Early Phase Studies are an integral part of development and important for providing crucial early insights that can govern the clinical development of new medicines in future. Biopharmaceutical companies that conduct Early Phase Studies quickly and efficiently are able to reach at critical go/no-go decisions at a faster pace.
In order to achieve this, sponsors require a flexible specialised strategic partner with the expertise to successfully implement Early Phase Studies that lead to meaningful results. The partner should have extensive experience in planning and conducting the implementation of Early Phase Studies, in addition to a proven track record for the adoption of efficient studies that will allow the institution to enjoy significant savings in time and cost. MHRA Phase 1 accreditation is preferred as this ensures consistent processes and adherence to GCP standards.
Early Phase Studies cover a wide range of studies in healthy individuals and other special populations, and span simple bioequivalence to include complex first-into-human studies. The Early Phase Studies will be carried out in a hospital integrated setting with immediate access to medical support and excellent on-site emergency services that provide sponsors with a safe and ideal environment to work in. The research needs to be directed on a daily basis by a senior doctor so as to ensure efficient conduct of all studies and high quality of data produced. Upon completion, these studies require the adoption of efficient strategies that allow for significant savings in cost and time. This guarantees the sponsor a competitive advantage through the delivery of the right return on investment.
Early Phase Studies, UK based – Learn more about expert delivery of Early Phase Studies at Richmond Pharmacology
In recent years, the interest in Adaptive Study Design has become evident from the growing quantities of clinical research that employs this model in the mid to later stages of medicinal development. It is today possible for pharmacological companies to conduct complex studies that require the application of the Adaptive model in, but not limited to; FTIH, TQT Studies, Japanese and Bridging Studies.
Any adaptations within an adaptive/ flexible study design will not require a protocol amendment as long as the initial protocol justifies and allows the potential for such adaptations. Some examples of these adaptations include:
- Dose selection – for instance define starting dose and maximum exposure only
- Dose selection for progression from SAD to MAD
- Flexibility with up-titrations or splitting of daily doses
- Optional cohorts
- Flexibility with subject numbers in cohorts
- Flexibility with subject numbers in sub-cohorts – staggering of dosing within cohorts
- Clinical judgment that is applied with stopping criteria – clinically significant drug related toxicities
- Flexibility with number of measurements/ samples and time points.
Adaptive Design is safe, intelligent and ensures the necessary flexibility for quickly responding to new information and progressing efficiently within umbrella study protocols. There is a favourable regulatory climate in the UK that supports adaptive study design in early phase research, including complex FTIH studies. Both the Medicines and Healthcare products Regulatory Agency – MHRA and the National Research Ethics Service – NRES support adaptive study design