
During the COVID-19 pandemic, Techsol was in the process of conducting an Ophthalmology related intraocular lens study for the correction of Aphakia. A 49 -year-old Asian Subject earlier diagnosed with Nuclear Sclerosis Grade II Cataract in both eyes, was screened and selected for the study per the inclusion and exclusion criteria. With a medical history of controlled hypertension, the Subject underwent cataract extraction and intraocular lens implantation as part of the ophthalmology study procedure. After the planned post-operative visit, the Subject reported redness, pain and itching on and off in the right eye to the Principal Investigator (PI) through a telephonic call because of the local travel restrictions mandated by the Indian government.
To ensure timely data capture and evaluation of the adverse event experience, the site investigator team arranged a video call and evaluated the subject’s safety and confirmed the condition as cystoid macular edema (CME) with reference to the approved clinical study protocol. On the same day, the Site Team also facilitated the Subject’s visit to the site with an ambulance for further medical assessment to complete the event classification and to examine the safety and overall well-being.
- The Site Team had to capture the complete adverse event information in a pandemic situation through a video conference.
- Additionally, the Site Team also had to facilitate the subject’s timely visit to the site for event analysis by following COVID-19 protocols mandated by the government.
- Ensuring subject’s safety against COVID-19 infection during the site visit was a critical priority during the peak pandemic time.
- With Techsol’s Clinical Operations team working from home, it was challenging to perform meticulous evaluation of the reported event and classifying it accurately as a Serious Adverse Event (SAE) as per clinical study protocol.
- The Site Team was trained on the ‘COVID-19 Risk Management Study Guidelines’ that had to be followed for facilitating subject site visits and handling of AEs and SAEs.
- Techsol’s Pharmacovigilance and Clinical Affairs team ensured that the Site Team handled the subject visit with all pre-cautionary preventative measures to avoid a COVID-19 infection during the entire visit.
- Techsol’s team coordinated with the Site team to investigate and accurately capture the SAE’s.
- The Principal Investigator examined both eyes and diagnosed Cystoid Macular Edema which was severe in the Subject’s right eye.
- Techsol’s Medical Expert reviewed and advised the PI to prescribe the appropriate concomitant medication to resolve the SAE.
- The SAE follow-up visit was scheduled and completed after 14 days from the date of the subject’s site visit.
- After completing all the follow-up visits, the Investigator prepared the final SAE Report and submitted to Ethics Committee and DCGI Regulatory authority.
With the COVID-19 experience, CROs, Site Investigators and Sponsors must ensure that the following best practices are implemented as standard processes for SAE handling and reporting:
- Establish effective site communication channels (telephone, video conference, etc.) to provide timely support to the Subject during an adverse event experience. Based on this case study, it is certain that using the right technology can minimize patient burden and faster resolution.
- Ensure that the clinical study site and CRO has the right infrastructure and relevant standard processes that must be followed for arranging subject visits during an unprecedented situation.
- Clinical teams must have ready-to-implement tested safety protocols for facilitating safe and convenient site visits to subjects in the event of a disaster.
- Medical review plays a significant role in determining causal relationships to avoid misclassification of adverse events and timely reporting of SAEs to health authorities.
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