When coping with a serious illness, and in particular cancer, most patients and their family members will explore all possible options for treatment. When traditional options have failed, or when the cancer is notoriously difficult to treat, some patients may request to participate in a clinical trial because they are hopeful that they will have a positive outcome. While no clinical trial can guarantee results like that, clinical trials have become increasingly more common in recent years.
In fact, some states are even adopting “right to try” laws that encourage patients to try treatment options that go outside the traditional clinical trial framework. Some advocates even call for reduced safety standards in order to get medications and treatments on the market faster in the event that they could potentially help patients. However, this comes at the cost of increasing the number of patients at risk for poor outcomes like the ones observed in the recent Juno Therapeutics clinical trial for adult leukemia patients.
The FDA and Clinical Trials: What Happened in the Case of Juno
The FDA has the ability to step in at any time during the IND approval process (the application that must be submitted by a drug company or trial manager) or during the trial itself if problems arise. The FDA is equipped to use a hold in order to stop the trial until further information can be uncovered. Holds, though, are rarely used. When they are activated, as has been the case for around 30 clinical trials conducted between 2008 and 2014, the median length for the investigation is eight months.
In Juno’s case, however, the hold lasted three days. Family members of those lost in the Juno adult leukemia clinical trial and other patients in the trial now have questions about their rights and their safety. Originally, research project managers believed that the problems were caused by the use of fludarabine, an addition to the original treatment plan for chemotherapy. The trial was initially restarted after the first hold when this was removed from the treatment plan.
In November, Juno stopped the clinical trial again after two more patients suffered fatal injuries linked to brain swelling. In total, five patients died. Four of those patients had symptoms with extremely similar timelines to one another, despite the fact that they passed away at different stages in the clinical trial.
The patients in this particular trial may have had limited options for treatment, but this does not mean that all precautionary measures should be ignored or that persistent problems should not be analyzed. The family members of the lost loved ones are left grappling with the question, “Could this have been prevented?”
The Response from Juno
Juno Therapeutics has issued statements that it’s too early to know whether or not the remaining portion of the trial will be continued, modified, or canceled entirely. When clinical trials go wrong, it can seem like a bit of a gray area legally in terms of recourse options. Patients who have suffered injuries or loved ones who have lost a family member might assume they don’t have any rights and may avoid taking legal action altogether. That could be a mistake, however, as victims and family members could be entitled to compensation depending on the situation. Although informed consent materials are required by these studies, which typically outline whether or not any compensation will be offered by the company in the event of adverse events occurring as a result of the trial, this does not mean those involved in the trial’s development or management are entirely free of liability.
How Clinical Trials Work and When Liability is an Issue
Before getting to the clinical stage, research managers and product developers should go through rigorous testing and theoretical determinations before starting a trial. Furthermore, all relevant scientific information behind the trial should be presented to the FDA at the stage of the IND. If this is not followed, patients may be severely injured.
No patient or family member should have to go through the process of discovering that injuries or deaths have occurred that should have or could have been prevented. Life after discovering that a clinical trial was unsafe or that the proper procedures were not followed can be overwhelming. For patients to figure out their next steps, it can often take speaking directly with an experienced lawyer.
If you believe that a loved one’s safety has been compromised in a clinical trial, or if you have reason to suspect that pertinent materials about a drug’s safety were hidden or otherwise not disclosed to all stakeholders, you may need to talk to a lawyer about next steps. Even though clinical trials are test runs to learn more about a particular treatment’s capability to be used with humans, clinical trial managers should always have patient safety as a top priority.
Legal cases involving a clinical trial gone wrong will always raise questions about liability. They will also tend to be extremely complex, highlighting the need for an experienced lawyer. Although all the details about why five patients died in the midst of a clinical cancer trial are not out in the open yet, the entire situation calls into question the importance of understanding your rights in a clinical trial. It can be challenging to figure out next steps and to determine what rights you may have to pursue compensation.
For any victims or family members associated with the Juno Therapeutics or any other clinical trial that went wrong, time is of the essence. Getting help from a dedicated lawyer early on can help you avoid common missteps, such as being told you have no right to pursue compensation or signing off on an early settlement agreement that does not encompass the full range of losses. If you or someone you know has been involved in a risky clinical trial with severe side effects, getting help now is the best way to figure out your next steps, which might even include pursuing a legal claim with the help of a lawyer.
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