CSH477 Evidence-based Healthcare: Practice informing research
Assignment 1: Case Study

Task Description

Acting as a practising pharmacist, you will use patient data from a given case study along with patient communication to conduct research, determine suitable clinical trials, and communicate your findings to a health professional via a clinical trial recommendation letter.

As part of this task, you are expected to interpret data from clinical trial registries (e.g. recruitment status, eligibility parameters) to determine whether a particular trial is suitable option for your patient. The ability to critically evaluate clinical trials, select the most fitting option, and justify your decision with evidence is an essential clinical skill. Equally important is your capacity to effectively communicate your evaluation and reasoning to another health professional.

You will communicate with another health professional via a clinical trial recommendation letter. In your letter, you will summarise the key clinical trial data you have researched and explain why you believe the selected trial is appropriate for your patient. Your explanation should detail how the trial addresses your patient's specific needs. The letter should be clear, concise, and professionally formatted, reflecting the communication standards expected in contemporary clinical practice.

An article published in the Australian Pharmacist in 2018 highlights the significant role pharmacists can play in clinical trial recruitment. It is noted that clinical trials are not uniformly integrated in the Australian healthcare system, which means many patients miss opportunities to participate simply because practitioners are unaware of available trials, and patients do not understand the potential benefits. As a pharmacist, you will be uniquely positioned to increase awareness of clinical trials within the medical community and to address the questions and concerns of patients considering trial participation.

This is an authentic assessment since it reflects the real-world practice of investigating novel therapies for patients who have exhausted conventional treatment options. This task emphasises the holistic approach driven by the patient-centric model of care delivery that aims at tailoring the treatment to suit various patient factors. This assessment is designed not only to refine your evaluative and decision-making skills but also to enhance your ability to communicate complex clinical decisions in a patient-centred manner. By undertaking this task, you will further develop the critical competencies required for modern clinical practice.

Barbeler, D. (2018). Pharmacists could play a key role in clinical trial recruitment. Australian Pharmacist. June 11, 2018. Accessed Feb 4, 2025.
https://www.australianpharmacist.com.au/pharmacists-could-play-key-role-in-clinical-trial-recruitment/

Weighting: 40%

Learning outcomes measured

1. Reflect and critically evaluate research problems related to future therapeutics and pharmaceutical research trends in advanced drug development and delivery for clinical practice.

2. Source, critically appraise, and synthesise literature of current challenges to inform future trends in healthcare.

3. Interpret and present complex and innovative knowledge to peers and non-expert audiences.

What you need to do?

Using the patient history and clinical information provided by their primary physician in the case study, along with additional data gathered from your patient interview, you are to evaluate the patient-specific factors and recommend a suitable clinical trial that involves drug or novel therapy intervention.

This assessment comprises three (3) components, all of which must be submitted by the due date:

1. Clinical Trial Research Tables:

Complete 2 tables summarising your research on two (2) clinical trials you have selected for your patient. A table template will be provided for you to do this. You will complete 1 table for EACH of the clinical trials.
Important: Attach full copies of both clinical trials as an appendix to your submission.

We also ask that you submit a copy of your patient discussion from workshop week 3 and 4. More details and guidance will be provided in these workshops.

2. Clinical Trial Recommendation Letter:

Prepare a one-page letter addressed to a medical practitioner. The letter should:

• Briefly and correctly summarise patient information

• Recommend one (1) suitable clinical trial for patient enrolment. This trial will be selected from one of your tables. Make sure you include the Title and CT number of the chosen trial.

• Provide a clear rationale for your recommendation

Letter Formatting requirements:

• Use the provided structural format for the letter (template)

• Times New Roman, font size 11

• Single line spacing (1.0)

• Margins: 2.54 cm on all sides

• Maximum length: one page

3. Reflection Paragraph

Submit a brief reflection (max 300 words) outlining:

• How Generative AI contributed to your research and writing process. Note the University supports the following resources. You need to restrict your GenAI use to these platforms to safeguard your intellectual property.

• Any limitations encountered

• Where human clinical judgment was essential

You also need to document any use of GenAI according to the University guidelines. This is to be supplied as part of your submission in this table.

Please Note

Once you have selected your two clinical trials for your tables, create copies of the trial information (print to PDF) to attach to your submission. Trial criteria can change over time, and your letter will be marked based on the attached trial, even if its content changes later. Saving an early copy safeguards your assignment.

We suggest that you self-evaluate your tables, letter, and reflection against the rubric.

Length

Each section will have the following lengths:

1. Clinical Trial Research Tables:

Two (2) completed tables using the supplied table template. Note only includes the key information; copying and pasting irrelevant information will impact your grade.
Important: Attach full copies of both clinical trials as an appendix to your submission.

We also ask that you submit a copy of your patient discussion from workshop week 3 and 4. More details and guidance will be provided in these workshops.

2. Clinical Trial Recommendation Letter:

Letter (one-page) with the following format:

• Use the provided structural format for the letter

• Times New Roman, font size 11

• Single line spacing (1.0)

• Margins: 2.54 cm on all sides

• Maximum length: one page

3. Reflection Paragraph

A brief paragraph reflection (maximum 300 words). You will also need to provide a table of evidence. The table information should inform your reflection.

Resources available to help you complete the task

The following resources will be available:

• Recorded introductory content – using clinical trial databases

• Workshop exercises to help you complete the tables. You will develop an example table (and receive feedback in class) that will guide your submission.

• Workshop activity on GenAI use

Note: As there are many parts to this assessment, you may find this checklist helpful as you progress through the task and complete your submission.

What do you need to submit?

1. 2 completed tables of clinical trial research using the provided CT table template.

2. A full PDF copy of each of the trials you analysed in the tables (these need to be legible and full copies).

3. A copy of the Cognitive script when you communicated with Evelyn Smyth (save to PDF format only).

4. A one-page Clinical Trial Recommendation in this Letter template.

5. 1 brief paragraph (max 300 words) – GenAI reflection.

6. Your prompts and any evidence of GenAI outputs in this GenAI table.

How to submit

The following should be provided as separate Microsoft Word documents:

• 2 tables of clinical trial research (these can be in the one document), using the specified CT table template. We will work on examples in the workshop.

• Letter using the specified letter template.

• GenAI reflection.

• GenAI use (tools, reason, prompts and validation) in the specified GenAI table. For guidance on what to write in this table, see the provided example.

The following should be provided as ONE (1) PDF document:

• The 2 clinical trials you refer to in your tables (full copies). Hint: “Save to PDF” is the best way to generate these.

• The transcript of your communication with Evelyn Smyth. This will be created in workshop 3 or 4, and you will be able to “save to PDF” your patient conversation. An example will be shown to you in the workshop.

The Word documents and the combined PDF need to be submitted to the Task 1: Case Study Portal at the same time.

Please Note (Extension Information)

• A 48-hour automatic extension is available for this assessment.

• The maximum allowable HiQ extension is up to 7/4/2026 (dependent on documentation).

How you will be assessed and moderated

Please refer to the criterion reference assessment (CRA) rubric located on Canvas (top of this page) and watch the assessment video.

This assessment item will be moderated by the teaching team before marks are released.

Gen AI Use

GO: GenAI use authorised

The ethical and responsible use of generative artificial intelligence (AI) tools is recommended for helping you prepare and understand the task. For example, you can use Co-Pilot to understand assessment instructions, explain clinical trial terminology, summarise inclusion/exclusion criteria, generate checklists for evaluating trial suitability (which you can use when reviewing the trials that you identified), use Co-Pilot to help you brainstorm or review your ideas, proofread, edit, and make the text more succinct in your letter or reflection.

Please reference all GenAI use using the provided table (see above submission section).

Note the University supports the following resources. You need to restrict your GenAI use to these platforms to safeguard your intellectual property.

More information can be found on GenAI use in this unit via the provided link.

Assistance with GenAI can also be found through the provided support resources.