Risk Management, Clinical Trials, Ethics and Quality in GSK3

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Discuss GSKs decision to market Strimvelis including: 5 Why GSK decided to market the product knowing that the market size is small.5 Information about GSK Pricing policy and the ethics surrounding this decision.5 Researching the average cost of clinical trialsforpharmaceutical companies and estimating the Return on Investment for GSK (if any) based on market size and pricing policy.6 3. Describe the clinical trials usually required for the introduction of a new product and compare this to the clinical trials actually conducted

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Risk Management, Clinical
Trials, Ethics and Quality

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Table of Contents
INTRODUCTION...........................................................................................................................3
MAIN BODY...................................................................................................................................3
1. Describe the clinical trials usually required for the introduction of a new product and
compare this to the clinical trials actually conducted by GSK...............................................3
2. Discuss GSKs decision to market Strimvelis including:...................................................5
Why GSK decided to market the product knowing that the market size is small..................5
Information about GSK Pricing policy and the ethics surrounding this decision..................5
Researching the average cost of clinical trials for pharmaceutical companies and estimating
the Return on Investment for GSK (if any) based on market size and pricing policy...........6
3. Identification of risks and risk mitigation..........................................................................6
4. Elements of Quality management system (QMS) and importance....................................7
CONCLUSION................................................................................................................................8
REFERENCES..............................................................................................................................10
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INTRODUCTION
Clinical trial refers to investigations in which people volunteer to study new methods of
treatments, interventions or tests in order to prevent, treat, detect or manage different health
problems. It includes various research programmes that are carried out regarding benefits of
various drugs, drug combinations and fresh methods of surgery (Soelberg Sorensen, 2017).
However, these investigations are helpful to apply more effective as well as efficient treatment
techniques in regards to increase patient outcomes. This assignment is based on
GlaxoSmithKline plc (GSK) which is known as a British multinational pharmaceutical company
to provide effective products for welfare of people. The present report will focus on comparison
between usually required clinical trials to actually conducted trials by GSK. It will also includes
decision to market in Strimvelis including pricing policy of and ethics. The identification of risks
and quality management system is given below.
MAIN BODY
1. Describe the clinical trials usually required for the introduction of a new product and compare
this to the clinical trials actually conducted by GSK
Clinical trails can be described as number of research investigations in terms of analysing
benefits of specific drug to treat or prevent particular health problem properly. It is necessary to
conduct proper trials in order to thorough study about benefits and side effects of a drug or drug
combination. Usually, clinical trails are required to be done on humans due to which they are
known as human clinical trials. However, these investigations are helpful to understand the
effectiveness of particular product to make sure about its suitability to make people well-being.
In addition to this, it is mandatory to ensure appropriate use of selected drug to avoid the extreme
complications in medical condition of a person (McMillan and et. al., 2017). Moreover, ensuring
through clinical trails is significant to get approval from authorised agencies for launching new
medication product in market with extra and effective benefits for gaining wellness of an
individual.
Comparison
Generally required clinical trials: This includes the criterion of conducting clinical
trials on human by putting appropriate amount of time and cost to gain accurate findings. It
includes to design clinical trails according to specific vaccine and related health problem.
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Meanwhile, it is essential to carry out study of clinical research phase and focus on the
investigation-al new drug process (IND). However, it is necessary to ask for assistance to
authorised regulatory body of drug research and approval and then they prepare IND review
team. Moreover, it is very important to take approval in respect of conducting study about
particular vaccine from regulatory body of country. Additionally, review team includes includes
several members such as project manager, medical officer, statistician, pharmacologist,
pharmakineticist, chemist and microbiologist.
Phase I: Initially, it is required to conduct experiment of particular vaccine, drug or
device in a small group (approx 20 to 80 individuals) regards to evaluate safety. It helps to
analyse the possible side effects and identify the way of utilising or delivered drug (Bryan and et.
al., 2017).
Phase II: However, the second trial includes the use of more participants (100 to 300
participants) as compared to phase I that is required to be prepared for assessing security as well
as efficacy of specific drug or treatment. This clinical trial consume certain years to complete the
desired analysis. However, it has a goal to gather preliminary data on whether drug works on
citizens who has specific health issue. It also continue the analysis about short term side effects
and safety of individuals.
Phase III: This stage of trial also consist large investigation in which comparison can be
establish between experiment vaccines or drug to a standards medication. It will facilitate the
evaluation of safety and efficacy of experimental medicines along with determining those side
effects which were not identified in phase II. However, the regulatory bodies or regulatory health
authorities will approve findings of clinical trials up to and analyse whether to sanction fresh
vaccine or drug.
Phase IV: This can be considered as final phase in which clinical trial will carry out after
gaining approval from authorised regulatory body in regards to utilisation of specific drug
(Perreault, Færch and Gregg, 2017). It includes the effectiveness of vaccine along with
monitoring safety at large level in context of diverse populations.
Actually conducted trials by GSK: The given organisation follow certain desired
aspects which are required to conduct clinical trials regarding Strimvelis to analyse its effects
along with relevant safety aspects. It has been analysed that they conduct the trials on animals
rather than humans to understand about the benefits of this medication. However, they have

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selected animals as participants in order to conduct trails at small and large levels which helps to
analyse various benefits of selected medication for solving inborn illness related to immunity.
Moreover, it has been evaluate that the conduct the investigation on animals to examine short
terms side effects and other relevant impact on them. Additionally, through these clinical trials,
GSK become successful to analyse benefits of Strimvelis to treat inborn illness which helps them
to take approval from European regulatory bodies for launching this product in market.
2. Discuss GSKs decision to market Strimvelis including:
Why GSK decided to market the product knowing that the market size is small.
The GSK has been decided to market the product knowing that the market size is small
because inborn illness of very critical health problem that requires an appropriate medication. It
has been analysed that the problem of inborn immunity illness is problematic which has limited
treatment due to which given organisation has small market size but they are much capable to
grab then all (Timmermans, Venet and Burzykowski, 2016). However, it is observed that inborn
errors of immunity is responsible for creating a severe condition in country as children with this
health problem did bot survive more than two years. In other words, GSK have decided to
market product as they can grab entire population of patient suffering from inborn illness of
immunity. Meanwhile, it can be said that Strimvelis is known to be better treatment option in
terms of making kids free from the selected diseases which has been proved by clinical trials to
gain survival of children for more than three years.
Information about GSK Pricing policy and the ethics surrounding this decision.
In context of GSK, they have specific pricing policy in regards to new product of
Strimvelis which was set at £ 594 K for 2 times the annual cost of enzyme replacement therapy.
It is known as an expensive treatment methods that cannot afford easily by every citizen.
However, this therapy is costly but at the same time much effective in order to treat the problem
of rare inborn illness of immunity (Daly and et. al., 2016). Meanwhile, it is observed that due to
this disease, a child get easily infected because of their weak immune strength for fighting with
different health problems. In addition to this, GSK has followed several ethics principles while
set price of given treatment that includes fairness, consider laws, convenience, availability and
justice.
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Researching the average cost of clinical trials for pharmaceutical companies and estimating the
Return on Investment for GSK (if any) based on market size and pricing policy.
The average cost per patient is £19505.57 in terms of conducting clinical trial or
pharmaceutical companies for analysing effects of specific drug accordingly. It is necessary to
make an appropriate budget for carrying out more effective as well as efficient investigations in
regards to particular vaccine to understand its benefits for treating health problems (Rinella and
Sanyal, 2016). Meanwhile, given organisation get appropriate rate of return because price of
Strimvelis (gene therapy) is much expensive which provide sufficient profit for company.
3. Identification of risks and risk mitigation
The identification of risk factors is very important in order to remain prepared for solving
relevant problem create in future. It includes the criterion of determining such elements that may
responsible for developing issues at the time of launching new product of GSK in market.
However, it is favourable to establish effective strategies to avoid these problems along with
introducing fresh product in market successfully. Meanwhile, risk mitigation technique can be
adopted by GSK in order to reduce the threats occur by developed issue which is suitable to
make launch of Strimvelis. It is necessary to make a list of risk factors with the help of
conducting risk assessment which facilitate to pre-prepare techniques for solving forthcoming
problems at the time of product launch. Risk mitigation is suitable to reduce negative impacts of
issues which facilitate to achieve success of product launching in market that is beneficial for
GSK.
In addition to this, Failure Modes & Effects Analysis (FMEA) that is known as a kind of
risk assessment tool which helps to determine influence of potential failures in a particular
procedure (Zhang and et al., 2017). It is helpful to analyse using several criterion such as
occurrence, severity and detection. However, two of them are given here.
Occurrence – This can be described as the process of identifying specific problem along
with evaluation the relevant causes due to which it occurs. It is necessary to understand the cause
of specific risk which is essential to be examined in order to prevent he same for avoiding threats
in launching of Strimvelis in market. However, it is significant to identify causes and put efforts
to prevent them which is beneficial to stop the occurrence of problem in launching event of given
medicinal product in market by GSK. In addition to this, it has been analysed that prevention is
better than curation due to which avoiding causing factors of risky activities is more beneficial as
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compared to work in specific issue after occurrence of the same. Meanwhile, it is very important
for GSK to conduct risk assessment process in regards to determine critical factors earlier and
remain prepare to avoid problems and reduce their negative effects on launch of Strimvelis in
market.
Severity – The complications refers to extreme critical situation in respect of any events
of market. It includes the criterion of analysing the impact of any kind of failure that occurs
which is required to be controlled through taking appropriate actions (Kelley, Cromwell and
Jerkins, 2016). Basically, it has been analysed that negative impact should be understand
thoroughly according to which correct risk mitigation techniques can be applied in order to
reduce the threats which facilitate to introduce Strimvelis in market in successful manner.
Meanwhile, it is necessary for an organisation to evaluate various effects of failure in different
sections of launching event of given product. In other words threats created by failure can be
solved and reduced when they can be identified in proper way. However, risk mitigation includes
to put efforts to modify the few of activities of launching event in order to avoid effects of
failures among audience which provide support to attain success of product launch respectively.
4. Elements of Quality management system (QMS) and importance
Strimveli is medicine which is use to treat immune related rare deficiencies caused by
enzyme adenosine deaminase introduced by GSK. In order to control and monitor this product in
market Quality Management System has applied so that corrective actions can be taken. The
elements of this quality control are as follows:
Change Control: It is one of element of quality management systems which ensures that
changes in product are introduced in such manner that it controlled and coordinate. It is
important for making only relevant and important changes and reduce chances of unnecessary
modifications (Knepper and et. al., 2016). The change control process within quality
management is process of reduction in activities, cost effective techniques to distribute resources
in implementing change. In context of present case of Strimveli it is important so that there is no
unnecessary changes in composition of medicines after it is introduced in market and its quality
is maintained.
Complaints and Recalls: This in quality management system is post introduced
techniques in which due to complaints of ineffectiveness of medicines they are recalled by
manufacturer. It is important so that there is no side-effects and deaths due to usage of medicines

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and company has negative impact on its brand name. This ensures that in genuine complaints by
consumers it is recalled so that the deviations can be checked and corrective actions can be taken
so that efficiency of Strimveli can be enhanced. It is needed that there should be proper evidence
that supports complaint so that recall process becomes shorter.
Deviation Management: It is part of quality management system which ensures that
efficiency is there in controlling variances, implementing corrective actions so that there is
reduction in frequency and occurrence (Jobes and et. al., 2016). This is proactive approach in
maintaining quality so that there is continues improvement in qualitative aspects. In case of
Strimveli it is important that this remains proactive in taking corrective actions on time and
avoiding happening of such accidents in future. This helps total quality process by continuously
improving quality from initiation to investigation phase.
Post Market Monitoring: This is quality management system practice which monitors
safety of drug or medical devices after it has been introduced in market. This concerns with drug
reactions, effectiveness, monitoring its quality and other promotional materials. It is important to
regulates its safety for consumers and identifies agencies which are connected with distribution
of that drug (Wartofsky and Van Nostrand, 2016). In context of Strimveli it is concern in two
ways, one is to check and monitor the effectiveness of drug and other is to apply different
promotional tool to promote it further.
All these elements are approach of post introduction actions for Strimveli so that there are
less complaints and recall, changes are controlled and corrective actions can be taken. These
elements are necessary to make quality management system more effective and proactive so that
GSK can monitor quality related aspects of Strimveli.
CONCLUSION
From the above report, it has been concluded that clinical trial can be described as to
study new procedures of providing treatment for preventing disease for wellness of people. It
includes comparison of trials which usually take place on humans whereas given organisation
use animals for conducting the study related to selected medicinal product. Meanwhile, the
success of clinical trials regarding launch of new medication for solving problem of inborn
illness related to immunity helps to gain approval from authorised bodies. Moreover, it includes
risk identification including their occurrence and severity to prevent their negative effects on
success of product launch. Additionally, it involves quality management system that should be
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considered by given company including relevant elements such as deviation management,
change control, post marketing monitoring and complaints & recalls.
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REFERENCES
Books and journals
Soelberg Sorensen, P., 2017. Safety concerns and risk management of multiple sclerosis
therapies. Acta Neurologica Scandinavica, 136(3), pp.168-186.
McMillan, M.T. and et. al., 2017. Multicenter, prospective trial of selective drain management
for pancreatoduodenectomy using risk stratification. Annals of surgery, 265(6),
pp.1209-1218.
Bryan, C.J. and et. al., 2017. Effect of crisis response planning vs. Contracts for safety on suicide
risk in US Army Soldiers: A randomized clinical trial. Journal of affective
disorders, 212, pp.64-72.
Perreault, L., Færch, K. and Gregg, E.W., 2017. Can cardiovascular epidemiology and clinical
trials close the risk management gap between diabetes and prediabetes?. Current
diabetes reports, 17(9), p.77.
Timmermans, C., Venet, D. and Burzykowski, T., 2016. Data-driven risk identification in phase
III clinical trials using central statistical monitoring. International journal of clinical
oncology, 21(1), pp.38-45.
Daly, M.B. and et. al., 2016. Genetic/familial high-risk assessment: breast and ovarian, version
2.2015. Journal of the National Comprehensive Cancer Network, 14(2), pp.153-162.
Rinella, M.E. and Sanyal, A.J., 2016. Management of NAFLD: a stage-based approach. Nature
reviews Gastroenterology & hepatology, 13(4), p.196.
Zhang, Y.Y. and et. al., 2017. Efficacy of omega-3 polyunsaturated fatty acids supplementation
in managing overweight and obesity: a meta-analysis of randomized clinical trials. The
journal of nutrition, health & aging, 21(2), pp.187-192.
Kelley, B., Cromwell, M. and Jerkins, J., 2016. Integration of QbD risk assessment tools and
overall risk management. Biologicals, 44(5), pp.341-351.
Knepper, D. and et. al., 2016. Detecting data quality issues in clinical trials: current practices and
recommendations. Therapeutic innovation & regulatory science, 50(1), pp.15-21.
Jobes, D.A. and et. al., 2016. Lessons learned from clinical trials of the Collaborative
Assessment and Management of Suicidality (CAMS). International handbook of suicide
prevention: Research, policy, & practice, pp.431-449.
Wartofsky, L. and Van Nostrand, D. eds., 2016. Thyroid cancer: a comprehensive guide to
clinical management. Springer.
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