Clinical Research Designing a Clinical Trial - Nursing Assignment Help

Assignment Task:

Task:

The Learning outcomes for this module are as follows:
i. Describe the research & development process for new pharmaceutical and biopharmaceutical products. Identify the critical factors and decision points.
ii. Describe the principal steps in discovering, modifying, assessing, and patenting new chemical and biological compounds (including advanced therapies) according to their therapeutic indication.
iii. Define the process of clinical trial design, including legal, regulatory, ethical and practical aspects and GCP.
iv. Identify the key strategic and operational issues in the clinical trial process, in terms of legislative requirements and Good Clinical Practice (GCP).
v. Identify the key issues involved in the conduct of a clinical study including investigator and site recruitment, investigative site management and conflict resolution.
vi. Outline the role of the Drug Safety Monitoring Board (DSMB) and other relevant study committees including
WHO, CIOMS, WMA, in the oversight of medicines regulation.
vii. Discuss the collection, evaluation and reporting of adverse event data in clinical trials. Assignment Format for this individual assignment Percentage

Instructions:

•  Design a clinical trial for a new pharmaceutical/biopharmaceutical product of your choice. Identify the key strategic and operational issues in the clinical trial process, in terms of legislative requirements, ethics and Good Clinical Practice (GCP).

a) Clearly outline the following:

o Study Rational – reason why the study is required
o Study Objectives - explain what the study is trying to demonstrate/measure
o Study Design - describe the phase and type of clinical trial study e.g. type of phase, name of phase, how many participants involved

b) Set up Study Protocol for your Clinical Trial:

o Design the Informed Consent Form (ICF) for your Clinical Trial
o Select Primary Efficacy Variable for your pharmaceutical product explaining why you think this primary efficacy variable is suitable and why it was selected
o Detail how often and at what stages of the trial you will collect this primary efficacy variable - give rationale for the collection time for this primary efficacy variable

•  Discuss the collection, evaluation and reporting of adverse event data in clinical trials.

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