Lecturers: Module: Clinical Research
1918970-38671500
Lecturers: Module: Clinical Research
Assignment Title: Designing a Clinical Trial
The Learning outcomes for this module are as follows:
Describe the research & development process for new pharmaceutical and biopharmaceutical products. Identify the critical factors and decision points.
Describe the principal steps in discovering, modifying, assessing, and patenting new chemical and biological compounds (including advanced therapies) according to their therapeutic indication.
Define the process of clinical trial design, including legal, regulatory, ethical and practical aspects and GCP.
Identify the key strategic and operational issues in the clinical trial process, in terms of legislative requirements and Good Clinical Practice (GCP).
Identify the key issues involved in the conduct of a clinical study including investigator and site recruitment, investigative site management and conflict resolution.
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.
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).
Clearly outline the following:
Study Rational reason why the study is required
Study Objectives - explain what the study is trying to demonstrate/measure
Study Design - describe the phase and type of clinical trial study e.g. type of phase, name of phase, how many participants involved
Set up Study Protocol for your Clinical Trial:
Design the Informed Consent Form (ICF) for your Clinical Trial
Select Primary Efficacy Variable for your pharmaceutical product explaining why you think this primary efficacy variable is suitable and why it was selected
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.
References provide references for your source data. References should be given in the body of the assignment and listed fully at the end using Harvard referencing style.
30%
30%
30%
10%
Page count:
Overall Assignment is
8 to 10 Pages Max. Total out of 100% for module 40% of marks for Individual Assignment
60% of marks for Written Exam
Submission details: Submit softcopy of assignment through Turnitin on Moodle by 23:55 Friday 12th August 2022
A similarity value of more than 30% will be investigated further and marks may be deducted.
Late submissions will be subject to penalties.
Please use reputable, relevant sources for your information such as government websites and academic databases e.g. www.clinicaltrials.gov, https://www.clinicaltrialsregister.eu, https://www.ich.org/page/efficacy-guidelinesPlagiarism of any kind will not be tolerated. At best, any plagiarised sections of the assignment will be excluded from marking and at worst, a case of academic misconduct will be initiated.
Marks will be awarded under the following headings - see rubric below for details.
Grading Scheme for the Individual Assignment
Criteria Descriptor Study Rationale
Study Objectives
Study Design Study Protocol including the
Informed Consent Form and the choice and collection of Primary Efficacy Variable
Collection, evaluation and reporting of adverse event data in clinical trials Quality of references / referencing
Weighting to total 100 30% 30% 30% 10%
80 + Great clarity in the reason why the study is required.
Clear demonstration of the primary / secondary objectives. Extremely well defined Study Design. Evidence of extensive reading and research of top quality sources Has an advanced understanding of the clinical trial study protocol. The hypothetical clinical trial is realistic and based on course material and beyond. Excellent informed consent form. Shows excellent insight/understanding of
regulatory guidance and other aspects for assessing efficacy variable of the trial. Demonstrates excellent understanding of key safety issues, collection, evaluation and reporting of adverse events involved in the conducting of a clinical trial study. Exceptional choice of relevant, top quality sources for the assignment. All from reputable or peer reviewed sources. Absolutely central to the focus of the assignment.
70-79 Very good clarity in the rationale for the trial. The objectives are very well explained. Very well defined Study Design. Evidence of extensive reading and research of mainly top quality sources Has a strong understanding of the clinical trial study protocol. The hypothetical clinical trial is realistic and based on course material and beyond. High quality informed consent form. Shows very good insight/understanding of
regulatory guidance and other aspects for assessing efficacy variable of the trial. Demonstrates very good understanding of key safety issues, collection, evaluation and reporting of adverse events involved in the conducting of a clinical trial study. Very good choice of relevant, worthy sources for the research. Mostly reputable or peer reviewed. Of major importance to the assignment.
60-69 Good clarity in the rationale for the trial. The objectives are well explained. Well defined Study Design. Evidence of good reading and research of information and resources Has a good understanding of the clinical trial study protocol. The hypothetical clinical trial is realistic and based on course material. Very good informed consent form. Shows good insight/understanding of
regulatory guidance and other aspects for assessing efficacy variable of the trial. Demonstrates a good understanding of key safety issues, collection, evaluation and reporting of adverse events involved in the conducting of a clinical trial study. Good choice of relevant, quality sources. Mainly reputable or peer reviewed. Of considerable importance to the focus of the research.
50-59 Some clarity in the rationale for the trial. The objectives are explained. The Study Design is fair. Some evidence of background reading and research.
Has a reasonable understanding of the clinical trial study protocol. The hypothetical clinical trial is fairly realistic and based on course material. Good informed consent form. Shows good understanding of
regulatory guidance and other aspects for assessing efficacy variable of the trial. Demonstrates an adequate understanding of key safety issues, collection, evaluation and reporting of adverse events involved in the conducting of a clinical trial study. Satisfactory choice of relevant, quality sources. Some are reputable or peer reviewed. Of importance to the focus of the research.
40-49 Satisfactory clarity in the rationale for the trial but could be better. The objectives are not well explained. Study Design could be improved. The text is referenced from limited sources, some of which are considered of reasonable quality. Has some understanding of the clinical trial study protocol. The hypothetical clinical trial is satisfactory. Fair informed consent form. Shows some understanding of
regulatory guidance and other aspects for assessing efficacy variable of the trial.
Demonstrates poor understanding of key safety issues, collection, evaluation and reporting of adverse events involved in the conducting of a clinical trial study. Some of the sources are of relevance but the quality of many of the sources needs to be improved.
30-39 Poor clarity in the rationale for the trial. The objectives are poorly explained. Study Design is poor. The text is referenced from extremely limited and/or unknown sources, blogs articles, Wikipedia, etc.
Has poor understanding of the clinical trial study protocol. The hypothetical clinical trial is poor. Informed consent form is poor. Shows poor understanding of
regulatory guidance and other aspects for assessing efficacy variable of the trial. Demonstrates little understanding of key safety issues, collection, evaluation and reporting of adverse events involved in the conducting of a clinical trial study. Poor selection of references. Many are from questionable sources. Lack of relevance to the research objective.
0 -29 The study rationale, objectives and design are all substandard. A significant lack of references of quality or relevance.
Does not conform to instructions. Many of the answers are inappropriate demonstrating that the question is not understood. No insight into subject matter.
Demonstrates little or no understanding of key safety issues, collection, evaluation and reporting of adverse events involved in the conducting of a clinical trial study. Very poor selection of sources. Many are from very questionable sources and are not particularly relevant.
