When you or a loved one is considering a cancer clinical trial, the first question isn’t always about the drug-it’s about whether you qualify. The answer lies in two powerful tools: biomarkers and inclusion criteria. These aren’t just medical jargon. They’re the gatekeepers deciding who gets access to cutting-edge treatments and who doesn’t. And in cancer care, getting past those gates can mean the difference between hope and helplessness.
What Are Biomarkers, Really?
Biomarkers are measurable signs in your body that tell doctors something about your cancer. They’re not guesses. They’re facts-like a fingerprint for your tumor. These can be genes, proteins, or even molecules in your blood or tissue. For example, a mutation in the BRCA1 gene, or high levels of the protein PD-L1, aren’t just data points. They’re signals that tell researchers: this patient might respond to this drug. The FDA breaks biomarkers into seven types, but for clinical trials, three matter most: predictive, prognostic, and pharmacodynamic. Predictive biomarkers tell you if a drug will work. Prognostic ones tell you how aggressive the cancer is. Pharmacodynamic ones show if the drug is hitting its target inside your body. In 2022, 92% of new cancer drug approvals by the FDA came with a biomarker requirement. That means if your tumor doesn’t have the right marker, you won’t be offered the drug-even if it’s working wonders for others. It sounds strict, but it’s not arbitrary. Trials using biomarkers to pick patients have a nearly 50% success rate in Phase 2, compared to just 27% for trials that don’t. That’s not luck. That’s precision.Inclusion Criteria: The Rules of the Game
Inclusion criteria are the rules you must meet to join a trial. They’re not random. Every single one is there for a reason: safety, science, or both. Common criteria include:- Stage of cancer (e.g., metastatic, not early-stage)
- Previous treatments (e.g., must have tried at least two lines of chemo)
- Organ function (e.g., kidneys and liver must work well enough to handle the drug)
- Performance status (e.g., able to walk and care for yourself)
- Age limits (sometimes, but not always)
- Biological markers (e.g., HER2-positive, EGFR mutation, MSI-H)
Why Biomarkers Are Changing Everything
Before biomarkers, trials were like casting a wide net. You’d enroll hundreds of people with the same cancer type-lung, breast, colon-and hope the drug worked for some. Most didn’t. Phase 2 failure rates were over 60%. Now, trials are like laser-guided missiles. You find the patients whose tumors have the exact target the drug is built to hit. The results? Faster recruitment, fewer dropouts, higher success rates. In 2022, 73% of new oncology trials used biomarkers for eligibility. That’s up from 41% in 2017. The market for biomarker testing in trials is projected to hit $42 billion by 2027. This isn’t a trend. It’s the new standard. Why? Because it works. Companies save money. Patients get better outcomes. Regulators approve drugs faster. Everyone wins-except maybe the patients who don’t have the right biomarker. And that’s the catch.
The Hidden Challenges: Testing, Timing, and Access
Biomarkers sound simple. Get a biopsy. Run a test. See if you qualify. But in reality, it’s messy. First, the test itself takes time. Specialized biomarker tests-like NGS panels or liquid biopsies-can take 7 to 14 days. That’s two weeks you might not have if your cancer is moving fast. And not every hospital can run them. You might need to send your tissue to a lab across the country. Second, not all biomarkers are created equal. Some are well-validated. Others are still experimental. The European Medicines Agency found that 68% of biomarkers used in early trials don’t have enough validation to be trusted for decisions. That means some patients get excluded-or included-based on shaky science. Third, access isn’t equal. A biomarker like HLA-A*02:01 shows up in 50% of Europeans but only 20% of North Americans. That means a trial designed in the U.S. might fail to recruit enough patients in Europe-or vice versa. Global trials are getting harder, not easier. And then there’s cost. Biomarker testing adds thousands of dollars to each patient’s screening. Many insurance plans don’t cover it unless it’s part of an approved treatment. So patients often pay out of pocket-or miss out entirely.What You Can Do: Navigating the System
If you’re exploring a clinical trial, here’s how to move forward:- Ask for biomarker testing early. Don’t wait for your oncologist to bring it up. Say: “Can you test my tumor for biomarkers like PD-L1, KRAS, EGFR, or MSI?”
- Know your options. Not all tests are the same. A tissue biopsy is the gold standard. Liquid biopsies (blood tests) are faster and less invasive-but not always accurate enough for eligibility. Ask which test will be used and why.
- Check trial databases. Use ClinicalTrials.gov. Filter by cancer type and biomarker. You’ll find trials that match your profile.
- Ask about centralized testing. Some trials send kits to your local hospital. Others require you to travel. Find out what’s involved before you commit.
- Get a second opinion. If you’re told you don’t qualify, ask if another center might. Biomarker testing protocols vary. What one lab calls “negative,” another might call “low positive.”
The Future: More Than One Marker
The next wave isn’t single biomarkers. It’s multi-omic panels-combining DNA, RNA, protein, and even immune cell data into one profile. By 2025, 65% of new trials are expected to use these complex signatures. AI is helping too. Companies are using machine learning to find hidden patterns in data that humans miss. One trial in 2023 used AI to identify a new biomarker in lung cancer that predicted response to immunotherapy with 89% accuracy-something no single gene had ever done. And soon, trials may adjust eligibility on the fly. Imagine starting a trial, getting your biomarker results, and then having the protocol change based on what it finds. That’s called “dynamic eligibility.” It’s already being tested in early-phase trials. The goal? No more one-size-fits-all. Every patient gets a trial built for their cancer-not the other way around.Final Thought: It’s Not Just Science. It’s Justice.
Biomarkers and inclusion criteria aren’t just technical tools. They’re ethical ones. They promise better outcomes. But they also risk leaving behind people who can’t access testing-because of where they live, how much they earn, or what kind of hospital they go to. The science is moving fast. The system? Not so much. That’s why patient advocates are pushing for standardized testing, insurance coverage, and global equity. Because no one should be denied a chance at a new treatment just because their hospital doesn’t have the right lab. If you’re in a trial-or thinking about one-know your biomarkers. Ask questions. Push for answers. Your cancer is unique. Your treatment should be too.What are the most common biomarkers used in cancer clinical trials?
The most common biomarkers in cancer trials include HER2 (breast cancer), EGFR and ALK (lung cancer), BRCA1/2 (ovarian and breast), KRAS and NRAS (colorectal), PD-L1 (many cancers), MSI-H/dMMR (colorectal and endometrial), and NTRK fusions (rare but targetable across cancer types). These are well-established, FDA-recognized markers used to match patients with targeted therapies or immunotherapies.
Can I still join a trial if my biomarker test is negative?
It depends. Some trials are strictly biomarker-positive only. Others have “basket” or “umbrella” designs that include biomarker-negative patients in control arms or different treatment groups. Always ask the trial team: “Is there a cohort for patients like me, even if my biomarker is negative?” Sometimes, you’re eligible for a different arm of the same trial.
How long does biomarker testing take, and can I speed it up?
Standard tissue testing takes 7-14 days. Liquid biopsies can be faster-sometimes under 7 days-but aren’t always reliable for eligibility. To speed things up, ask if the trial uses a centralized lab with expedited processing. Some trials pre-ship test kits to your doctor. Others partner with commercial labs like Foundation Medicine or Tempus that offer faster turnaround. Don’t wait-ask about timing before you get your biopsy.
Why do some trials reject patients even if they have the right biomarker?
Having the biomarker is just the first step. Trials also require specific cancer stage, prior treatments, organ function, and overall health. For example, a patient with an EGFR mutation might still be excluded if their liver enzymes are too high or if they’ve had a recent heart attack. Biomarkers are necessary-but not always sufficient. Every criterion is there to protect your safety and ensure the trial’s scientific validity.
Is biomarker testing covered by insurance?
In the U.S., Medicare and most private insurers cover FDA-approved biomarker tests when used to guide treatment. But for experimental or exploratory biomarkers used only in trials, coverage is inconsistent. Some trials cover the cost. Others don’t. Always ask the trial coordinator in writing: “Who pays for this test?” and get it in your consent form.
Gregory Gonzalez
Oh wow, another sanctimonious op-ed about how precision medicine is finally here to save us. Let me guess - the next article will be titled 'Why Your Dog’s DNA Should Be Screened Before You Adopt It.' The real tragedy isn’t that patients get excluded - it’s that we’re all supposed to clap while the pharmaceutical industry turns oncology into a VIP club where only the genetically privileged get in. 🙃
And don’t get me started on the $42 billion market projection. That’s not science. That’s a hedge fund’s wet dream with a lab coat.
Meanwhile, my cousin in rural Alabama still waits six months for a basic biopsy. But hey - at least her tumor’s PD-L1 status is *technically* documented in a database somewhere. Progress, baby.
Someone should write a book called 'Biomarkers: The New Red Tape for the Dying.' I’d buy ten copies and burn them in protest.
Also, why do we still call these 'trials'? They’re not experiments. They’re eligibility gauntlets dressed in white coats.
And yes, I know I sound bitter. But when your insurance denies a test that could save your life - and then the company profits off the data you gave them - bitterness is the only rational response.
Let’s not pretend this is equity. It’s algorithmic eugenics with better PR.
And before you say 'it’s better than nothing' - no. It’s better than nothing for the people who already had access to begin with.
So congrats, science. You made cancer care even more exclusive. And you called it innovation.
Bravo.
Now where’s my Nobel Prize for being the only one brave enough to say this out loud?
Ronald Stenger
Let’s be real - this whole biomarker thing is just the FDA’s way of outsourcing risk to patients. You want a new drug? Prove you’re genetically worthy. Meanwhile, China and India are running trials on 10,000 people with zero biomarkers and getting results faster. Why? Because they don’t waste time filtering out the 'unqualified.'
Here’s a radical idea: what if we just gave the drug to everyone and let outcomes decide? No more gatekeeping. No more expensive tests. No more corporate middlemen.
And don’t give me that 'safety' crap. We’ve been giving chemo to people with failing kidneys for decades. Now suddenly we care? When the profit margin drops?
This isn’t medicine. It’s market segmentation with a stethoscope.
Also - 73% of trials use biomarkers now? That’s because Big Pharma figured out they can charge $500K per patient and call it 'personalized.'
Meanwhile, I’m sitting here watching my uncle die because his tumor had the mutation but his insurance said 'no coverage for exploratory testing.'
So yeah - keep your precision. I’ll take a shot in the dark any day over this bureaucratic nightmare.
Samkelo Bodwana
I come from a small town in South Africa where the nearest lab that does NGS testing is 800 kilometers away, and the cost is more than most families earn in a year. I’ve seen people cry because they were told their cancer had a targetable mutation - but they couldn’t get the test done. So yes, I understand the science. But science without access is just poetry.
When you say 'global equity,' do you mean it? Or is it just a line in a grant proposal? I’ve sat in rooms with American doctors who talk about 'precision oncology' like it’s a luxury spa - while mothers in Limpopo are choosing between food and a biopsy.
It’s not that biomarkers are bad. It’s that we built a system where the tool is brilliant, but the ladder to reach it is broken.
What if trials were designed backwards? Start with the patient who has nothing - then build the test around them, not the other way around.
Imagine a world where a village clinic could send a drop of blood, and a week later, a machine in Nairobi or Delhi tells you: 'Yes, this mutation exists. Here’s the drug. Here’s how to get it.'
That’s not sci-fi. That’s logistics. And we’re not even trying.
Maybe the real innovation isn’t in the gene - it’s in the heart.
Let’s stop celebrating the test and start fixing the access.
And if you’re reading this and you’re in a position to help - don’t just donate to a lab. Donate to a bus. Or a courier. Or a nurse who walks 10 kilometers to deliver a kit.
That’s the kind of precision that saves lives.
Not just the ones in the data.
The ones in the dirt.
Emily Entwistle
OMG this is SO important!! 🙌 I literally cried reading this because my mom just got rejected from a trial last week because her PD-L1 was 'low positive' and the protocol required 'high' 😭
But guess what? We’re not giving up!! 💪 I’ve already messaged 3 different cancer centers and found ONE that accepts liquid biopsies and has a faster turnaround!! 🚀
Also - did you know some trials now let you retest after 3 weeks?? So if you’re denied, don’t take 'no' for an answer!! Ask if they’ll retest with a different method!!
And if your oncologist doesn’t mention biomarkers first - ASK!! Like, straight up say: 'Can we test for everything? I want to know ALL my options.'
Also, if you’re in the US - check out Patient Advocate Foundation. They help with insurance battles!! 🤝
YOU ARE NOT ALONE. And your cancer is NOT just a number in a database. 💖
Keep fighting. I’m rooting for you!! 🌈✨
Duncan Prowel
While the article presents a compelling narrative regarding the increasing reliance on biomarkers in oncology trial design, one must not overlook the epistemological and logistical constraints that accompany such an approach.
Firstly, the assumption that biomarker-driven stratification inherently improves therapeutic efficacy is predicated upon a reductionist model of carcinogenesis - one that assumes singular molecular drivers dominate clinical outcomes. Yet, tumor heterogeneity, clonal evolution, and microenvironmental interactions suggest a far more complex reality.
Secondly, the assertion that '73% of new oncology trials use biomarkers' is statistically accurate, yet it obscures the fact that many of these biomarkers are not validated to the same standard. The EMA’s finding that 68% of early-trial biomarkers lack sufficient validation raises serious concerns regarding the reproducibility and clinical utility of such selection criteria.
Thirdly, the economic implications of centralized testing infrastructure are not adequately addressed. The cost differential between academic centers and commercial labs, coupled with the absence of universal reimbursement protocols, creates a two-tiered system of care that is ethically indefensible.
Finally, the notion that 'everyone wins' except those excluded is a dangerous oversimplification. Those excluded are not collateral damage - they are patients. And their exclusion, when rooted in systemic inequity rather than biological irrelevance, constitutes a form of institutional neglect.
One must therefore ask: are we advancing medicine - or merely automating bias?
Perhaps the next frontier is not more biomarkers - but a rethinking of trial design itself, one that integrates adaptive, decentralized, and equity-centered methodologies.
Until then, we risk turning hope into a privilege.
Bruce Bain
So here’s the deal: if you got cancer, you gotta get tested. That’s it. No drama. No fancy words.
They don’t care if you’re rich or poor - they care if your tumor has the right marker. If it does? You might get the new drug. If it doesn’t? You don’t.
It’s like getting a key to a car. No key, no ride.
So ask your doc: 'What’s my marker?' If they don’t know - find someone who does.
And if you’re waiting for 'the perfect trial'? There isn’t one. But there are a hundred. You just gotta look.
Don’t wait. Don’t hope. Go find your key.
That’s all.
Jonathan Gabriel
So let me get this straight - we’re now running cancer trials like it’s a dating app: 'Swipe right if you have KRAS G12C.'
And the worst part? We’re calling this 'progress.'
Meanwhile, the same companies that built this system are patenting the tests, charging $5,000 a pop, and then acting shocked when people can’t afford them. Oh no! The market didn’t account for poverty? How tragic.
And don’t even get me started on 'dynamic eligibility.' That’s just corporate speak for 'we’ll change the rules after you’ve traveled 300 miles and missed two weeks of work.'
AI says it found a new biomarker with 89% accuracy? Cool. But did it account for the fact that 40% of Black patients get misdiagnosed because the training data was 90% white? No. Because that’s not in the algorithm. It’s just numbers.
And the 'one-size-fits-all' model? That was never the problem. The problem was that we never gave everyone the same shot to begin with.
Now we’re just making the exclusion look smarter.
It’s not precision medicine.
It’s precision exclusion.
And I’m tired of being told to be grateful for a system that only works if you’re lucky enough to be born with the right genes - and the right bank account.
Also - typo: 'pharmacodynamic' is spelled right but nobody knows what it means. Just say 'does the drug work in your body.'
Language matters. Especially when your life depends on it.
Don Angel
I just want to say - thank you for writing this.
My sister was told she didn’t qualify for a trial because her liver enzymes were 'slightly elevated.'
She was 52. She walked every day. She cooked for her kids.
They didn’t ask if she was in pain. They didn’t ask if she’d been on chemo for 18 months.
They just looked at a number.
And now she’s gone.
I don’t hate science.
I hate systems that turn people into data points.
And I hate that we don’t fix it.
So thank you.
For saying it out loud.
And for reminding us - it’s not just about the biomarker.
It’s about the human behind it.
benedict nwokedi
Let’s be honest - this whole biomarker thing is a distraction.
Who really benefits? Not patients.
Big Pharma. The FDA. The labs. The data brokers.
They’ve created a system where you need a genetic passport just to live.
And the real agenda? To make cancer a subscription service.
Every test. Every scan. Every 'personalized' drug - all billed separately.
And if you don’t have the right mutation? You’re not a patient. You’re a liability.
They don’t want to cure cancer.
They want to monetize it.
And the 'equity' talk? That’s PR for investors.
Meanwhile, your insurance denies the test. Your doctor says 'we don’t have the kit.' Your town has no lab.
So you die quietly.
And the stock price goes up.
It’s not science.
It’s surveillance capitalism with IV drips.
And if you think AI is going to fix this? Please.
AI was trained on the same biased data that got you excluded.
It’s not smarter.
It’s just faster at locking you out.
Wake up.
This isn’t medicine.
This is a prison built with DNA.
deepak kumar
As someone from India, I’ve seen both sides - the hospital with the latest NGS machine and the village clinic where they still use paper records.
But here’s what I’ve learned: the science is not the problem. The system is.
My cousin had an EGFR mutation - but the test cost more than his monthly salary.
So we went to a nonprofit trial site that partnered with a U.S. lab - and they did it for free.
It took 12 days. He got the drug. He’s alive today.
So yes - biomarkers matter.
But so does compassion.
And so does pushing for partnerships.
Don’t wait for the system to fix itself.
Find the people who are already fixing it.
Nonprofits. Global health NGOs. Academic hubs.
They exist.
And they’re not waiting for your permission.
So don’t wait either.
Ask. Push. Call. Email.
One person can change the path for another.
And that’s the real biomarker - human connection.
Not DNA.
Heart.
Dave Pritchard
I work with families every day who are scared, confused, and overwhelmed.
This article? It’s a lifeline.
But here’s what I tell them: You don’t have to understand all the jargon.
You just have to ask three questions:
1. 'What tests can we do?'
2. 'What happens if we don’t do them?'
3. 'Who pays?'
And if they say 'we don’t know' - go somewhere else.
There are people who care. There are trials that will take you.
And even if you don’t qualify today - you might tomorrow.
Keep checking ClinicalTrials.gov.
Every week, new trials open.
Every month, new markers get approved.
You are not behind.
You are not broken.
You are still in the game.
And you deserve to know your options.
So keep asking.
Keep pushing.
And don’t let anyone make you feel small for wanting to live.
You’re not just a patient.
You’re a person.
And your life matters.
Always.
kim pu
Okay so like - biomarkers are just the new witch hunts, right? 🤡
‘Oh, your tumor has a KRAS mutation? That’s a red flag. Bye!’
Meanwhile, my aunt had ‘bad’ markers but lived 7 years on chemo while the ‘perfect’ patient died in 4 months.
Science is a suggestion, not a sentence.
Also - why do they always say ‘personalized medicine’ like it’s a spa day? I’m not getting a facial. I’m fighting to breathe.
And ‘dynamic eligibility’? Sounds like they’re just changing the rules because they can’t recruit enough people who fit the original fantasy.
Also - why is ‘MSI-H’ spelled like a secret code? Can we just say ‘tumor is glitchy’? That’s what it is.
And who decided that ‘performance status’ means ‘you have to walk’? What if you’re paralyzed but your brain’s fine? Are you just… not eligible?
Also - why is it always ‘you need to try two chemo drugs first’? What if those chemo drugs killed your kidneys? Do you just… die slower now?
This isn’t medicine.
This is a video game where the devs forgot to code for the people who don’t look like the demo character.
And I’m so tired of being told to be grateful for the crumbs.
Give us the whole damn cake.
Or at least stop pretending the crumbs are a five-star meal.
Also - I spelled ‘biomarker’ wrong on purpose. Just to mess with the system. 😘