Frequently asked questions
About care-integrated clinical trials, patient safety, and the act. Click a question to see its answer.
Care-integrated clinical trials
What is a care-integrated clinical trial?
A clinical trial built into ordinary medical care. A patient gets a screened treatment through their own doctor, and their outcome is recorded from routine medical records and pooled with every other clinic's.
The UK's RECOVERY trial worked this way in hospitals during COVID-19. In 89 days it showed that dexamethasone, a cheap steroid, cut deaths among the sickest patients by up to a third.
Why not just use existing clinical trials?
Most patients cannot join one, because eligibility rules exclude them or the nearest site is too far away. Repurposed generic drugs rarely get trials at all, because no company can recover the cost. One ten-year review found 573 existing drugs that researchers had proposed as Alzheimer's treatments.
Source: PubMed Central, PMC10512468
Are the trials randomized?
Most patients choose a screened treatment with their doctor, and their outcomes are recorded and pooled. That shows patterns quickly, but on its own it does not prove that a treatment caused the result.
Patients can also choose to join centrally run randomized comparisons, as RECOVERY did. The trial, not the doctor, assigns each patient a treatment at random. There is no placebo arm. Every published result says which method produced it.
Why do they cost less?
They use existing clinics and routine records instead of building a separate research site for each study. RECOVERY cost about $500 per patient, compared with about $41,000 per patient in the trials behind new FDA approvals (Manhattan Institute, 2023; Moore et al., JAMA Internal Medicine, 2018).
Does the initiative tell patients which treatment to choose?
No. Treatment decisions belong to patients and their doctors. We explain the evidence and the research methods, and give no medical advice.
How can I help?
Add your name, or endorse the initiative as an organization. Clinics, researchers, data partners and funders can also partner with us.
Safety and data
Who decides a treatment is safe enough to offer?
An independent review board of 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. The board also approves each clinic and consent form.
What happens if something goes wrong?
Serious side effects reach the board within days, and the board can pause new patients until the problem is resolved. Current patients can continue if stopping would be riskier. Every protocol is reviewed at least once a year.
Are bad results published?
Yes. Each board publishes a yearly report for each protocol, including results that were bad, null or unclear. Boards may not leave them out.
What happens to patients' data?
Medical records stay with the patient's clinic. Outcome reports carry a coded ID, not a name, and are published only de-identified. Small groups are combined so no one can be identified.
The act
Who can get treatment under the act?
Any patient whose doctor recommends a screened treatment and records the clinical reason in the medical record, with written informed consent. A patient does not need a life-threatening illness, to be unable to join a trial, or to have used up approved options first.
Which treatments qualify?
A treatment qualifies in one of four ways. It has passed Phase I or comparable early testing in people. It has a documented record of safe use in people, including evidence gathered under regulators on the World Health Organization's published list. It is built on a well-understood biological method, such as a genetic treatment made for one patient, with supporting lab or animal data and a safety review every six months or every ten patients. Or, for a device, it has been studied under FDA device rules, is judged not significant-risk, or is authorized by a qualifying regulator.
Schedule I drugs never qualify.
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 share outcome data.
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.
Does the act change a patient's regular insurance coverage?
No. Insurers do not have to cover experimental treatment under the act, and coverage mandates and network rules do not apply to it. Coverage for everything else stays the same, and insurers may choose to pay.
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 reports only 21 investigational drugs used under the law from May 2018 to December 2024. 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.
Who is liable if something goes wrong?
The bill protects doctors, clinics and review boards that take part in good faith from liability under state law, except for gross negligence, reckless or willful misconduct, fraud, or concealing safety information. 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.
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 clinic and protocol. The consent form states the cost and that the treatment is experimental. Serious side effects can pause new patients. Every result, including failures, is published, so a clinic cannot hide poor results.
Doctors and clinics
What does this cost a small practice?
Taking part is optional. A practice can show competence with a statement from its medical director. The outcome record uses what is already in the chart: boards must accept medical records, and no one may require duplicate entry. The practice can let its electronic health record, a central sponsor or a contractor submit for it.
Trials through ordinary care pay practices for consent, treatment, follow-up and data submission.
Does the act stop the medical board from disciplining bad doctors?
No. The state keeps its authority over gross negligence, incompetence, exploitation, fraud, concealment and practice outside lawful scope. It cannot discipline a doctor merely for recommending or giving a treatment the act permits.
Still have questions?
Email hello@acceleratedmedicine.org, or tell us how you would like to work with us.