Hitting the Sweet Spot

June 1, 2006

Pharmaceutical Executive

Volume 0, Issue 0

By leveraging EDC's features, sponsors can manage study progress better, adapt to opportunities, reduce trial times, and monitor patient safety.

Enormous interest and rapid uptake has spurred electronic data capture (EDC) within the pharma industry. And why not? EDC has made it fundamentally easier to manage clinical data and, in the process, complete trials.

William Claypool, MD

Most companies have bought into the idea that EDC is a logistical replacement for paper-based recording of clinical data. But the industry, for the most part, has yet to take advantage of the qualitative advantages of collecting data in an electronic format. These EDC "sweet spots"—which include data capture beyond letters and numbers, data analysis, and study management—can be seen in studies across many therapeutic areas, but have particular application in complex disease areas. Paper-based methods are not inadequate, but are more prone to error, inefficiency, and delayed access to data, and can affect study management and even the outcome.

Data Capture

By its very name, it's obvious that the core function of EDC systems is data capture. However, EDC effectively expands the scope and type of data that investigators can capture easily. This has particular utility in several specialty areas.

Oncology Clinical testing for oncology drugs often involves tracking very sick patients within clinical trials who must take multiple medications. Because of the number of medications and the frequency of change, the management of concomitant medication data presents one of the most difficult challenges for companies; investigators often find it hard to track the start and stop dates of individual medications. EDC systems categorize and display these measurements easily.

These systems also minimize queries by automating the coding of medications—Advil, Motrin, and ibuprofen are all the same medication, but for accurate analysis it is essential that they are referenced the same way. EDC systems also can track a variety of indicator lesions for solid tumors, and issue automatic queries if any indicator lesions are not recorded in subsequent visits.

Ophthalmology Researchers often find it best to capture observations in opthalmology trials with specific drawing tools that allow investigators to show the nuances of specific lesions or visual defects. They use the tools to take actual notes on the elecronic diagram or make changes to drawings. Modern EDC systems can capture these images, and supplement them with text narrative, to provide a fuller and more accurate description of a variety of eye pathologies.

Neurology/Psychiatry These clinical trials are highly complex and usually require rating scales to measure and benchmark the effectiveness of the drugs that are under study. These scales can be somewhat subjective and can be difficult to use consistently between evaluators, but they can combine crucial data with clinical findings (i.e. the use of MRIs with clinical observations for MS studies.)

Dermatology Diseases of the skin are usually visually apparent, and clinical trials that study dermatology conditions benefit from capturing photographic images of the affected skin. Here, EDC systems capture and catalog images in the study, which can augment the narrative and assist with analysis, review, and publication of study results. Although advanced image analysis is currently beyond the scope of most clinical studies because it is only cost effective at large volumes, EDC can help it become a more crucial element in the future.

The capture of radiographic, MRI, and PET scanning data—or binary displays such as ECGs and Pulmonary Function tracings—can help companies more fully capture the data available to them. Finally, esoteric laboratory data are frequently generated in university settings on platforms that have no password controls and no audit trail associated with them. In other words, they are not compliant with 21 CRF Part 11, a regulation that allows electronic records and signatures to be as valid as paper records and handwritten signatures. Using an EDC system, these can be captured in a 21 CRF Part 11-compliant manner.

Data Analysis

EDC also offers several advantages to companies that use it to analyze the data they collect during clinical trials.

In part, that's because EDC offers a safety net against errors. EDC has built-in edit checks, so there are fewer errors that can creep into the database. Given that the cost of correcting a single error starts at about $150—depending on when during the trial it is caught and corrected—this can result in significant savings.

Additionally, an EDC system can increase the efficiency of data coding, provided that the system is coupled with an auto-encoder and the auto-encoder is updated with sponsor dictionaries throughout the study. Statistical transformation and interpretation of data is easier when the system can perform data exports to common pharma industry platforms.

Beyond facilitating the statistical analysis of clean datasets, a quality EDC system also can help sponsors share and interpret clinical data with partners or key investigators. These technologies allow data interpretation to be done collectively or in an online forum where discussions can be threaded below the statistical tables.

Study Management

EDC helps companies replace out-of-control clinical studies with study management. This refers to the mechanical details of running a trial—keeping up to date on enrollment status, whether monitors have been checked, or if sites are entering data in a timely manner. These details streamline the process and make it easier.

As more sponsors have experienced the benefits of this control, the demand for EDC and e-clinical systems has grown. In the near future, new study-management tactics are expected to drive even greater demand:

Customizable reporting capabilities EDC systems have steadily added clinical-trial management functionality, including the ability to produce customized real-time reports. The ability to better see what is happening in a study makes management more timely, and more proactive—rather than reactive. In addition, EDC systems coupled with interactive voice response (IVR) technologies eliminate redundancies and discrepancies in front-end randomization data. They also integrate telephonic-based, electronic patient-recorded outcomes (e-PRO) data directly into the study database. These benefits make the whole process easier and simpler, with less manual effort.

Full service Full-service EDC is an integrated process that includes the combination of technology with all other services to get the best possible results. It is an attractive option for sponsors that are resource-challenged or require additional data-management support. Some commonly requested full-service EDC offerings include data management, data integration, and statistical services.

Trial management systems EDC vendors have added features that eliminate the need to support and integrate multiple applications, including front-end document-management systems and scheduling systems. This used to require tedious tasks like data re-entry, but since EDC already captures much of the data that drives these systems, it will make the process more efficient.

Future Enhancements

If companies incorporate EDC into their clinical trials, there will be greater involvement ultimately with regulatory agencies in the sharing of ongoing study progress. EDC offers sponsors a variety of capabilities to improve the conduct of clinical trials. These capabilities include improved data capture, data analysis, and study management—all of the EDC "sweet spots." To understand how these capabilities simplify the conduct of a clinical trial, consider them in the context of therapeutic practice areas that have a high degree of complexity, or where the integration of data can facilitate the study.

By leveraging these features, sponsors will be able to manage their studies more effectively—that benefits the subject and the sponsor. They also will be able to manage complex data, reduce errors, integrate information, and gain insight into trial trends.

William Claypool, MD is CEO of Phoenix Data Systems. He can be reached at bclaypool@pdsedc.com