“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.
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.
Speaking on “Evolving global regulatory expectations on data integrity”, Dr Shrinivas Savale, Pharmaceutical and Biopharmaceutical Consultant, Ahmedabad said “With the regulatory inspections world over identifying several incidences of critical/ major gaps in the compliance to various GxP requirements, a lot of emphasis has been given on data integrity, and thus, reliability of the data supporting any regulatory approvals.”
During his presentation he thrown some light on the need/approaches for ensuring data integrity through good process controls (QMS with data governance), data sharing/transparency as well as global initiatives in the era of ‘big data’ and technological advancements in clinical research in coming years.
Talking on “Ethics Committees - recent developments & Challenges in Scientific and Ethical Review” Nagendrappa. M. H, Chief Executive Officer, Clinotek India - Center for Advanced Clinical Research Studies, Bangalore said that for all practical reasons, it is impossible for regulatory authorities to be present at all clinical trial sites to ensure safety for the participants. They rely on Ethics Committees (ECS) to ensure protection of trial subjects.
He also pointed out the gross negligence happening in the stage of informed consent process which is one of the most important, but unfortunately the most ignored in India. As a result of the above and not limited to, there were over 2000 cases of serious adverse events (SAEs) leading to death were reported since 2009. In very few cases, the compensation was paid to the victim's family. To prevent scientific misconduct and better handle the identification and reporting of SAEs, it was inevitable for Central Drugs Standard Control Organization (CDSCO) to implement strict measures in place to ensure the protection of rights, safety and wellbeing of trial participants
Besides, Dr Sam T Mathew, Head-Clinical e-Submission and Technical Compliance Delivery, Scientific and Medical writing, GlaxoSmithKline, Bangalore spoke on “Authorship in Clinical Publictions: Is there a way to Quantify the Contributions?”, Dr Anand Eswaraiah, Head Biometrics, Medical and Regulatory Affairs, Syngene International, Bangalore on “Innovation and Future Clinical Trials”, Ranjith P.U, Senior Associate Manager (QC), Eli Lilly services India on “Medical writing deliverables-Different Attributes of Quality” and Dr Shabana Khan, Senior Manager PK/ PD, Navitas Lifesciences, Bangalore on “Stem Cells in Clinical Trials” at the one day conference.
Representatives from MSN Pharma, Bioclinica, D2L Clinical Solutions, Norwich Clinical Services, Panexcell Clinical Lab, Clinotek, Sapthagiri Clintrac, Alchemy Clinical Research Services, Biointegrity, and Institute of Clinical Research India (ICRI) were present during this conference. The conference concluded with adoption of a resolution in which its participants set forth their recommendations to future of clinical trials.
Delegates posing with speakers of CLINICA -2017