By Justin Yamashita, MSc. Benchtop, site, CRO: three levels of basic and clinical research, explained without spin.

Clinical trials are a last resort for the desperate, reserved for people who've run out of standard options, and there's no real way to find one anyway.

The myth didn't come from nowhere. Decades ago, early-phase cancer trials mostly did enroll patients who'd exhausted standard treatment, and that history is part of how 'last resort' became common wisdom passed between patients. For a long time, finding a trial that existed outside your own doctor's network was also genuinely hard: there was no single required public list. Both of those things used to be true. Neither one still is.

And now, as an oncology project manager, I have seen the industry have issues where studies cannot meet timelines and run out of funding for the project, or it takes longer for the clinical trial to enroll its full complement of patients because people don’t know about clinical trials and miss the opportunity, or people are afraid or have disdain for the pharmaceutical industry, which is only a part of the clinical research pipeline. By learning what this is all about, you can help share the word, we can enroll studies faster, and hopefully be a part of bringing more potentially life changing therapeutics to market.

Am I seeing the full picture, or only part of the evidence?

o   Trials exist for every stage, including newly diagnosed patients and prevention, not only people out of options. Such as the clinical trials I run in oncology, we look at first line treatments (for people who haven’t been treated for that cancer yet), or second line treatments (for people who have tried one medication already and need to try another). You may see study titles say “treatment naïve” for first line, or “previously treated” for second line.

Who funded this, and do they have a stake in the answer?

o   The person selling the alternative benefits directly when you believe the real door is shut. Normally, those people are not publicly disclosing the kickbacks or affiliate link proceeds they score by getting people to buy their alternative treatments. While doctors have to report investments in pharmaceutical companies and any payments for speaking at events, etc. through the Sunshine Act (The Physician Payments Sunshine Act passed in 2010).

Am I applying the same standard everywhere?

o   You'd hesitate to buy a supplement from a stranger with no track record, then let that same stranger talk you out of a monitored, informed-consent process.

o   Or, when you use the weather app or check the weather channel, you understand when new data comes in and a forecast changes. But is the same standard being applied to research when new information comes in and scientists report updated guidance?

Rooty's shorthand for all three of those questions: does it have a receipt? There's a two-minute game by that name that walks you through spotting the difference between a claim and a proof: openlabelmedia.com/does-it-have-a-receipt-2.

1. Start at our Root to Rx centralized Clinical Trial Registries guide, a free, no-signup directory to every major registry in the world, including ClinicalTrials.gov, the U.S. government's own list. The site was modernized on June 25, 2024, so its search box is right on the homepage [1].

2. Type your condition. Add your city or state under location, and set status to "Recruiting."

3. Open a study. Read "Eligibility" to see if you fit, and "Contacts and Locations" for who to call.

4. Bring it to your doctor or a trial coordinator. You don't enroll alone. Someone walks you through it.

The same guide also covers international registries, including the WHO's portal at trialsearch.who.int, which searches many national registries at once [2].

"I can't find one" is usually "no one showed me where to look." Now you know where. And when a new diagnosis comes up, it’s okay to ask your doctor about clinical trial options, or to look yourself and bring it to them.

The Wall of Sam’s

Add a comment and tell me: has anyone ever told you a treatment option was "not for you" without checking whether that was even true?

You just got the dinner-table version. Forward this to the person who needs it, and you are on your way to a Series 1 card. You can help increase awareness about clinical trials, and be a part of helping prevent people from being misled by social media influencers.

Want Thursday and Friday too?

The Informed (Thursday) and The Verdict (Friday) do not come automatically. You have to turn them on yourself. It takes ten seconds and it is the only way the full week lands in your inbox. Opt-in Instructions

Try it yourself: see if you’d have caught this week's Black Box Warning costume on your own.

1)       The Skeptic Type quiz sorts you into your pattern in about two minutes: openlabelmedia.com/skeptic-type.

2)       Got Skepticism? runs any claim through the same one-question move Sam just used.

3)     Stay in the Room shows you how to disagree without a fight so that you can talk to people about these difficult topics.

The quiz and both games play in your browser at openlabelmedia.com, and I would love to see your results on social media!

[1] ClinicalTrials.gov Modernization, National Library of Medicine (nlm.nih.gov/news/Modernized_ClinicalTrials.html), effective June 25, 2024.

[2] WHO International Clinical Trials Registry Platform (trialsearch.who.int).

For educational purposes only. Nothing in this newsletter is medical advice. Talk to your doctor before making any health decision.

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Disclosure: Root to Rx is published independently by Open Label Media LLC. Views expressed are personal views of Justin Yamashita and do not represent his employer or any affiliated organization. No employer resources or proprietary information are used. Every claim is sourced from publicly available materials.

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