A Unified Approach to Clinical Trials

Transcription

1 A Unified Approach to Clinical Trials A whitepaper describing how a Unified Approach enhances the safey, simplicity and speed of clinical trials. 2010

2 2 of 6 Table of Contents 1 The Clinical Problem Approaches to the Problem Partner Integrate Unify Why a Unified Approach? Scalable Framework Quality Efficiency Cost Next Steps... 6 International, Inc. A Unified Approach to Clinical Trials

3 3 of 6 1 The Clinical Problem Conducting even one clinical trial is a monumental undertaking. It involves managing diverse staff at a variety of different locations, complex software and hardware configurations, tight budget and timeline constraints, and many variables outside the direct control of a study management team (not the least of which is drug potency and efficacy). To compound this problem, clinical research requires multiple clinical studies to bring even one drug or device safely to market. Study Concept Initial Protocol Development Protocol Protocol Finalization Budget Development Study Team Assignments Filings Authorization CRF Development Authorization Efficacy... Protocol Amendment Enrollment, Data Collection, Data Cleaning... Site Selection, Contracting, And Training... First Patient In IRB Approval Site Payment... Periodic Safety IRB Approval Study Drug Manufacturing, Distribution and Management... Periodic Safety Lab Data Management... Database Lock Clinical Study Report Creation Adverse Event Tracking / Management... Last Patient Out Data Analysis Figure 1: Clinical Trial Process Filings As the above figure shows, a wide array of activities must be undertaken in order to run a clinical trial. Each niche of the clinical trial process has its own set of specialty vendors. The problem in conducting clinical trials is to determine the safest, fastest and most cost-effective way to perform all of these tasks, while maintaining regulatory compliance and producing usable clinical data. International, Inc. A Unified Approach to Clinical Trials

4 4 of 6 2 Approaches to the Problem To date, three approaches have emerged: Partner, Integrate and Unify. Each approach has benefits and drawbacks. 2.1 Partner Companies in the Clinical Trial industry may elect to partner with other vendors in order to meet their needs for conducting clinical trials. This approach may create a solution providing instant gratification, which may be hard to ignore. However, because of the nature of disparate systems, partnering may also lead to management of multiple vendor contracts, as well as manual integration of data, systems, and user accounts. Clinical efficiencies are left Figure 2: Complex System Mapping unfilled, and each partner system must be mapped to the other systems in an eclinical offering. As the number of systems increases, the time and cost of mapping and validating those systems increases exponentially. 2.2 Integrate 2.3 Unify Integration is a similar concept to partnering, except that the products are brought in-house instead of maintained through a partnership agreement. As with the Partner approach, this approach may provide instant gratification. In comparison to the Partner approach, the number of vendor contracts may be reduced. However, the synchronization of data between the disparate systems may still lead to performance, stability, and usability issues. Although the systems have been brought in-house, mappings must still be made between each of them. As the final integrated product gains more components, these mappings will again expand exponentially, increasing costs dramatically. An illustration of the complexities created from mapping between multiple disparate products can be seen in Figure 2. Unifying solutions rely on a single underlying architecture upon which all functions are built. The result is improved usability through a single database and user interface. Unifying solutions also reduce the number of vendor contracts as fewer or no disparate systems are required. A Unifying solution also provides interoperability with outside systems when necessary. One Database Figure 3: Mappings for Unified Solution International, Inc. A Unified Approach to Clinical Trials

5 Technology 5 of 6 3 Why a Unified Approach? 3.1 Scalable Framework One Trial eclinical Knowledge ONE TM Services Vault Connect Figure 4: One Diagram A unified approach to clinical trial software consists of an underlying software and database architecture that combines traditionally separated clinical trial functions into one complete package. However, a truly unified approach is not only a combination of software and hardware, but also includes managerial principles, service offerings, and well-defined processes. A clinical trial cannot be conducted without the base technology, the knowledge to use that technology, a system to manage the trial, and a repository to store the data. 3.2 Quality All Trials To produce high quality clinical data, a secure, proven technology must be utilized and users must be adequately trained on that technology. Clinical trial technology must not only be fully compliant with regulatory guidelines from a variety of countries, but also have exceptionable usability and contain intuitive functions for all end users, regardless of native language or technological background. In a unified approach, the technology will always be accessible with the same username and password, and all screens will follow the same user interface pattern. Users will not be confused when moving from function to function; rather they will have the sense of using only one product that happens to be capable of many different things. A unified approach will also provide the training and learning pathways necessary to keep all study personnel up-to-date on the latest clinical software features, as well as clinical processes. This training should consist of courses that are well-documented from a regulatory standpoint, and also include learning materials that enable scalable continued education to a potentially large number of study personnel. International, Inc. A Unified Approach to Clinical Trials

6 6 of Efficiency 3.4 Cost The goal of any clinical trial is to produce the necessary clinical data in the shortest time possible. This cannot be done without well defined plans for designing and conducting the trial and analyzing and submitting the clinical data. A unified approach can provide a high level of efficiency by providing a single interface for the end user. Users will be able to maintain a high proficiency level in a single system, resulting in fewer errors and less wasted time correcting those errors or discovering how to perform certain functions. A unified approach will also include a service offering to align, or connect, the various processes of the vendor and client. A unified approach is not simply an offering of bundled technology, but is also a service offering intended to maximize the efficiency of clinical trial processes, from the design and implementation phase, to activities involved in conducting a study, to reporting on and analyzing the clinical data and ultimately submitting the data to a regulatory body. Conducting a clinical trial can be a very costly endeavor. A unified approach keeps costs low by reducing the number of vendor contracts and mappings between disparate systems. As the number of disparate systems are reduced, the cost of training users on those systems also decreases. Quality and efficiency have a direct effect on cost as well. As those improve, overall costs will decrease. Quality does not have to improve at the expense of higher costs; rather by implementing a unified solution with well-defined training processes and intuitive software, costs can be controlled. In addition, a clinical trial solution must be scalable to a large number of studies and personnel. Without this capability, it may become too expensive or take too long (and thus be too expensive) to deliver a drug to market. A unified approach provides scalability through the use of a singular, robust technology offering combined with efficient training methods and smart service offerings to identify efficiencies in the clinical trial process. 4 Next Steps A unified clinical solution can improve quality and create efficiencies and cost savings for organizations of all sizes. Companies adopting unified strategies across the enterprise are able to shift focus from system deployments to clinical trial processes, growth and leadership activities.if the thought of a flexible unified system supporting your clinical trial needs sounds like the next step for you, ask for s Implementing a Unified Clinical Trial Solution. We ll send you the ONE whitepaper which will help you understand how to begin unifying your trials. has been helping organizations with or without existing infrastructure obtain the benefits of a truly unified clinical trial solution for 15 years. Contact us in North America at (866)-677-DATA (3282) or in Europe at ; or you can us marketing@datatrak.net. International, Inc. A Unified Approach to Clinical Trials