Digital clinical trial: A new norm in clinical research

• Main Authors: Sayanta Thakur, Sandeep Lahiry
• Format: Article
• Language: English
• Published: Wolters Kluwer Medknow Publications 2021-01-01
• Series: Perspectives in Clinical Research
• Subjects: clinical trial; digital technology; remote consultation
• Online Access: http://www.picronline.org/article.asp?issn=2229-3485;year=2021;volume=12;issue=4;spage=184;epage=188;aulast=Thakur

The advent of digital technologies has been well blended with every aspect of human lives. Despite not being a new concept, the adoption of digital health technologies in clinical research, i.e., digital clinical trial has not been utilized extensively. However, with the prevailing COVID-19 pandemics, such transformation in clinical trial seems imminent. Few components of a trial such as consent, remote site monitoring, recruitment process which can be modified through digital technologies, are further specified by the regulatory authorities such as FDA and EMA. However, such novel method cannot be implemented without facing any limitations. All stakeholders pertinent to virtual clinical trial including the provider of digital technologies should align themselves with the patient-centric approach to propagate this concept. It is expected that such a transition is well accomplished and adopted by the sponsors without any compromise in scientific as well as ethical standard.