To date, 12 products have been approved under the Animal Rule. It is highly recommended that sponsors of products that are to be developed under the Animal Rule meet with the FDA and other government entities early in the development process to ensure that the efficacy and safety studies that are planned will meet the FDA’s requirements for approval of the product
Query management is a standard process utilized by Data Management (DM) and Clinical Operations (ClinOps) for data cleaning. The resources and costs associated with query management are not trivial because querying is a long,multi-step process that involves many individuals at the sponsor company, Contract Research Organization (CRO)and investigational sites.
Dr Jules Mitchel from Target Health was an author on this publication on Risk-Based Monitoring (RBM), which focused on the various RBM approaches and their effect on quality. For mor information, go to http://www.targethealth.com/resources
The FDA and other regulatory bodies have issued multiple guidance documents addressing technology tools that are used in clinical trials.
To evaluate whether use of a scalp cooling system is associated with a lower amount of hair loss among women receiving specific chemotherapy regimens for early-stage breast cancer and to assess related changes in quality of life.
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 economic impact of using a paperless trial master file (TMF or eTMF) in a 80-center study in ulcerative colitis.
In this report we summarize the information presented in the SCRS webinar titled, "The Monitoring Dynamic: An Evolving Process and Relationship with the Site." Our panelists discussed the ways in which representatives from all branches of the industry are working to create a better understanding of, and smoother adjustment to, the use of Risk-Based Monitoring of clinical trials.
Taliglucerase alfa is a beta-glucocerebrosidase enzyme replacement therapy approved in the United States, Israel, and other countries for treatment of Type 1 Gaucher disease in adults, and is the first approved plant cell—expressed recombinant protein. In this report, taliglucerase alfa pharmacokinetics were assessed in adult and pediatric patients with Gaucher disease from separate multicenter trials of 30 Units/kg and 60 Units/kg doses infused every 2 weeks.
The benefits of eSource data: collecting data digitally without having to record the data on a piece of paper first.
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.
Study results using a quality-by-design method, risk-based monitoring, and real-time direct data entry.
Nobody wants to receive a Form FDA 483 after an FDA inspection of a clinical site, drug/device company, manufacturing plant or other entities subject to regulatory inspections. Nevertheless, while inspection findings are inevitable, they are not intended to be "the end of the world."
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.
Describing a drug development program initiated using a quality-by-design approach, with special attention paid to assuring proactive quality planning at all stages of development.
CWWeekly’s semi-monthly company profile feature, Insider Insights, interviews executives of companies and organizations in the clinical trials space. Writer Ronald Rosenberg sat down with Jules T. Mitchel, Ph.D., president of Target Health.
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.
In order to assess the impact of direct data entry (DDE) on the clinical trial process, a single-site, phase 2 clinical trial, under a US investigational new drug application (IND), was performed where the clinical site entered each subject’s data into an electronic data capture (EDC) system at the time of the office visit and the clinical research team implemented a risk-based monitoring (RBM) plan.
Target Health, Inc. participated in study design, regulatory activities, and data management, and reviewed all versions of the manuscript for this clinical trial.
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.
Mention medical devices and diagnostics (MD&D) and most life scientists think of surgical instruments, catheters, prosthetic limbs, artificial joints, and imaging machines. Yet, recent advances in genomics and bioinformatics, coupled with nanotechnology and innovations in the biomaterials field, are transforming the MD&D industry.
Jules Mitchel might be a good source to consult if you doubt the continents of services and technology are tectonically colliding. With his wife, Joyce, Mitchel runs Target Health, a small New York contract research organization (CRO) that has always been keenly interested in building its own technology—both for the sake of internal efficiency and for what customers can do with it. Business sounds good.
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.
The goal of this paper is to describe what new career opportunities are now available to CRAs with the advent of Internet-based clinical trials.
To optimize clinical development, WellSpring turned to Target Health to provide an Internet-based electronic case report form (CRF) without having to supply software to each study site. There was immediate cost savings of 30 percent from a paper trial.
Target Health is a good example of a company that defies categorization. With 22 employees, a fifth of whom are software developers, it is a small contract research organization (CRO) in Manhattan. But Target also develops its own commercial-grade applications for electronic data capture (EDC), as well as clinical data and trial management.
In addition to new efficiencies, Internet based clinical trials introduce new responsibilities for clinical research teams and investigators alike.
One of the most difficult parts of implementing Internet-based Clinical Trials, has nothing to do with the fundamental technology, but rather with making the necessary changes in structure, mind-set and culture within the sponsoring company as well as the clinical study sites. Choosing the right people to manage and execute the process is key to the success of any program.