Dr. Lindsay McNair, MD, MPH, MSB | Chief Medical Officer, WCG

Dr. Lindsay McNair has extensive experience in the pharmaceutical industry. Prior to joining WCG, she was a consultant to pharmaceutical and biotechnology companies, providing medical guidance on clinical development strategies and study designs for new drug studies, and medical oversight of all phases of clinical trials. Dr. McNair teaches graduate-level courses on the scientific design of clinical research studies. She has been actively involved in IRB work for 18 years, and has a Master’s of Science in Bioethics with a concentration in research ethics.

  • How do I establish an IRB for reviewing clinical trials?

    How do I establish an IRB for reviewing clinical trials?

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  • Should we create a protocol deviation for an unscheduled visit?

    Should we create a protocol deviation for an unscheduled visit?

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  • Question: Can participants be reconsented over the phone when an ICF is updated?

    Question: Can participants be reconsented over the phone when an ICF is updated?

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  • Question: What are ethical considerations for a trial with a pre-study washout period?

    Question: What are ethical considerations for a trial with a pre-study washout period?

    We are working with a sponsor on the design and conduct of a double-blind placebo-controlled study of an investigational new drug for Alzheimer’s disease. The study design includes a one-month...

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  • Question: Is IRB review required for survey results that may be published?

    Question: Is IRB review required for survey results that may be published?

    I am working with a for-profit company to develop survey questions for patients who have a specific illness. Without IRB approval I may not be able to publish any results; but, getting IRB approval or

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  • An Introduction to Ask the IRB Experts Forum

    An Introduction to Ask the IRB Experts Forum

    Clinical research is complicated. At WCG, we get questions about clinical research all the time— from researchers, from clinical team members at biopharma companies, from members of institutional...

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  • Question: Do sponsors have to change their informed consent documents?

    Question: Do sponsors have to change their informed consent documents?

    I work for a small biotech company. We’ve been hearing some of our investigators talk about a new regulatory requirement for informed consent documents that includes a summary section in the front...

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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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  • Recommendations for Study Sponsors on Informed Consent Documents

    Recommendations for Study Sponsors on Informed Consent Documents

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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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  • Removing Barriers: Reimbursement and Compensation for Participation in Oncology Clinical Trials

    Removing Barriers: Reimbursement and Compensation for Participation in Oncology Clinical Trials

    The impact of participant payments on clinical trial recruitment.

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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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  • Citizen Ethicists: Does moving protocol review into the hands of potential participants provide adequate protections?

    Citizen Ethicists: Does moving protocol review into the hands of potential participants provide adequate protections?

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  • Not Like Everyone Else: Unique Challenges for Small & Emerging Biopharma Companies

    Not Like Everyone Else: Unique Challenges for Small & Emerging Biopharma Companies

    Small and emerging biopharmas are conducting almost 50% of clinical trials in the U.S., often with lean teams, resources and infrastructure. Learn how to reduce the pressure on teams and timelines.

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  • Do the Right Thing: Unique Ethical Issues in Oncology Research58:17

    Do the Right Thing: Unique Ethical Issues in Oncology Research

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  • Fifty Years of Change: Henry K. Beecher and Protecting Human Subjects1:00:34

    Fifty Years of Change: Henry K. Beecher and Protecting Human Subjects

    In June of 1966, physician-researcher Henry K. Beecher published a paper entitled “Ethics and Clinical Research.” Explore the history and motivation that led to Dr. Beecher’s ground-breaking paper.

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  • Early Access to Investigational Drugs: Lessons Learned from Ebola56:02

    Early Access to Investigational Drugs: Lessons Learned from Ebola

    Learn about the regulatory framework that governs the use of investigational drugs outside clinical trials (formerly called “compassionate use”), and the ethical challenges surrounding it.

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  • Clinical Data Disclosure: The Complicated Efforts to Make Research Transparent56:14

    Clinical Data Disclosure: The Complicated Efforts to Make Research Transparent

    Learn status of the requirements and recommendations for data-sharing from EMEA, FDA and PhRMA, and how to determine the steps to navigate the complicated field of data transparency compliance.

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  • Clinical Trial Recruitment Practices: The Evolution of Ethical Considerations

    Clinical Trial Recruitment Practices: The Evolution of Ethical Considerations

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