Early Phase Bridging Studies – What To Look For In A Clinical Research Organisation
Early Phase Bridging Studies are exploratory, first-in-man studies that are critical for developing a potential new drug. Early Phase Bridging Studies are conducted most often but not always in healthy volunteers from different populations to
Early Phase Bridging Studies are exploratory, first-in-man studies that are critical for developing a potential new drug. Early Phase Bridging Studies are conducted most often but not always in healthy volunteers from different populations to with the objective of establishing a proof of safety of the new molecule within either population (for example Japanese and Caucasian volunteer panels), as well as its pharmacokinetics in healthy volunteers and often other specialist study populations, before it proceeds to clinical trials with patients. Such studies are the essential step before a go or no-go decision is taken for further development.
Early Phase Bridging Studies are an integral phase of development and are vital to providing crucial early insights that can govern the clinical development of new medicines for different populations in future. When a CRO conducts Bridging Studies in a quick and efficient manner, biopharmaceutical companies are able to reach critical “go/no-go” decisions much faster. In order to achieve this, sponsors require a specialized strategic partner with the expertise and flexibility to successfully implement of Early Phase Bridging Studies that produce meaningful results.
During the Studies, both research and the well being of the volunteer should be high on the agenda of the CRO. In addition, the research with the different populations or ethnicities should be carried out in accordance with strict ethical and scientific principles governed by each countries Health and Medical Regulatory Authorities.When selecting a CRO for your Early Phase Studies or Bridging Studies, go for one that has successfully conducted numerous successful Studies over many years, and has a proven track record in adopting efficient strategies that allow for significant savings in time and costs.
The CRO should have years of experience in the planning and conduct of study types that cover a wide range of Studies in both healthy individuals and special populations, for example, Japanese volunteers, spanning simple bioequivalence to complex first-into-human studies. Find out if the CRO has obtained MHRA Phase 1 accreditation as this is a guarantee that their processes have been consistent and adhered to GCP standards.
A good CRO should have a hospital integrated setting that offers immediate access to medical support as well as excellent on-site emergency services that provide sponsors with a safe and ideal environment for Early Phase Studies. You want to partner with a company that has established uniformity within senior management over many years, and whose senior doctors are in charge of directing all research on a day to day basis. To verify whether the CRO has had the efficient conduct of all its past studies, simply check the quality of their regular publications in peer reviewed journals. The company should also demonstrate high-quality data that facilitates subsequent regulatory filing as a mark of its good reputation.
Today’s economic environment has forced the pharmaceutical industry to do more at less cost and a faster rate, in bringing new compounds efficiently and early enough into the market. These studies are ultimately designed to determine the effectiveness of new ways for the detection, prevention and treatment of diseases. In fact, the purpose of every Early Phase Study is to answer a specific question.
The main aim of Early Phase Studies, therefore, remains to bring innovative drugs that have been discovered in the laboratory to patients, thereby broadening their treatment options.Writing on behalf of Richmond Pharmacology Ltd, Matt Donald is passionate about the research conducted that helps in the development cycle of new chemical entities, which in turn produce the data that allows bio-tech and pharmaceutical companies to develop new medicines for mankind. Click to learn more about Japanese Bridging Studies.