Clinical trials account for 60-70% of the time and more than 90% of the cost incurred in drug development. Data capture challenges are a significant contributor to the problem.
A few years ago, I read an article about a clinical trial in a developing country where the same 100 kids were vaccinated five times in a period of five months. To make matters worse, the data was recorded as data points from 500 ‘unique’ subjects. I couldn’t believe that with so much advancement in technology, such unethical practices are still happening in the 21st century.
Around the same time, I read Dr. Eric Topol’s thought-provoking book “The Creative Destruction of Medicine” which was based on the digital revolution in the health care industry with a significant focus on clinical trials. After further research on data collection activities in clinical trials, I realized that the current process of data collection in clinical trials is very costly, time consuming and inefficient. It was obvious to me that we need to start thinking about technology innovations to support and optimize the clinical trial processes leading to efficiency and transparency in the collection and management of subject data.
Clinical trials account for 60-70% of the time and more than 90% of the cost incurred in drug development (Institute of Medicine, 2010) (Roy, 2012). The average drug-to-market time is about 15 years and aggregate costs are a staggering $1.8 billion (Orloff, et al., 2009) (Kalorama Information, 2012). On average, the per-patient clinical trial costs increased by 70% from 2008 to 2011 and the average length of a trial increased by 70% from 1999 to 2005 (Per-Patient Clinical Trial Costs Rise 70% in Three Years, 2011) (Kaitin, 2008).
Electronic Data Capture Systems
The introduction of Electronic Data Capture Systems (EDCs), such as Medidata Rave and Oracle InForm, into the clinical trial space held out a promise that data collection would be cleaner, faster, and cheaper. Although there was some improvement in the process, these systems still require an internet connection to use real-time. Also, they are complicated to use resulting in many study coordinators capturing data on paper with later data entry by someone proficient in using the system.
Due to the portability and ease of use in busy clinical environment, newer tablet-based EDC systems, are fast gaining popularity and are poised to change the way we conduct trials today. However, the major tablet-based EDC systems in use today, such as BioClinica’s Express EDC and Kantar Health’s InTrial, only support online data capture and so direct entry by the coordinators is still restricted to areas that have reliable Internet availability. Recently, OpenClinica integrated with Mi-Forms, a system that uses digital ink and tablet for offline data collection. But, Mi-Forms are heavily dependent on handwriting recognition technologies.
Clinical Trials in the Developing World
In the past few decades, developing countries have become an important source of clinical trial sites, not only because of the potential for cost-savings but also due to the presence of a large heterogeneous patient base (Markets andMarkets, 2014). A major drawback of expanding data collection activities in developing countries, however, is the lack of adoption of technology in these resource poor settings. I am from India and am a founding board member of an India-based startup, iKureTechSoft, that is dedicated to providing sustainable rural healthcare delivery. This experience helped me to understand the challenges of capturing health related data at the point of data collection in these settings. Similar operational and technological challenges are faced by clinical trials collecting data from these parts of the world. I strongly believe there needs to be a better way to capture clinical trial data in these settings.
My experience as a clinical trial study subject
In order to better understand the ins and outs of clinical trials, I participated as a study subject in a few of them. The lack of technology use in these trials was obvious, even when the study site was in the technology capital of the US, California’s Silicon Valley. The first thing I was required to do was to sign a paper consent form, which the researcher then copied, and stacked away in a bulky binder stored in a shelf with several other similar binders. The researcher informed me that they need to store these forms for purpose of onsite monitoring to avoid compliance issues. Often they also have to fax/e-mail or upload signed consent forms to an internet portal for remote monitoring. No question, I thought, this clunky manual, labor intensive, and time-consuming process could definitely be made more efficient and cost effective through technology.
I also learned through participation in these trials, literature review, and market research that even with the advent of electronic data capture (EDC) systems, most sites adopt a hybrid data capture (subject to paper then data entry to EDC system) process, due to various reasons. As I mentioned, the most prevalent of the currently available EDC systems are web-based. Lack of internet availability at source of data collection hinders direct data entry into these systems. These EDCs also need a laptop/desktop for data entry. Lack of a handheld device often makes it inconvenient to use these systems in a busy clinic environment. Further, lack of integration of EDC systems with medical devices and other clinical software also prompts investigators to complete paper case report forms, during subject visits, and later manually enter the information into EDC systems.
Unfortunately, this apparently convenient way of data collection has its downsides too. In spite of incurring all expenses of EDC systems, the sponsors are deprived of the full benefit of this technology. Hybrid data capture system leads to a high reliance on source data verification (SDV). Study Monitors travel to study sites around the world to manually verify the accuracy of the data entered against original data sources in order to maintain regulatory compliance. This accounts for more than 30% of clinical trial time and costs (Tantsyura, et al., 2010). To reduce this enormous time and cost of SDV, the industry has adopted various alternative approaches of risk based monitoring. However, cost of data collection in clinical trials still remains high and is a major cause of the cost and long duration of these trials.
The CliniOps Solution
To address these challenges, I co-founded a company, CliniOps, to leap-frog to a tablet-based eSource solution ‘CliniTrial,’ that’s compliant and supports offline data collection, through our patent-pending technology. Our user friendly hand-held offline data capture system is compatible for use in a busy clinic environment and thereby promotes electronic data capture at source. This, coupled with powerful edit checks drastically reduces the need for SDV. We have also introduced medical device and software integration to further automate data collection at source. CliniTrial also has provision of biometric registration and electronically signed consent forms to not only bring about increased transparency in the subject recruitment and data collection process, but, to also reduce the burden of SDV. Thus, our vision is to develop a fully automated clinical trial workflow through technology innovation.
eClinical Forum survey. (2009, October). More Paper, More Burden? Retrieved April 2014, from ClinPage Web site: http://www.clinpage.com/article/more_paper_more_burden/C5
inVentiv Health Clinical. (2014, January). Clinical Trial Educators: inVentiv Health Clinical. ( inVentiv Health Clinical) Retrieved April 2014, from http://www.inventivhealthclinical.com/Collateral/Documents/English-US/Clinical-Trial-Educators_Game-Changers-in-Patient-Enrollment.pdf
Califf, R. (2009). ACS and Acute Heart Failure Models. Institute of Medicine Workshop on Transforming Clinical Research in the United States. Washington, DC.
Canavan, C. (2006, June). Integrating Recruitment into eHealth Patient Records. Applied Clinical Trials.
ClinPage. (2010). Medidata EDC Enhancements. Retrieved from ClinPage Web site: http://www.clinpage.com/article/medidata_edc_enhancements/C5
Cros NT. (2013, January). EDC Use Rises Despite Concerns; CROS NT Acquires Simple, Low Cost EDC System. Retrieved 2014, from Cros NT Web site: http://crosnt.blogspot.com/2013/01/EDC-use-rises-despite-concerns-crosnt-acquires-symphony-edc-system.html
Institute of Medicine. (2010). Transforming Clinical Research in the United States: Challenges and Opportunities. Institute of Medicine. Washington, D.C.: The National Academies Press. Retrieved from http://www.nap.edu/catalog/12900.html
INTRALINKS SURVEY. (2011, June). With Paper, Site Pain: Clinpage. Retrieved April 2014, from Clinpage website: http://www.clinpage.com/article/with_paper_site_pain/C9
Kaitin, K. (2008). Impact Report: Growing Protocol Design Complexity Stresses Investigators, Volunteers. Boston: Tufts Center for the Study of Drug Development. Retrieved from http://csdd.tufts.edu
Kalorama Information. (2012). Outsourcing in Drug Development. New York: Kalorama Information . Retrieved from www.kaloramainformation.com
Krall, R. (2009). US Clinical Research. IOM Drug Forum Clinical Trials Workshop. Washington, D.C.
MarketsandMarkets. (2014, January). eClinical Solutions Market by Products (CDMS/EDC, CTMS, Ecoa , Randomization & Trial Supply Management, Safety), Services, Buyers (Pharma/Biopharma, CROS, Healthcare Providers) & Delivery Modes (Web Hosted, on-Premise, Cloud-Based) – Global Forecast to 20. (MarketsandMarkets) Retrieved 2014, from MarketsandMarkets Web site: http://www.marketsandmarkets.com/Market-Reports/eclinical-solutions-market-553.html
National Cancer Institute. (2013, February). Cancer Clinical Trials: National Cancer Institute. Retrieved April 2014, from National Cancer Institut web site: http://www.cancer.gov/cancertopics/factsheet/clinicaltrials/clinical-trials
Oracle Health Sciences. (2012). Remote Data Capture: Acquisition and Analysis. Touch Briefings.
Orloff, J., Douglas, F., Pinheiro, J., Levinson, S., Branson, M., Chaturved, P., . . . Patel, N. (2009). The future of drug development: advancing clinical trial design. Nature Reviews Drug Discovery, 8, 949-957.
Parekh, S. (2013). Electronic Data Capture in Clinical Trials: Does the emerging world still lag behind in EDC adoption? Applied Clinical Trials. Retrieved from http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/article/articleDetail.jsp?id=823545&pageID=1
Paul, S., Mytelka, D., Dunwiddie, C., Persinger, C., Munos, B., Lindborg, S., & Schacht, A. (2010). How to improve R&D productivity: The pharmaceutical industry’s grand challenge. Nature Reviews Drug Discovery, 9(3), 203-214.
Per-Patient Clinical Trial Costs Rise 70% in Three Years. (2011, July ). Retrieved May 2014, from Cutting Edge Information website: http://www.cuttingedgeinfo.com/2011/per-patient-clinical-trial-costs/
Roy, A. (2012). Stifling New Cures: The True Cost of Lengthy Clinical Drug Trials. Manhatten Institute for Policy Research. New York: Manhatten Institute for Policy Research.
Tantsyura, V., Grimes, I., Mitchel, J., Fendt, K., Sirichenko, S., Waters, J., & Crowe, J. (2010, November). Risk-Based Source Data Verification Approaches: Pros and Cons. Therapeutic Innovation & Regulatory Science, 44(6), 745-756.
Tufts Centerforthe Study of Drug Development. (2012). Study monitor workload high & varied with wide disparity by global region. Impact Report, Tufts University.
Visiongain. (2011, July). Pharma Clinical Trial Services: World Market 2011-2021.
Avik Pal, Founder & CEO, CliniOps, Inc.
Avik is the Founder & CEO of CliniOps (www.cliniops.com). Before starting CliniOps, he worked with two successful start-ups for over a decade. He is also a Founding Board member at iKure, a social entrepreneurship healthcare startup in India. Avik holds a B. Tech from Indian Institute of Technology (IIT), and an MBA from University of San Francisco, where he was awarded the ‘McLaren Fellowship’. He is also the President of ‘IIT Foundation’, San Francisco Chapter. Avik is passionate about Social Entrepreneurship and Impact. He also enjoys travelling and has travelled to 25+ countries worldwide, including an amazing expedition to Antarctica.