I’m working on a health & medical writing question and need support to help me study.
- Review: PowerPoint in the Resource section below for an overview on writing a protocol synopsis
- Review: (2) examples of abbreviated protocol synopses found on ClinicalTrials.gov (below)
- Outline: Your version of a study – this can be somewhat similar to those found on ClinicalTrials.gov
- Topic: “Pediatric Sore Throats”
- Purpose: Your study’s purpose is to assess the safety and efficacy of a product
- Read: Background information on pediatric sore throat treatments (see article link below)
- Read: Look up other articles to aid you in 1) study design, 2) writing a brief background, etc
- Read: Everything on this page – I’ve provided all the details you need to be successful
- Confidence: You should have a good sense of an appropriate study question after reading and checking the examples at ClinicalTrials.gov. In the next few sections of this page though, I’ll walk you through the thought process that will help you get started…
- ClinicalTrials.gov Example Protocols:
- Note: notice the highly scientific language used in these two examples—use as a pattern for your own work
- https://clinicaltrials.gov/ct2/show/NCT02486835?cond=cough+syrup&draw=2&rank=1 (Links to an external site.)
- https://clinicaltrials.gov/ct2/show/NCT03005067?cond=common+cold&draw=2&rank=9 (Links to an external site.)
- Background Information on Pediatric Sore Throats:
- However, your proposal synopsis cannot copy the examples “too closely”
- NOTE: 20% of your grade will be deducted for copying an example study too closely prior to grading the rest
Think about the following to arrive at a research question you can use to start writing your proposal:
- what do we know—what do we not know
- who’s at risk and from what
- what safety and efficacy concerns are there
- are there known questions related to known pediatric sore throat treatments
- are there any known controversies among pediatric physicians
- what are you curious about on this topic
Next, ask yourself questions like these:
- Do pediatric practitioners need a new “test product” – ie, would a fictitious product improve the treatment of pediatric sore throats versus the standard of care (SOC) described in the article?
- Do you think the dosage is wrong for current test products?
- Do you think the dosage is right, but applied to the wrong age groups?
- Do you think the SOC treatment is correct so you don’t need a “new drug” but you think patients should take it for longer/shorter than the prescribed amount of time currently advocated?
- Do you think the SOC treatment should be combined with another (currently available) medication and that the combination will improve outcomes? How would you measure this?
- Do you think children with underlying baseline comorbidities are at risk for complications from standard of care treatments? If yes, which ones and how would you test this theory?
- Are you concerned about the side effects of the current SOC and think your product can reduce them? By what %? Over what time period?
- Do think there is a gap in literature related to comparing two standards of care: (x) versus (x)
- Do you think (x) population responds better to a treatment than another population? Why and how would you test it?
- Do you think the safety of your “product” is superior to the SOC?
- Do you think the efficacy of your “product” is superior to the SOC?
Ok, now you’ve thought about things that could be potential research questions its critical you pause to outline the following:
- Purpose Statement
- Objectives (Primary and Secondary – at a minimum you need both)
- The reason for this is that if you perform a study with a single objective and the data don’t support your RQ or hypothesis, you have a null study (ie, typically not publishable)
- A secondary objective provides you with a fallback – you may be able to find publishable results to support it in your data