First-in-human (FIH) trials aim to identify the safety, tolerability, pharmacokinetics (PK) and appropriate dosing regimen of an investigational drug and serve as basis for further (efficacy) trials. Traditionally, these Phase I trials are conducted in healthy volunteers (HV), while being developed for patients.
The recent regulatory environment generally allows or often even requests to include patients in early phase studies. Hence ethical and scientific pros and cons need to be carefully evaluated when deciding on the trial population, depending on what we want to achieve with these clinical pharmacology trials.
Sponsors must approach inclusion of patient’s cohort in so called “hybrid” Phase I clinical trials with some caution and strategical considerations to ensure the correct route of clinical development for their molecule.
The continuous development of noncytotoxic modalities, including molecularly targeted agents with more favorable safety profiles, and considerable early efforts in biomarkers research has led to increasing numbers of clinical pharmacology studies being conducted in HVs.
This webinar will explore the advantages and challenges of standard vs “hybrid” early phase trials.
The first presentation in this webinar will focus on the advantage and inconvenience of conducting specific types of Phase I studies in HVs with a case study as practical example.
During the second session, successful involvement of patient populations in early phase clinical trials in using “hybrid” study design will be discussed. The presenter will focus on the importance of the feasibility of such studies in patients, elaborated by a practical case study.
Finally, the present and future of “hybrid” early phase clinical trials will be discussed. “One size does not fit all” is applicable for early phase trials – especially for hybrid designs. Phase I units need to be flexible and experienced to accommodate innovative approaches. This means being able implement special techniques as well as having access to patient populations. A scientifically oriented CRO and Phase I unit can work as a valuable partner with sponsors to make the best choice for their new early drug development approach.
- Early Phase/FIH trials in HVs: Pros and Cons (+ Case study)
- Hybrid studies and feasibility considerations for patient involvement (+ Case study)
- Flexible handling of “hybrid” or classical Early Phase/CP trials: present and future
- Q&A session
Nariné Baririan – Clinical Pharmacology Expert
Nariné is pharmacist with PhD in Pharmaceutical Sciences with 15 years’ experience in Clinical Research. In her function, she is leading consultancy projects at SGS to support sponsors in development of study design, CTP, CDP, STA and provides clinical pharmacology expertise.
Arash Ghalamkarpour – Associate Medical Director
Dr. Arash Ghalamkarpour is an MD and holds a Ph.D. in Biomedical Sciences. He has held the role of Associate Medical Director at SGS since 2016. His main responsibilities include supporting clinical development programs and strategic feasibility assessments in patient studies.
Katrien Lemmens – Medical Director CPU
Dr. Katrien Lemmens is an MD with a PhD degree and years of clinical pharmacology and early drug development experience via different roles at Janssen Pharmaceuticals, Ablynx/Sanofi and SGS. From 2020, she has acted as Medical Director of the Clinical Pharmacology Unit (CPU) at SGS.
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