Watchdog files lawsuit against FDA to revamp informed consent, citing 150 deaths

By Melissa Fassbender contact

- Last updated on GMT

(Image: Getty/William_Potter)
(Image: Getty/William_Potter)

Related tags: Informed consent, Clinical trials, Fda

The lawsuit cites more than 150 alleged clinical trial-related deaths since 2014 with plaintiffs calling on the FDA to update current informed consent regulations.

The Center for Responsible Science (CRS) last week filed the lawsuit​ against the Food and Drug Administration (FDA) after its citizen petition was denied.

Submitted in June 2014, the petition sought an increase in protections for clinical trial participants, citing more than 150 alleged treatment-related deaths in clinical trials over the last four years.

“A lawsuit isn’t going to address the bigger issue,”​ said Jim Kremidas, executive director, Association of Clinical Research Professionals (ACRP).

“We have informed consent guidelines in place. It’s more a matter of how we implement them. Some clinical research coordinators (CRCs), principal investigators (PIs) and other site staff are very good at informed consent; others aren’t as effective,”​ he told

Kremidas added, “What’s needed are well-defined standards and the right kind training to help clinical trial professionals do an even better job protecting and serving patients.”

Plaintiff claims

The lawsuit was filed by the watchdog in addition to clinical trial participants and the father of Max Vokhgelt, who reportedly died two days after receiving an experimental cancer therapy.

The plaintiffs state that clinical trial participants “should be aware of differences in the data between preclinical animal testing and clinical human-subject experimentation,”per the case documents​.

“Because Vokhgelt has other children who he fears may need experimental cancer treatments, he also would like the FDA to mandate that drug sponsors alert people of the risks of using data from preclinical animal testing before they decide to do a clinical trial,”​ the case reads.

The two other plaintiffs – Hal Garcia-Smith and John Tessmer – have participated in clinical trials and “believe that informed consent should include warnings about the differences between animal and human testing.”

Among the deaths mentioned​ is that of a BIA 10-2474​ trial participant in 2016, following which the European Medicines Agency (EMA) released adapted guideline stressing a sponsor’s responsibility to define the uncertainty associated with the medicines tested in clinical trials.

“The recent documented failure of traditional preclinical testing to weed out deadly toxicities leaves the human recipient as the real arbiter on the safety of new medicines. Those exposed to new therapies with an unknown safety profile are the true guinea pigs,” ​said CRS President Dr. Neil Wilcox in a press release.

CRS has not responded to a request for comment as of press time.

Milstein added, “We simply are asking FDA to revise informed consent regulations to help ensure that trial participants get all of the information necessary to make an informed decision. That is the least we can do for those who are willing to take the risk to advance medical progress.”

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