Target Health is pleased to announce that it provided advice to a local physician on how to request and obtain a Single Patient IND for Compassionate Use and that the IND has been cleared. Response from FDA was very rapid and IRB approval of the protocol is expected shortly. Target Health is managing the commercial IND that was cross-referenced in the application.
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For more information about Target Health or any of its software tools for clinical research, please contact Dr. Jules T. Mitchel or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors
TARGET HEALTH excels in Regulatory Affairs and works closely with many of its clients performing all FDA submissions. TARGET HEALTH receives daily updates of new developments at FDA. Each week, highlights of what is going on at FDA are shared to assure that new information is expeditiously made available.
Physician Request for a Single Patient IND for Compassionate or Emergency Use
When a physician would like to request an Investigational New Drug (IND) application to use an unapproved drug or other product for a single patient, the first step is to obtain permission from the manufacturer. Without the consent of the manufacturer, the unapproved product will not be available to the patient. After the manufacturer agrees to provide the product, the recommended procedure is to submit the following information to the appropriate review division. The request may be made by facsimile with a letter to follow.
Request for a single patient IND for Compassionate or Emergency Use should be stated at the top of the correspondence.
Brief Clinical History of the patient including the diagnosis, the disease status, prior therapy, response to prior therapy and the rationale for requesting the proposed treatment.
Proposed Treatment Plan including the dose, route, planned duration, monitoring procedures and modifications (e.g. dose reduction or treatment delay) for toxicity. Reference a published protocol or journal article if appropriate.
Drug Supply Reference Statement which would name the supplier or manufacturer and a statement that a Letter of Authorization to cross reference an appropriate IND of the supplier or Drug Master File (DMF) of the manufacturer is included. The treating physician must contact the supplier or manufacturer for such a statement.
Informed Consent Statement that states that informed consent and approval of an appropriate Institutional Review Board (IRB) will be obtained prior to initiating treatment. There are some IRBs that have specific procedures for approving emergency requests.
Investigator Qualification Statement that specifies the training, experience, and licensure of the treating physician. The first two pages of a Curriculum Vitae typically contain this information and are usually sufficient.
FDA Form 1571 completed with the treating physician listed as the sponsor. Form 1571 and other forms can be downloaded from the Internet.
Contact telephone number and facsimile number. If the request is approved, an IND number will be issued by the FDA and the treating physician will be contacted by phone or fax with a letter to follow. The IND is considered active upon issuance of the number. The IND sponsor (treating physician) will then contact the drug supplier and provide the IND number. The supplier may then ship the drug directly to the treating physician.
For more information about our expertise in Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.
Many individuals take vitamins in the hopes of preventing chronic diseases such as cancer, and vitamins E and C are among the most common individual supplements. A previous large-scale randomized trial suggested that vitamin E may reduce risk of prostate cancer, however, few trials have been powered to address this relationship. No previous trial in men at usual risk has examined vitamin C alone in the prevention of cancer. As a result, a study published online in the Journal of the American Medical Association (2009;301(1):(doi:10.1001/jama.2008.862) was performed to evaluate whether long-term vitamin E or C supplementation decreases risk of prostate and total cancer events among men participating in The Physicians’ Health Study II. This study is a randomized, double-blind, placebo-controlled factorial trial of vitamins E and C that began in 1997 and continued until its scheduled completion on August 31, 2007. A total of 14,641 male physicians in the US initially aged 50 years or older, including 1,307 men with a history of prior cancer at randomization, were enrolled. Active treatment included individual supplements of 400 IU of vitamin E every other day and 500 mg of vitamin C daily. The main outcome measures included diagnosis of prostate and total cancer. Results showed that during the mean follow-up of 8.0 years, there were 1008 confirmed incident cases of prostate cancer and 1943 total cancers. Compared with placebo, vitamin E had no effect on the incidence of prostate cancer (active and placebo vitamin E groups, 9.1 and 9.5 events/1000 person-years (hazard ratio [HR], 0.97 P = .58) or total cancer (active and placebo vitamin E groups, 17.8 and 17.3 cases/1000 person-years (HR, 1.04 P = .41). There was also no significant effect of vitamin C on total cancer (active and placebo vitamin C groups, 17.6 and 17.5 events/1000 person-years (P = .86) or prostate cancer (active and placebo vitamin C groups, 9.4 and 9.2/cases per 1000 person-years (P = .80). Neither vitamin E nor vitamin C had a significant effect on colorectal, lung, or other site-specific cancers. Adjustment for adherence and exclusion of the first 4 or 6 years of follow-up did not alter the results. Stratification by various cancer risk factors demonstrated no significant modification of the effect of vitamin E on prostate cancer risk or either agent on total cancer risk. According to the authors, in this large, long-term trial of male physicians, neither vitamin E nor C supplementation reduced the risk of prostate or total cancer and that these data provide no support for the use of these supplements for the prevention of cancer in middle-aged and older men.
Scientists at Karolinska Institutet and Lund University in Sweden have succeeded in inducing people with an amputated arm to experience a prosthetic rubber hand as belonging to their own 1) ___. The results can lead to the development of a new type of touch-sensitive prosthetic hands. The illusion of having a rubber hand was achieved by touching the stump of the amputated arm out of sight of the subject while simultaneously touching the rubber hand in full view of the same subject. This created the illusion that the sensory input was coming from the prosthetic hand rather than from the 2) ___, and that the hand belonged to the subjects own body. The effect was confirmed by the subjects own descriptions of the experience and by their tendency to point to the hand when asked to localize the point of 3) ___. That they experienced the rubber hand as their own was also substantiated physiologically in that they started to sweat when the hand was pricked with a needle. The study, which was carried out at the Red Cross hospital in Stockholm, opens up new opportunities for developing prosthetic hands that can be experienced by wearers as belonging to their own bodies, which would be a great benefit to patients and which is considered an important objective in applied 4) ___ . Well now be looking into the possibilities of developing a 5) ___ hand that can register touch and stimulate the stump to which its attached, says Henrik Ehrsson, one of the researchers involved in the study. If this makes it possible to make a prosthetic sensitive by cheating the brain, it can prove an important step towards better and more practical prosthetic hands than those available today. The study is part of the EUs SmartHand project, which is administered from Lund University. The objective of the SmartHand project is to develop a new type of thought-controlled prosthetic hand with advanced motor and sensory capabilities.
ANSWERS: 1) body; 2) stump; 3) stimulation; 4) neuroscience; 5) prosthetic