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How would Digital Personal Data Protection Act 2023 impact clinical trial conduct?
Dr Usha Sahni
Digital Personal Data Protection Act 2023 is an Act to provide for the processing of digital personal data in a manner that recognises both the right of individuals to protect their personal data and the need to process such personal data for lawful purposes and for matters connected therewith or incidental thereto. The provisions of this Act shall not apply in respect of the processing of personal data necessary for research, archiving or statistical purposes if the personal data is not to be used to take any decision specific to a Data Principal - the individual to whom the personal data relates. As clinical trial data are used for obtaining new drug approval, they are relevant for the patients - Data Principals – participating in clinical trial, the sponsors conducting clinical trials in India should ensure the rights of patients to protect their personal data. So, the provisions of this Act are likely to impact processing of digital personal data collected during conduct of clinical trial. Processing in relation to personal data, means a wholly or partly automated operation or set of operations performed on digital personal data, and includes operations such as collection, recording, organisation, structuring, storage, adaptation, retrieval, use, alignment or combination, indexing, sharing, disclosure by transmission, dissemination or otherwise making available, restriction, erasure, or destruction. So, this Act is likely to impact many clinical trial conduct processes such as informed consent, documentation, storage and archival of data, processing of data outside India, future use of data.
In digital trials, when visits are conducted at a patient's home, how do we file 1572 forms?
Dr Sanjay Dalal
FDA instructions to Form 1572 state that if the protocol specifies that the investigative product can be administered at a subject’s home (for example, the protocol allows for daily injections to be administered by a registered nurse in the subject’s home), the subjects’ home addresses do not have to be listed on the Form FDA 1572. Study records should reflect that the test article was administered at subjects’ homes per the protocol. For inspectional purposes, the address listed in Field 3 of Form 1572 should be the physical location where all trial-related records are accessible and where the investigator is located and trial personnel can be interviewed, either in-person or remotely. All information required under applicable regulations for investigational products to be maintained for trial participants should be accessible at this site.
We are planning to set up Data Safety Monitoring Board (DSMB)/Data Monitoring Committee (DMC). What information DMC should review?
Dr Mona Bhalerao
FDA has published a guidance “Establishment and Operation of Clinical Trial Data Monitoring Committee”. This guidance recommends:
- A DMC will generally review data related to the conduct of the study (that is, the quality of the study and its ultimate ability to address the scientific questions of interest), in addition to data on effectiveness and safety outcomes.
- These data may include, among other items:
- Rates of recruitment, ineligibility, noncompliance, protocol violations and dropouts, overall and by study site;
- Completeness and timeliness of data;
- Degree of concordance between site evaluation of events and centralized review;
- Balance between study arms on important prognostic variables;
- Accrual within important subsets.
- Relevant external data on safety.
Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com
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