Right-to-Try Law

Right-to-Try Law

In 2018, the landmark Right to Try act (RTT) was passed in Congress. The bill was adopted by the US Food and Drug Administration (FDA) and was first implemented in Colorado followed by other states. This act provides a possible way for patients who have been diagnosed with life-threatening diseases or conditions who have tried all approved treatment options and who are unable to participate in a clinical trial to access certain unapproved (i.e., investigational) treatments.

Criteria for the Drug:

For an investigational treatment to be eligible under the Right-to-Try act, it must have completed the first phase of clinical trial testing. Phase I evaluates the safety and tolerability of the drug in healthy volunteers and looks at parameters such as how the drug is absorbed and eliminated, and how it affects the body. Further, for a drug to be made available under the Right to Try act, it must not be approved for any other medical uses.

Criteria for the Patient:

In order to access an investigational drug under the Right to Try act, the patient needs to meet specific criterial established by the FDA, The patient should have a chronic disease or determined to be terminally ill by his or her physician. Such end-stage diseases include advanced-stage cancer, end-stage kidney or liver diseases, autoimmune diseases, and neurological diseases like Alzheimer's or Parkinson's disease.

Criteria for the Physician:

A physician can refer the patient for treatment under the Right to Try act or a patient can request treatment from their physician upon learning about the Right to Try option. In either case, the physician allowing the access must meet strict criteria. He or she should be in good standing with the medical board and have an active medical license. Although the investigational drug in question it is undergoing testing through the standard clinical trial process, the patient seeking to use it under the Right to Try act is not enrolled in the clinical trial per se or considered a clinical trial participant. It should be very clear that the patient needs access as a last resort- having exhausted all other treatment options. As a final step, the physician must obtain written legal consent from the patient or guardian.

If you are interested in joining a study, you can use ClinicalConnection.com to search clinical trials near you and learn more about what is available.

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