Tag Archives: clinical trial

Principles on Clinical Trial Data Sharing Reaffirm Commitment

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BIO member companies will honor, at minimum, the following commitments: REGISTERING CLINICAL TRIALS: BIO member companies will register all company-sponsored clinical trials conducted in patients in an appropriate public registry, such as ClinicalTrials.gov or the European Clinical Trials Database (EudraCT). SUMMARIZING THE RESULTS OF CLINICAL TRIALS: BIO member companies will post technical summary results in a clinical trials database as follows: For approved products, all company sponsored clinical trials testing both safety and efficacy in Read More >

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Successful Public-Private Partnerships

According to BayBio, biomedical companies that can harness the power of patient groups will get medicines, devices and diagnostics to market faster, cheaper and smarter, helping patients and rewarding investors. Gail Maderis, ‎President & CEO at BayBio, debuted their preliminary whitepaper entitled “Successful Public-Private Partnerships” today at the 2013 BIO Investor Forum. BayBio surveyed nearly 100 biotech and foundation CEOs, vice presidents of research, directors of patient advocacy and others across the United States. Following Read More >

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Uniting To Accelerate Pediatric Medicine

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Drug companies inherently absorb significant risk when developing compounds and biologics for clinical use. A recent article suggests that only one out of every 12 drugs that enters clinical trials succeeds and the cost of a drug successfully reaching the market now exceeds an average of $5 billion when you add up the cost of all those that failed along the way. For many indications, such as Alzheimer’s and autism, the need for new treatments Read More >

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New FDA Final Guidance on Clinical Trial Institutional Review Boards

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On Tuesday, August 27th, the FDA finalized its Guidance for Institutional Review Boards, Clinical Investigators and Sponsors on Institutional Review Board Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an Investigational New Drug/Investigational Device Exemption is Needed.  In an article published earlier today, the Pink Sheet’s Sarah Karlin summarized the goals of this guidance as strengthening human subject protection during clinical research and increasing the efficiency of Read More >

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FDA Issues Final Guidance on Clinical Trial Oversight

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The FDA released its final guidance governing clinical trial oversight and urges a risk-based approach to monitoring. The Agency builds on the main tenets described in the original 2011 draft guidance, urging drug and medical-device sponsors to utilize more remote and targeted risk-based monitoring rather than relying solely on on-site methods. The guidance provides various risk-based monitoring strategies and clarifies that while the Sponsor can transfer monitoring responsibilities to contract research organizations (CROs), the CROs Read More >

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