Clinical trials are how researchers demonstrate the safety and efficacy of their investigational products (like drugs, devices, or procedures) as they seek regulatory approval and broad market acceptance. Throughout the multi-stage process, all clinical trials must manage a variety of compliance-related requirements.
Failure to manage foreseeable compliance issues can undermine the efforts of the trial sponsor and trial investigators to demonstrate both the safety and efficacy of the investigational therapy. If not properly managed and resolved, compliance issues can increase the risk that the promising new investigational intervention may not receive regulatory approval.
The ability to address these potential compliance issues before they are able to jeopardize the future of the investigational product can lead to better outcomes for trial sponsors and investigators and, ultimately, give patients access to today’s most promising new therapeutic interventions.
Trial sponsors and trial investigators must develop and adhere to strategies that address these critical requirements to enable the most beneficial outcomes. That commonly includes:
- Ensuring adherence to privacy requirements spelled out in the Health Insurance Portability and Accountability Act (HIPAA) regulations
- Gathering informed consent from trial participants
- Ensuring data integrity throughout all phases of the clinical trial and comply with current Good Clinical Practices (GCPs)
- Creating appropriate, consistent trial protocols for participating investigators, providing appropriate training for all, and communicating protocol revisions or amendments with all stakeholders in a timely fashion
- Verifying and maintaining appropriate qualifications for all sites and all trial investigators involved in the process
- Safeguarding trial participants with regard to potential safety issues, including adverse events, drug to drug interactions and more
- Avoiding or resolving all potential conflicts of interest that trial investigators may have
- Creating processes to collect and store relevant documentation and making it accessible (as required by regulators or as needed for audits and future research)
There are a variety of consequences for stakeholders when compliance issues arise within any of these areas:
- Federal exclusion or debarment
- Civil monetary penalties
- Application of criminal law
- Breach of Clinical Trial Agreement (CTA)
- Lawsuits from study participants
- Loss of funding
- Damage to corporate and brand reputation
- Missed opportunity for market entry and loss of potential earnings
Careful planning and conscientious effort are both needed to develop and adhere to a comprehensive risk management plan. Trial sponsors and trial investigators must be clear and decisive when designing and communicating the study protocol and data management plan and must provide consistent training for all trial staff. The goal is to continuously anticipate, address, and rectify compliance requirements and lapses.
A comprehensive risk management plan and a thoughtful, rigorous data gathering and documentation process can help stakeholders to recognize and reduce potential compliance risks, determine their severity, and take proactive action to mitigate and reduce those risks to acceptable levels. Today’s clinical trials must be designed to anticipate and minimize potential compliance issues in order to safeguard the health and safety of patients, protect the sponsor’s reputation, and to respond to periodic inspections and audits with no surprises or setbacks.
This blog is intended to be informational in nature. The information and other content provided in this blog, or in any linked materials, are not intended and should not be construed as medical advice, nor is the information a substitute for professional medical expertise or treatment.
If you have any questions or concerns, please talk to your doctor. Never disregard professional medical advice or delay in seeking it because of something you have read on this blog or in any linked materials. If you think you may have a medical emergency, call your doctor or emergency services immediately.