined, from discovery to preclinical to clinical, and beyond. Altasciences is a fully integrated CRO with pharmaceutical CDMO capabilities, and all their teams share access to a proprietary database. Pharmaceutical and biotechnology companies of all sizes count on Altasciences’ innovative, integrated approach for preclinical studies and clinical trials. Partnering with the Altasciences team means you gain expertise in a wide variety of therapeutic indications and study types, including first-in-human clinical trials and CNS clinical trials. This CRO/CDMO offers sponsors access to many resources, including more than 580 beds, highly trained and experienced staff, and a recruiting database with more than 400,000 potential participants.
Partner with Altasciences for an ethnobridging study at https://www.altasciences.com/
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