EDC’S POTENTIAL EXPENSE CHALLENGE IN CLINICAL TRIAL IMPLEMENTATIONS

An significant component of each clinical trial is Clinical Trial Management Systems (CTMS). Selecting the correct CTMS helps overcome organizational problems, such as planning , training, efficiency and reporting of clinical trials. Electronic data collection (EDC) is a well-established building block in which extensive clinical trial efficiencies can be brought into action. EDC’s the presence in the clinical trials sector has taken a significant step from its original origins of double-entering systems on stand-alone desktop computers in the 1990s, which have grown as a web-based tool that enhances the quality of knowledge, reduces costs , reduces deadlines for clinical development and provides users with a strong basis for new experiments.

 Although EDC has a long history and acknowledges that “everyone uses EDC,” many sponsors of biopharmaceuticals and medical devices are still performing paper-based studies. The initial costs of the transition to EDC are generally listed as a challenge. As such, they may conclude that EDC solutions for small firms are usually too large or that they are uncertain of the seller ‘s ability to provide high-quality technology, training and customer support, as expected.

Making the transition to EDC

The introduction of EDC technology transforms the data management scenario of clinical trials and provides many advantages for the field. Initially, EDC adoption instead of paper-based approaches was slower, but it could not be achieved by EDC with CRFs or with standard databases, making a reasonable argument for investment. This would not lead to a reverse investment. In recent years, EDC’s use of paper CRFs has shifted considerably with only very few demands being considered today.

Design concepts are easily changed to fit any new study, saving time for the creation and processing of CRFs for paper. On average, EDC is 41% less pre-study planning time. Using EDC the data are collected and input only once with a paper system into a data collection tool, data must first be entered into a case report, accompanied by a data entry category in an electronic system. This not only increases processing time but also affects the completeness of the transcription.

EDC also allows immediate data cleaning and does not entail extensive data maintenance work by a processing group. Unlike paper studies in which the logical checks of the data collected a week or month ago are carried out by the data administration group, EDC system logic checks are performed if the site enters and submits data, enabling it to be cleaned in real time.

Ultimately, EDC provides users easy access to clean data at low running costs following proper device selection and development and effective research management. Switching to EDC has been reported to save 30 percent on average of the time it takes for a clinical study.

Cost of clinical trials based on paper vs EDC

To decide to conduct research with EDC, it is important to carefully evaluate its overall costs compared with those of paper based processes. In making a true cost comparison, decision makers must take into account more than the initial cost of buying an EDC device. The only emphasis on initial costs overlooks the substantial downstream costs savings that can be accomplished by reducing the number of requests, quicker query resolution, faster data visibility by sponsors and CROs and less visits to monitoring. The last patient / last visit weeks or months earlier than his paper counterpart, and the locking of database more rapidly, are both substantially savings. And these advantages appear to be cumulative as new technologies’ efficiencies usually improve over time as end users become acquainted with them through repeated usage.

Direct costs should include double entry fees per page, visits to the monitoring system, average query resolution cost, downstream savings and more (see the Cost Considerations: EDC vs. Paper page for sidebar costs for comparison).

The advantages of EDC over Paper based Clinical Trial

Quality of data:

A comparison of manual query reasons is provided here. These figures are based on the amount of questions posed in paper forms.

• 48% of requests collected in paper are due to the lack of data; 0% are due to EDC.
• 35% of the questions that were presented by paper resulted from incoherent details, compared to 5% by EDC.
• 9% of requests received by paper resulted from out-of-service information, compared with 0% by EDC.
• 7% of the inquiries were asked to explain by using document, and 0% was asked for EDC.

1. Financial benefits:clinical research is one of the most costly drug domains. It takes more than 13 years and 1.3 billion dollars, or an average of 146 million $annually, to get a new drug approved by an initial private investment.1 Forrester Research has examined cost savings for Novartis, which used an open-source customer EDC framework for more than 400 clinical trials in the first place. The operating savings were significant in a 12-month Phase-II clinical trial with twenty sites and ten patients per site.

Thanks to remote control, less visits, shorter recruiting times, reducing (or removing) printing costs, quicker data entry, and lower costs of cleaning of records, the costs of the clinical trial have been reduced from $732,000 to 384,000.6 Visiting costs have been cut by 50 percent, data cleaning costs 80 percent, and all other operating expenses have been reduced by 32 percent. An EDC will allow savings in relation to paper between 49 and 62 percent.

2. Time Saving: If you use an EDC, your queries could be reduced by 86 percent, your study time could be reduced by 30 percent and your database stock could be reduced by 43 percent. A single data entry, which substitutes for completing the paper CRFs followed by the double input, saves significant time by monitoring remotely and reducing the number of queries. Overall, the time needed for drug development has been estimated to reduce by up to 30%. 9 It is important to remember that the time savings during database lock are the most important. It was shown that there are less missing data and less bugs and questions with EDC when it is time to lock a database than with paper-based systems. The database lock, as seen in the table below, can take up to nine days with paper, while the database lock is completed with an EDC system in one day only.
3. Clean and efficient data and minimized queries:  EDC usage results in significantly reducing types of data errors, such as out of range values and data missing, found in paper based CRF studies. More in the clinical trial with EDC mistakes are found and corrected much earlier than in paper-based systems which can only rely on ad-hoc mid-study analyses. At the time the entry is made, EDC edit controls are automatically and visibly resolved so that cleaner data is generated in the database. In a case study performed by Applied Clinical Research, an EDC system compared a paper query system with edit tests, showing a 65 per cent decrease in queries.
4. Traceability:Title 21 Code of Federal Regulations Part 11(21 CFR Part 11) is the Federal Law of the United States applicable to electronic records and clinical signatures.12 EDC systems must track all audit trail data shift to 21 CFR Part 11 compliant. Vendors must also prepare and assess and correct possible risks for disaster recovery. It is important to remember that EDC systems encourage answering questions of FDA reviewers, as they can automatically monitor any changes.
5. Simplified Monitoring:EDC systems allowed remote monitoring significantly reduces monitoring costs. EDC makes it easier to detect inconsistencies or errors in data entry at an early stage. The overall savings for a study of 20 sites can be estimated at up to $60,000.
6. Minimized  Data entry:Clinical data must first be written on paper for paper-based systems, then replicated data must be put into a central system, which is time consuming and error-sensitive.
7. Responses: Some EDC systems provide real-time alerts and reporting, which allow essential data access for decision makers immediately. Real time reports enable authorities to identify delays, such as delayed sites, more pro-actively and to be reactive to data in order to ensure patient safety. In the end, EDC systems allow sponsors to evaluate effectiveness or safety in the drug development phase sooner. EDC allows the pharmaceutical, biotechnology and medical device industries to concentrate on creating the best-in – class medications, biological products and devices for patients that save time and millions of dollars in medicine design.
8. Re – usability: The ability to reuse the system for future studies is a feature of EDC which reduces the cost of EDC adoption over the course of time. When the forms and their editing checks are formed, it is possible to store them in libraries and to reuse them for an endless number of studies.
9. Mid-study changes:EDC systems make changes in the mid-study much easier than paper-based research, such as introducing new fields in the Case Report Form (CRF). Some EDC systems support CRF versions in a matter of seconds to update automatically all CRFs in selected locations.
10. Patient safety:Enhanced data quality, increased reactivity and decreased time for the analysis itself lead to better drugs being provided faster. Many EDC features have an even greater effect: quicker reports of adverse effects , for example, will help to make decisions earlier and easier and save hundreds of thousands or thousands of patients from exposure to safe medicines.