Compassionate Use | Right-to-Try

JohnSmith

Q&A with Dr. Art Caplin on "Right-to-Try" laws and the "Compassionate Use" program.

January 15, 2016: http://www.cancernetwork.com/oncology-journal/medi...

I thought the following was useful:

Question: What advice and/or tips would you give to clinicians with terminally ill patients who have exhausted all their therapy options and are interested in trying experimental drugs? What information is crucial for them to have before moving forward?

Answer (Dr. Caplan): They need to monitor the literature to see what trials are going on and should check ClinicalTrials.gov - although that site has many problems, among them a failure to update the status of trials that may be listed as open, but actually have closed enrollment.
Visit the drug company's website, if there is one, to see what they say about compassionate use. The patient should find out the name of the Chief Marketing Officer (CMO), and requests should be made specifically to that person.

Requests ought to include all relevant medical and social data, including a statement that any treatment alternatives have been tried or, if not, why; the reasons that the patient cannot get into a clinical trial or employee assistance program; a comment on likelihood of compliance and the practicality of administering a new drug or biologic; a promise to provide information about what happens to the patient if compassionate use is granted; and all contact info for the doctor, patient, and patient's key family member.

artistatheart

good info, thanks for the hundreth time John!