Lindsay McNair

Content created by Dr. Lindsay McNair, Chief Medical Officer of WCG

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

The impact of participant payments on clinical trial recruitment.
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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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Returning Study Results to Research Participants

Studies show clinical trial participants want to know what was learned from their involvement. Many sponsors are implementing plans to deliver plain language summaries to trial participants.
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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
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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

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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Clinical Trial Recruitment Practices: The Evolution of Ethical Considerations
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Clinical Trials and Social Media - Friends or Foes?
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To What Extent Do Risks Need to Be Minimized?
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The Science of Meetings
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Practical Ethicist: Assessing Research Benefits
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Simplifying Complexity
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Scientific Review by the Ethics Committee
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Role of Statistician
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IRB Authority
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Equitable Selection of Subjects
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Lindsay McNair

Single-Patient Expanded Access: WIRB experience in 2018

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

Recommendations for Study Sponsors on Informed Consent Documents

Virtual Clinical Trials Best Practices

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

The impact of participant payments on clinical trial recruitment.

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.

Returning Study Results to Research Participants

Studies show clinical trial participants want to know what was learned from their involvement. Many sponsors are implementing plans to deliver plain language summaries to trial participants.

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

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

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

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.

Clinical Trial Recruitment Practices: The Evolution of Ethical Considerations

Clinical Trials and Social Media - Friends or Foes?

To What Extent Do Risks Need to Be Minimized?

The Science of Meetings

Practical Ethicist: Assessing Research Benefits

Simplifying Complexity

Scientific Review by the Ethics Committee

Role of Statistician

IRB Authority

Equitable Selection of Subjects