Clinical Pharmacology definition // Drug Repurposing

Clinical Pharmacology definition

Diagram including intrinsic and extrinsic ethnic factorsIn today’s economic environment, globalization of pharmaceutical products has turned into the key to success for drug manufacturers. Investors in new drug development are therefore required to do more at less cost and faster rate now. However, sponsors are facing a new challenge due to, as the in the original population could vary with the population in the new region.
Consequently, the regulatory authority in the new region has limited the willingness to rely on foreign clinical data to approve a new compound. To overcome the issue, in recent years, the bridging studies have become essential and critical for pharmaceutical sponsors to develop a potential new drug.

What is a Bridging Study?

According to ICH E5 guideline, a bridging study on a medicine can be defined as an additional study executed in the new region to "build a bridge" with the on safety, efficacy, and dose response. This bridging of clinical studies is usually made by allowing to the population in the new region.

In other words, a bridging study is a supplemental study on a medicine that is performed in the new region to build a bridge between the information available from the tests already done and the questions arising from the regulatory authority due to ethnic factors. Bridging studies done to assess the efficacy of new drugs could provide additional drug response data in the population of the new region. A study may be accepted as a bridging study too, if the regulatory authority in the new region requires no bridging study to provide clinical data for efficacy.

History of Bridging Study

In the early 90s, global development of drugs became an important concern for pharmaceutical sponsors to success in the international market. The ethnic sensitivity of a newly developed drug in different regions was therefore getting much attention from the sponsors as well as regulatory authorities. As the ethnic factors could affect the medicine's efficacy, safety, and dose response, the executed clinical trial data in original region required extrapolation and/or bridging for the new region.

To solve the issue, in 1998, the International Conference on Harmonization (ICH) introduced a guideline (ICH E5) entitled "Ethnic Factors in the Acceptability of Foreign Clinical Data". The ICH E5 guideline proposes a general outline for assessing the impact of ethnic factors upon a medicine’s efficacy, safety, and dose response. A and a bridging study in the new region are included as the mainstays of the harmonized final document.

The objectives of the ICH E5 guideline are to:

  • Evaluate the influence of extrinsic and intrinsic ethnic factors
  • Minimize duplication of clinical data
  • Facilitate acceptance of foreign clinical data
  • Describe the use of bridging studies

Importance of Bridging Studies

A drug or vaccine may work well in the population of the region where the clinical study is done. However, questions can arise about how it will perform in the different region on a dissimilar ethnic population. The regulatory authority in the new region is therefore required reviewing all the foreign clinical data of the medicine to consider the application for registration. To fulfill the regulatory requirements in the new region, sponsors have often duplicated all or much of the foreign clinical data in support of registration. Moreover, sponsors are requested to perform more clinical studies to satisfy the regulatory authority in the new region.

Although ethnic variations among populations may alter a pharmaceutical compound’s safety, efficacy, or dose response, but many drugs have similar characteristics and effects across regions. Regulatory requirements for duplication of clinical evaluation for every new drug or vaccine can delay the accessibility to new therapies; the requirements can unnecessarily waste resources of drug development, as well. Thus, the concept of bridging studies has brought up to solve the issues inherent to extrinsic factors caused by different ethnicity.

A bridging study saves duplication of effort by using the complete clinical data package and performing only the additional tests, which are necessary to assess the efficacy and safety of the compound. The ICH E5 guidance proposes that there is no need to run a clinical evaluation from the beginning for a new region. By conducting a bridging study, the sponsor can use the previous test results with the addition of new tests, which covers the difficulties that could arise because of ethnic differences between the original population and the new group. Bridging studies are also performed when a modification in the manufacturing level - preparation, packaging, storage, or dosage - or other changes done that might affect the safety, efficacy, or dose response of the medication.

Properly executed bridging studies provide crucial early insights for a recent developed drug, which can help govern the future clinical development. By conducting a bridging study, pharmaceutical sponsors are therefore able to reach critical “go/no-go” decisions faster now.

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