The drug development process is a long, tedious, and expensive journey. A pharmaceutical company (“pharma”) can expect to spend on average 10 years and $2.5 billion to complete a clinical trial.1,2,3
The regulatory process for approval of a new drug
The Food and Drug Administration (FDA) is the governing body that regulates drug and biologic approval. The FDA requires pharma to perform three human clinical phase trials, Phase I-III, before applying for a license to sell that drug. Phase I trials demonstrate drug safety in fewer than 100 healthy volunteers, while phase II studies evaluate drug efficacy in hundreds of patients.4,5 Phase III clinical trials are the most complex, costly, and time-consuming because they include thousands of patients.4,5 Upon successful completion of Phase III clinical trials a company may file a New Drug Application with the FDA.4,5 If the application is approved, that company can sell and market that drug in the USA. Phase IV trials occur after drug commercialization.5
Since only 12% of drug applications are approved by the FDA, clinical trials are risky, costly, and lengthy and can result in billion dollar gains or losses, depending on whether the drug receives approval.1,2,6 These odds are not in pharma’s favor. To fuel continued growth pharma must strategically invest in the development and acquisition of innovative biologics and personalized medicines to bolster their drug pipelines (Figure1). In addition, there is mounting pressure for pharma to collaborate with clinical research organizations (CROs, companies that design and conduct clinical trials) to improve clinical trial efficiencies by decreasing costs and timelines, improving quality and safety, and gathering more data that better informs trial endpoints.2,6
Improving the clinical trial process with EDC
A government sponsored study recently identified several strategies in which pharma and CROs are mitigating clinical trial barriers including the use of electronic records, simplified SOPs, and lower-cost facilities, among others.6 Of these strategies, the wider use of electronic data capture (EDC) through the use of smartphones and wearables, like Fitbits, will dramatically disrupt how clinical trials are designed and executed creating value to all stakeholders.6,7
How does EDC pertain to clinical trials? EDC refers to software that electronically collects, stores, and manages clinical and laboratory data.8,9,19 As an end-to-end management system, EDC systems have been implemented by the large CROs and are estimated to be a $2-5 billion market by 2020.10,11,12 EDC systems have improved clinical trial management by improving recruitment, statistical analysis, site monitoring timelines and costs, site management, data collection, data security, data accessibility, and error rates.6,13,14.19 Theses efficiencies have resulted in a 17.6% decrease in trial timelines and a 9.8% decrease in trial costs.6 These are big wins for pharma and consumers.
Wearable devices in the evaluation of new drugs
While EDCs have proven their worth in improving clinical trial data management, Litmus Health (“Litmus”) is taking it a step further by using their clinical trial science platform to enable trial sponsors to make better go/no-go decisions during Phase I-II clinical trials.15,16,17 The company’s technology collects patient data from wearables, smart devices, and home sensors and then uses algorithms to align and integrate data from multiple patients at multiple time-points with the goal of identifying trends in patient outcomes, quality of life, environment, etc. (Figure 2).11,15,16 By having access to and a better understanding of the trends observed in Phase I-II trails, trial sponsors and CROs are able to design a leaner, and subsequently, more time- and cost-efficient Phase III trial. The Litmus technology is new to the market, being pilot tested in a clinical trial at the University of Chicago.15,18 The real-time sleep and activity data from patients suffering from Inflammatory Bowel Syndrome will be used to personalize treatment and manage disease symptoms.15,18
The advent of Litmus’ data collection and analysis technology will transform the way clinical trials are designed and performed with the goal of advancing drugs with the greatest human health impact factor. Conversely, these datasets may empower pharma to pull the plug on clinical trials earlier if a drug is ineffective or unsafe which could save time and money. However, with limited clinical trial exposure, Litmus faces several hurdles to technology awareness, adoption, and implementation that could be delayed due to inherent factors in the clinical trial process including limited IT infrastructure, workflow of healthcare professionals, lack of training, and up-front costs.9 Furthermore, the strength of this technology is in its ability to collect and analyze large amounts of data, but will all this data prove useful or only a small subset? Litmus should consider evaluating multiple data points and sources with CRO partners to determine the types of data that bring value in actual clinical trials. Only time will tell the outcome, but it is likely that Litmus’ souped-up EDC system will disrupt how clinical trials are performed. (795 words)
- Dimasi, J., Grabowshi, H.G., and Hansen, RW. Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics. 2016. 47: 20-33.
- Pharmaceutical Research and Manufacturers of America. 2015 biopharmaceutical research industry profile. Washington, DC: PhRMA; April 2015. http://www.phrma.org/sites/default/files/pdf/2015_phrma_profile.pdf
- Feyman, Y. Shocking Secrets Of FDA Clinical Trials Revealed. Forbes. Jan 24, 2014. http://www.forbes.com/sites/theapothecary/2014/01/24/shocking-secrets-of-fda-clinical-trials-revealed/#703a333a2279
- http://www.fda.gov/downloads/drugs/resourcesforyou/consumers/ucm284393.pdf (Figure 1)
- National Library of Medicine, National Institutes of Health. https://www.nlm.nih.gov/services/ctphases.html.
- Sertkaya, et al. Eastern Research Group. Examination of Clinical Trial Costs and Barriers for Drug Development. ASPE. US Department of Health and Human Services. https://aspe.hhs.gov/report/examination-clinical-trial-costs-and-barriers-drug-development
- Field, A. Where the action is in wearbles: Healthcare niches. Cisco. August 01, 2016. https://newsroom.cisco.com/feature-content?type=webcontent&articleId=1781211
- Kush. R. Electronic Data Capture-Pros and Cons. BioExecutive International. June 2006. https://www.cdisc.org/system/files/all/reference_material/application/pdf/bei26kushsup.pdf.
- Parekh, S. Electronic Data Capture in Clinical Trials. Applied Clinical Trials. September 1, 2013. Vol 22, Issue 9. http://www.appliedclinicaltrialsonline.com/electronic-data-capture-clinical-trials
- eClinical Solutions Director of Electronic Data Solutions Honored in PharmaVOICE 100.FierceHealthcare.August 2, 2011, http://www.fiercehealthcare.com/it/eclinical-solutions-director-electronic-data-solutions-honored-pharmavoice-100.
- Fassbender, M. Early stage clinical trials get boost from modern EDC platform. Outsourcing Pharma. Nov 2, 2016. http://www.outsourcing-pharma.com/Clinical-Development/Litmus-Health-launches-modern-EDC-platform (Figure 2)
- Stanton, D. Medidata chasing an every-increasing slice of the $2bn EDC market. Outsourcing Pharma. April 27, 2015. http://www.outsourcing-pharma.com/Commercial-Services/Medidata-chasing-greater-share-of-2bn-EDC-market
- Electronic Data Capture/Clinical Trial Management Systems – Smartphone apps for clinical trials. FierceBiotech. http://www.fiercebiotech.com/special-report/electronic-data-capture-clinical-trial-management-systems-smartphone-apps-for
- Lopienski, K. The Beginner’s Guide to an Electronic Data Capture (EDC) System. Forte Research Systems. Feb 2, 2016. http://forteresearch.com/news/beginners-guide-electronic-data-capture-edc-system/
- Litmus Health Launches Clinical Data Science Platform Focused on Health-Related Quality of Life.prweb.October 27, 2016. http://www.prweb.com/releases/2016/10/prweb13799965.htm
- Baum, S. Litmus Health uses wearables to collect patient data for clinical trials. Med City News. October 27, 2016. http://medcitynews.com/2016/10/litmus-health-launches-adding-digital-health-companies-supporting-clinical-trials/
- http://www.litmushealth.com/ (cover image photo)
- Tracking real-time data to personalize treatment for IBD. ScienceLife.May 17, 2016, https://sciencelife.uchospitals.edu/2016/05/17/tracking-real-time-data-to-personalize-treatment-for-ibd/.
- Fundamental Aspects of Electronic Data Capture.OpenClinica. assessed on November 16, 2016. https://www.openclinica.com/electronic_data_capture/