USA Law and Practice Contributed by: Daniel Kracov, David Marsh and Alice Ho, Arnold & Porter
determination as to appropriate status under clearance and approval processes.
FDA regulations specify the requirements appli- cable to the composition and activities of IRBs. 2.3 Public Availability of the Conduct of a Clinical Trial The US National Institutes of Health maintains a database at clinicaltrials.gov, where most controlled, interventional clinical investigations – other than Phase I clinical investigations – of drugs or biological products subject to FDA regulation must be registered and study results must be posted. Although there is no general requirement to publish clinical trial data in jour- nals, the industry has pledged to seek such publications wherever possible, as a matter of practicality. 2.4 Restriction on Using Online Tools to Support Clinical Trials Online tools may be used as long as they com- ply with applicable requirements – for example, privacy, data security, auditability, informed con- sent and other good clinical practice require- ments, as well as establishing lawful status if such tools incorporate certain regulated medical device functionalities. Particular requirements apply to recruiting subjects for clinical studies, whether online or otherwise. 2.5 Use of Data Resulting From Clinical Trials The personal data resulting from clinical trials is considered protected. However, as long as any transfer of resulting data to a third party or an affiliate is consistent with contractual obliga- tions, informed consent, and privacy protections, transfers are permitted. In certain scenarios, the sponsor and the FDA will have access to such information (including patient-identifiable infor- mation) in order to conduct and analyse the data from the study properly and ensure that subjects are protected.
2. Clinical Trials 2.1 Regulation of Clinical Trials
For drugs and biologics, unless subject to spe- cific exemptions, an investigational new drug (IND) application must be submitted to obtain FDA clearance prior to engaging in clinical research. Such submissions typically include: • extensive pre-clinical data; • information on chemistry, manufacturing and controls; • prior human data; and • the proposed protocol(s). The FDA has 30 days either to allow the clinical study to proceed or to impose a clinical hold until outstanding issues are resolved. Similar rules apply to medical device research and, depending upon the risk posed by the device, a device study may require the sub- mission of an investigational device exemption (IDE) prior to initiating clinical research. Non-sig- nificant risk device studies may be conducted with just Institutional Review Board (IRB)/Eth- ics Committee approval. The FDA maintains an array of good clinical practice regulations gov- erning clinical research, including study sponsor, IRB, and investigator responsibilities. 2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial As noted in 2.1 Regulation of Clinical Trials , in addition to obtaining clearance to proceed with clinical research by filing an IND or IDE applica- tion (as appropriate), virtually all studies must be reviewed by one or more IRBs prior to initiation.
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