WCG Blog

Insights from the WIRB-Copernicus Group

  • 4 Tips to Bolster Your Regulatory Strategy

    4 Tips to Bolster Your Regulatory Strategy

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  • To Mitigate Placebo Response, Test, Train and Control Expectations

    To Mitigate Placebo Response, Test, Train and Control Expectations

    The placebo effect: it’s the curse of clinical trials across indications. Luckily, training patients to accurately report their symptoms has been proven to reduce placebo response.

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  • Amendments to the NIH Guidelines: Effects on Human Gene Transfer Research

    Amendments to the NIH Guidelines: Effects on Human Gene Transfer Research

    On April 25th, NIH Director Francis Collins announced the release of the amended NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. The most important take-home...

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  • 4 Recurring Risks to Consider in Early Phase CNS Research

    4 Recurring Risks to Consider in Early Phase CNS Research

    Early phase CNS research is plagued by a higher than average failure rate and complicated by a lack of discreet endpoints. So how can sponsors ameliorate their chances of success from the start?

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  • CNS Science Has Outpaced Tool Development; It’s Time to Catch Up

    CNS Science Has Outpaced Tool Development; It’s Time to Catch Up

    For the first time in decades, we’re developing CNS drugs with new mechanisms of action. Unfortunately, our measurement tools are stuck in the past.

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  • Site Score Card: Expert Tips for Moving Up the Ranks

    Site Score Card: Expert Tips for Moving Up the Ranks

    How can a site move up the selection list and participate in these trials? It’s as simple as one word: metrics.

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  • Unique Challenges for Medical Device Clinical Trials

    Unique Challenges for Medical Device Clinical Trials

    Adjudication of events of interest can support overall study integrity and ensure reliable, consistent definitions are provided to regulators and the scientific community.

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  • Single-Patient Expanded Access: WIRB experience in 2018

    Single-Patient Expanded Access: WIRB experience in 2018

    In 2018 WIRB approved 100% of the single-patient EA requests that were submitted for review.

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  • Is the Government Shutdown Already Impacting Drug Development?

    Is the Government Shutdown Already Impacting Drug Development?

    For biopharma sponsors, investigators, patients and families, these limitations are already translating into real impacts on development programs.

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  • Limited IRB Review: Are You Prepared for January 21st?

    Limited IRB Review: Are You Prepared for January 21st?

    On January 21, 2019, most federally funded research will need to follow the 2018 Requirements of the Common Rule. This post talks through the original and revised rules, and how they may apply to you.

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  • Infograph: Rethinking Patient Recruitment

    Infograph: Rethinking Patient Recruitment

    Despite advances in science, medicine and tech, 90% of clinical trials struggle to meet enrollment. We propose flipping the funnel to address site resourcing issue and convert recruits into enrollees.

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  • Germline Modification for HIV Prevention is Unjustified

    Germline Modification for HIV Prevention is Unjustified

    Daniel Kavanagh, PhD, responds to recent news of germline editing of human embryos in China.

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  • FDA Guidance: Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations

    FDA Guidance: Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations

    A brief analysis of the FDA's recent guidance on harmonizing FDA regulations with the Common Rule.

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  • Interested in Boosting Patient Enrollment and Engagement Rates for Your Next Clinical Trial? Add a Genetic Counselor to the Mix

    Interested in Boosting Patient Enrollment and Engagement Rates for Your Next Clinical Trial? Add a Genetic Counselor to the Mix

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  • Are Your Raters Undermining Your Alzheimer’s Trials?

    Are Your Raters Undermining Your Alzheimer’s Trials?

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  • Homing In On a Moving Target: Meeting the Challenges of Alzheimer’s Disease Research

    Homing In On a Moving Target: Meeting the Challenges of Alzheimer’s Disease Research

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  • Changes to Human Gene Transfer Oversight at NIH

    Changes to Human Gene Transfer Oversight at NIH

    Insights on recent NIH changes to oversight of Human Gene Transfer (HGT) research under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.

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  • Gene Therapy: New Draft Guidance Will Impact Clinical Trial Designs

    Gene Therapy: New Draft Guidance Will Impact Clinical Trial Designs

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  • The Eligibility Conundrum in Clinical Trial Protocols: FDA Issues Workshop Report

    The Eligibility Conundrum in Clinical Trial Protocols: FDA Issues Workshop Report

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  • Importance of Training Today’s Oncology Research Reviewers on Tomorrow’s Science

    Importance of Training Today’s Oncology Research Reviewers on Tomorrow’s Science

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