Clinical Research Definition Clinical research is research that

Clinical Research

Definition: § Clinical research is research that directly involves a particular person or group of people, or that uses materials from humans, such as their behaviour or samples of their tissue. A clinical trial is one type of clinical research that follows a predefined plan or protocol.

3 – 6 years Regulatory Review LSM 5 Compounds Phase III Number of Volunteers 20 – 100 Drug Development Lifecycle 100 -500 1000 - 5000 6 – 7 years 1 Approved Drug 0. 5 – 2 years Phase IV: Post-Marketing Surveillance 250 Compounds Clinical Trials MAA Submission 5000 – 10000 Compounds Pre-Clinical IMPD Submission Pre-Discovery Drug Discovery

Clinical Trials: Phase I • 20 – 100 healthy volunteers • Approx. 1. 5 years • To determine safety, tolerability, pharmacokinetics (how absorbed/metabolised and eliminated? ), side effects? • Conducted in an inpatient clinical trial clinic and closely monitored • Often 1 - 5% of the dose used in animal testing • Dose ranging, placebo controlled, randomised and double-blinded • Companies; Richmond Pharmacology, Eli Lily, Ono

Clinical Trials: Phase II • • • 2 years 100 – 500 volunteers Test effectiveness in treating targeted disease / medical disorder Determining dose that minimises adverse events Continuing safety Companies; Ono, AZ, Roche, PPD

Clinical Trials: Phase III • 3. 5 years, longest and most costly trial • 1000 – 5000 volunteers, statistically significant data about safety, efficacy and benefit / risk • Multiple sites, randomised, use of placebo • ID adverse drug reactions & determine dose for more diverse population • Plans for full scale production & manufacture • Companies; Takeda, Pfizer, Novo Nordisk, Amgen

Clinical Trials: Phase IV & Manufacturing • Post-Marketing Surveillance Trial, the license has already been granted • Monitoring of: • • Side effects Safety Long term risks and benefits How well it works • Periodic reporting to the authorities • Manufacturing – formulation, scale up and production of the medicine. • • May be requested by sponsor for competition / new market discovery purposes Companies; GSK (Consumer Healthcare), Biogen, Gilead

3 – 6 years Regulatory Review LSM 5 Compounds Phase III Number of Volunteers 20 – 100 -500 1000 - 5000 6 – 7 years 1 Approved Drug 0. 5 – 2 years Phase IV: Post-Marketing Surveillance 250 Compounds Clinical Trials MAA Submission 5000 – 10000 Compounds Pre-Clinical IMPD Submission Pre-Discovery Drug Discovery

Types of Roles § Clinical Trial Administrator (CTA), Clinical Trial Coordinator (CTC), Clinical Admin Associate § Clinical Research Associate (CRA), Clinical Research Scientist § Clinical Study Manager, Global Study Manager, Clinical Project Manager, Clinical Operations Lead, Clinical Country Lead § Associate Clinical Director, Clinical Project Director, Senior Study Management Director § Senior Director, Vice President (VP)

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