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OMB Issues New Notice on Common Rule Delay

January 8, 2018

The OMB Office of Information and Regulatory Affairs (OIRA) posted a notice on its website Jan. 5  noting that OIRA is reviewing a final rule titled “Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects.” This notice follows but does not replace an October posting noting the review of a proposed final rule titled “Federal Policy for the Protection of Human Subjects: Proposed 1-Year Delay of the General Implementation Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Year” suggesting a more general delay of unknown length.  The three provisions were not specified in the listing. It’s currently unclear whether either rule will be published as a final rule before the Jan. 19, 2018, implementation date. Read the posting here: https://www.reginfo.gov/public/do/eoDetails?rrid=127821

ABPI Study Demonstrates New Record in European Clinical Trial Transparency

Drugmakers in the European Union disclosed clinical trial results within a year more than 90 per­cent of the time, according to a study sponsored by the Association of the British Pharmaceutical Industry. Covering all trials associated with more than 140 new medicines approved in the EU, the study demonstrated annual increases in the 12-month disclosure rate, up from 71 percent in 2009 to 93 percent in 2014. The rise coincided with the launch of clinical data transparency initia­tives from the European Medicines Agency. Of the 542 evaluated clinical trials, 505 were disclosed on a registry or in scientific literature within a year of first regulatory approval or completion of the trial — with 96 percent, or 518, being disclosed by the end of the study, through July 2016. The study recommends methods to improve disclosure rates and to allow trials to be tracked easier in the future, such as routine inclusion of trial registra­tion numbers in abstracts or PubMed indexing, or standardizing responsibility for publication of clinical trial data as part of the due diligence pro­cess in licensing or acquisition deals. The report, published in the journal Current Medical Research and Opinion, also suggested policymakers consider the resources wasted when duplicating efforts across trial registries. The ABPI said it plans to pursue these topics through roundtable discus­sions in 2018.

ClinicalTrials.gov Updated To Allow Better Geographic Searches

ClinicalTrials.gov has been updated to include additional local search functions, a new glossary feature and redesigned study record pages. The homepage allows visitors to limit searches to currently recruiting studies, or studies planning to recruit participants in the future. Results also can be filtered to within range of a specified city, mak­ing it easier for potential participants to find open and accessible clinical trials. The National Library of Medicine, which maintains the online database, described the changes as the first in a series. Future updates will be listed on a What’s New page. The glossary allows users to look up frequently used terms and definitions without navigating away from the page, although sponsors and investiga­tors should continue to refer to the Data Element Definitions documents for the items required for submissions, the NLM said. A new Results Submit­ted tab allows users to track the quality control review process conducted by NLM staff. Informa­tion submitted by sponsors and investigators is not posted until all major issues, including errors, deficiencies or inconsistencies, have been ad­dressed. A table of dates outlines submitted data and NLM review cycles. In addition, study record pages now contain a link to Key Record Dates for tracking milestones such as trial registration, post­ing of results and clearing QC criteria. The record page layout was also redesigned to make the most important information more prominent.

FDA to Commit to Faster Schedul­ing of End-of-Phase Meetings

In a new draft guidance, the FDA committed to faster scheduling of end-of-phase meetings with applicants, down to two weeks instead of three, while moving up deadlines for related meeting packages. The document also outlines standard­ized procedures for requesting, preparing, schedul­ing, conducting and documenting interactions with the agency. Of the four types of formal meet­ings that can be requested, Type A meetings cover important safety issues or stalled development programs, such as dispute resolution meetings, clinical holds and meetings following a refuse-to-file letter. Applicants can expect responses to Type A requests within 14 days. Type B meetings include pre-IND, -NDA or -BLA meetings; emergency use authorizations; REMS or postmarket requirements; and the meetings afforded by a breakthrough therapy designation. They are typically granted within 21 days. Type B previously included end-of-phase meetings, as well as meetings leading up to the launch of Phase III clinical trials. They are now considered “Type B (EOP)” meetings, with 14-day goals. Type C meetings, meanwhile, cover any other request from an applicant, at 21 days. During the meetings themselves, the new guidance now states that FDA policy prohibits audio or visual re­cording of discussions. FDA minutes are the official record of the meeting, which are issued within 30 days. The draft guidance on meeting requests is available here: fdanews.com/12-28-17-FormalMeetingGuidance.pdf.

INC Research/inVentiv Health Becomes Syneos Health

INC Research/inVentiv Health has changed its brand identity to Syneos Health (pronounced SIN-ee-ohs). The company’s integrated platform leverages a combination of clinical and commer­cial solutions. For example, behavioral insights are leveraged to accelerate clinical trial recruitment, and therapeutic know-how infuses multi-chan­nel commercial programs to better engage in­creasingly hard-to-reach stakeholders. All of these solutions are designed to improve the likelihood of launch success. Syneos Health common shares are expected to trade on the Nasdaq Global Se­lect Market under the new ticker symbol “SYNH” by January 9, 2018. Until then, Syneos Health will continue to be listed under INC Research Hold­ings, Inc. and the symbol “INCR.”