“Data Sharing, Post Study Access To Trial Medication Are Emerging Frontiers”

“Data Sharing and Post study access to trial medication for study subjects are the two emerging frontiers in clinical research space,” said Dr Saral Thangam, CEO & Managing Director, Norwich Clinical Services.

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Speaking at a conference on “CLINICA: Recent trends and approaches in Clinical research, Clinical trial and Medical writing” organised by ABC Biologics in Bangalore on September 1, she said “Data sharing, whether elective or required, creates an obligation for the original investigators who obtain funding, design studies, collect and analyze data, and publish results to make their curated data and associated”.

She further noted that data from well-designed and well-executed research not only are useful for the original purpose and secondary analyses by the original researcher but also can be repurposed for a variety of applications, including independent replication, avoidance of duplicative studies, generation or testing of new hypotheses, and the general advancement of clinical and biologic understanding.

Talking about Post Trial responsibilities: continued access to trial medication she observed that informed consent for continued access to medication must be obtained. “The regulations that bind this complex topic is still under evolution,” she concluded.