Lindsay McNair
Content created by Dr. Lindsay McNair, Chief Medical Officer of WCG
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Read PostSingle-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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Read FlipbookRecommendations 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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Read PostIs 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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Read PostThe Eligibility Conundrum in Clinical Trial Protocols: FDA Issues Workshop Report
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Read PostImportance of Training Today’s Oncology Research Reviewers on Tomorrow’s Science
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Read PostCitizen 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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58:17Watch VideoDo the Right Thing: Unique Ethical Issues in Oncology Research
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1:00:34Watch VideoFifty 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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Read FlipbookClinical 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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56:14Watch VideoClinical 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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56:02Watch VideoEarly 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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Read FlipbookTo What Extent Do Risks Need to Be Minimized?
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Read FlipbookThe Science of Meetings
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Read FlipbookPractical Ethicist: Assessing Research Benefits
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