Should we create a protocol deviation for an unscheduled visit?
Question: Can participants be reconsented over the phone when an ICF is updated?
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...
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
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...
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...
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
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.
Looking Ahead in 2019 Whitepaper
In this paper, 17 WCG thought-leaders provide insights on what they anticipate in 2019 in clinical trial technology, regulatory changes, and scientific developments.
Removing Barriers: Reimbursement and Compensation for Participation in Oncology Clinical Trials
The impact of participant payments on clinical trial recruitment.
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.
Do the Right Thing: Unique Ethical Issues in Oncology Research
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.
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.
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.
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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