Risk-based approaches to monitoring (RBM) in clinical research1, 2, characterized by more cerebral operations with focus on critical processes and data components, are growing in popularity.
The FDA has cleared for marketing a medical cooling device from Lund, Swedenbased Dignitana. Digitana engaged Target Health as its CRO, using its web-based eSource-enable EDC system to collect direct data entry from patients. According to Target Health, this is the first product to be approved using in its pivotal trial, direct data entry of patient data at the time of the clinic visit into an EDC system, with no need for paper records.
Dr. Jules Mitchel, President of Target Health, speaks at DIA 2015 in Washington DC.
The benefits of eSource data: collecting data digitally without having to record the data on a piece of paper first.
From CBI Conference, March 2015: Impact of Risk-Based Monitoring and eSource Methodologies on Clinical Sites, Patients, Regulators and Sponsors
In 2010, the European Medicines Agency (EMA) issued a “Reflection Paper Expectations for Electronic Source Data and Data Transcribed to Electronic Data Collection Tools in Clinical Trials,” and in 2013, the United States Food and Drug Administration (FDA) issued the “Guidance for Industry: Electronic Source Data in Clinical Investigations”. These documents support the concept of the use and acceptance of eSource documents in lieu of paper records by regulatory agencies.
Avoiding resistance and inefficiencies when there are new ideas and new opportunities, and experience from the real world.
When original data are captured through validated electronic systems, there is no need to perform source document verification (SDV)> The key to regulatory compliance becomes the availability of validated, independent, contemporaneous copies of source records.
Study results using a quality-by-design method, risk-based monitoring, and real-time direct data entry.
Target Health and Life-On-Key are pleased to announce that Year 2 of a 2 year project, sponsored by a grant from the BIRD Foundation, has begun. The goal of the project is to integrate any electronic medical record (EMR) with any electronic data capture (EDC) system used in clinical trials.
Some of us may be curious and adventuresome, while some of us are not; and that is okay. Some say “if it ain’t broke why fix it” and put off decisions until a crisis hits. While some crises are predictable and others seem to happen by chance, unfortunately, crises can be catastrophic and lethal, or at a minimum, require energy and resources to reverse.
Experience from Phase 3 Study Using Risk-Based Monitoring and eSource
With the advent of today’s online world, from web-based banking to plane reservations to shopping, it makes little sense for clinical research sites to collect patient data on a piece of paper and then transcribe the data to an electronic data capture (EDC) system.
Target Health Inc., and LifeOnKey Inc., announced at CLINTECH 2013 that they are recipients of a $900,000, 2-year award from BIRD Foundation. The award, entitled, “EMR/EDC HUB - An Electronic Bridge between Medicine and Science," will integrate the EMR with electronic data capture (EDC) systems for clinical trials.
Monitoring of clinical trials includes several disciplines, stakeholders, and skill sets. The aim of the present study was to identify database changes and data entry errors to an electronic data capture (EDC) clinical trial database, and to assess the impact of the changes.
A variety of quality assurance (QA) procedures are typically implemented to ensure that clinical trial are carried out as designed, that good clinical practices (GCP) and regulations governing the conduct of trials are followed, and that data used to assess treatment effects are accurate and complete.
It is rare for the clinical trials industry to spend time and money on a tedious and labor intensive process when it is not required by the U.S. Food and Drug Administration (FDA). But that’s exactly what is happening with source data verification.
The high cost of source data verification (SDV), particularly in large trials, has made it a target of scrutiny over the last decade. In addition, the positive impact (ie, cost-benefit ratio of SDV) on overall data quality is often questioned. As a result, regulators and industry groups have started looking at alternative SDV approaches.
Oversight of the clinical trials includes clinical research, data management, biostatistics, project management, regulatory and quality assurance. One of the goals of monitoring of clinical trials is to have accurate data for the analysis of efficacy and safety.
Historically, clinical trial data were collected at the clinical research site on pieces of paper designated as Source Documents. These data were transferred manually by the site to paper case report forms (CRFs), which were then monitored against source documents by CRAs to basically see how accurately information could be copied from one piece of paper to another.
Sometimes it seems as if we've been discussing electronic medical records (EMRs) forever. Those of us in the healthcare trenches, whether physicians, patients, employers, payers or government officials, can easi Iy be forgiven for having more than a dollop of cynicism about the current enthusiasm about the adoption of EMRs.
Common wisdom holds that drug makers should stay out of the business of developing information technology (IT) software and instead buy one of the many proven, off-the-shelf solutions. But that’s not necessarily the best and cheapest way to collect data or manage clinical trials.
Jules Mitchel and Irene Ghilezan at Target Health, Inc, and Thersa Luna and Susan Carroll at Prometheus Laboratories, and Aida Bibliowicz at Cato Research Ltd, feel that turning away from our love for paper is the best way to optimize clinical trials.
With the proper Electronic Data Capture toolbox, the clinical group may now be able to deploy a full EDC study in days rather than weeks or months.
The technology is ready and available.What the industry is waiting for are the innovators, trailblazers and ‘risk-takers’ to take the plunge. The pharmaceutical industry has reached a fork in the road.There will be those who will choose to stay where they are in the short term, and there will be those who will embrace the integration of EHR and EDC systems.
Electronic data capture can be invaluable to speed clinical development processes. A recent study demonstrates the reliability of data collected by this method.