Most clinical trial data can now be collected directly and automatically — at the moment of inception — without the need to transcribe and verify source records or integrate software. This direct-to-database model is far simpler, faster, cleaner, and compliant than paper-based methods. And, with the right eSource platform, trial data can be aggregated, integrated, and classified to accelerate data analysis for insight-based decisions in real time.

Direct Data Capture: What’s Not to Like?

Direct Data Capture (DDC) technology ingests trial and patient source data captured directly at the source. The speed and directness of eSource data offers a number of advantages to Sponsors over traditional paper-based methods of recording trial data and even over limited-use electronic data capture (EDC) systems. Foremost among these are:

• Improved study oversight.  With role-based visibility to data in real time, study teams can intervene as needed to reduce risks and monitor patient progress in a timely fashion.
   
• Greater control over protocol execution. eSource technology provides automatic calculations and includes instructions to reduce errors. Guided information entry protects against protocol deviations, ultimately reducing the number of data queries.
   
• Accelerated decision making. There is no lag time since eSource data doesn’t need to be transcribed, loaded, verified, and integrated.
   
• Higher quality data. With Direct Data Capture technology, there’s less room for human error. There is no transcription. No patient diaries hurriedly completed in the clinic parking lot. No errors or omissions in visit records. The technology flags missing, erroneous, or inconsistent data based on pre-determined logic.
   
• Use of digital biomarkers. With advances in wearable and sensor technologies, state-of-the art instruments specific to a therapeutic area can be developed to complement existing assessments and augment traditional clinical trial data. Our work to date has demonstrated that mobile devices can be easy for patients to use, secure, and valuable in detecting disease and tracking patients’ ongoing status. In time, we believe that they will be used in conjunction with other scales to determine an individual’s disease probability, severity, and risk for progression, with applications in clinical trials as well as medical practice.
   
• Time and cost savings. When data are captured electronically from the source, there is no need for it to be transcribed into a software program nor is there any need for Source Data Verification (SDV). Plus, the process generates fewer data queries and streamlines the query management process.

Naturally, clinical development, operations, and IT leaders seek to rationalize and optimize the mix of technology available to support their trials. Given the digitization of trial data, the ideal solution supports real-time data collection into a single eSource ecosystem that is scalable, sustainable, and customizable. 

To discuss how to leverage direct data capture for your clinical trials, talk to one of our experts or learn more about eSource Technology.

The post Straight from the Source: How Capturing Data Directly is Transforming Trials appeared first on Clinical ink.

Advances in the treatment of systemic lupus erythematosus (SLE), the most common type of lupus, have been few and far between. However, with the introduction of two new therapies in 2021, that appears to be changing. Approximately 70 trials for new treatments are currently either underway or starting up. 

Even so, advanced lupus research remains a challenge for several reasons: 

• The systemic and unpredictable nature of SLE means that the assessments are highly complex, and the documentation required is extensive.
• The variability of the data increases the complexity of data input into an Electronic Data Capture (EDC) system, with a high volume of data queries involved.
• Traditionally, there has been a significant time lag between the patient visit and the data review. This is often because there isn’t enough documentation to support scoring and grading.
• Competition for patients in clinical trials provides a more significant challenge when conducting trials.

Given these difficulties, several life sciences companies and contract research organizations (CROs) asked us if our Direct Data Capture technology could be used to improve the assessments and data collection in SLE trials.   

Introducing a better way

In answer to this challenge, we created the electronic Lupus Assessment Suite® (eLAS). eLAS® is a data capture tool that allows clinicians to complete a focused physical exam in the presence of the patient. During the exam, clinicians will be able to check off SLE symptoms on electronic versions of the required assessments, grade and score the findings, and upload the data directly from their tablet to the sponsor’s dataset. The tool guides the investigator through the documentation in a logical order, auto-populates repeated fields, presents data from previous visits for comparison, and employs edit checks to prevent errors and omissions. It also highlights any patient safety concerns that the data may indicate. eLAS® supports collecting patient-reported outcomes (PROs) during the patient visit. 

Overall, eLAS® is designed to provide straightforward, efficient, and reliable Direct Data Capture (DDC). It also eliminates manual errors associated with traditional paper methods.

Immediate data collection, edits, and reviews

This streamlined approach to collecting data can produce a marked improvement in data quality, patient safety, timing, and the cost of lupus trials. Here’s how:

• Direct input during the patient visit – This makes it possible to correct discrepancies and complete missing information immediately, which might only have been discovered long after the patient left the clinic in paper-based assessments. Automatic edit checks also prevent out-of-range entries and skipped fields, leading to fewer queries between the data monitors and the site.
  
• No duplicate entries or transcription needed – Investigators need only enter data into the tool once, as repeated information will automatically populate the required fields. There is also no need to transcribe the data from paper forms into an EDC system, eliminating the need for source data verification (SDV).

• A streamlined flow of data to the study team – Before the patient leaves the clinic parking lot, the data can be uploaded to the portal for review by:

• Adjudication teams to make prompt decisions on patient eligibility. 
• Medical safety teams to spot any adverse reactions to the study drug or manifestations of lupus that are potentially life-threatening.
• Data monitoring teams to begin the appropriate queries.
• Data management teams with a real-time dataset.

Our Direct Data Capture software for clinical trials is efficient for both sites and study teams. Not only does it eliminate transcription and SDV, it also reduces the number of data queries and removes the time lag to complete datasets. In sending cleaner and more complete data to study teams, the tool reduces study timelines, bolsters sponsor confidence, and brings clarity to market authorization decisions. 

The patient is at the center of all these advantages. Our system provides patient outcomes with the highest confidence available, which is our goal with each clinical trial we have the opportunity to serve. If you’d like to find out more about the eLAS® suite, please contact us.

Authors

Will Combs
Partner Alliance Director, Clinical ink

Doug Pierce
President & Co-Founder, Clinical ink

The post Transforming Lupus Trials with Direct Data Capture appeared first on Clinical ink.

What’s the Advantage of DDC and How Does it Relate to Source Data?

Understanding the advantages of DDC vs. EDC requires us to clarify the definition of eSource. But first, what do we mean by source? 

Source documentation is the fountainhead of data — that initial data recording, whether it’s a digital thermometer reading, a BP entry in the electronic medical record (EMR), a paper form, or an ePRO entry. eSource in clinical trials is simply the direct digitization of source data with no intermediate steps. Collecting data in this format is better for timelines, audit tracking, accuracy, consistency, and overall data quality and visibility. eSource covers a wide variety of data types, including labs and imaging data, patient-reported data, as well as clinical data captured by site staff into a mobile device.

Clinical ink’s integrated eSource solution includes DDC, clinical outcome assessments (eCOA), patient-reported outcomes (ePRO), eConsent forms, and the direct digitization of the information collected during a clinical trial, such as physical examination findings, vital signs, ECG, and blood or urine screens. And here’s the key: These data are entered directly into the DDC software in real-time as they are collected. This is critically different from traditional EDC workflows, in which data are collected in a variety of ways during the patient visit and later transcribed into the EDC application. 

Using a DDC device, site staff enter data during the moment that matters, the patient visit, so errors can be corrected and omissions flagged. Edit checks run at the point of data entry, resulting in cleaner, more complete data. Clean, complete data means fewer queries and increased productivity for sites. Eliminating the need to transcribe source data into an EDC application saves time and reduces error, and eliminates the need for source data verification (SDV) — one of the biggest burdens of study monitoring. “SDV” is something of a misnomer, considering that it is performed long after the patient visit, and all that can be verified is that the transcription is accurate.

What if There Are Existing Medical Records That Need To Be Incorporated?

In any trial, at a patient’s first visit, historical information such as medical history, laboratory, or medication data will likely need to be transferred into the research record. It’s no different when you implement DDC technology. Pre-existing information in the paper or electronic medical record, the PRO record, or elsewhere may need to be transcribed into the DDC software — the same way it would need to be transcribed into a traditional EDC. Because these initial data were, in fact, transcribed (unlike most of the DDC data), they will need to be verified. Clinical ink’s DDC allows these data to be scanned and uploaded to the eSource database, where they can be remotely verified. In contrast, new data collected will be directly captured into the electronic research record, needing neither verification nor transcription. 

What About Regulations? Are Regulatory Authorities in Favor of Using eSource Data?

Over the years, regulatory authorities have discussed data capture frequently with the industry. With the advent of tools, technologies, and approaches that embrace a more direct capture of data, the FDA, the EMA, and other regulatory agencies issued eSource-related white papers and guidances, embracing this type of approach. In 2019, the EMA released a qualification opinion on eSource in which Clinical ink’s eSource solution is identified more than 10 times in relation to its use in multiple eSource studies conducted in Europe. Throughout, the agency makes it clear that eSource via Direct Data Capture is not only acceptable — it is the preferred method for data collection.

Of course, you want to make sure your vendor can configure their systems to be compliant with applicable regulations — 21 CFR Part 11, GDPR, HIPAA, and any other relevant guidance set forth by local regulatory agencies.

These references should provide perspective:

July 2019 – EMA

Qualification opinion on eSource Direct Data Capture (DDC)

September 2013 – FDA

Guidance: Electronic Source Data in Clinical Investigations

August 2010 – EMA

Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials

What if I’m Not Sure About Internet Connectivity?

If internet access is unavailable for your clinical trial, you might be wondering what options you should consider when looking for the ability to carry out decentralized, home-based, or hybrid studies. DDC is ideally suited for highly mobile data collection. Devices in homes, ambulatory centers, or remote medical locations can function independently and facilitate proper study execution through well-designed workflows and edit checks that ensure the right data is collected during the patient encounter.

Then, as soon as the internet can be accessed, the data is uploaded to the web portal for review by the broader study team. This flexible data collection capability supports a wide range of study designs, from 100% virtual visits to a mix of virtual and site-based visits. Clinical ink’s DDC technology features fully integrated televisit functionality to enable data to be collected when and where it makes the most sense to the patient. At the end of the day, that’s what matters the most.

Enhance Your Studies with DDC From Clinical ink

Learn more about how Clinical ink’s DDC technology saves you time, produces cleaner data, and builds confidence in both decision-making and study conduct.

Author: Doug Pierce, President & Co-Founder, Clinical ink

The post Advantages of Using DDC for Your Clinical Studies appeared first on Clinical ink.