Exactly what is clinical trial coverage and what does it do? Simply said, this vital insurance is a form of errors and omissions coverage specifically designed to address the risks associated with conducting medical research.
Just as medical malpractice coverage addresses the unique risks of physicians and other medical professionals, clinical trial coverage offers security and protection against financial loss and liability coverage for injuries to trial volunteers, including no-fault compensation (where required) and other risks.
There are generally two types of clinical trial coverage. Endorsement coverage requires purchasers to buy a policy on a per medical research project basis. Endorsement policies are subject to post trial audit that can lead to additional premium.
Blanket clinical trial policies, however, cover all clinical trials. It features a one-time premium amount and reduces potential coverage gaps. To see the differences between blanket and endorsement insurance, check out the table below. Since the vast majority of organizations conduct multiple clinical trials, Dumont recommends blanket coverage.
Clinical Trial Insurance: Comparing Blanket and Endorsement Coverage
| FEATURES |
BLANKET |
ENDORSEMENT |
| Premium Charge |
One-time policy payment for all trials |
Uncertain/subject to change based on end-of- policy-period audits |
| Premium Costs |
Can be perceived as expensive |
Potential cost savings can be negated by compliance expenses and auditing adjustments |
| Audits |
None |
Collecting and presenting data adds to direct and indirect costs |
| Coverage differences per trial |
None |
New trials can be subject to coverage changes |
| Coverage gaps |
None |
Potential |
| Trial approval |
Not Necessary |
Essential |
| Timing |
Work can continue or begin at policy inception |
Delays possible due to insurance process and approval |
| Trial protocol changes |
Reporting unnecessary |
May impact coverage |
| Participant amount changes |
Does not affect coverage. |
May impact coverage |
|
