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Clinical trials are complex, time consuming, and data intensive. Yet pharma remains one of the few industries that is still largely paper driven.
Clinical trials are complex, time consuming, and data intensive. Yet pharma remains one of the few industries that is still largely paper driven. Those in the industry that have adopted e-technology are using the internet to transform clinical trials management. One such technology is the clinical portal, a web-based application that integrates information from multiple sources and trial sites and delivers it quickly and efficiently to the clinical trial team.
This article presents a model for successfully building clinical portals that speed up and improve communications as well as elevate project management to a new level. It also offers a few lessons learned from pharma sponsors' early clinical portal efforts.
A clinical trial manager receives a phone call from her director, a senior pharma executive, requesting details about the trial's progress. At her desk, she logs onto a website. From there, she views the number of site locations and enrolled patients, the status of case report forms (CRFs) and outstanding queries, laboratory results, and serious adverse event information. Within seconds, she relays to the director everything he needs to know about the trial's status as well as the decisions she will make based on the information presented.
None of that is wishful thinking. The ability to tap into such data is available now through clinical portals. Such portals use the web to create a virtual community, enabling real-time communication among trial sponsors, monitors, investigator sites, and other participants. Real-time web portal communication allows for earlier identification of problems and opportunities and can help teams make better, faster, and more informed decisions. (See "Desktop Data.")
Clinical project teams locate sites and investigators, distribute protocols and study guidelines to investigative teams, enroll patients and track their progress throughout the study, and monitor the flow of CRFs. A portal can display real-time metrics for all of those activities. Clinical portals can contain study documents, key study metrics, training materials, timelines, budgets, discussion forums, and actual clinical data. Clinical portals are valuable to team members in many ways:
Real-time information. Project team members need access to up-to-date information about site and patient enrollment, CRF and query metrics, and clinical data. Clinical portals contain real- time or near real-time information and are accessible through a single website. By having access to such current information, team members can more quickly identify problems and develop better informed solutions.
Integrated and accessible information. In addition to displaying integrated information, clinical portals include search and report capabilities. Project team members no longer need to review reports from disparate sources or create new reports combined from those sources. The clinical project team can use the integrated information to make decisions rather than spend time creating the information they need.
Secure access. Authorized individuals can access real-time clinical data. Such data, even if blinded, may still provide important information. That is particularly true for product safety issues. Using carefully designed security and authorization processes, certain users may be unblinded to review safety information. For example, trial planners can give members of a data safety monitoring board access to safety-related information. Early identification of safety issues can save money by enabling earlier go/no-go decisions, and early detection can prevent patient deaths.
Collaborative tools. Portals provide a secure environment in which clinical trial teams and sponsors can collaborate, regardless of geographic location. Communication through clinical portals can be more secure than communicating through e-mail. Most e-mail is not secure, but portals are implemented using data encryption and other security mechanisms. By collaborating over the internet, team members can solve problems faster, work together on documents, track progress toward meeting deadlines, schedule meetings, and hold discussion forums.
Worldwide internet access. Team members all over the world can easily obtain study information by accessing the portal. In fact, it is often faster to access the internet than it is to upload documents from internal company network drives. Moreover, team members located in disparate offices may not have access to internal network drives. By accessing information through the web, project members can obtain information immediately and avoid waiting to receive documents from other sources, thus facilitating the sponsor's ability to expand clinical trials to geographic locations with target patient populations.
Portals are crucial for every component of the clinical trial. Team members can use the portal as a repository for documents both in process and in final form. When site and patient recruitment begins, the portal becomes the central source of metrics for enrollment.
As the trial progresses and data management metrics become increasingly critical, clinical portals denote the number of paper or electronic CRF pages at each stage, from collection through data cleaning. In addition, they track the number of queries at each stage and any other information critical to the trial.
Portal implementation teams-made up of project leaders, web designers, and technical specialists-must understand the clinical trial process and its specific technologies. They must ensure that portal users have access to the most current and final versions of all documents. Users should have confidence in the portal as their main source of obtaining information. If the portal does not have a document when needed, users will find other means of obtaining it, eliminating the need for the portal.
Project team members receive information from many sources, including internal document and trial management systems and reports from outside vendors. Those sources can be conflicting and difficult to interpret because some reports are more up-to-date than others. Therefore the goal is for the portal to be a single, unified information source that provides real-time or near real-time data.
From a technical standpoint, that goal can create design and implementation challenges. One successful approach to securing timely information is to use "push agent" technology. Data from the sponsor's system or other third parties is automatically "pushed" into the database that underlies the portal. Various data sources can forward information to the portal database either on a scheduled or an event-triggered basis. For example, when a clinical trial uses an interactive voice response system (IVRS) for patient enrollment, the portal updates itself immediately each time a new patient is entered into the study. Alternatively, the portal can be updated on a pre-defined schedule of any frequency. Scheduled updates are ideal for large data feeds such as clinical databases or for data that is less time sensitive.
It is important to note that it is not the portal's role to duplicate the functions of source systems. Nor is it intended to serve as a data management, finance, or project management system. Instead, the portal is designed to be a place where information from various source systems is "copied" for the purpose of integrating it and making it readily accessible.
Although much of the information displayed on the portal is similar across clinical trials, every study is different. Portals must be flexible enough to provide users with the information they need for their particular trial. Customization often relates to the specific data feeds required or to preferences regarding the visual display or "slicing and dicing" of data for a given program. For instance, one pharma sponsor may wish to view information about queries outstanding for more than 28 days, while another prefers to view the same information for queries that are 7 days old. Some clinical trial teams want all versions of documents; others want only the most current. Portals can and should accommodate different requirements.
Some sponsors may request entirely new functions. In one large implementation, the sponsor asked for a web-based, decision-support tool to help manage recruitment. The sponsor needed a program that would respond to different scenarios and answer questions such as the following:
Technology providers can build such customized tools according to each pharma company's needs. (See "Checklist for Choosing a Vendor.")
Checklist for Choosing a Vendor
Individual users also have different information needs. Some senior executives may only want to see summary information about a trial. Others, such as trial monitors, need extremely detailed information. A trial monitor preparing for a site visit, for instance, needs to know everything about that particular site:
Portals provide drill-down capabilities so users can access increasing levels of detail regarding a particular trial, investigator site, or patient. For clinical portals to be successful, they must satisfy users at every level.
With multiple users at various levels, security is critical. All users must have a unique ID and password. They must be assigned appropriate levels of access, based on their position. The company must also maintain servers in a secure physical environment with data encryption systems, firewalls, and regular backup. Those backups should be stored off-site at a secure facility.
Successfully building and implementing a clinical portal requires six steps:
1. Define requirements. Together, the technology team and the sponsor determine which documents to post on the website, establish the metrics and reports they want to have displayed, and identify the clinical data they want made accessible. They must also define access levels and policies for each data field.
The metrics component is often the most complicated. Displaying metrics requires the integration of several data sources, both internal and external to the sponsoring company. The implementation team must define the required metrics and their corresponding data sources, along with the appropriate personnel contacts who understand the database structure and fields. The team must also define the frequency of updates from a given data source, establishing whether those updates must be performed on a real-time or periodic basis. That ensures that when the portal goes live, it will provide users with the correct information in the way they need to see it.
Defining requirements early in the process helps avoid implementation delays. The planners should set a date by which requirements are "frozen" for the initial portal release. Subsequent requests will then be part of regular, controlled releases of new components and versions of the portal.
2. Establish clean data policies. Every portal raises data management issues such as the need to provide "clean" metrics. The portal runs the risk of being a garbage-in/garbage-out information source if it doesn't receive quality data. During the design phase, the sponsor should make policy decisions about what level of clean data is acceptable and who should monitor its quality. The information's source, such as the clinical trial management system, should be responsible for providing clean, high-quality data to the portal.
3. Create the "shell." After reviewing the requirements, the technical team builds a visual representation of the sponsor's requirements. At this point, however, the "shell" does not contain any documents or metrics. The project manager shows it to the sponsor to obtain feedback on the portal's look and feel.
Creating a shell accomplishes three things:
4. Obtain documents. If the sponsor has finalized documents, the outsourcing vendor makes them available on the portal. Sponsors also can create a separate document repository for work in progress. That system enables colleagues to collaborate on the creation of a document with built-in controls, such as an audit trail that records all changes and prevents two people from editing the document at the same time.
5. Build the site. It is unnecessary to create the entire site immediately. The portal's development can be modular and implemented in parallel with the study's roll-out. Typically, there is an early need to support document posting and document collaboration as trial planners finalize the protocol and other study documents. As the clinical team recruits and enrolls sites, the technical team can add site recruitment metrics to the portal. Similarly, when they enroll patients, they must make patient recruitment metrics available.
The remaining trial management metrics, such as CRF and queries, can "go live" when the clinical project team begins generating those documents. Access to actual clinical data is added as the information flows into the system. Using that modular approach allows for rapid portal start-up.
6. Solicit feedback. The implementation team must also regularly follow up with users to find out what they like about the portal and what needs improvement. User suggestions can be incorporated into new version of the portals. It is essential to solicit feedback from both supporters and non-users of the system. Non-user feedback can help designers understand why some people are not taking advantage of the system. The team can then improve the portal to address those issues. Non-users who turn into supporters become the strongest advocates. Surveys can be useful, but direct interaction with users is indispensable.
For a portal to be successful, it is essential that the project team sees its value and buys into the benefits of using the technology. There are several ways to accomplish that.
Define success appropriately. Clinical portals are designed for a limited numbers of users, most likely project teams and investigators. For a clinical trial team, success may mean hundreds of log-ins per month, not thousands or millions, as is the case for commercial websites. Clinical portals can be considered successful if a project team member logs on at least once a week. Each time users log on to the portal, they save time, because they don't have to search for documents or prepare reports.
Eliminate other methods. It is important to eliminate alternative methods for communicating the same information. That way the portal becomes the exclusive source for clinical trial team members to obtain the data they need. In one clinical trial, a team leader posted meeting minutes on the portal but continued e-mailing those minutes to the team. When he stopped the e-mails, clinical portal usage increased immediately.
Promote the clinical portal. Every clinical portal needs champions-those who understand and believe in its benefits. They must then reinforce the message with the clinical trial team members. Training sessions conducted by the IT outsourcing vendor also reinforce the champions' message. Experience has shown that after using the portal once, users see how easy it is to obtain information, and they come to appreciate how it can improve their day-to-day work.
Understand the users. Clinical portal users represent many functions and levels, including senior executives, project managers, site managers, trial monitors, medical writers, project scientists, marketers, and administrative assistants. They all visit the portal for different reasons. Some users want summary information and others want the details. To be of significant value, the clinical portal must offer information to satisfy all those users and their different needs with as little navigation-fewest number of clicks-as possible. Users need to be able to configure their own "home page," making the information of greatest interest to them readily accessible upon return.
Anticipate resistance. Technology adoption is fraught with management challenges, and the implementation of a portal is no different. Training, communication, and buy-in are key ingredients to overcoming those obstacles.
A unique challenge to gaining buy-in is the potential concern from team members about the visibility of individual performance information. For instance, if there is a backlog in data entry, it will be evident to all who view the portal, including management. Although that visibility may leave team members feeling exposed, it cannot be accepted as an excuse for withholding information or communicating more slowly. Whatever the cause, it is important to understand and address potential sources of resistance. Managers must reassure study teams that they will not be penalized or micro-managed as a result of using the system.
Clinical portals can be a "one-stop-shop," containing all the information clinical trial teams need to manage their studies more efficiently. Senior executives can save everyone's time by getting needed information from the portal rather than phoning staff members. Project managers reduce sponsors' costs by using portals to monitor patient enrollment, trial milestones, budget/ spending, and recognize or anticipate problems early. Trial monitors can better prepare for site visits through information available on the portal. Eliminating the need to compile and prepare status reports on a regular basis reduces overall personnel requirements.
Continuing industry trends will drive the growth of portal applications. In an era of collaborations and mergers, portals provide a mechanism for enhancing communication across global pharma companies and between trial sponsor companies and outsourcing service providers. As outsourcing continues to increase as a strategic element of drug development, sponsors can rely on information from portals to carefully monitor the performance of contract research organizations and other biopharmaceutical outsourcing service providers and to compile comparisons among vendors. (For more information, see "Portal Resources.")
Because clinical portals improve access to "real-time" information, they can dramatically improve decision making capabilities and enable earlier go/no-go decisions. Earlier decisions in the development process can minimize costs and shorten project timelines. Overall, the benefit of using portals in project management is the streamlined completion of clinical trials and, ultimately, accelerated time to market for new products.