Originally Published EMDM September 2001
Web Watch
Shredding the Paper Trail: Are Web-based Clinical Trials the Answer?
OEMs must weigh the pros and cons before making the move to an Internet-based clinical trial system.
Jamie Graham
When a delay of a single day can cost thousands of dollars, the time it takes a company to get its product to market is of utmost importance. By shaving time off of the clinical trial process using a Web-based system, companies can begin collecting revenue that much sooner. Making the transition from a traditional paper-based clinical trial to an Internet-based trial system may save time and money; however, before committing resources to an Internet-based system, companies should assess their need for faster clinical trials versus the cost of implementation.
The primary mission of a Web-based clinical trial is to take an antiquated paper process and speed it up, using the efficiencies of a Web-based system. According to Paul Bleicher, chairman and chief scientific officer of clinical trial software company Phase Forward Inc. (Maidenhead, Berks, UK), a Web-based clinical trial can save time by facilitating efficient data entry and reducing the amount of remote monitoring needed.
In the paper-based process, a clinical research assistant transfers the data from a patient’s chart to a case report form (CRF) at the research site. The data are checked by a study monitor and passed to a data entry clerk. The forms are checked for discrepancies, and then entered into the database by two independent data entry clerks. The data must then be checked for inconsistencies and inaccuracies using computerized edit checks and manual review, which can add at least 13 weeks to a clinical trial.
A Web-based system can condense these steps. For instance, Phase Forward’s InForm software allows certain parameters to be set for the form fields to avoid data entry errors, and automatic questions are asked at the time of data entry, instead of months later. This not only saves time in the initial steps, but also alerts users immediately to data errors and reduces the number of manual queries that must be performed. The process also provides rapid feedback and cleaner initial data.
The time saved can translate into tremendous cost savings. “Speeding the time it takes a product to get to market can save companies hundreds of thousands of dollars,” says Jim Grosspietch, director of marketing at NetRegulus (Minneapolis, MN, USA), a regulatory software provider. An Internet-based clinical trial can save costs in numerous ways if done correctly. “Remote monitoring coupled with reduced visits saves costs. E-mailing documents and accepting on-line signatures save money,” says Lee Palles, CEO of nTouch Research Corp. (Raleigh, NC, USA), a clinical trial consulting firm.
Reducing the number of queries done for error checking can also result in tremendous cost savings. Normally, there are two types of queries in a paper-based system. An automatic query is done with a computer program to catch various data entry errors. The more costly of the queries is the manual query. A manual query entails correspondence between the data auditors and the site monitors. The auditors aren’t allowed to change data, so they must transmit any question to the site monitors, who then look up the data in their records and then make the changes if any are necessary. The process is time-consuming and can be costly depending on the number of queries. Bleicher says Phase Forward’s InForm system can cut down on the number of manual queries by as much as 60%.
In addition, an on-line system offers the advantage that metadata—basically the data about the data being collected—is saved electronically. The metadata make it easier to track not only the data, but also the trial process itself. From a regulatory perspective, metadata are extremely useful because they track the process of collecting the data. Electronic records are kept on such things as who collected the data, where they collected the data, and how many times the data were changed. Also, the metadata give a clinical trial team the opportunity to view the trial process and fix inefficiency problems that normally would not have been caught in a paper process.
Getting Started
What is needed to implement a Web-based clinical trial? First, the cost of implementing a Web-based trial versus the size of the trial must be taken into consideration. The primary purpose is to save money, so companies should determine if moving to a Web-based trial is feasible. Before signing on to do an Internet-based clinical trial, look at the type of data that will be collected and decide what would be needed to run an effective trial. It can take three to four months to set up a trial, and the cost of establishing trial sites in various locations can add up quickly, according to Nick Lucas, senior director of data management at the clinical trial consulting firm Quintiles Ltd. (Bracknell, Berks, UK).
“Very often the remote locations don’t have Internet access, or even a computer,” says Lucas. Not only does the company have to purchase the hardware, but it also has to send personnel to the sites to provide assistance.
Some manufacturers, primarily pharmaceutical companies, have all of the capabilities needed to support their on-line clinical trial software, such as a high-speed, reliable Internet connection; constant technical support for worldwide trials; real-time monitoring of data; disaster recovery capabilities and systems; and physical security controls. However, many device companies don’t have the capabilities or the need to implement an entire information technology system in-house.
For those companies that don’t have all the necessary technology, there is another option. Most device manufacturers opt for an application service provider (ASP). Instead of purchasing a company’s software and supporting it in-house, a manufacturer can rent the software. In doing this, all of the capabilities listed above are contracted out. Commercial ASPs offer leasing arrangements to customers, providing a viable alternative for companies that don’t want to procure and implement complex systems themselves. Typically, an application leased through an ASP will look and function exactly the same as if it were purchased by a customer. Phase Forward’s InForm and NetRegulus PQIntelligence software are both available through an ASP hosting service and provide lower-cost alternatives to supporting the software in-house for smaller companies.
Potential Problems
“There are lots of ways to implement a Web-based trial. The worst way is to simply replicate the paper trial without giving thought to the nuances and advantages of the Internet paradigm. A true vision of what the study will be in an Internet-based trial is necessary to realize the full potential of the Internet,” Palles says.
Lucas says out that some companies have a problem letting go of the paper process in order to make an Internet-based system work. “We have customers who still want a paper CRF. They’re gaining nothing from that. They might as well stick to the paper process,” he says.
Also, companies should be wary of using data too early in the process. “The data may be visible immediately, but may not be completely clean. You have to think twice before you make certain decisions using data that hasn’t been monitored for errors,” Lucas says.
Preparation Is the Key
Even though they are designed to improve a trial’s efficiency, Web-based programs aren’t a necessary cure-all for inefficient clinical trial systems. Palles says thorough planning well ahead of time will eliminate most of the problems companies encounter when making the transition from a paper-based system to a Web-based system. “You must make sure the entire Internet-based trials platform will work reliably. This includes the ergonomic design of the on-line CRFs [the main user interface], stability of the application software, a robust network to accommodate thousands of hits daily, and adequately trained users,” he says.
In short, the best way to avoid pitfalls is to be prepared. Research various ASPs and consider all of the possible advantages and disadvantages your company might gain or lose by using Internet-based clinical trials.
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A Success Story Vasca Inc. (Tewksbury, MA, USA) made the transition from a paper-based clinical trial to an Internet-based trial two years ago, while preparing to bring its LifeSite body access device for dialysis patients to market. The company decided to use Phase Forward as an application service provider (ASP) of its InForm software to perform the 200-patient, 20-site, Web-based trial. Michael Patz, Vasca’s director of clinical affairs, outlined areas where the company saved time and money. In Keeping on top of the data more closely. It was easier for the company to do a quick initial review of the data and to identify any potential problems in the trial that wouldn’t have been noticed as early in a paper trial. In Cutting the number of monitors and data entry clerks. The number of monitors was reduced by one-third because the use of an electronic case report form (CRF) enabled the monitor to review the data remotely before going on-site, thus increasing on-site time efficiency. The electronic CRF also eliminated the need for hiring data entry clerks, as the data was entered into the database by the site coordinators. In
Reducing travel expenses. Vasca cut travel expenses by 30%. The monitors could review the data remotely, instead of visiting sites multiple times a month. In
Cutting the number of manual queries. In
the paper-based process, generating queries entailed data management personnel
reviewing the data, writing the queries on paper, bundling all the queries
for each site, mailing the queries, and then waiting for replies. Using
the Internet-based system, data management personnel queried on-line in
real time, and the site investigators replied to each query much faster
than to a paper query. Also, by setting parameters for the fields in the
CRF, transcription and typographical errors that weren’t found until
a month later by data management personnel in the paper-based system were
caught immediately by the software program. Patz says each manual query
cost the company <120 to <180 on the average, so Vasca realized
huge costs savings by automating part of the query process. The company locked its database one week after the data for the last patient in the study was received. This was a seven-week improvement over the time it took to achieve database lock in the paper-based trial conducted initially for the LifeSite device. The company was able to get the product on the market a month earlier than was expected. “We saved time and money from the get-go,” said Patz about the transition to a Web-based trial. However, Patz says that a Web-based trial is not cheap, and though Vasca experienced success using the Internet for trials for its LifeSite device, it still relies on a paper-based system for some trials. “It depends on the size of the trial. Considering the initial setup cost and the monthly fee to support the ASP, it is still cost-effective to use the paper-based system in smaller trials,” Patz says. “You really need to go on a case-by-case basis, and decide which method is best for you according to the size and complexity of the trial,” he adds. |
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