By Kevin Quinley, Quinley Risk Associates, LLC
Springtime brings March Madness and the college basketball championships. No championship trophy awaits top CROs, but the fruits of victory will go to CROs that build strong risk management systems and that have financial protection against liability claims. Amid increasing litigation, CROs face liability claims and lawsuits from subjects who assert injury due to a clinical trial going awry. To protect themselves, CROs need the safety net of liability insurance coverage.
To get the best deal on liability insurance coverage, CROs must demonstrate the presence of sound risk management programs. Insurance underwriters are the gatekeepers who decide on the availability and cost of CRO insurance coverage. They may demand substantial information for their risk assessment process. CROs that can showcase strong safety programs can “sell” themselves as a desirable risk and leverage the best deal for financial protection. Here, the best deal means the broadest insurance coverage at the lowest cost.
What will underwriters look for? What risk management features can CROs spotlight to position themselves in the best light? Here are seven factors to consider:
1. Informed consents. Have these reviewed by legal counsel to ensure they are clear and comprehensive. Beyond the wording and drafting, the process of presenting informed consent forms to subjects must be informative and elicit consent. Those delivering informed consents to subjects must be properly trained. Informed consents cannot be too brief or too detailed. If they are too short, plaintiff attorneys will argue that you cut corners. If they are too detailed, the same attorneys will claim you drowned out the true message in a sea of minutiae. It is a balancing act. Further, informed consents should avoid technical, legal, and medical jargon that most subjects will not understand. With the growing prevalence of clinical trials in international settings, translations of informed consents are crucial to ensure that risks and potential benefits are clearly communicated.
2. Patient recruitment practices. CROs must see that patient recruitment processes are bulletproof. In court, plaintiff attorneys will try to portray a process that plays fast and loose with patients, taking in subjects that do not fit the profile needed in order to “hit the numbers” or to gain recruitment bonuses.
3. Quality investigators. Astute underwriters may probe the following aspects:
Have you selected qualified physicians to fulfill the investigator roles?
When you identify noncompliance incidents, do you take prompt action?
Does the CRO stop using investigators with known compliance issues and avoid using those with prior “baggage?”
Does the CRO thoroughly vet investigators and conduct due diligence in selecting them?
4. Clear roles and responsibilities. Clinical trial outsourcing is a growing phenomenon. This fact makes it critical for CROs to outline all roles and responsibilities in their agreements with other parties. If an adverse outcome arises, the division of labor codified in documentation may become crucial. In serious situations, it may not be immediately clear how something happened or who is responsible. Responses in addressing adverse subject outcomes must be collaborative. Insurers underwriting CROs will seek clarity in contracts spelling out just what the role of the CRO is and is not.
5. Claims history. Has the CRO had any prior liability claims or lawsuits? If so, what did they cost? Were any litigated to conclusion or were they settled? How recent or aged are the closed claims?
6. Regulatory baggage. What has been the relationship between the CRO and the FDA? Have there been any regulatory actions against the CRO?
7. Risk management infrastructure. Does the company have a full-time risk manager? Does the CRO view adherence to FDA guidelines as the “end all and be all” of risk management or realize that meeting FDA guidelines represents merely a floor, not a ceiling?
Savvy CRO managers and executives will put themselves in the shoes of insurance underwriters and ponder the features that go into differentiating good risks from poor risks. Using these considerations as specifications in building your risk management program will yield dividends in the form of lower costs and broader coverage for financial protection.
Kevin Quinley is a risk management specialist and principal of Quinley Risk Associates, LLC, Fairfax, VA.