A review of clinical trials lawsuit king Alan Milstein's Web site.
A Clinical Trials Litigation Web Site
Alan Milstein is the king of U.S. clinical trials lawyers. He has pursued several high-profile cases, including those brought against the Fred Hutchinson Cancer Research Center (Seattle, WA), the University of Pennsylvania (the Jesse Gelsinger case), and the University of Oklahoma Health Sciences Center. Click on his law firms Web site (sskrplaw.com/gene/) for clinical trials litigation, and you will be introduced to the actual lawsuits for these cases. They are fascinating examples of the myriad good clinical practice problems that can occur at a clinical study site.
Much more about good clinical practice (GCP) can be found at this Web site. It features numerous documents and commentary on studies and experiments:
The site has links to bioethics organizations, a bioethics chronology prepared by Milstein, and a section on the Gelsinger case that describes three popular myths of human experimentation (according to Milstein):
Risk. The purpose of a clinical trial is to benefit medicine and science at little or no increased risk to the subject.
Oversight. Somebody is watching. Investigators are watched by institutional review boards (IRBs); IRBs are watched by the Office for Human Research Protections (OHRP); the OHRP is watched by the Food and Drug Administration (FDA); the FDA is watched by the Department of Health and Human Services (DHHS); and the DHHS is watched by Congress.
Informed consent. The informed consent document shows evidence that informed consent was given.
This Web site should be mandatory reading for those being trained in GCP, as it includes more material on the topic than most books do. Although there is a decided slant to the coverage, its selection and inclusion of historical events and documents makes it a valuable tool for understanding how and why we have instituted various protections, imperfect as they are, for conducting clinical studies.
Douglas R. Mackintosh, DrPH, is president of GCPA, Inc., 12208 Fairfax Station Road, Fairfax Station, VA 22039, (703) 988-9080, fax (703) 988-9082, email: GCPAudits@aol.com, hometown.aol.com/GCPAudits.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.
Funding Cuts Threaten Diversity in Clinical Research
June 27th 2025In this video interview, Kyle McAllister, co-founder, CEO, Trially, discusses how recent federal funding cuts are likely to undermine research focused on underrepresented populations, and why long-term investment in community-based studies is essential to closing persistent health equity gaps.
Pfizer Reports Strong Phase III Results for Hympavzi in Hemophilia Patients with Inhibitors
June 26th 2025The Phase III BASIS trial found that once-weekly subcutaneous Hympavzi reduced treated bleed rates by 93% in patients with hemophilia A or B with inhibitors, offering a promising new prophylactic option for a population with limited therapeutic choices.