Clinical Trial in a Pharmacy

Running head: PHARMACY 1
Student name
Student No.
Unit
Title: Clinical Trial in a Pharmacy

PHARMACY 2
Topic one
In her speech, Daniela Caiazza talked about the Clinical Research organization (CRO),
the CRO services, drug development, late phase clinical trials and the Novotech and RMIT intern
program. She described CRO as a company that has developed since the 1970s and they help
medical device, biotechnology and pharmaceutical industries in research services. Among the
facts that caught my attention in her presentation were the facts on drug development. The cost
for developing a drug until it reaches the market according to her was between $ 500 million and
$ 2 billion!! She also gave the developmental stages is drug discovery until it is approved. What
surprised me in Poonam Dharane speech was how much they have achieved since 2011. They
have discovered 11 new medicines, have secured more than 8 000 colleagues worldwide and also
have had a huge investment in 2015. Also the speech on how large drug manufacturing
companies minimized companies and specialize in cancer immunology caught my attention.
Daniela Caiazza explained about the life cycle of a clinical trial. It was an interesting
topic but I would have wished she explained in more details. She could have explained more on
how various types of data are obtained, how the data is processed so as to address different
research questions and also how reports and publications are generated and to what audience
these reports given (Zarin, 2013). I would also have wished Poonam Dharane to explain more on
the diseases they are focusing on to attain transformation. I would ask her how this
transformation would be achieved. In the conclusion it was mentioned that they were currently
monitoring 10 different trials. I would like to know how much this could take, how exhausting it
could be and how much one should give out so as to attain the companies set goals as far as the
trials are concerned.

PHARMACY 3
Topic two
Early phase clinical trials include a series of steps that help to explain a new drug or a
certain treatment works in a patient (Luu et al. 2012). After being successful in one phase then
the drug goes to the next phase for further testing. In the early phase clinical trials, two
regulatory pathways are involved according to Dr. Johnson’s lecture, the clinical trial notification
(CTN), where the ethics committee and TGA are notified. No approval as the product research is
not evaluated; and the clinical trial exemption (CTX), where the TGA analyses the information
on CMC and quality and safety while the ethics committee approves the study. Early phase
clinical trial involves different phases, phase 0 trials to phase 4 trials (Cook, Hansen, Siu and
Razak, 2015). First the product is administered to volunteers. This stage involves a small number
of people (between 20 and 80 volunteers). This study is designed to find out whether the drug
functions as expected. Then the first time in human (FTIH), SAD and MAD studies are
conducted. The Single Ascending Dose (SAD) study involves administering a low starting dose
to a small number of the volunteers. This study is done to understand the pharmacodynamics,
tolerability and safety characteristics and also come up with maximum tolerated dose (Deng,
2017).
In multiple ascending dose (MAD) study, multiple administrations of the dose is given
to the participants. The dose could be administered once in a day or in multiple times depending
on the compound. The MAD study is based on the MAD study results (Shen et al. 2019). Other
trials conducted after the FTIH are the drug interaction, where the participants are studied on
how they are affected by the product, bioequivalent, fed vs fasted and special population. The
Nucleus Network have additional types of the number of trials conducted during the early phase
clinical trials. These include proof of concept, pharmacokinetic, TQTc, radio-labelled, food