Gupta Sandeep K
Department of Pharmacology, Dhanalakshmi Srinivasan Medical College and Hospital, Siruvachur, Perambalur, Tamil Nadu, India.
Indian J Pharmacol. 2015 Jul-Aug;47(4):349-53. doi: 10.4103/0253-7613.161247.
There is an urgent need to expedite the time-to-market for new drugs and to make the approval process simpler. But clinical trials are a complex process and the increased complexity leads to decreased efficiency. Hence, pharmaceutical organizations want to move toward a more technology-driven clinical trial process for recording, analyzing, reporting, archiving, etc., In recent times, the progress has certainly been made in developing paperless systems that improve data capture and management. The adaptation of paperless processes may require major changes to existing procedures. But this is in the best interests of these organizations to remain competitive because a paperless clinical trial would lead to a consistent and streamlined framework. Moreover, all major regulatory authorities also advocate adoption of paperless trial. But challenges still remain toward implementation of paperless clinical trial process.
迫切需要加快新药上市时间,并简化审批流程。但临床试验是一个复杂的过程,复杂性的增加导致效率降低。因此,制药机构希望朝着更技术驱动的临床试验过程发展,用于记录、分析、报告、存档等。近年来,在开发提高数据捕获和管理能力的无纸化系统方面确实取得了进展。采用无纸化流程可能需要对现有程序进行重大更改。但这符合这些组织保持竞争力的最佳利益,因为无纸化临床试验将带来一个一致且简化的框架。此外,所有主要监管机构也提倡采用无纸化试验。但在实施无纸化临床试验过程方面仍存在挑战。