By Brendan Tarte, U.S. life sciences underwriter, Beazley
While in-person trials have resumed post-pandemic, much of the technology implemented remains part of the process of identifying, recruiting, and treating patients. At the same time, AI capabilities have rapidly accelerated, impacting how this and other information is collected, aggregated, and analyzed. Sponsors today are taking advantage of new opportunities to amass data sets and electronic health records (EHRs), run algorithms and machine learning processes, and translate complex data into natural language.
All of these advances promise to greatly improve the efficacy and efficiency of clinical trials, but as always, with advancements also come new risks. Let’s take a closer look at the emerging trends and associated risk considerations.
Clinical Trial Tech Trends And The Risks They Bring
Clinical trials always have required strong risk management practices, including ensuring a well-designed protocol, addressing potential risks adequately, implementing measures to protect the safety of study participants, conducting a thorough informed consent process, enduring compliance with regulatory requirements, and adhering to GCP guidelines. These remain unchanged.
However, clinical trials face a new range of risks due to technology exposures. Consider each of the following trends in clinical trial design and technology and the inherent risks they bring:
- Virtual and decentralized trials: With advancements in technology, there is a shift toward virtual and decentralized trials. This allows participants to participate in trials from the comfort of their own homes, reducing the need for travel and physical site visits. However, new risks inherent with remote trials include concern over how at-home dosing is safely managed and how sponsors and/or institutions are ensuring the accuracy and security of the data that is collected.
- Wearable devices and remote monitoring: Wearable devices such as smartwatches and fitness trackers are being used to collect real-time data on participants’ health and activities. This enables continuous monitoring and provides researchers with more real-time and detailed information. In addition to concern over maintaining proper security and thinking about vulnerabilities driven by the technology and its potential failure, trial sponsors and coordinators must also consider how to identify and respond to adverse events when patients are not monitored in person.
- Digital health technologies (DHTs): The integration of digital health technologies, such as mobile apps, telemedicine, and EHRs, is facilitating remote data collection, monitoring, and communication between participants and researchers. But when relying upon third-party software, who is responsible for a security breach? Vendor management is a key concern, as is maintaining proper security and addressing potential failure of the technology.
- Big Data and artificial intelligence (AI): AI algorithms can analyze large amounts of data to identify patterns, predict outcomes, and optimize trial design and participant selection. Big Data and AI have the potential to accelerate the discovery and development of new treatments, optimize trial efficiency, enhance participant safety, and enable personalized medicine in clinical trials. However, the ethical use of associated virtual and telehealth tools and ethical concerns related to data bias are resulting risks.
- Personalized medicine: There is a growing focus on personalized medicine, where treatments and interventions are tailored to individual patients based on their genetic makeup, lifestyle, and other factors. This approach aims to improve treatment efficacy and minimize adverse effects. But risks include the ethical use of virtual tools and monitoring, as well as concerns around information privacy.
- Patient-centric approaches: Clinical trials are becoming more patient-centric, and patient input is valued to ensure that trials address their needs and preferences. Real-world evidence (RWE), data from routine clinical practice and patient experiences, is being increasingly used to complement traditional trial data, helping provide a more comprehensive understanding of treatment effectiveness and safety and enabling better targeting of appropriate patients for trials and treatments. The biggest risks here may arise from flawed data, which could lead to misidentifying participants against inclusion/exclusion criteria or incorrect data reporting.
It is important to take precautions to ensure that all new advancements are implemented with privacy protection, transparency, accountability, and ethics in mind. It is also important to have the appropriate insurance coverage in place to mitigate any potential liability.
How Risk Managers Can Ensure Proper Protection
There are several key questions that risk managers should ask themselves to ensure robust protection for clinical trials:
- How is technology used in the trial? Is it a product/service provided to others, or is it proprietary?
- How are liabilities managed via contracts and hold harmless agreements?
- What degree of patient/participant contact is involved? What medical malpractice exposures are present?
- Will telehealth services, such as remote monitoring, be utilized?
- Whose insurance policy is this? Do additional parties require coverage?
Insurance needs will vary based on these questions — and on the specific products or services within the scope of the clinical trial. Typically, risk managers should look for an insurance policy that offers some or all of the following coverages:
- Product liability insurance, which covers liability for bodily injury and property damage arising from the development and use of the study drug or medical device during the clinical trial.
- Errors and omissions insurance, which covers damages arising from services performed or advice given by the company for a fee or other remuneration in connection with a clinical trial. This frequently includes CROs, universities, or laboratories.
- Healthcare professional liability, or medical malpractice insurance, which covers liability arising from bodily injury claims by subjects from services received during a clinical trial.
- Tech errors & omissions insurance, which covers financial injury arising from a tech product or tech service used during or in support of a clinical trial. This is a growing exposure for those involved with clinical trials, as software services play an increasingly important role in participant enrollment and data analysis.
- Cyber liability insurance, which covers liabilities and losses arising from a security or data breach. These incidents could impact patient data or temporarily inhibit the insured from continuing their operations.
Brokers play an important role in advising their clients about each of these products and helping them to identify the right level of coverage; carriers should provide broker partners with regular educational materials including newsletters, webinars, videos, and blogs to ensure that they are fully cognizant of the evolving risks and options available to their insureds.
Emerging Clinical Trial Technologies Need Coverage That Keeps Pace
Trial sponsors, universities, hospitals, CROs, and IRBs are continually looking for ways to improve the efficiency, accessibility, and patient experience in clinical research, ultimately leading to better treatments and outcomes. The opportunities afforded by the recent growth in technology capabilities offer huge benefits toward this goal, making this a pivotal time for the industry. By partnering with brokers and carriers to explore options for mitigation and management of the new associated risks, life sciences companies can make the most of the latest trends in human clinical trial technology, secure in the knowledge that they are fully protected.
Note: The information set forth in this communication is intended as general risk management information. Beazley does not render legal services or advice. It should not be construed or relied upon as legal advice and is not intended as a substitute for consultation with counsel. Although reasonable care has been taken in preparing the information set forth in this communication, Beazley accepts no responsibility for any errors it may contain or for any losses allegedly attributable to this information. BZ SL 218.
About The Author:
Brendan Tarte is an underwriter for miscellaneous medical and life sciences at Beazley, a leading global specialty insurer. In this capacity, he underwrites products liability, errors & omissions, healthcare professional liability, and general liability for a wide array of clients within the life sciences industry. Clients include those involved with the supply, design, development, manufacture, and distribution of pharmaceuticals, medical devices, and biological products.
link