Treatment may proceed once the Institutional Review Board at the treating physician's medical center agrees and the patient has signed the appropriate informed consent forms. The physician then calls the supplier of the drug or therapy, provides the IND number, and the drug is shipped, usually by express shipping service. The physician then treats the patient according to his plan. As part of the process, upon receipt of the FDA letter, the physician is required to fill out FDA Form 1571, provided with the letter, and provide a complete copy of the original correspondence. In some cases, when treatment is extended, the physician is required to submit an annual report on the patient's progress.
Some suppliers also request a follow up report in return for providing the drug.
The Single Patient IND is a very special application because it relates to an individual patient who is confronting an immediate medical crisis. It is hoped that treatment under the Single Patient IND will be successful. However, even if the IND is granted and treatment proves successful, the company producing the drug or therapy may not find the results useful. When a physician provides a new drug or therapy in a Single User situation, the protocol may be tailored to the specific patient. It may not be applicable to the overall population of patients with the same disease.