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In clinical trial/BE study, is pregnancy reported as an adverse event, or should it be documented in pregnancy notification form only?
Dr Nitin Kulkarni
In Indian setting, there is no mention of pregnancy during clinical trials in new drugs and clinical trials Rules 2019.
User manual for SAE reporting (serious adverse event) on Sugam portal defines SAE as:
• Important medical event (IME) that may not result in death, be life threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon medical judgment, it may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
• SAE of “congenital anomaly” defined as exposure to a medical product prior to conception or during pregnancy resulting in an adverse outcome in the child.
• Pregnancy would qualify as important medical event (IME). Hence in India it would be reported as an SAE.
However, internationally e.g. FDA has following recommendations:
• Under FDA guidelines, pregnancy itself is not automatically classified as an adverse event (AE) or serious adverse event (SAE). However, it may be reportable if associated outcomes or circumstances meet AE/SAE criteria.
• When pregnancy must be reported.
FDA expects pregnancy to be reported when:
a) The investigational product may affect pregnancy: Teratogenicity, embryotoxicity, or reproductive risk (based on preclinical or prior clinical data).
b) Pregnancy occurs in a subject or partner during study drug exposure: Even if there are no complications, many sponsors require notification for safety tracking.
c) There are adverse pregnancy outcomes such as miscarriage, stillbirth, ectopic pregnancy, congenital anomaly or birth defect, complication (e.g., preeclampsia), elective or spontaneous abortion,
In addition, partner pregnancies if a male subject’s partner becomes pregnant, are often tracked and reported (especially in oncology/immunotherapy).
ICH recommends:
Individual case safety report (ICSR) the data elements and their format are suitable to describe several types of case reports including those without adverse events or adverse reactions, such as medicinal product administration during pregnancy, overdose, medication error, or potential lack of efficacy.
Under Indian GCP norms, optometrists, opticians, lab staff and other data entry staff cannot become investigator if they want to publish their data collected, during their normal duty hours as retrospective study data, in a hospital where clinical research is conducted. With out EC clearance, retrospective study data cannot be published. What is the solution to publish the data collected?
Dr Sreevatsa
The use of real-world data collected in clinical practice for academic research or for industry studies raises a variety of ethical issues such as patient’s right of privacy and confidentiality, data protection, data de-identification, data sharing, scientific design of study, and informed consent requirements.
Real-world study, whether prospective or retrospective design study, requires review by EC before approval. The EC should consider all ethical issues (vide supra) with a specific focus on:
• Purpose of the study – academic, commercial.
• Risk–benefit assessment.
• Scientific design.
• Protection of privacy and confidentiality.
• Informed consent process – waiver.
• Applicable international rules for global registry, e.g., GDPR, Health insurance portability and accountability Act.
• Data de-identification.
• Collaboration with other local or international institutes – data sharing.
• Registration of study in Clinical Trials Registry - India.
It is important to make non-medical staff aware of the ethical issues and requirements for conducting research on patient data. If they want to publish data collected, they should write a research proposal which considers all scientific and ethical requirements for a real-world study.
Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com
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