Please read the instructions very well and follow them. The purpose of this assignment is to draw on existing core research, analytical, and process-centered skills in order to develop a short study proposal for one of the topics listed below or of your own choosing. The short protocol template should be completed with each section expanded in as much detail as required, but enough to demonstrate a clear stepwise process in the proposal’s development. For example the rationale section should serve to provide a referenced rational with a view to the mechanism of potential effect of the intervention under investigation and any specific design components incorporated. Delete the guidance text and fill your content there. There is no correct approach, often the out the box designs prove to be the solution to long standing unmet need, change dogma and lead to a paradigm shift in a sector. Be as different or traditional as you wish. Do not lift paragraphs from existing studies that may be relevant to your topic of choice, plagiarism will be assessed. You will then present your short protocol on the 21st May 2021 over 5 to 10m and pitch the study design in our follow-up session. Assessment The written assignment (70% of overall grade) should be between three to five pages long not including references and appendices. Use Arial 11 and 1.15 spacing. Specifically, the rationale should be ideally between 200 and 500 words and contain multiple references. I will be looking for: – Diligence in the rational building through literature review and consideration of the impact/importance of the study. – Quality in presentation, text, and grammar – practice for grant expressions of interest. – ‘Blue skies thinking’ Innovation in methodology, data collection, setting, accessing representative populations, etc… – …OR solid and deliverable design through traditional approaches. The oral presentation (30%) is an opportunity to build confidence in presenting and provide constructive and supportive feedback to your peers. Everyone gets a bit nervous so relax! For this I will be looking for: – Concise slides that you talk to vs read words from – A very short summary of how you felt your presentation went and bits you found difficult – Feedback to your peers on what you enjoyed in their presentations plus any suggestions Internship For those that might be interested in further learning and exposure to clinical trials, there is an opportunity to opt in your short protocol for a panel review by experienced triallists at the MRINZ who will offer a competitive, a paid internship at the Institute over the summer period to one student. Short Study Protocol – Title Study Title Scientific title as would appear in registry – see www.anzctr.org.au for examples Design Recruitment approach / blinding/ intervention assignment / allocation and control type Phase Pilot / Feasibility / I / II / II / IV / other Coordinating Centre Main centre for the study / Principal Investigator host organisation Sites Where is the trial being conducted (setting) Rationale Referenced summary as to why the trial is needed and justification of the potential efficacy of the intervention for the condition of interest (200 to 500 words) Interventions What are you testing? What are you testing against? Duration of treatment How long with the intervention be used by a participant?Study population Who are you recruiting? Enrolment Summarise how you will find the participants, screen, consent and enrol them Inclusion criteria What parameters must be present? (Bullets) Exclusion Criteria What parameters must not be present? Study Procedures Short summary of what participant involves with times. (Visit 1 (Day 1)….. remote diary phase (Days x to x)….Visit 2 (Day X)… etc) Primary Outcome Defines the study as positive or negative. Is the basis of the sample size. Secondary Outcomes List of other outcomes which can be clinical, procedural, economic, logistical. Randomisation Randomised or not randomised. Proportions eg 1:1 / 1:1:1 / 1:2 etc Sample size calculation Rationalise your sample size. Beware the rabbit hole, various approaches depending on design. Focus on using a MCID, Standard Deviation, 90% power and 5% alpha and play here: https://www.sealedenvelope.com/power/continuous-superiority/ then fill out as per: Based on a minimum clinically important difference (MCID) of [X] and Standard deviation (SD) of [X] for the change in [primary outcome or [X], each treatment group would require [X] participants. Accounting for an assumed dropout rate of 20%, [X] participants would be required per arm (X total) having 90% power at 5% one sided alpha. Statistical Analyses Find a similar design/paper and focus on basic understanding one test from it relevant to your proposal. This understanding comes through repetition and applied use. Timeline How long from signing the contract through development, regulatory submission, site initiation/training, recruitment, data cleaning, analysis, publication? Budget Try to develop an understanding of all roles involved in terms of FTE, equipment costs, travel, regulatory and journal manusсrіpt submissions, travel, etc. Who will be involved in your study across all phases? What travel and consumable expenses are there? References Mainly from rationale and Sample size sections. Appendices Any study flow charts for timelines / validated outcome measures etc List of topics allocated – you may swap or opt for a self-selected design. If you swap you must inform me and await approval prior to starting. Condition Active treatment Student Endometriosis Cannabinoids
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