You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
What happens if you have a site that requests to use an unapproved device that could be life-saving for a patient without an Investigational Device Exemption (IDE)? The device has been through the phases of clinical trials and the Sponsor is working on submitting the premarket approval (PMA). The site in question was part of that clinical trial but now the study and enrollment goal has been met and the both the site and study are closed.
Topics: Compassionate Use, IDE Studies
A group of us found ourselves asking this very question after a monitoring visit…what is the difference between a compassionate use subject and a subject who is enrolled in a study without meeting all the inclusion/exclusion criteria (planned protocol deviation)? In both cases the subject does not meet inclusion/exclusion criteria.
As always, we took it to the Federal Regulations/Guidances to see what they said.
Topics: Compassionate Use, Protocol Deviations, FDA
In March of 2014, we wrote about Compassionate use in Unapproved Medical Devices. To briefly summarize, compassionate use refers to the use of an unapproved device or drug in a single patient or small group where the condition of the patient/group is serious and there is no alternative treatment. The FDA can use regulatory discretion to determine if an investigational drug/device can be used and FDA approval is required prior to use. This clause has come under the spotlight recently with the treatment of two American health care workers and a Spanish priest with an experimental drug, ZMapp, developed by the pharmaceutical company MAPP Pharmaceuticals. ZMapp is a serum-based drug that previously had not been clinically tested in humans. It represents a number of drugs and vaccines that are currently being developed to combat Ebola, a single-stranded RNA virus that is highly pathogenic with a fatality rate of up to 90%. According to the World Health Organization, as of 16 August 2014 there have been 2240 reported cases and 1229 deaths from this disease spanning four countries in West Africa (Guinea, Liberia, Sierra Leone, and Nigeria).
Topics: World Health Organization, Compassionate Use, Animal Rule, Ebola Virus, FDA
When and how is compassionate use of unapproved medical devices allowed? The Federal Regulations explicitly state how an unapproved device should be used in a compassionate use situation by a physician. The FDA website also provides a training presentation on this topic.
Topics: Medical Devices, Compassionate Use, FDA