Clinical Trial in a Pharmacy

This document discusses clinical trials in a pharmacy, including drug development and early phase clinical trials. It also explores the ethical considerations in clinical research.

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.

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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

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interaction, absolute bioavailability, Japanese vs Caucasian metabolism and Chinese vs
Caucasian metabolism. The importance of early phase clinical trials include attaining safety and
tolerability, obtaining profile for ADME (absorption, distribution, metabolism and excretion). It
is also important in imaging techniques as well as pharmacodynamics assessments (Tabrizi,
Bornstein and Suria, 2010).
Topic three
Social and scientific value, scientific validity, fair selection, favourable risk benefit
ratio, independent review, informed consent, and respect for potential and enrolled participants
make clinical research ethical. Social and scientific value help in evaluating intervention and
treatment which is important in increasing knowledge, improving health and well-being.
Scientific validity involves use of scientific methods and principles to produce valid and reliable
data. Fair selection of subjects is important as it helps prevent vulnerable and stigmatized people
from being the target in risky research and also ensure that the socially powerful are not favoured
in the research (Bender, Schindler & Friberg, 2015). Favourable risk benefit ratio is important in
minimizing risks and enhancing the potential benefits. It also promotes non-maleficence, non-
exploitation and beneficence. People are able to understand social values and also gain some
scientific knowledge. Independent review involves reviewing the research trial design, the
proposed subject population and risk benefit ratio of those unaffiliated with the study. This
enhances public accountability and reduces cases of conflict of interest. Independent review
disseminates ethical, scientific, financial and intellectual knowledge. Informed consent is
providing the participants with information about the research, risks, benefits and its purpose so
that they could understand and decide voluntarily if they should enroll for the research. Respect
for potential and enrolled subjects involves allowing them drop from the research, protecting

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their privacy, informing them of any new potential benefits and risks, keeping them informed on
the results of the research and maintaining their welfare. Taking an example from Dr Nguyen's
lecture, a certain researcher fabricated scientific results published in journals. This was wrong an
in breach of clinical research ethics.

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References
Bender, B. C., Schindler, E., & Friberg, L. E. (2015). Population pharmacokinetic–
pharmacodynamic modelling in oncology: a tool for predicting clinical response. British
journal of clinical pharmacology, 79(1), 56-71.
Cook, N., Hansen, A. R., Siu, L. L., & Abdul Razak, A. R. (2015). Early phase clinical trials to
identify optimal dosing and safety. Molecular oncology, 9(5), 997–1007.
doi:10.1016/j.molonc.2014.07.025
Deng, D. (2017). On biostatistics and clinical trials. Retrieved from:
http://onbiostatistics.blogspot.com/2017/11/sad-and-mad-single-ascending-dose-
and.html
Luu, K. T., Bergqvist, S., Chen, E., Hu-Lowe, D., & Kraynov, E. (2012). A model-based
approach to predicting the human pharmacokinetics of a monoclonal antibody
exhibiting target-mediated drug disposition. Journal of Pharmacology and
Experimental Therapeutics, 341(3), 702-708.
Shen, J., Swift, B., Mamelok, R., Pine, S., Sinclair, J., & Attar, M. (2019). Design and Conduct
Considerations for First-in-Human Trials. Clinical and translational science, 12(1), 6–
19. doi:10.1111/cts.12582
Tabrizi, M., Bornstein, G. G., & Suria, H. (2010). Biodistribution mechanisms of therapeutic
monoclonal antibodies in health and disease. The AAPS journal, 12(1), 33-43.
Zarin, D. A. (2013). Participant-level data and the new frontier in trial transparency. New
England Journal of Medicine, 369(5):468–469.

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