Case Study: Use of Decentralized Clinical Technologies in Lower Urinary Tract Symptoms

Nadina Jose, Avik Pal

Oct 2022 DOI 10.35460/2546-1621.2022-0052     Access   

Abstract

A clinical study with 49 participants was started and completed at the height of the Covid-19 pandemic with the use of decentralized clinical trial (DCT) methodologies. All participants and the study team remained safe and were able to conduct the study efficiently. Patients were able to provide consent electronically, received experimental supplements and were given the option to provide feedback through the system’s telemedicine feature.

 

Key words: Decentralized clinical trials DCT, LUTS Lower Urinary Tract Symptoms 

  1. Center for Drug Evaluation, Research. Electronic Source Data in Clinical Investigations [Internet]. U.S. Food and Drug Administration. FDA; [cited 2022 Oct 28]. Available from: https://www.fda.gov/regu­latory-information/search-fda-guidance-documents/electronic-source-data-clinical-investigations
  2. Török ME, Underwood BR, Toshner M, Waddington C, Sidhom E, Sharrocks K, et al. Challenges and opportunities for conducting a vaccine trial during the COVID-19 pandemic in the United Kingdom. Clinical Trials [Internet]. 2021 Jun 22;18(5):615–21. Available from: http://dx.doi.org/10.1177/17407745211024764
  3. Why decentralized clinical trials remain a black box to most research sites [Internet]. Contract Pharma. [cited 2022 Oct 28]. Available from: https://www.contractpharma.com/contents/view_experts-opinion/2022-03-18/why-decen­tralized-clinical-trials-remain-a-black-box-to-most-research-sites/%20ief%20Clinical%20Trial%20Officer%20at%20Florence%20Healthcare03.18.22
  4. Deloitte Report 2022. Reimagining clinical trials in the age of the digital patient. Deloitte.com. [cited 2022 Oct 28]. Available from: https://www2.deloitte.com/content/dam/Deloitte/us/Documents/life-sciences-health-care/us-lshc-envisioning-digital-trials-new.pdf

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