Theorem Clinical Research

Ethics/Regulatory

Proposed health IT strategy aims to promote innovation, protect patients, avoid duplication

Friday, April 4, 2014 12:05 PM

HHS has released a draft report that includes a proposed strategy and recommendations for a health information technology (health IT) framework, which promotes product innovation while maintaining appropriate patient protections and avoiding regulatory duplication. The congressionally mandated report was developed in consultation with health IT experts and consumer representatives and proposes to clarify oversight of health IT products based on a product’s function and the potential risk to patients who use it.

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New structure for NIHR Clinical Research Network

Thursday, April 3, 2014 11:06 AM

The National Institute for Health Research (NIHR) Clinical Research Network, which provides more than $471.4 million a year to support the delivery of clinical research studies in the NHS, has reconfigured and will be operating in a new streamlined structure.

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Congress approves one-year renewal diabetes research funding

Wednesday, April 2, 2014 01:51 PM

The U.S. Senate has approved legislation for a one-year extension of the Special Diabetes Program (SDP)—an initiative that accounts for roughly one-third of all federally funded type 1 diabetes (T1D) research in the U.S. The decision comes on the heels of the March 27 approval of the legislation by the U.S. House of Representatives, and will extend SDP funding for the National Institutes of Health (NIH) at the current level of $150 million, as part of the “Protecting Access to Medicare Act of 2014.”

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Health Research Authority business plan approved to streamline research in U.K.

Wednesday, April 2, 2014 01:44 PM

The U.K. Department of Health has approved the Health Research Authority (HRA) funding plans for HRA Assessment and Approval. This funding means the HRA will be able to reduce duplication and bureaucracy by incorporating assessments by NHS staff alongside the independent Research Ethics Committee opinion, which will result in one application, one assessment and one approval for research in the NHS in England.

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NICE seeks views on how it assesses drugs and other technologies for the NHS

Friday, March 28, 2014 03:15 PM

The National Institute for Health and Care Excellence (NICE) has begun a formal consultation on proposed changes to the way it makes recommendations on new medicines and other treatments for use in the NHS. NICE assesses the clinical and cost effectiveness of new technologies to help ensure patients have access to effective treatments and the NHS makes the best use of its resources.

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Chesapeake IRB acquires Goodwyn IRB

Thursday, March 27, 2014 09:39 AM

Chesapeake IRB has completed the acquisition of Goodwyn IRB.

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PHT launches FDA Roadmap App for patient-focused outcome measurement

Wednesday, March 26, 2014 11:44 AM

Launched by PHT, a provider of technologies used to collect patient-driven eData for clinical research, the new FDA Roadmap App is the first mobile app designed to help sponsors navigate the Roadmap to Patient-Focused Outcome Measurement in Clinical Trials, released by the FDA in conjunction with its Clinical Outcome Assessment Qualification Program. The program and roadmap highlight the process by which a sponsor should consider, choose and/or develop a patient-focused outcome measurement strategy in a clinical program.

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European Medicines Agency launches adaptive licensing pilot project

Thursday, March 20, 2014 01:03 PM

The EMA is inviting companies to participate in its adaptive licensing pilot project. Interested companies should submit ongoing medicine development programs for consideration as prospective pilot cases.

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U.K. forms early access to medicines scheme

Monday, March 17, 2014 01:41 PM

The U.K. government has announced a new scheme that aims to give patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorization.

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vfa CEO responds to German pharmaceutical policy changes

Monday, March 3, 2014 12:46 PM

The German Bundestag is implementing a number of pharmaceutical policy changes within the scope of the 14th law amending Book V of the German Social Code, including an extension of the drug price freeze to 2017.

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