Clinical Development

Clinical development and clinical trials can be separated into 4 stages: Phase I clinical trials, Phase II clinical trials, Phase III clinical trials, and Phase IV clinical trials.  Many pharmaceutical and biopharmaceutical companies will outsource the clinical development and clinical trials to a clinical research organization (CRO), often referred to as a contract research organization.  While some CROs can handle all of the phases of clinical trials, many will specialize in specific phases.

The Phase I clinical trial is the first experiment in which a drug is tested on the human body, primarily to assess the safety of the new drug.  The number of subjects is normally between 10 and 100 people.   Clinical development services commonly outsourced to CROs during Phase I include chemistry, manufacturing, and controls support (CMC), general toxicology studies, design, analysis and reporting tools (DART), as well as API and clinical trial materials manufacturing.  The clinical trial studies include bioanalytical testing, PK/PD modeling, population PK, data analysis, regulatory affairs strategy and submission, protocol design, medical writing, quality control/assurance, pharmacodynamics models as well as study design and a variety of patient studies.

The aim of the Phase II clinical trial is to examine the safety and efficacy of the drug in the targeted disease group utilizing dosages of varying strengths.    Phase II clinical trials may be divided into Phase IIa and Phase IIb with IIb being an extension to the safety and efficacy studies from IIa.  The number of patients in the Phase II trial is typically 50 – 500.  Phase II clinical development is highlighted by abuse liability studies, formulation services such as characterization, chemical reactivity, excipient reactivity, commercial formulation development, product release testing, and preliminary process identification.  Clinical Trial Materials (CTM) manufacturing is also done, often outsourced to contract manufacturing  organizations (CMO).  Clinical trial studies in Phase III include clinical operations management, medical and safety services, data management, biostatistics, electronic patient reported outcomes (ePRO), patient enrollment & randomization, patient management, study start-up, site recruitment & site monitoring, data collection, and global site management.

Phase III clinical trials are typically an extension of the Phase II clinical trial to confirm the efficacy of the drug in a large patient group.  Phase III trials are normally conducted in several hospitals in different demographic locations.  Patient numbers for Phase III clinical trials can vary from hundreds to tens of thousands of patients.  The development and trial services in Phase III offered by CROs and CMOs are similar to those in Phase II but at a much larger scale.

Phase IV clinical trials are postmarketing approval trials to monitor the efficacy and side effects of the drug in an uncontrolled, real-life situation.