Lindsay McNair
Content created by Dr. Lindsay McNair, Chief Medical Officer of WCG
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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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58:17
Do the Right Thing: Unique Ethical Issues in Oncology Research
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1:00:34
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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Clinical Trial Recruitment Practices: The Evolution of Ethical Considerations
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Looking Ahead in 2018: Insights into Clinical Research Trends from Our Experts
In this paper, WCG thought-leaders provide insights on what they anticipate in 2018 in clinical trial technology, regulatory changes, and scientific developments.
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Clinical Researcher: Getting the Right Signatures on Informed Consent Documents
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Clinical Trials and Social Media - Friends or Foes?
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56:14
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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56:02
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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To What Extent Do Risks Need to Be Minimized?
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The Science of Meetings
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