Clinical Trial Malpractice

Clinical trials play a critical role in advancing healthcare and ensuring that new treatments meet rigorous standards before reaching the public. While clinical trials employ unproven treatment methodologies, they nonetheless are subject to strict rules and regulations, in part to ensure that the people involved in such trials do not suffer undue harm. Regrettably, healthcare providers conducting clinical trials do not always abide by the proper procedure and standards, and their carelessness often harms the trial participants. If you suffered losses due to the negligence of a healthcare professional during a clinical trial, you may be able to recover damages in a clinical trial malpractice lawsuit, and you should speak to an attorney. The knowledgeable Baltimore medical malpractice attorneys at Arfaa Law Group are adept at navigating complex matters, and we can aid you in seeking the full amount of damages recoverable under the law.

Clinical trials are systematic research studies that assess the safety, efficacy, and potential benefits of new medical interventions in humans. These trials progress through phases, from small-scale safety assessments to large-scale efficacy evaluations, followed by long-term monitoring. Clinical trials are typically subject to stringent regulations and oversight by research ethics committees and regulatory agencies. These oversight mechanisms are in place to prevent malpractice, protect participants, and ensure the scientific validity of the research. Clinical trial malpractice can still occur if individuals or organizations involved in clinical trials do not adhere to these regulations and ethical standards, however, or engage in negligent behavior that harms participants. For example, the failure to provide participants with clear, comprehensive, and understandable information about the trial, its risks, and potential benefits or coercing participants into participating can be considered malpractice. Neglecting to monitor participants' health and well-being during the trial can lead to adverse events and insufficient medical care and can be a form of malpractice as well. Similarly, insufficient oversight and delays in addressing safety concerns can result in harm to participants and may give rise to a malpractice lawsuit.

People harmed by clinical trial malpractice will often pursue damages in a civil lawsuit. To recover compensation in a medical malpractice claim, the plaintiff will generally need to prove the defendant’s negligence. In Maryland, to prove the negligence of a defendant healthcare provider, the plaintiff needs to demonstrate that the defendant owed them a duty of care. Generally, this duty arises out of the doctor-patient relationship. The plaintiff then must show that they breached the duty owed by violating the applicable standard of care. In other words, the plaintiff must offer evidence demonstrating that the defendant deviated from what a reasonably competent healthcare provider would do under similar conditions. Finally, the plaintiff must show they suffered actual harm and establish a causal connection between the breach of the standard of care and their injuries. In other words, they need to prove that the healthcare provider's actions or negligence directly caused their losses.

In Maryland, it's typically necessary to provide expert testimony from a qualified medical expert to help the judge and jury understand the medical aspects of the case and to establish the breach of the standard of care and causation.

Maryland has a statute of limitations that limits the time within which a party can file a medical malpractice lawsuit. The time limit may vary depending on the specific circumstances out of which the harm arose; as such, it is essential for anyone harmed by a negligent provider to consult with an attorney to determine the applicable deadline.

Clinical trials allow for advances in medicine while providing patients with conditions that are challenging to treat potentially curative care. Unfortunately, errors and oversights during the administration of clinical trials can cause significant emotional and physical trauma and, in many cases, constitute malpractice. If you suffered losses due to clinical trial malpractice, it is wise to confer with an attorney about your rights. The skilled Baltimore lawyers of Arfaa Law Group understand the damage preventable medical errors can cause, and if we represent you, we will fight to help you seek a just outcome. We regularly represent people in medical malpractice lawsuits in Baltimore, where our office is located. You can reach us at (410) 889-1850 or through our online form to set up a meeting.