The Care-Integrated Clinical Trials Act

Every patient's treatment can help the next patient. This proposed state law lets any patient get a screened, promising treatment through their own doctor, lets clinics charge enough to offer it, and publishes every result.

Any patient can get the most promising treatments through their own doctor, after independent review and with written consent.
Clinics can charge for treatment, so they have a reason to offer treatments nobody else will fund.
Every result is published, good or bad, so the next patient chooses better.

What the act does

Review: An independent board approves each treatment, clinic and consent form.
The board has at least five members: a physician, an outcomes researcher, an ethicist, a non-scientist and a member unaffiliated with the clinics and makers it reviews. None may have financial ties to the clinic or the maker. A treatment qualifies through early safety testing in people, a documented record of safe use in people, a well-understood biological method with supporting lab or animal data, or evidence specific to a device. One approval can cover many qualified clinics.
Access: A treating doctor's documented recommendation and written consent are all a patient needs.
The treating doctor records the reason for the treatment in the medical record. A patient does not need a life-threatening illness, to be unable to join a trial, or to have used up approved drugs first. The consent form covers the treatment, realistic outcomes, other options, known and unknown risks, the treatment's federal status, and what data is collected. It also says insurance does not have to pay and when the patient owes the cost. If a patient cannot consent, a legal representative can.
Payment: Clinics may charge for treatment. No insurer or state program has to pay.
The patient, family, charities, employers, research sponsors, and insurers that choose to can pay. The consent form says insurance does not have to pay and when the patient owes the cost.
Safety: Serious side effects are reported within five days, and an unresolved safety finding stops new patients.
Reports go to the board and the state health department. The board must also reassess if a trial of the same treatment elsewhere stops for safety. Current patients can continue only if their doctor and the board decide stopping is riskier. Every protocol is reviewed at least once a year.
Results: Every outcome is reported in one open format and published, de-identified.
Each board publishes a yearly de-identified report for each protocol, including bad, null and unclear results. Small groups are combined, so no one can be identified.

A trial built into everyday care saved a million lives

RECOVERY was built into normal hospital care across the UK's National Health Service. Any hospital could enroll patients during their care, with little extra paperwork, and outcomes came from routine health records.

89 days
to show that a cheap steroid cuts deaths among the sickest COVID patients by up to a third. Typical trials take years.
4
treatments found that save lives, out of more than a dozen tested side by side.
$500
per patient, 82 times less than the $41,000 of a typical trial.

Sources: RECOVERY Collaborative Group, New England Journal of Medicine, 2021; NHS England, 2021; Manhattan Institute, 2023; Moore et al., JAMA Internal Medicine, 2018.

Common questions

Who pays, and what does it cost the state?

No insurer or state program has to pay. The patient, family, charities, employers, research sponsors, and insurers that choose to can pay.

Clinics may charge for treatment, so they have a reason to offer new treatments, and one board approval can cover many clinics. Other ways to pay include installments or memberships, crowdfunding, patient-aid groups, free supply from the maker, and lower prices for patients who agree to share more data than the required outcome record.

Running the act costs the state about $200,000 to $500,000 a year by our estimate, with a planning figure of $300,000. It is not an official fiscal note. The state pays for no treatment, runs no trial platform or database, and licenses no facilities. Review-board fees, $500 to register and $250 a year, offset part of the cost.

How is this different from the federal Right to Try law?

The federal Right to Try Act (2018) lets a patient with a life-threatening illness, who has used up approved options and cannot join a trial, ask a maker for a drug that has passed Phase I and is still in development. The maker does not have to agree, may charge only its direct costs, and sends the FDA a yearly summary of doses supplied, patients treated, uses, and serious side effects and their outcomes, but not whether patients improved. The FDA's yearly reports list only a handful of drugs given this way. It does not cover drugs already approved for other conditions.

Under this act, any patient whose doctor recommends a screened treatment and records the reason can get it with written consent, clinics can charge for it, and every result is published.

Source: FDA, Right to Try annual reporting summary

Who is liable if something goes wrong?

The bill limits liability under state law for the people who review, provide or give a treatment under the act. The limit does not cover gross negligence, reckless or willful misconduct, intentional harm, fraud, concealing safety information, or a material violation of the act. Makers of the treatments stay liable under ordinary state law. Federal law still applies, and the federal Right to Try law's protections cover only patients who meet its rules.

Does it replace randomized trials?

No. The bill also lets ordinary doctors enroll patients in centrally run randomized trials, as RECOVERY did, alongside treatments an independent board has screened.

Could clinics exploit patients by charging for experimental treatment?

Unproven stem-cell clinics show why people worry about this. The act answers it four ways. The board approves each protocol and each clinic that offers it. The consent form says the treatment is experimental and that insurance does not have to pay. An unresolved serious safety problem stops new patients. Every result, including failures, is published, so a clinic cannot hide poor results.

More background

Your state
The patients waiting in each state, and what the act would change there.
The state that went first
How one state's 2025 law opened access through licensed centers, and how this act builds on it.
Impact model
How much sooner treatments could arrive if every state adopted the act.