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Regulatory Update, April 2015

Wednesday, April 1, 2015

FDA seeks comments on identifying potential biomarkers important to drug development

The FDA is seeking information to facilitate development and qualification of biomarkers in areas related to human drug therapeutics. The FDA is encouraging interested groups and individuals to submit information on specific medical and biological areas in which novel biomarkers can be identified that would mean­ingfully advance drug development. The FDA encourages respondents to describe evidentia­ry considerations that are important to qualify these biomarkers for a specific context of use.

A biomarker is an objective characteristic that is measured and evaluated as an indica­tor of normal biologic processes, pathogenic processes or pharmacologic responses to treat­ment. The path to development of promising therapeutics can be enabled by the availability of biomarkers that are analytically validated and clinically qualified for a specific context of use (i.e., the manner of use, interpretation and purpose of use). Qualification is based on a body of evidence that demonstrates the biomarkers are fit for purpose in drug devel­opment and evaluation. Biomarkers that are qualified can help to progressively reduce un­certainty about the outcome of clinical devel­opment programs.

Interested readers should read the entire Federal Register notice, published Feb. 13, which provides in detail the information that must be submitted and the questions the FDA wishes to have answered in these submissions.

Submit electronic comments to http://www.regulations.gov or written comments to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. It is only necessary to send one set of written comments. To ensure the FDA con­siders your comments, submit all comments by April 14, 2015; identify comments with Docket No. FDA-2014-N-2187.

FDA draft guidance on developing drugs for treating alcoholism

The FDA has announced availability of a draft guidance for industry titled Alcoholism: Developing Drugs for Treatment. The FDA be­lieves there is a need for additional pharmaco­logic treatments for alcoholism.

Traditionally, alcoholism treatments have been assessed based on the number of patients who refrain from drinking altogether. Patients who attain and sustain complete abstinence from alcohol may be assumed to accrue clini­cal benefit. However, other patterns of drinking also may be valid surrogates for clinical benefit. This guidance provides supporting informa­tion for endpoints based on patterns of drink­ing that may be considered appropriate mea­sures of clinical benefit.

To ensure the FDA considers your com­ments on this draft before it begins work on the final version, submit written or electronic comments on the draft as instructed above by April 13. Identify comments with Docket No. FDA-2015-D-0152.

Draft NIH policy on the use of a single IRB for multi-site research

The NIH published a request for public comments on the NIH Guide for Grants and Contracts’ draft policy to promote the use of a single IRB of record for domestic sites of multi-site studies funded by the NIH.

Regulations allow institutions that partici­pate in multi-site studies to use joint review, rely on the review of another qualified IRB or establish other arrangements. However, NIH believes too few institutions involved in multi-site studies are taking advantage of this option.

Proponents of the single IRB model main­tain that review of a multi-site study by the IRB of each participating site involves significant administrative burden in terms of IRB staff and members’ time to perform duplicative re­views. Use of single IRBs in multi-site studies, on the other hand, has been shown to decrease approval times for clinical protocols and may be more cost effective.

Importantly, there is no evidence that mul­tiple IRB reviews enhance protections for hu­man subjects. In fact, the use of a single IRB may lead to enhanced protections for research participants by eliminating the problem of distributed accountability, minimizing insti­tutional conflicts of interest and refocusing IRB time and resources toward review of other studies. With regard to ensuring local perspec­tives are addressed, the assessment of a study’s risks and benefits and the adequacy of the in­formed consent should not generally require the perspective of a local IRB. Local contextual issues relevant to most studies can be addressed through the involvement of ad hoc members or consultants with the necessary specialized knowledge or expertise or by submission of in­formation by the individual site(s).

The draft policy proposes that NIH-funded institutions will be expected to use a single IRB of record for domestic sites of multi-site studies unless there is justification for an exception (see exceptions in the notice). The draft policy ap­plies to all domestic sites participating in NIH-conducted or NIH-supported multi-site studies, whether supported through grants, contracts or the NIH intramural program. By expecting all domestic multi-site studies to use a single IRB, this policy should help achieve greater efficien­cies and speed the initiation of studies across NIH’s entire clinical research portfolio.

Although the comment period already has closed, interested persons can read the com­ments that were submitted on the Office of Clinical Research and Bioethics Policy OCRBP web site.


The Regulatory Update is excerpted from Research Practitioner, Volume 16, Number 2, March-April 2015

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