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What is the authorisation procedure for conducting clinical trials in your jurisdiction?
In the United States, a ‘clinical trial’ is commonly defined as a scientific investigation involving the use of an experimental drug, medical device or clinical intervention on a human being. The conduct of clinical trials in the United States is regulated by two federal agencies – the Food and Drug Administration (FDA) and the Office of Human Research Protection (OHRP) – both of which are within the US Department of Health and Human Services.
Clinical trials conducted for the purpose of seeking approval to market and sell a new drug, medical device or clinical intervention are regulated by the FDA under the authority of the Federal Food, Drug and Cosmetic Act and its associated regulations.
Clinical trials conducted for the purpose of establishing generalisable knowledge, which can be published in a reputable peer-reviewed publication, are regulated by the OHRP under the authority of the Public Health Services Act and its associated regulations. The OHRP also regulates clinical trials funded by the federal government, including clinical trials funded by the US National Institutes of Health.
The specific procedures for conducting a clinical trial are set forth in the associated regulations for each of these agencies and strict compliance is required. For FDA-regulated clinical trials, the objective of these trials is to produce sufficient scientific evidence to statistically demonstrate the safety and efficacy of the experimental drug, medical device or clinical intervention before the product may be sold to consumers in the United States. For OHRP-regulated trials, the objective is more academic and focuses on the development of information that will advance scientific learning which could not be achieved without the involvement of a human subject.
For both FDA and OHRP-regulated trials, the clinical trial must be conducted under the immediate oversight of a non-governmental human subject protection committee called an institutional review board. The regulations set forth the requirements for the composition and charge of the institutional review board to ensure that the clinical trial is conducted in a manner that protects the rights of the human subjects, including the right to know that participation in the clinical trial is voluntary and subject to the participants’ informed consent.
How robust are the standard good clinical practices followed in your jurisdiction?
Good clinical practice is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that:
- involve the participation of human subjects;
- are developed in a collaborative effort by the International Conference on Harmonisation; and
- are issued under the E6 Guideline.
Clinical trials regulated by the FDA must follow good clinical practices codified in the FDA regulations at Parts 50 and 56 of Title 21 of the Code of Federal Regulations. The FDA has issued guidelines on good clinical practice compliance, which may be found at www.fda.gov/downloads/Drugs/.../Guidances/ucm073122.pdf.
Clinical trials regulated by the OHRP are not required to follow all aspects of good clinical practice, but the agency has adopted specific regulations to address human subject protections at Part 46 of Title 45 of the Code of Federal Regulations.
Reporting, disclosure and consent
What are the reporting and disclosure requirements for the results of clinical trials?
In the United States, the Food and Drug Administration Amendment Act (21 USC §301 et seq) requires all applicable clinical trials to register and report results on a government-administered website (www.clinicaltrials.gov). The law defines applicable clinical trials to include all clinical trials involving a drug, biologic or device, where:
- the trial has one or more sites in the United States;
- the trial is conducted under a FDA investigational new drug application or investigational device exemption; and
- the trial involves a drug, biologic or device that is manufactured in the United States or its territories and is exported for research.
If a clinical trial involves a drug in Phase I, the results are not required to be submitted. For a clinical trial of a device not previously approved by the FDA, the law allows for a delay in reporting the results until one year after the approval or clearance of the device by the FDA.
What are the informed consent obligations with respect to clinical trial subjects?
The Food and Drug Administration requires that clinical trial subjects be given adequate information to make an informed decision on whether to participate. The subject must be given sufficient time to consider all information and the opportunity to ask questions and have those questions answered. The entire process must take place under circumstances that minimise the possibility of coercion or undue influence. As the trial progresses, there is a continuing duty to provide information to the subject.
What are the insurance requirements for clinical trials?
In the United States, there are no regulations mandating human clinical trial liability insurance. However, most foreign jurisdictions do require minimum insurance and the regulations vary considerably by country. Multi-country trials are likely to require multiple insurance policies. Companies sponsoring clinical trials need to understand all regulatory requirements, legal obligations and the availability of insurance before committing to conduct trials in certain countries. Since some countries now require admitted policies only (a policy written and issued in a specific locale by an insurer authorised to transact business under local law), lead time for procuring insurance has increased. In addition, certain insurance companies will underwrite only up to a maximum amount per country, so that companies may find themselves with limited options if carriers have already reached their country maximum for coverage. As a result, it is recommended that companies considering clinical trials work closely with brokers and lawyers familiar with jurisdictional requirements before entering into sponsorship agreements.
What data protection issues should be considered when conducting clinical trials?
Most clinical trials today are designed according to International Conference on Harmonisation guidelines with multiple jurisdictions in mind. Accordingly, data protection must be approached with the same mindset. The data protection issues break down into two basic categories:
- data integrity and retention; and
- patient privacy.
With regard to data integrity and retention, the FDA periodically issues guidance for industry documents on its website, which should be consistently monitored for updates. In 2013 the FDA published a document concerning electronic source data in clinical investigations, which covered:
- identification and specification of authorised source data originators;
- creation of data element identifiers to facilitate examination of the audit trail by sponsors, the FDA and other authorised parties;
- ways to capture source data into the electronic case report form using either manual or electronic methods;
- clinical investigator responsibilities with respect to reviewing and retaining electronic data; and
- use and description of computerised systems in clinical investigations (see www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM328691.pdf).
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