Trial-access debate

Open your materials, follow the steps, then turn in your work.

Argue a position on who should get access to experimental cancer drugs through clinical trials and right-to-try laws.

2. Start the work

Read the two-page trial-access briefing in the PLTW course shell and highlight one fact for and one against expanded early access.

Show all 5 required steps
  1. Read the two-page trial-access briefing in the PLTW course shell and highlight one fact for and one against expanded early access.
  2. Pick a stakeholder role: patient, oncologist, drug maker, or insurer, and write your opening claim in one sentence.
  3. List two pieces of evidence that support your claim using the terms clinical trial and side effect.
  4. Trade claims with a partner role and write one respectful rebuttal to their strongest point.
  5. Vote on the class position and record your final stance plus the reason you would give a patient.

Lost your place? Reopen today's Trial-access debate record. Find the last completed evidence ID, check it against the claim ceiling, and continue with the first unfinished step rather than restarting the whole task.

Check your work before submitting

  • You'll be able to state who controls access to experimental cancer treatments and why.
  • You'll be able to defend a position using clinical-trial evidence and counterargument.

3. Turn in your work

DueCheck Schoology
Hand in
One-sentence final stance plus the patient-facing reason you would give for your position.
How to submit and name your file

Use the submission route shown on today's page.

In Schoology, open your course and the assignment for this lesson. Attach your file, select Submit, and check that it appears in the submission.

PDF upload help

You get two school days for every day you were absent, so this deadline moves with you.

Find this lesson's Schoology assignments

These are existing assignments for your section. Follow the directions in the assignment you are working on; this list does not add new work. Check Schoology for each deadline.

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How this lesson connects

Keep using what you learned last class: Malignant cells lose their normal shape and break through tissue boundaries, so a pathologist can read invasion and disorganization on a slide to judge whether a cancer can metastasize and how dangerous it is. Today: A defensible biomedical decision separates scientific evidence from value judgments, identifies who may benefit or be burdened, and states the uncertainty and tradeoffs that remain.

Optional: listen or watch a unit review
Optional unit study notebook
Cancer treatment: staging with the TNM system, chemotherapy, and targeted and immune therapies.
Open the notebook
Optional review video
Audio overviewVideo overviewMind mapStudy guideFlashcardsQuizData table
Need help? Warm-up, timing, and directions

💡 Big idea: A defensible biomedical decision separates scientific evidence from value judgments, identifies who may benefit or be burdened, and states the uncertainty and tradeoffs that remain.

  1. 0-8Silent read of trial-access briefing; highlight one pro, one con
  2. 8-15Choose stakeholder role; draft opening claim sentence
  3. 15-30Build evidence list (2 facts using required vocabulary)
  4. 30-50Pair debate: swap claims, write rebuttal
  5. 50-65Class vote and full-group discussion of strongest arguments
  6. 65-80Write final stance + patient-facing reason; exit ticket
Mr. Mendoza's 5-minute intro
  • Every approved drug began as an experiment someone had to decide was worth the risk.
  • Today you will step into that decision from four different stakeholder angles.
  • Your job is to argue a defensible position, not to find the right answer, because there may not be one.
  • By the end you will have practiced the claim-evidence-rebuttal structure you will use on the WebXam.
Know by the end
  • Clinical trials test and efficacy before a drug reaches the market.
  • Right-to-try laws allow terminal patients access outside normal trial pathways.
  • Expanded access decisions involve medical, ethical, and economic stakeholders.

PLTW connection and today's work

Open the trial-access debate activity in myPLTW for Unit 3, Lesson 3.4 Building a Better Cancer Treatment, Activity 3.4.3 Clinical Trials (open vs blind), and review the CER rubric.

Today's stopping point: Cancer-launch morphology benchmarks should be green; this debate opens the cancer-treatment unit.

PLTW activity titles identify the course connection. If your account will not open, use the posted materials for today and tell Mr. Mendoza. Do not mark an online activity complete unless you completed it.

Course connection

  • Activity 3.4.3 Clinical Trials
Open Activity 3.4.3 Clinical Trials in myPLTW

Use the turn-in directions at the top of this page. Do not create a second submission unless your teacher asks for one.

Show another explanation or a smaller first step

Need help? Choose a starting point

Need a running start
Sort today's statements about Trial-access debate into observation, teaching model, and decision before writing a claim.
On track
Complete the assigned One-sentence final stance plus the patient-facing reason you would give for your position., cite at least two evidence IDs, apply the reviewed rule, and name one limitation.
Stuck? Get unstuck
Use the sentence frame: E1 shows ____. E2 helps explain ____. Therefore I can claim ____, but I cannot claim ____.
Push me further
Identify one additional measurement, control, or stakeholder perspective that could change the decision, then explain exactly how it would change the claim level.
Lesson resources: reading, slides, and vocabulary
Socratic teaching slide deck

The deck carries the prior idea forward, lets you inspect an analogy, maps the rule to biology, and ends with the same evidence decision and exit ticket used on this page.

Generated from this lesson's canonical data with a red-team citation check.

Carry forward

cells lose their normal shape and break through boundaries, so a pathologist can read invasion and disorganization on a slide to judge whether a can metastasize and how dangerous it is.

Daily take-home

A defensible biomedical decision separates scientific evidence from value judgments, identifies who may benefit or be burdened, and states the uncertainty and tradeoffs that remain.

Inspect the analogy

A review board sorts scientific evidence, stakeholder needs, possible benefits, possible burdens, and uncertainty before choosing a policy.

  1. Which statements are scientific evidence?
  2. Which statements express a value or priority?
  3. Who receives the benefit and who carries the burden?
Rule

Use science to estimate consequences, then state the value judgment and tradeoff that determine the decision.

Where it breaks

A review-board model organizes reasoning but does not make one ethical principle automatically outweigh every other principle.

Map the analogy to biology
  • Evidence cards map to source-backed findings.
  • Stakeholder cards map to affected people and priorities.
  • The recommendation maps to an explicit tradeoff with a named uncertainty.
Read this first

Driving question: A patient with stage IV and months to live wants a drug that has passed only Phase I testing. Should the oncologist, the drug maker, the insurer, or the patient get the final say?

What you already know: cells lose their normal shape and break through boundaries, so a pathologist can read invasion and disorganization on a slide to judge whether a can metastasize and how dangerous it is.

New idea: A defensible biomedical decision separates scientific evidence from value judgments, identifies who may benefit or be burdened, and states the uncertainty and tradeoffs that remain.

Visual or model: F1. F1. A lesson illustration or teaching diagram for Trial-access debate. Use it with E1-E3; it is a model or context image, not experimental or patient data. What to notice: Trace the labeled testing, treatment, or biological process and identify where evidence limits the decision.

  1. Observe or measure the relevant feature in trial-access debate.
  2. Organize the observation with a stable evidence ID.
  3. Apply this rule: Use science to estimate consequences, then state the value judgment and tradeoff that determine the decision.
  4. Choose the option the evidence supports and state the limit of the conclusion.

Real biomedical example: Today the medical interventions team uses Trial-access debate to make a bounded evidence decision. Scientific evidence can inform the options and likely consequences, but it cannot choose a single value-neutral answer.

What the evidence supports: E1-E3 and F1 support the daily take-home when the response meets the stated success criteria.

What it cannot prove: The package does not support claims beyond this lesson's or any real patient diagnosis.

Vocabulary:
  • : A medical procedure that removes a small sample of from the body so it can be examined under a microscope for disease such as .
  • staging: Classifying how far a has grown and spread, which guides treatment choices and predicts likely outcomes.
  • : Treatment that uses powerful drugs to kill rapidly dividing cells throughout the body, though it can also harm some fast-growing healthy cells.
  • radiation: Energy that travels as waves or particles; in medicine it can image inside the body or destroy harmful cells like .
  • : A treatment that attacks specific molecules cancer cells rely on, harming those cells while sparing more healthy cells than older .
  • : Programmed, controlled cell death that the body uses on purpose, including to clear the seam between two tissues during .
  • : An unintended effect of a medicine or treatment that happens in addition to its intended benefit, ranging from mild to serious.

Use it now: Choose one decision option. Cite E1 and E3, then explain how the rule connects the evidence to your choice.

Go further, optional: The source links below are optional enrichment. Every fact required for today's local evidence decision appears in this lesson package.

Evidence set and decision
E1 · Source fact

U.S. Department of Health and Human Services is the source this lesson's claim is checked against: The Belmont Report

Limit: Scientific evidence can inform the options and likely consequences, but it cannot choose a single value-neutral answer.

E2 · Teaching model

Use science to estimate consequences, then state the value judgment and tradeoff that determine the decision.

Limit: A review-board model organizes reasoning but does not make one ethical principle automatically outweigh every other principle.

E3 · Task criterion

You can state who controls access to experimental treatments and why.

Limit: E3 defines the classroom product or success criterion. It is not independent scientific evidence and cannot justify a clinical or causal claim.

PLTW-GEND-2026-11-17 · Simulated classroom evidence scenario

Your role: medical interventions team member

Decision: Your team must decide what the evidence from trial-access debate supports before submitting the exit response named on today's page.

  • Argue the case by weighing this patient's autonomy against the of everyone still waiting behind the trial.
  • Give the patient the Phase I drug, since someone with months to live has nothing left to lose.
  • Wait on the call until testing beyond Phase I shows whether this drug does anything at all against the patient's .

Response: State one choice, cite at least two evidence IDs, explain the rule that connects them, and add one limitation. Submit it as the exit response.

Claim ceiling: Today's evidence supports a classroom claim about trial-access debate. It cannot prove causation, diagnose a real patient, or justify action outside this room.

Composite case file · PLTW-GEND-2026-11-17

Reason for review: Your team must decide what the evidence from trial-access debate supports before submitting the exit response named on today's page.

Context: Today the medical interventions team uses Trial-access debate to make a bounded evidence decision. Scientific evidence can inform the options and likely consequences, but it cannot choose a single value-neutral answer.

Timeline:
  • T1: Read the two-page trial-access briefing in the PLTW course shell and highlight one fact for and one against expanded early access.
  • T2: Pick a stakeholder role: patient, oncologist, drug maker, or insurer, and write your opening claim in one sentence.
  • T3: List two pieces of evidence that support your claim using the terms clinical trial and .
  • T4: Trade claims with a partner role and write one respectful rebuttal to their strongest point.
  • T5: Vote on the class position and record your final stance plus the reason you would give a patient.
Evidence records:
  • E1: U.S. Department of Health and Human Services is the source this lesson's claim is checked against: The Belmont Report
  • E2: Use science to estimate consequences, then state the value judgment and tradeoff that determine the decision.
  • E3: You can state who controls access to experimental treatments and why.

Measurements: Use only the measurements, units, graph, or counts supplied in today's task. No additional patient measurement is implied.

Figure finding: Teaching diagram for Trial-access debate. Trace the labeled testing, treatment, or biological process and identify where evidence limits the decision. This is a teaching model, not patient or experimental data.

Uncertainty: This is a composite classroom scenario. Missing history, measurements, or confirmation tests remain unknown and limit the conclusion.

Math moment
Formula or setup

Rate or percent = part / comparison total x 100%. Percent change = (new - comparison) / comparison x 100%.

Worked parallel example

If 18 of 60 records meet a condition, the frequency is 18 / 60 x 100% = 30%.

Units and reasonableness

Name the comparison total. A percent describes the supplied group and does not automatically predict an individual's outcome.

Try it with today's data

Use today's supplied counts to calculate one rate, risk, frequency, or percent change. Show the denominator and interpretation.

Watch the trap

Students often think A polished answer about Trial-access debate is trustworthy even when its evidence source, comparison, or limitation is missing.. The trap: Presentation quality cannot raise the evidence level. Scientific evidence can inform the options and likely consequences, but it cannot choose a single value-neutral answer.

Worked example · a parallel case (guides, does not reveal)
Worked CER on a parallel case
Completes: Models the exact CER deliverable (Claim, Evidence, Reasoning) on a parallel bioethics access case so students can copy the structure and depth, not the answer: a single-sentence claim naming who should decide, evidence drawn from how the medical system actually handles the case, and reasoning that ties the evidence back to the claim.

Parallel case (not today's prompt): A 12-year-old is the only close tissue match to donate a kidney to a sibling in kidney failure. The child says yes, but a minor cannot legally give full informed consent. Should the parents, the transplant surgeon, a hospital ethics committee, or the child have the final say on whether the donation happens?\n\nClaim: A hospital ethics committee, not the parents or the surgeon alone, should have the final say on whether a minor donates a kidney to a sibling, with the child given a real chance to refuse.\n\nEvidence: Living kidney donation is a surgery a healthy person does not medically need, and it carries real risks such as bleeding, infection, and the loss of one of two working kidneys for life. A 12-year-old cannot legally give informed consent, so someone else must decide for them. Parents have a clear interest in saving the sick child, which can pull them toward saying yes even when it is not in the donor child's best interest. For this reason, most transplant centers require a separate donor advocate and review by an independent ethics committee before a minor is allowed to donate, and courts have stepped in when a family and a hospital disagreed.\n\nReasoning: The person facing the risk of surgery is the donor child, but that child cannot legally weigh those risks alone, so the decision has to be shared. Handing the final say to the parents alone creates a conflict of interest, because they are also trying to save their other child, and handing it to the surgeon alone puts one person in charge of a life-altering choice for a healthy patient. An independent ethics committee is built to check exactly this kind of pressure: it can confirm the medical facts, protect the donor child's right to say no, and make sure the decision serves the donor and not only the sibling in need. That is why the committee, with the child's voice included, should hold the final say.

Why this matters

This model shows the level of evidence and organization needed to complete: Models the exact CER deliverable (Claim, Evidence, Reasoning) on a parallel bioethics access case so students can copy the structure and depth, not the answer: a single-sentence claim naming who should decide, evidence drawn from how the medical system actually handles the case, and reasoning that ties the evidence back to the claim.

Build yours step by step
  1. Name the prompt or task.
  2. Answer it directly with the key evidence.
  3. Check that the response matches the requested format.
Change it for a new task

Keep the structure. Replace the question, facts, measurements, and evidence. Then recheck units, vocabulary, and whether the conclusion goes beyond the evidence.

Also due today: Record the class vote and your final stance, and submit the exit ticket to Schoology before leaving class.

See the full worked example
Portal terms
CER:
Claim, Evidence, Reasoning: make a claim, back it with evidence, explain your reasoning.
SOP:
Standard Operating Procedure, the exact steps to follow (especially in a lab).
Tracker:
Your PLTW progress log where you record completed evidence.
myPLTW:
The PLTW course site where you do the online activities. Find it in Clever with your Microsoft sign-in, right next to Schoology.
This unit's vocabulary

Tap the speaker to hear a term. Add two of these to your notebook glossary with a definition and an example in your own words.

Build your vocabulary · optional, for extra credit

Pick just 2 or 3 words from today and make them yours: write what each one means in your own words, name the context clue or evidence that helped, then give one example from what you actually did in Trial-access debate. Try your own words first; the glossary is there if you get stuck. This is voluntary and counts as extra credit, so keep it short.

biopsy
staging
chemotherapy
radiation
targeted therapy
apoptosis

Saved on this device. Show Mr. Mendoza or add these to your notebook glossary to claim the extra credit.

Teacher-posted resources

Classroom documents for this lesson are posted in Schoology. Open Clever, then Schoology, and find each one by the name shown on its card.

Use during lessonFor: Everyone
MI Activity 3.3.1 Diary of a Cancer Patient
worksheet/handoutPosted in Schoology
Open in Schoology

Open this when the class reaches this activity and use it to complete the required lesson artifact.

Placement rationale

Matched treatment and therapeutic choices by path:Medical-Interventions/Unit-3_How-to-Conquer-Cancer/3.3_Treating-Cancer; keywords:, radiation, cancer. Score 146. Visibility: student-schoology (student-facing resource; link through Schoology rather than local path).

Catch-up / reteachFor: Need extra support
MI 3.4 Progress Tracker & Study Guide
worksheet/handoutPosted in Schoology
Open in Schoology

Use this if you were absent, got stuck, or need another pass before you submit the lesson artifact.

Placement rationale

Matched treatment and therapeutic choices by path:Medical-Interventions/Unit-3_How-to-Conquer-Cancer/3.4_Building-a-Better-Cancer-Treatment; keywords:treatment, cancer. Score 142. Visibility: student-schoology (student-facing resource; link through Schoology rather than local path).

Sign in to Clever with your district Microsoft account to open Schoology or myPLTW. Follow today's posted steps. If myPLTW will not open, use the posted alternative and tell Mr. Mendoza. Turn in your completed work through the Schoology assignment.

Practice: try a question, then check your answer

Claim ceiling for this check: Today's evidence supports a classroom claim about trial-access debate. It cannot prove causation, diagnose a real patient, or justify action outside this room.

Quick self-check · commit, then reveal

A student makes a certain conclusion about Trial-access debate from one classroom result. What must the student add before the conclusion is defensible?

How sure are you?

Write an answer and pick a confidence to unlock the key.

Cumulative WebXam review · flash practice

Fast retrieval with instant answers, not the commit-then-reveal check above. Try each from memory first: write what you remember about the earlier units, then check yourself here.

Tap an answer to check it · nothing is recorded or graded
[Review: Editing the Code: Gene Therapy and Its Ethics] One major challenge that keeps gene therapy from being perfect is complete integration, which means
[Review: Molecule to Patient: Unit 2 Synthesis] A genetic counselor's main role on the health care team is to
[Review: When Cells Forget the Rules: Cancer Launch] When cancer cells break away and spread to other areas of the body, this process is called
Which test is used to make the definitive determination of whether cancer is present by removing a small sample of tissue?
Missed class or ready for more?
🔬 Pre-lab simulations · 2 for this lesson

Run this before you touch the bench. It is built from the real lab procedure, so the decisions you make here are the ones you will make with the equipment in your hands. This lesson has more than one, and they cover different skills.

The Drug That Does Nothing to Most People
Open the simulation →
Same Light, Two Strains: the DNA repair plate set
Open the simulation →
Where this leads: careers

What today's skills lead to. These are real health-science careers this course builds toward. Tap one to see, on the US Department of Labor's O*NET site, what the job actually involves, what it pays, and how fast it is growing.

What to do if you were absent
Today was a debate: do this instead

Record a two-minute voice memo arguing your trial-access stance from one stakeholder role, then post one written rebuttal to a classmate's posted claim in the course shell discussion.

NCI: Clinical Trials Basics

Use the submission route shown on today's page.

If MR. MENDOZA is absent

Class still runs. Complete the online activity above (it's self-guided). Need the concept taught without a teacher? Use this authoritative explainer:

National Cancer Institute: Types of cancer treatment
Optional extra credit (async)

You've passed Unit 2, so the optional extra-credit track is open. Complete reserved-unit work from home, including virtual labs, for extra credit. Each item shows its correct submission route.

Open the extra-credit track
How this is graded
For: Exit ticket: One-sentence final stance plus the patient-facing reason you would give for your position.
  • Complete
    Every required part of the artifact is present, nothing left blank.
  • Accurate
    The science and the data are correct and match the evidence.
  • Scientific reasoning
    You explain your claim with evidence and reasoning (CER), not just an answer.
  • Professional communication
    Clear, organized, labeled, and written the way a clinician or scientist would.
  • Submitted
    Go to Schoology to turn this in. Submit one PDF. Put your first and last name in the document header. Name the file: FirstName LastName - Assignment Title - YYYY-MM-DD.pdf. If you cannot get in, see Mr. Mendoza. Do not skip the work.