When a clinical trial happens, usually the company putting forth the opportunity for patients to take part in a new treatment comes with its own set of risks. However, sometimes those situations can go above and beyond what even research project managers would expect. In a situation in which one or more patients sustains critical injuries, who is responsible? What are the next steps that should be taken? These are just two of the questions that might be asked by injured victims or the loved ones of someone who has passed away in a clinical trial.
In the best case scenario, a clinical trial will show minimal risks and maximum benefits for patients, leading to the delivery of such a treatment, device, or drug on the marketplace. As is the case with the recent Juno Therapeutics clinical trial for cancer treatment for adults with relapsed acute lymphoblastic leukemia shows, however, the consequences of a clinical trial gone wrong can be devastating. In that clinical trial, five separate patients suffered cerebral edema and ultimately died as a result.
The treatment in question involves a new chance to use genetically engineered T-cells in order to attack the cancer cells of affected adults. The drug is called JCAR015 by Juno. The first two deaths in the clinical trial were believed to have been a result of an added chemotherapy treatment, fludarabine. The trial’s protocol was changed as a result of those incidents, but three other patients also sustained brain swelling that led to their deaths.
Although the FDA is involved in the clinical trial process in a few key ways, these are not clearly documented, nor are the processes behind them available to the public. This makes it challenging to answer the concern about whether or not the FDA could be held responsible for any role it might have played or failed to play in the Juno Therapeutics cancer clinical trial. When the first three cancer patients in the trial passed away early in 2016, the FDA took the opportunity to put the trial on hold. As is the case for any clinical trial, the FDA requires an investigational new drug authorization, or an IND, when a company is ready to enter the clinical trial phase. At any time during the review of the IND or the trial itself, the FDA has the chance to exercise a hold if a problem arises.
Holds, however, don’t happen that often: a recent study identified that 30 or less had been ordered among the thousands of clinical trials between 2008 and 2014. What makes the adult leukemia Juno Therapeutics cancer clinical trial interesting, however, is that the median length of an FDA hold is eight months, but Juno was only requested to stop for three days.
It’s unclear what the FDA did during those three days in order to determine that the hold should be lifted, which is raising questions around Washington D.C. and in the healthcare industry. Some experts are calling for greater transparency with patient safety at the core.
For those family members who lost their loved ones in this trial, however, there are many questions and concerns remaining. Those individuals may be entitled to recover compensation after speaking with an experienced injury attorney. Getting legal help is strongly recommended for anyone who has been injured in a clinical trial.
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