Clinical Trial Liability Lawsuits

Why Should You Attend:

There are several types of injury that can arise in clinical trials that sponsors, investigators and staff should be aware of so that they can avoid them. Understanding the sources of risk, such as possible conflicts of interest, patient eligibility/ineligibility, informed consent and protecting patient dignity can held avoid or minimize the likelihood of errors or omissions resulting in clinical trial protocol violations and liability.

Investigators are at risk of litigation from errors of the study sponsor; at the same time, sponsors are at risk of litigation from mistakes or oversight by investigators or their staff. To protect each party from liability created by the other, a mutual indemnification by the sponsor and the institution is generally included in the clinical trial agreement.

This presentation will:

• Help you distinguish between the types of litigation in clinical trial liability lawsuits
• Identify and avoid sources of risk that can bring liability
• Gain appreciation of the importance of formal training for conducting clinical trials
• Discuss clinical trial liability insurance to ensure protection

Safeguarding trial subjects is a key priority and awareness of clinical trial liability can help preserve their rights and avoid harm. This webinar will provide inputs to protect sponsors, investigators and their staff from the cost of defending lawsuits that result from the fault of the other party.

Areas Covered in the Webinar:

• Types of litigation
• Sources of risk
• Legal duties of clinical trial sponsors
• Inventory control and defective devices
• Examples of actions considered to be fraud
• Examples of clinical trial liability lawsuits
• Insurance to provide protection

Who Will Benefit:

• Healthcare providers interested in conducting clinical research
• New clinical research coordinators
• New principal investigators
• Administrative managers in charge of clinical research
• Regulatory compliance associates and managers

Instructor Profile:

Jonathan McDermed has more than 30 years of experience in oncology, clinical research, product development, regulatory/clinical affairs and marketing in the pharmaceutical, medical device and in vitro diagnostics industries. He is a PharmD graduate of the University of Southern California and was an associate professor of clinical pharmacy at USC, assigned at the USC/Norris Comprehensive Cancer Center in Los Angeles, CA, where he was an investigator and co-investigator of Phase I-II studies of novel serotonin (5-HT3) receptor antagonists for preventing chemotherapy-induced nausea and vomiting.

He is recognized as a subject matter expert in prostate cancer diagnosis, prognosis and treatment. He was instrumental in the development and r510(k) clearance of a novel, immuno-PCR assay for quantitating prostate cancer specific antigen (PSA) serum levels in men following prostatectomy and the NADiA ProsVue PSA slope assay for identifying men at a reduced risk of clinical recurrence. He has published numerous abstracts and peer-reviewed manuscripts throughout his career and presented the results of his research studies in the US and in international oncology and urologic oncology symposia.

Topic Background:

Research, by definition, involves risks. It is up to everyone involved – sponsor, investigator, and clinical research coordinators to try to minimize those risks for subjects. Failure to do so often prompts legal action. The targets of litigation are typically investigators and clinical institutions. However, sponsors, institutional review boards (IRBs)/research ethics committees (RECs), and even patent holders of medical devices are increasingly being named in lawsuits. Because the number of malpractice lawsuits is increasing and the amount of awards has skyrocketed, it is important that investigators recognize the sources of risk and how to protect themselves through careful and ethical conduct of clinical trials.

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