The risk-based monitoring: what is it?
In a few years, we are seeing a real change in how to make a clinical trial monitoring at the international level.
Indeed, a new risk-based approach was integrated in Good Clinical Practice (GCP, ICH GCP, Section 5.1) and in the European Directive 2005/28 / EC. We talk about “Clinical trials monitoring adapted to risk” (or “risk-based monitoring”).
In this article we will explain you this concept that may seem a bit complicated at first.
You are CRA and you want to make sure your insurance for clinical trials is consistent. You are a project manager or manager of clinical operations and you want to be confident with your choice of clinical trials insurance? Here are some tips to follow.
As far as I am concerned, I am referring to on Frederick Nouaille, an insurance expert, who was kind enough to write this article for our blog to allow us to better master the subject.
Insurance for clinical trials, how to choose it well?
Whether it is suggested by the Good Clinical Practice (ICH-E6), imposed by the law of a country or by the ethics committees, the insurance subscribed out by the promoter has two main tasks:
- First and foremost, it allows participant to access a compensation following an injury because of his participation in the clinical study.
- By funding the compensation of the participant who is a victim of personal injury, the insurance also assists the promoter in his risk-taking during the development of a new drug or medical device. Indeed, a promoter who would incur liability for damages suffered by volunteers in one of his studies could see his funds heavily impacted and might even filing for bankruptcy if it is a start-up.
For the reasons mentioned above, insurance is essential to the achievement of a clinical study. However, it must be chosen carefully because, for many, nothing is more like insurance…than insurance! Here as promised some good practices in buying insurance for clinical study:
- Local obligations for insurance of clinical studies must be known. As mentioned earlier in this article, these requirements may come from the regulations of the country where the clinical trial is conducted, the Ethics Committee, the investigation centers, etc. The insurance to which the entity has subscribed should be in line with local requirements. Thus the decision to recruit subjects in Germany and Hong Kong for the same protocol will result in the subscription of two very different insurances either at the definition of policyholders, guarantee levels or type of insurer.
- The guarantee levels are minima to comply when required by local obligations. In addition, many countries do not impose guarantee levels. A reflection should be systematically performed to whether the risk is sufficiently covered. The essential components of risk in a clinical study are: the type of study (phase 1 “first-in-man” generally present a greater risk that a study on non-invasive medical device), the tested product, number of participants, the country in which the study takes place, and duration of this study.
- Deductibles are the amounts charged to the purchaser of the insurance contract (the promoter) in case of disaster (one study participant who makes a claim because he has suffered injury). The type of duty (per participant and / or per protocol) and their amount could have a significant cost for the promoter.
- The choice of insurer, including its financial strength and its experience in the field of medical research is important, since in case of a complaint from a subject (sometimes several years after the study starting point), the insurer must meet and master the present compensation arrangements of the country in which the insurance has been established.
The choice of clinical trial insurance is not negligible, and a mistake in this area could have serious consequences for the promoter. It is best to get help from professionals to better negotiate. There are a handful of specialized insurance brokers in clinical studies; because of their knowledge of local requirements and the insurance market, they are the ideal partners of promoter keen of good management of risks and costs!
i4CT Insurance for Clinical Trials
Insurance brokerage clinical trials
Frédéric Nouaille is an insurance broker specializing in healthcare companies: from biotechnology company to health facilities. Through his two companies (i4CT and A&RS) he manages all the insurance needs of organizations both French and foreign.
Tips of clinical research blog: And if your insurance for your study in France has already been subscribed, you can still check if your insurance certificate for France complies in assuring that:
- The insurance company has its head office or a branch in France or in a state member of the European Community or of the European Economic Area (EEA).
- The insurance certificate is dated.
A statement of this type is noted on the certificate “complies with French law and regulations on biomedical research, particularly the provisions of the law of 20/12/1988 88.1138, as amended by subsequent legislation: 90.86 Law of 23/01 / 1990, Decree 91-440 of 05/14/1991, 94,630 law of 25/07/1994, 97-888 decree of 01/10/1997, Decree 2002-722 of 03/05/2002, 2004,806 law of 09 / 08/2004, Decree of 26/04/2006 2006,477. ”
- Your insurance certificate specifies the full title of your clinical trial if your insurance certificate does not include these elements, you can refer this information to your project manager.
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