Virtual Clinical Trials: Perspectives in Dermatology
- 3 March 2020
- journal article
- review article
- Published by S. Karger AG in Dermatology
- Vol. 236 (4), 375-382
- https://doi.org/10.1159/000506418
Abstract
Background: The cost of developing a new drug is approximately USD 2.6 billion, and over two-thirds of the total cost is embedded in the clinical-testing phase. Patient recruitment is the single biggest cause of clinical trial delays, and these delays can result in up to USD 8 million per day in lost revenue for pharmaceutical companies. Further, clinical trials struggle to keep participants engaged in the study and as many as 40% drop out. To overcome these challenges pharmaceutical companies and research institutions (e.g., universities) increasingly use an emerging concept: virtual clinical trials (VCT) based on a remote approach. Summary: VCT (site-less) are a relatively new method of conducting a clinical trial, taking full advantage of technology (apps, monitoring devices, etc.) and inclusion of web platforms (recruitment, informed consent, counselling, measurement of endpoints, and any adverse reactions) to allow the patient to be home-based at every stage of the clinical trial. Studies have shown that VCT are not only operationally feasible, but also successful. They have higher recruitment rates, better compliance, lower drop-out rates, and are conducted faster than traditional clinical trials. The visual nature of dermatological conditions, the relative ease in evaluating skin diseases virtually, and the fact that skin diseases often are not life-threatening and rarely require complex examinations make VCT very attractive for dermatological research. Further, making correct diagnoses based on photographs and patient symptomatology has always been part of the dermatologist’s routine. Thus, VCT are in many ways made for dermatology. Herein we describe VCT and their implications in dermatological research.Keywords
This publication has 20 references indexed in Scilit:
- Innovation in the pharmaceutical industry: New estimates of R&D costsJournal of Health Economics, 2016
- Teleconsent: A novel approach to obtain informed consent for researchContemporary Clinical Trials Communications, 2016
- Two Decades of Teledermatology: Current Status and Integration in National Healthcare SystemsCurrent Dermatology Reports, 2016
- Using e-technologies in clinical trialsContemporary Clinical Trials, 2015
- Electronic informed consenting: A boon to modernize consenting processPerspectives in Clinical Research, 2015
- Unsuccessful trial accrual and human subjects protections: An empirical analysis of recently closed trialsClinical Trials, 2014
- Web-based trial to evaluate the efficacy and safety of tolterodine ER 4mg in participants with overactive bladder: REMOTE trialContemporary Clinical Trials, 2014
- Patient-centered online management of psoriasis: A randomized controlled equivalency trialJournal of the American Academy of Dermatology, 2012
- Translational research: 4 ways to fix the clinical trialNature, 2011
- From Informed Consent through Database Lock: An Interactive Clinical Trial Conducted Using the InternetDrug Information Journal, 2004