The Risks and Rewards of Clinical Trial Participation
It is not uncommon to turn on the radio or TV and hear an invitation to participate in a clinical trial that offers hope for an annoying — or serious — condition with no current cure. These trials are essential in advancing medical knowledge and can bring relief to some participants. Still, while these rewards are often worthwhile, the potential risks can be devastating.
When participants suffer injuries as a result of a clinical trial, they may or may not have legal recourse. Our Charlotte medical malpractice lawyers believe these injuries require further evaluation.
How Clinical Trials Work
Anyone considering participating in a clinical trial should begin by carefully reviewing all of the information provided at ClinicalTrials.gov, but the following information provides a high-level overview of the process:
• After screening applicants for eligibility, the qualified group receives extensive information about the trial, including the reasons for the trial, what participants are required to do — and, of course, any known risks.
• Participants must sign an Informed Consent document as a condition of participation. This document essentially confirms that the participant was educated, understands the information, and knows the possible risks, benefits, and treatment alternatives. The document does not represent a contract, however. Participants can leave the trial at any time.
• The actual trial process is monitored by any number of federal agencies, and participants typically continue their relationships with their usual health care providers.
Informed Consent Does Not Waive all Rights of Participants
Most teams that conduct clinical trials have good intentions and are guided with an eye toward patient safety and ethical treatment. Still, even individuals who believe they were well-informed when agreeing to become a clinical trial participant can sustain injuries they did not expect for many reasons, such as the following:
• Side effects that were not predicted within the original training
• Unexpected changes in a dosage that cause ill effects
• Conflicting information received by medical professionals involved in the trial
Obviously, clinical trials do not carry guarantees. Participants should understand that the medication or devices under trial may not heal their conditions and they might even cause additional harm. While the participants’ informed consent signatures can provide important evidence for the defense in legal cases, they do not automatically absolve clinical trial teams and facilities from liability.
In the event of injury caused by a clinical trial, participants should seek advice from medical malpractice attorneys who understand the intricate law behind these studies and can identify when legal options are available to participants or their families.