What Is Ethnobridging and Is it Right for Your Phase 1 Medical Trial?

Posted by WCCT Global on May 17th, 2021

When developing a clinical pathway for regulatory approval of a new drug, early clinical development is one of the most critical parts of the overall program. It can set the tone for subsequent phases, determining the pace of the clinical trial. Ethnobridging can reduce costs and development time. Here is how Ethnobridging works and why it might be a good fit for your phase 1 clinical trial.

What Is Ethnobridging?

Ethnobridging helps demonstrate the equivalence or difference between Asian and non-Asian populations by comparing a drug’s pharmacokinetics after being administered to two or more representative sample groups. The key to Ethnobridging is that clinical trial sponsors can recruit patients in a “global” manner but within a single geographic region and potentially removing the need to repeat the same study in another country. This means the trial’s data regarding the safety and efficacy of the drug are more likely to reduce cost and saving time in the long run, all while supporting global trials. The ability to collect data of this kind in the early phases of clinical development without traveling overseas is invaluable.

Why Should Ethnobridging Be Part of a Clinical Trial?

The two significant benefits to Ethnobridging are the potential for faster clinical development and costs reductions. Preparing and conducting trials overseas in the early phases of clinical research can add years to development, commonly referred to as “drug lag.” Similarly, increasing research costs overseas can cause a clinical trial to outpace its budget quickly. Therefore, performing Ethnobridging in a clinical study can help to avoid these potential obstacles while still obtaining essential data. Instead, an Ethnobridging trial can highlight differences between Asian and non-Asian subjects related to bodily absorption, safety, metabolism, distribution, elimination, and more. Having this data earlier in a clinical trial means sponsors can better plan for Phase 2 or 3 without slowing down these later phases, which can be more costly.

How can Ethnobridging Benefit Clinical Research?

During clinical research, the researcher aims to ensure that the trial drug is safe and effective for the ethnic groups being tested Typically, this is achieved by performing another trial in the country where those populations live, such as China or Japan. In an Ethnobridging trial, the Phase 1 trial can be performed in the United States on an Asian population that corresponds to the trial’s target demographics. Performing a clinical trial in a single location can be faster and more cost-effective than preparing and conducting other trials in China, Korea, or Japan. Conducting clinical research that uses Ethnobridging strategies in conjunction with other Phase 1 clinical trials means getting more data regarding ethnic differences, which can lead to saved cost and time. In short, Ethnobridging expedites the process for the trial to advance to Phase 2 and 3 trials overseas.

How Can a CRO Perform Effective Ethnobridging?

One of the best ways to perform Ethnobridging is by partnering with a contract research organization (CRO) with Ethnobridging experience. The CRO will have a database of participants, segmented by ethnic group, who are likely eligible to participate in a clinical trial. They will also operate the necessary Phase 1 clinical trial units, which makes conducting the trial easier. Partnering with a CRO that has multilingual recruiting, marketing, and clinical operations staff can also significantly increase the efficiency and effectiveness of the trial.

About WCCT Global, an Altasciences company

WCCT Global, an Altasciences company, is a full-service early phase contract research organization (CRO) that caters to the biotechnology, pharmaceutical, and medical device industries. When sponsoring a clinical trial with WCCT, partners are offered a collaborative, innovative, and agile approach to clinical research. WCCT achieves this by utilizing specialized regulatory and clinical professionals. The CRO offers partners the necessary resources for early clinical development, including an 80,000-square-foot clinical pharmacology unit (CPU) with 180 beds, which is ideal for conducting Phase 1 clinical trials. The CPU includes a CLIA-certified and CAP-accredited on-site Safety Reference Laboratory and a USP-797 compliant room for sterile drug preparation. With extensive Phase 1 clinical trial experience, WCCT has expertise in Ethnobridging, First-in-Human, infectious disease and vaccines, ophthalmology, women’s health, and nicotine and tobacco clinical trials. WCCT is also recognized as an industry leader in Asian Ethnic Bridging studies, especially with Japanese participants.

Partner with WCCT to utilize the CRO’s Ethnobridging strategies at https://sponsor.wcct.com/

Original Source: https://bit.ly/33CevRR