Chapter 4

Clinical Phase I-II

Clinical trial programs consist of several phases each of which is focused on evaluating drug safety
and effectiveness of efficacy information on ongoing clinical trialscan be found
www.clinicaltrials.gov.
Trial gov in phase one of clinical trials the drug is usually tested in healthy volunteers to determine
its safety and pharmacokinetics in phase two the drug is given to a group of about 100 to 250
patient with the disease pre evaluate its efficacy and to determine the optimal dose in addition the
safety of the drug and its side effects are evaluated as these may be different in patients compared
to the healthy volunteers tested in phase one Novartis also conduct trials called proof of concept
or POC trials which are often a mix of phase 1 and phase 2 studies a group of well-defined patients
is treated with the drug candidate to provide an early indication whether it actually affect the target
in the intended way or has a beneficial impact on the disease these studies allow Novartis to rapidly
invest resources on drug compounds which are effective and safe this way the appropriate
medicines can reach the patients faster the data from phase 1 and phase 2 studies provide the
scientific confidence necessary to continue the development of the compound in larger clinical
trials.
Chapter 5
Clinical Phase III
In Phase three of clinical trials 1.000 to 3.000 or even more patients are recruited for research with
the investigational drug phase three clinical trials are undertaken to confirm the effectiveness of
the new drug monitor side effect compare it to establish treatments and gather additional
information to allow drug to be used safely.
Chapter 6
Registration & Pharmacovigilance
To be used safely to bring a new medicine on the market every new drug needs to be registered by
the Health Authority data from all clinical trials are collected and compiled into a document called
registration dossier the registration dossier will include efficacy and safety data to support the final
intended use of the drug the dossier is then customized for different regions and countries around
the world to meet the requirements of health authorities this is a crucial step to ensure that patients
all over the globe can access the innovative medicines that have made it through the complex drug
discovery and development process once the registration dossier is approved and and the product
is launched several activites will continue like drug safety monitoring which is mandatory post
authorisation safety updates annual reports and any additional information required by the Health
Authority must be provided at defined intervals as long as the drug remains on the market often
phase four clinical trials are initiated to gather additional data not collected in the phase three
program this may include efficacy safety additional benefit and risk information as well as
phamaco economic data our mission is to provide safe and effective treatments that benefit patients
and improve the quality of their lives .