Clinical trials are a great way to test new treatments and advance medicine. However, when healthcare providers are not careful, they may injure patients during a clinical trial. Our malpractice lawyers are here to help protect your rights if you’re injured during a clinical trial.
What Is a Clinical Trial?
A clinical trial tests a new medicine on a smaller group of patients before it is released to the general public. Clinical trials are necessary to help determine a drug’s efficacy and safety. There are three phases of clinical trials that a medication must pass before the U.S. Food and Drug Administration (FDA) approves it.
Phases of Clinical Trials
There three phases of clinical trials are:
PHASE I
During phase I, the clinical trial is conducted on a small number of participants, typically between six and ten volunteers. The goal at this phase is to determine how human patients react to the medication. Researchers take detailed notes on the symptoms the study participants experience. Medical malpractice lawsuits during this phase are sometimes filed when sick people get sicker or even die after taking the medicine.
PHASE II
Phase II clinical trials usually include between 20 and 300 participants. During this phase, researchers may divide participants into different groups, often based on the stage of a disease that they are in. The purpose of this phase is to determine how different doses affect a variety of patient populations.
PHASE III
Phase III clinical trials may involve between 300 and 3,000 participants. Researchers compare the outcomes of the drug to other treatments. Researchers focus on how to best prescribe the drug to patients going forward.
Regulations for Clinical Trials
Clinical trials are heavily regulated due to using humans as test subjects, including by the World Medical Association’s Declaration of Helsinki. Many medical research bodies also comply with the requirements of the Good Clinical Practices Network.
Risks of Clinical Trials
Some of the risks that you might face in a clinical trial include:
- Taking a dangerous medication – Because the drugs have not been completely vetted, they may cause dangerous side effects providers are not aware of. Some drugs may cause long-term effects and complications.
- Taking an ineffective medication – By participating in a clinical trial, you may not be trying other forms of medicine that might be more effective. Your health may be adversely affected by this.
- Taking an improper dosage – You might receive an improper dosage that is way too high or too low, which can also adversely affect your health.
Signs Your Rights Might Have Been Violated During a Clinical Trial
Some signs that your rights might have been violated during a clinical trial include:
- You did not receive a proper explanation of the potential risks of the clinical trial.
- You did not receive consent forms.
- You felt coerced into participating in the clinical trial.
- Your health got significantly worse after participating in the clinical trial.
Possible Legal Remedies for Harm Caused by Clinical Trials
There may be a variety of legal remedies available if you were injured during a clinical trial, including:
Compensation Funds
Sometimes, a special compensation fund is created to provide financial compensation to clinical trial participants who sustain injuries.
Malpractice Insurance Claim
Injured participants may file a claim against a clinical trial’s malpractice insurer, such as a Philadelphia hospital’s malpractice insurance. This insurance covers injuries caused by a medical provider’s negligent care.
Medical Malpractice Lawsuit
Another option is to file a Philadelphia medical malpractice lawsuit against the party responsible for the clinical trial or the organization that is sponsoring it.
Contact the Philadelphia Medical Malpractice Attorneys at ER Legal Today
If you believe that you or your loved one was injured in a clinical trial due to a healthcare provider’s negligence, reach out to the experienced Philadelphia medical malpractice attorneys at Eisenberg, Rothweiler, Winkler, Eisenberg & Jeck, P.C. Our Philadelphia malpractice lawyers often take on the toughest cases and prevail, leading to some of the biggest results in Pennsylvania’s history. Contact us today for a free, confidential consultation to discuss your legal rights and options.
