Clinical Trial Assessment

Running head: CLINICAL TRIAL ASSESSMENT
CLINICAL TRIAL ASSESSMENT
Name of the Student
Name of the University
Author’s Note:

1CLINICAL TRIAL ASSESSMENT
Part 1
Answer to the question number 1:
Yes, this study will be under the area of clinical trial for investigational medicinal product
and will be subject to the ‘European Directive on Clinical Trials and The Medicines for
Human Use (Clinical Trials) Regulations (UK)’. The reason behind this is that this study
intend to investigate the effect of a new drug on human and therefore it had to be abide by the
directive and guideline provided by the afore mentioned agency (Mrc.ukri.org, 2019).
Answer to the Question number 2:
Before the start of this clinical trial, approvals have to be taken from several organization
bodies. The name and purpose of these organizational bodies are mentioned below:
Approval from Independent Scientific Review: First of all, it should be approved by a
group of scientist or researchers who will not be involved in this investigation to check the
protocol and study design (Mrc.ukri.org, 2019).
Approval from Ethics committee: Approval has to be taken from an individual ethics
committee and they check about the potential side effects of the treatment, patient recruitment
procedure, patient consent and whether this investigation is adhering to safety, rights, well-
being and dignity of the participants (Mrc.ukri.org, 2019).
Approval from Site- Specific assessment: Approval has to be taken from organization (like
hospitals) where this trial will take place to evaluate that the organization has required
equipment, staff and expertise (Mrc.ukri.org, 2019).
Approval from Clinical Trial Authorisation (CTA): every clinical trial comprises of
medical device or medicinal treatment has to be approved by Clinical Trial Authorisation
(CTA) (Mrc.ukri.org, 2019).

2CLINICAL TRIAL ASSESSMENT
Answer to the question number 3:
Five other set- up task that’s need to be completed before the patient recruitment is
mentioned below:
1. Detailed scientific protocol for this investigation has to be in place before the patient
recruitment.
2. Assent documents and consent documents for the participants have to be ready.
3. A timeline for this investigation has to be drafted so that the participants can be aware of
the duration of the trial before giving consent.
4. IRB or Institutional Review Board has to be created so that it can be handle the matter
related to the confidentiality certificate and other necessary documents.
5. This investigation requires human use and therefore, a SMP or Safety Monitoring Plan has
to be created.
Answer to the question number 4:
Two weakness of this study design are mentioned below:
1. During the recruitment of the participants, no exclusion criteria were considered and
selected by the authors. Exclusion criteria like age, co-morbid disease might have made the
patients participating in this study more relevant.
2. The follow up period for this investigation is only 6 months and this is relatively low with
regard to clinical trial on human. Drug X will be used as a treatment for this investigation. A
drug can have side effects which might be expressed after six months. Therefore, 6 months
follow up period is too low for clinical trial with human and can be considered as a weakness
to this study design.

3CLINICAL TRIAL ASSESSMENT
Answer to the question number 5:
Two strengths of this study design are mentioned below:
1. The randomization of this investigation will be computer generated. This is a significant
strength of this study as computer generated randomization will reduce the chances of
biasness during the group allocation.
2. One more strength of this study is that it will recruit patient with both MVR and MVR and
CABG. Therefore, from this investigation, it can also be interpreted that whether the drug X
has an effect on the CABG or not.
Answer to the question number 6:
The following improvements could be implemented in the study design to make it better:
1. Exclusion criteria like age, previous cardiac history, and co- morbid disease could be set up
in order to make the participants more relevant to this study design.
2. Follow up period for this investigation could be around 12 months from the completion of
surgery.
3. Number of sample size could be increased. The higher the sample size, the better it is.
Answer to the question number 7:
a) After the surgery, the patient will in the sole discretion of the PI or his/ her colleagues.
Therefore, any complication which might appear will be treated by the PI or his/ her
colleague’s sole discretion. In case of any scenario mentioned above, the PI or his/ her
colleague might treat the patient with might have reactionary effect with drug X or it might
interfere in the results. As a result, the final interpretation of the intervention method might
be erroneous.