| Course | HCR 579 Translational Research in Drug Discovery and Development |
|---|---|
| Module | Module 6 |
| Paper type | Protocol presentation |
| Length | About 486 words, 4 pages |
| Format | APA 7 slide deck with speaker notes |
| School | Arizona State University |
| Program | MS in Regulatory Science |
| Updated | October 2026 |
Free sample paper for HCR 579 Module 6
Matching Drugs to Mutations: Presenting the NCI-MATCH Precision Medicine Protocol
Student Name
MS in Regulatory Science, Arizona State University
HCR 579: Translational Research in Drug Discovery and Development
Instructor Name
Month Day, Year
Slide 1: Matching Drugs to Mutations
NCI-MATCH: a national precision medicine trial for advanced cancers.
Speaker notes: Today I will describe a protocol that asked a simple question with a complicated answer: can we treat cancer by its mutations rather than its organ?
Slide 2: The Question
Do patients whose tumors carry a specific genetic alteration respond to a drug targeting that alteration, whatever the tumor type?
Speaker notes: Traditional trials enroll by cancer type. NCI-MATCH enrolled by molecular target, an approach often called a basket design, with many baskets running at once.
Slide 3: Who Enrolled
Adults with advanced solid tumors or lymphomas that had progressed on standard treatment, or rare cancers without standard treatment.
Speaker notes: These patients had limited options, which made a targeted treatment worth testing and justified the fresh biopsy the protocol required.
Slide 4: Screening
Fresh tumor biopsy. Central next-generation sequencing of 143 genes plus protein tests for four markers.
Speaker notes: Central testing kept results consistent across hundreds of sites. Biopsies were safe, with fewer than 1% severe events at the interim analysis (Flaherty et al., 2020).
Slide 5: Assignment
A validated computer platform matched each patient's alterations to one of many subprotocols, each testing one targeted drug.
Speaker notes: Rules, not individual oncologists, decided assignments, so every patient with the same alteration was handled the same way. That consistency is what makes the results interpretable.
Slide 6: Subprotocol Design
Each subprotocol: single arm, one drug, one alteration. Primary endpoint: objective response rate. Secondary: progression-free survival.
Speaker notes: Single-arm designs suit rare alterations where randomization is impractical. A response rate well above what is expected without treatment signals that the drug deserves further study.
Slide 7: The Interim Analysis
Profiling succeeded in 87.3% of samples. Alterations occurred as often as expected, but enrollment onto treatment lagged.
Speaker notes: Histology exclusions and a mismatch between resources and demand meant fewer patients reached treatment than predicted (Flaherty et al., 2020).
Slide 8: Midcourse Changes
Revised mutation frequencies. More patients screened. More treatment arms added. Faster assay: 93.9% completion and a 14-day turnaround.
Speaker notes: A precision protocol must adapt as it learns. These changes show that the design has to be built for revision from the start.
Slide 9: Regulatory and Translational Lessons
Broad screening is essential. Many accessible treatment options are needed. Central testing and rule-based assignment make results credible.
Speaker notes: Since this trial, regulators have approved some drugs for any tumor carrying a specific alteration, showing how tumor-agnostic evidence can reach labels. Matching also depends on genomic reference data that underrepresent many populations (Popejoy & Fullerton, 2016), and the course text stresses that translation depends on such infrastructure as much as on drugs (Shah & Wells, 2020).
Slide 10: Summary
Treat the mutation, not the organ. Screen widely. Assign by rules. Adapt as you learn.
Speaker notes: NCI-MATCH proved that national genomic matching is feasible and taught how to design the next generation of precision trials. Thank you.
References
Flaherty, K. T., Gray, R., Chen, A., Li, S., Patton, D., Hamilton, S. R., Williams, P. M., Mitchell, E. P., Iafrate, A. J., Sklar, J., Harris, L. N., McShane, L. M., Rubinstein, L. V., Sims, D. J., Routbort, M., Coffey, B., Fu, T., Zwiebel, J. A., Little, R. F., . . . NCI-MATCH Team. (2020). The Molecular Analysis for Therapy Choice (NCI-MATCH) trial: Lessons for genomic trial design. Journal of the National Cancer Institute, 112(10), 1021-1029. https://doi.org/10.1093/jnci/djz245
Popejoy, A. B., & Fullerton, S. M. (2016). Genomics is failing on diversity. Nature, 538(7624), 161-164. https://doi.org/10.1038/538161a
Shah, K. P., & Wells, C. E. (2020). Translational research in drug discovery and development: A Top Hat interactive text. Top Hat Monocle.
HCR 579 Module 6 instructions, in plain terms
Assignment 4 is a presentation worth 75 points, due in Module 6 of HCR 579, the module on how changes in regulations affect translational research. According to the syllabus, the deck must describe a precision medicine protocol. You can present a published protocol, such as a basket or umbrella trial, or one you design, but in either case the audience needs to understand the scientific question, how patients are selected by biomarker, how treatment is assigned, the endpoints and statistics and the practical or regulatory challenges. Slides should be short; speaker notes, or recorded narration if your instructor asks for it, carry the explanation and the citations. Precision medicine protocols raise questions about testing, consent and equity that the course's final ethical paper picks up, so noting them here prepares you for Module 7.
How the HCR 579 Module 6 example is put together
Ten slides carry the protocol, each with presenter notes. It opens with the protocol's central idea, then states the question and explains the basket design. Separate slides cover who enrolled, how tumors were screened and how treatments were assigned by a rule-based platform. A design slide gives the subprotocol structure and endpoints. Two slides report the interim analysis and the changes it forced, with numbers from the published report. A lessons slide connects the trial to later tumor-agnostic approvals, and the final slide sums up four lessons in short phrases. Notes cite the source where data appear. Numbers appear in the notes, not on the slides, so the slides stay readable.
HCR 579 Module 6 rubric: what earns full marks
The presentation is scored out of 75. A strong presentation explains the precision medicine question clearly, describes biomarker selection, testing, assignment, endpoints and statistics accurately, discusses practical or regulatory challenges and presents them in clean, readable slides with notes that explain rather than repeat. Points are lost when slides are text-heavy, when the protocol's design is vague, when endpoints are missing and when the presentation ignores what went wrong or was learned. Readers value presentations that connect the protocol to regulatory change, since the module studies how rules shape translational research. Presentations that end with lessons rather than a summary of facts tend to score higher.
HCR 579 Module 6 help with common mistakes
Choose a protocol with a published design paper. Outline the slides before writing notes: question, population, testing, assignment, design, endpoints, results or status, lessons. Keep slide text to short phrases. Put numbers and citations in the notes. Include at least one challenge the trial faced. Rehearse to keep within any time limit. If you are designing your own protocol, the desk can check its biomarker and endpoint choices. Show the deck to a friend outside medicine; anything they cannot follow needs simplifying. Give each slide one message. Make sure the protocol you describe is real or clearly labeled as your design.
Write yours, or have the desk draft it
This paper is an original model document written by our desk, not a submitted student paper and not an official Arizona State University document. Read it for the moves, then write your own to the instructions in your classroom. If you want one built to your exact prompt and rubric, the first custom sample is free and arrives in 24 to 48 hours.
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HCR 579 Module 6 questions, answered
Where can I find a free HCR 579 Module 6 sample paper?
This page carries the complete Assignment 4 slide deck presenting the NCI-MATCH precision medicine protocol.
What is a basket trial?
A trial that enrolls patients by a shared molecular alteration across different cancer types and tests a drug targeting that alteration.
How did NCI-MATCH assign treatments?
A validated computer platform matched each patient's tumor alterations to a subprotocol testing one targeted drug.
What was the primary endpoint in NCI-MATCH subprotocols?
Objective response rate, with progression-free survival as a secondary endpoint.
What did the NCI-MATCH interim analysis show?
Testing worked in 87.3% of samples, but fewer patients than expected reached treatment, prompting larger screening and more arms.