Assess your practical understanding of clinical trials insurance
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Many important details (languages, wording, ..) are necessary to pass the regulatory barriers, with variations according to the countries.
We suggest you look for professional help. You will save time to focus on your candidates and your research process.
#1 Clinical trial insurance is a liability insurance
Insurance of clinical trials is typically a liability insurance that is to say it protects against claims (= with financial demands), from patients, former patients, practitioners, authorities, etc.
#2 Clinical trial insurance is compulsory
In some countries (United States, Brazil, China for example), insurance is not compulsory;
Other countries, such as the United Kingdom, New Zealand and Finland, require subscribing to a local policy but without mentioning limits;
Others, like France or Germany, require insurance for all tests, the limits being specified in the policy.
Even if not compulsory, insurance can be unavoidable if required by the local Ethics Committees.
#3 Limits of insurance can be freely chosen by the sponsor
#4 There are limits of insurance per patient & per protocol
Limits are set:
-by patient (ex 600 000 euros)
-by protocol (= per test) (ex 2 000 000 euros)
– possibly “per aggregate” (eg 3 000 000 euros) reflecting the maximum amount that the company agrees to have to pay (for example over a whole year)
#5 Some insurers refuse new molecules
New molecules, very innovative or invasive medical devices, very original research methods …:
The insurer has an aversion to unexpected cases, which prevents it from referring to actuarial tables to rate the risk (or simply accept / reject it)
#6 Certificate has to be set in the language of the country
Or more precisely in ALL the languages of the country (ex French / Dutch in Belgium).
May times the certificate is issued 1 in English 2 in the local language.
#7 Certificate must list the addresses of the centers
Some countries / some committees are satisfied with the mere mention of the number of centers, others demand the list of centers, others the addresses: Legal needs unfortunately vary a lot from country to country.
#8 In France, the Huriet law grants 10 years to introduce a claim
Victims can submit their claim for 10 years from the end of the search.
#9 In the USA, clinical trial insurance & liability insurance are equivalent
In the US, biotech companies fill a demand for classic Liability (a bit the equivalent of the Medical Liability Insurance they already benefit from).
#10 Protocol & Patient Information Letter are the sole documents needed by the insurer to quote
These 2 documents are the main pieces:
-The Protocol allows the insurer to examine the boldness of the research project and the quality of the methodology
-The Patient Information Letter (anyway mandatory) makes clear that the patient is correctly (and in simple words) warned. This is for the benefit of both the sponsor and the insurer.
– the insurer will also analyze the possible discrepancies between the 2 documents
In addition, the insurer obviously needs quantitative (number of patients screened) and qualitative data (countries chosen, number of centers, duration of study, quality of the CRO).