INDUSTRY NEWS
FDA has been preparing a draft guidance document on informed consent for IVD device studies using leftover human specimens that are not individually identifiable. The agency believes that such studies can be conducted using leftover specimens obtained without informed consent, while protecting the human subjects who are the source of such specimens.
“This guidance represents a significant step forward by FDA to collaborate with industry to provide a least burdensome path forward for the analysis of leftover specimens obtained during the course of human clinical trials,” says Katie M. Smith, PhD, director of medical research at Biogen Idec Inc. (San Diego). “The burden on industry appears to be minimal to moderate, and therefore does not pose a major hurdle for industry to obtain human specimens to further the development of new diagnostic tests. The IVD industry should be heartened that a reasonable compromise between the protection of human subjects and the facilitation of key research and development by industry has been established by this FDA guidance.”
Some industry analysts believe that this guidance will assist researchers in moving quickly through the development process and minimizing initial costs. While IVD companies still have to collect prospective patient specimens with Institutional Review Board (IRB) approval, as well as consent for the clinical results that are submitted for FDA approval, this guidance provides another option for earlier development.
“Requiring regulatory-approved sample collections and specimens with informed consent increases the cost of obtaining leftover samples, and, more importantly, the time to obtain these specimens,” says Richard Vincins, director of regulatory affairs at Teragenix Corp. (Fort Lauderdale, FL). “Numerous research scientists are requesting samples only for predevelopment studies or development needs that are not any part of a regulatory submission. But these research scientists are then stifled by the hurdles their own companies place on them for obtaining IRB-approved samples. Allowing the use of nonidentified samples with minimal clinical demographics and the known state of these specimens provides IVD manufacturers with immediate access to these specimens.”
Some analysts hope that the FDA guidance will address those situations in which informed consent was not successfully obtained, but could still qualify for enforcement discretion given conformance to the guidance.
“IVD study sponsors that meet the criteria for qualifying for FDA enforcement discretion will be able to obtain, more easily, access to residual or archived clinical samples for clinical validation of new tests,” says Thomas M. Tsakeris, president of Devices and Diagnostics Consulting Group Inc. (Rockville, MD). “Many patient samples may be useful in other future IVD clinical studies as stored samples. Thus it will be important for study sponsors to obtain informed consent for future uses of these samples, particularly for samples that may be associated with patients who have rare diseases or disorders. However, such informed consent may not be obtained in every case.”
Other analysts believe that providing certain additional clinical information would bolster research and development efforts, while not jeopardizing protections for patients.
“FDA is moving in the right direction, but it should take this guidance further,” says W. Jeffrey Allard, PhD, vice president and chief scientific officer at Fujirebio Diagnostics Inc. (Malvern, PA). “We already have the right to use remnant samples if we did not obtain patient-specific information. But it should be fair game to obtain remnant samples with minimal clinical data. For example, appropriate clinical data should include type of cancer, age of patient, and clinical status such as ‘newly diagnosed,’ ‘under therapy,’ ‘responding to therapy or progressing on therapy,’ etc. This level of information is essential to making remnant samples useful, and does not compromise the safety or confidentiality of the patient.”
According to FDA officials, the agency is hoping to release the draft guidance sometime during the spring. Additional information about this guidance can be accessed via the FDA Web site at www.fda.gov/OHRMS/DOCKETS/98fr/E6-73.htm.
