Phases of Clinical Trials
Definition
Phase I
Tolerability or PK as primary endpoint in the protocol, independent of the study population and secondary parameters
Study types included
- Safety & Tolerability studies (Single/ multiple dose in patients or healthy volunteers)
- Oncology studies in patients with tolerability / MTD as primary endpoint (efficacy might be a secondary endpoint)
- Drug-Drug interaction & Food Effect
- PK in renal or hepatic impaired patients
Phase IIA
Exploratory (non-pivotal) study that has clinical efficacy, Pharmacodynamicsor biological activity as primary endpoint, conducted in patients or healthy volunteers.
- Proof of concept, efficacy, or mechanism
- Mechanistic studies
- Dose range exploration
- Pilot studies
Phase IIB
Definite dose range finding study in patients with efficacy as primary endpoint.Exceptionally, Phase II studies can be used as pivotal trials, if the drug is intended to treat life-threatening or severely-debilitating illnesses as in oncology indications
- Definite dose finding studies
- Extension studies of Phase IIB studies
Phase IIIA
A Pivotal* study that is a trial designed & executed to get statistically significant evidence of efficacy and safety as required by HAsfor NDA / sNDA approval.It also includes studies with the aim to include claims into the label as well as Postmarketingcommitments.
- Pivotal studies (vsplacebo / comparator)
- Long term saftey studies for registration
- Local registration studies􀂃Post marketing study commitments
- Phase IIIA extension studies
Phase IIIB
A study started prior to approval and whose primary intention is support of publications rather than registration or label changes. The results are not intended to be included in the submission dossier.
- Studies intended to support publication, claims or to prepare launch, which start before approval but are not intended for Regulatory submissions
Phase IV
A study started after approval with primary intention to support publications rather than registration or label changes The results are not intended to be included in a submission dossier.
- Post Marketing Surveillance studies
- Studies intended to support publication claims
Clinical Development Plan(CDP)
- It bridges the gap between vision and the day -to -day activities of large multidisciplinary organizations.
- The vision is transformed into distinct implementation phases and discrete steps, called clinical studies, each with well defined milestones and deliverables.