Full Answer
What does investigational mean in medical terms?
An investigational drug can also be called an experimental drug and is being studied to see if your disease or medical condition improves while taking it. Scientists are trying to prove in clinical trials: If the drug is safe and effective. How the drug might be used in that disease.
What does it mean when a drug is being studied?
An investigational drug can also be called an experimental drug and is being studied to see if your disease or medical condition improves while taking it. Scientists are trying to prove in clinical trials: If the drug is safe and effective. How the drug might be used in that disease. How much of the drug is needed.
What should I know about an investigational drug before taking it?
Before you can be given an investigational drug either through a clinical trial or through expanded access, your healthcare provider must give you additional information about the potential risks and potential benefits of the drug. As promising as an investigational drug may sound.
What is expanded access to investigational drugs?
Or maybe your healthcare provider has talked to you about treating you with an investigational drug through expanded access. An investigational drug can also be called an experimental drug and is being studied to see if your disease or medical condition improves while taking it. Scientists are trying to prove in clinical trials:
What is a treatment IND?
The treatment IND [21 CFR 312.34 and 312.35] is a mechanism for providing eligible subjects with investigational drugs for the treatment of serious and life-threatening illnesses for which there are no satisfactory alternative treatments.
When did expanded access start?
In the US, one of the earliest expanded access programs was a compassionate use IND that was established in 1978, which allowed a limited number of people to use medical cannabis grown at the University of Mississippi, under the direction of Marijuana Research Project Director Dr. Mahmoud ElSohly.
What is the difference between expanded and right to access?
The criteria for a patient to be eligible to request a drug under Right-to-Try are similar to Expanded Access. But with Expanded Access, the FDA determines whether the drug has the potential for a beneficial effect in a patient and an IRB must review and approve the treatment protocol.
What is the difference between expanded access and compassionate use?
Expanded access, also called “compassionate use,” provides a pathway for patients to gain access to investigational drugs, biologics, and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions for which there are no comparable or satisfactory therapy options available outside ...
What is expanded use in clinical trials?
Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable ...
What is an EAP in clinical trials?
Expanded access is a regulatory mechanism by which an investigational drug can be made available outside of a clinical trial to treat patients with serious or life-threatening conditions for which there are no satisfactory treatment options.
What is investigational therapy?
Investigational therapies are treatments that have not yet been proven to be beneficial but are being investigated as part of a research study. They may or may not become part of accepted, standard treatment regimens.
What is right to access for investigational products?
The Right to Try Act permits/allows eligible patients to have access to eligible investigational drugs. An eligible patient is a patient who has: Been diagnosed with a life-threatening disease or condition.
What is the right to treatment?
For patients and families, this means that a person admitted to a public psychiatric hospital has a right to receive—and should receive—the standard of care delivered in any accredited psychiatric setting.
What is compassionate use treatment?
Compassionate drug use means making a new, unapproved drug available to treat a seriously ill patient when no other treatments are available. Drugs that are being tested but have not yet been approved by the US Food and Drug Administration (FDA) are called investigational drugs.
What is compassionate care treatment?
Listen to pronunciation. (kum-PA-shuh-nut yoos) A way to provide an investigational therapy to a patient who is not eligible to receive that therapy in a clinical trial, but who has a serious or life-threatening illness for which other treatments are not available.
What is the compassionate use Act?
Proposition 215, or the Compassionate Use Act of 1996, is a California law permitting the use of medical cannabis despite marijuana's lack of the normal Food and Drug Administration testing for safety and efficacy.
What is an IND for an unapproved drug?
The emergency use of an unapproved investigational drug or biologic requires an IND. If the intended subject does not meet the criteria of an existing study protocol , or if an approved study protocol does not exist , the usual procedure is to contact the manufacturer and determine if the drug or biologic can be made available for the emergency use under the company's IND.
What is life threatening in clinical trials?
Life-threatening means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted and diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival.
What is the emergency use provision in the FDA regulations?
The emergency use provision in the FDA regulations [21 CFR 56.104 (c)] is an exemption from prior review and approval by the IRB. The exemption, which may not be used unless all of the conditions described in 21 CFR 56.102 (d) exist, allows for one emergency use of a test article without prospective IRB review.
1.0 Purpose
1.1. The purpose of this policy and procedure is to describe the requirements for utilization of an investigational drug or device (test article) for treatment use.
2.0 Policy
2.1.
3.0 Definitions
3.1.1.
4.0 General Considerations
4.1. Except as described below, use of an investigational drug or device (test article) for treatment under expanded access requires review and approval by the convened IRB before treatment with the investigational drug may begin (21 CFR 312.305 (c) (4)).
5.0 Investigator procedures
5.1.1. Determine that the probable risk to the patient from the investigational drug is not greater than the probable risk from the disease or condition (21 CFR 312.310 (a) (1))
7.0 Informed Consent
7.1. Written informed consent must be obtained from the patient or patient’s legally authorized representative (LAR) in accordance with provisions of 21 CFR 50.25 and HRPP Policy 5.1 (Obtaining Informed Consent from Research Subjects).