Clinical Trials 101
What brokers should know about human clinical trials for unapproved drugs and unapproved medical devices
By Florentina Cornea, Senior Underwriter, Life Sciences
Clinical trials are a critical part of both pharmaceutical development and the development of the companies involved in bringing drugs or medical devices to market. The companies trying to develop the drugs or the medical devices will operate under complex regulations and need to ensure that insurance requirements are met.
How clinical trials work
In general, clinical trials must pass through several phases in order to be approved by national regulatory authorities and deemed safe for use in humans:
Phase I trials are conducted to assess safety. Usually the testing involves a small number of healthy participants. These are often conducted by Contract Research Organizations (CRO’s) on behalf of the researchers. CROs also have particular insurance requirements including Errors & Ommissions.
Phase II trials assess effectiveness and further evaluate safety. This phase of trial usually involves participants who have the disease or condition under investigation. Normally participants are randomly assigned to groups or conditions, with one condition being the treatment (program, drug, etc.) under consideration, and at least one comparison condition. Phase II studies involve a limited number of closely monitored participants.
Phase III trials involve a large number of participants, are intended to gather further evidence of effectiveness, monitor adverse reactions, and gather additional evidence of effectiveness for specific indications.
Phase IV trials may explore specific effects, or be designed to determine effects on morbidity and mortality or on specific populations. For drugs and medical devices, Phase IV trials are conducted after the drug or the medical device has received approval for sale.
Regulation of clinical trials
The sponsor (e.g., a pharmaceutical company that developed the drug or medical device of a clinical trial) submits their application to Health Canada in Canada, the FDA in the United States and other regulatory bodies (depending on the country in which the trials are conducted).
The Research Ethics Board or the Institutional Review Board (IRB) ensures researchers take the appropriate steps to protect the rights and welfare of human subjects in a research study.
In general, all clinical trials require the following legal documentation:
- Informed consent form, which is a process for getting a person’s consent to receive therapy before they participate in a clinical trial.
- Protocol describing what types of people may participate in the trial, the length of the trial, and the schedule of test, procedures, medications and dosages.
Each of these documents will need to be approved individually, for each Phase of the trial(s).
If the trial is conducted in a country other than Canada or the U.S., other documentation might also be needed, depending on the requirements of the ethics committees where the clinical trial is conducted. This documentation includes:
- Information on the local sponsoring company.
- Appropriate localized legal language for the informed consent and protocol documentation.
- Local lead investigator information, including his or her name, address, phone number and email address.
- Specific local insurance policies, where required
For medical devices, both Health Canada and FDA categorize devices as Class I, II, III, or IV, based on the risks associated with their use, including the degree of invasiveness, duration of contact with the patient, energy transmission hazard and consequences of device malfunction or failure (the higher the class the higher the hazard).
With regards to drugs, the regulatory bodies are responsible for authorizing the importation and sale of drugs for the purpose of clinical trials.
From preclinical trials to sale, the clinical trial process may take 12 to 18 years—though not always. Depending on the type of clinical trial, they can cost upwards of $1 billion. Clearly, it is a massive investment and one that needs to be protected with adequate insurance coverage.