USA Law and Practice Contributed by: Daniel Kracov, David Marsh and Alice Ho, Arnold & Porter
2. Clinical Trials 2.1 Regulation of Clinical Trials
requirement to publish clinical trial data in journals, the industry has pledged to seek such publications wherever possible, as a matter of practicality. 2.4 Use of Online Tools to Support Clinical Trials Online tools may be used as long as they comply with applicable requirements – for example, privacy, data security, auditability, informed consent and other good clinical practice requirements, as well as estab- lishing lawful status if such tools incorporate certain regulated medical device functionalities. Particular requirements apply to recruiting subjects for clinical studies, whether online or otherwise, and study sub - ject recruitment tools should generally be reviewed by the study IRB. 2.5 Use of Data From Clinical Trials The personal data resulting from clinical trials is con- sidered protected. However, as long as any transfer of resulting data to a third party or an affiliate is con- sistent with contractual obligations, informed consent and privacy protections, transfers are permitted. In certain scenarios, the sponsor and the FDA will have access to such information (including patient-identifi- able information) in order to conduct and analyse the data from the study properly and ensure that subjects are protected. 2.6 Personal or Sensitive Data A database containing personal or sensitive data may be subject both to contractual and statutory protec- tions obliging maintenance of data security and pri- vacy.
For drugs and biologics, unless subject to specific exemptions, an investigational new drug (IND) applica- tion must be submitted to obtain FDA and Institutional Review Board (IRB)/Ethics Committee clearance prior to engaging in clinical research. Such submissions typically include: • extensive pre-clinical data; • information on chemistry, manufacturing and con- trols; • 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 outstand- ing 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 submission of an inves- tigational device exemption (IDE) prior to initiating clinical research. Non-significant risk device studies may be conducted with just IRB approval. The FDA maintains an array of good clinical practice regulations governing clinical research, including study sponsor, IRB, and investigator responsibilities. 2.2 Securing Authorisation to Undertake a Clinical Trial As noted in 2.1 Regulation of Clinical Trials , in addi - tion to obtaining clearance to proceed with clinical research by filing an IND or IDE application (as appro- priate), virtually all studies must be reviewed by one or more IRBs prior to initiation. FDA regulations specify the requirements applicable 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 posted. Although there is no general
3. Marketing Authorisations 3.1 Product Classification
Product classifications are typically made by assess- ing the primary mode of action of the product and whether it works by chemical, biological, mechanical or other means. If the product combines chemical, biological and/or mechanical modalities, a Request for Designation may be submitted to determine how the FDA believes the product should be regulated, under definitional and pathway provisions.
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