Vaccines – Tracking Multiple Doses

Challenge

Vaccine dosing studies usually require information to be entered with high accuracy in a short amount of time. Blood draws often occur every 10 to 15 minutes during an initial time period and then hourly or every several hours for a second time period. When collecting information on paper for several cases at the same time, this can become challenging since the data requires the phlebotomist’s signature, and the date and time the information was recorded. Additional observations, such as the case’s physical reactions (injection site reactions, mood, level of energy or lethargy, etc.) are often required in addition to lab data.  Depending on study objectives, the extent of data collection can vary and collecting large amounts of data in a short time on paper can be stressful and prone to errors. Further, when labs results are returned and analyzed, the results must be integrated with existing patient data. Each data entry process on paper introduces the change for human entry errors. The challenge was to develop an electronic system that would streamline the data collection process, reduce errors, and stress.

Proposal

Prelude Dynamics proposed the study use Prelude EDC, an electronic data collection system, to allow researchers to capture information in real-time, follow the natural work flow of the study process, and ease data collection. The proposed system would automatically integrate lab results into patient files, compare them to established lab normals and flag outliers, and allow the researcher to determine if the flagged outliers were clinically significant.

Background

Vaccine trials usually consist of understanding real-time antibody development occurring post-introduction of the vaccine. Generally, different dose amounts are compared to determine the optimal dose to produce an effective vaccine. This requires the researcher to collect multiple blood samples after initial dosing. The intervals of the blood collection are typically every 10 to 15 minutes for an initial time period and then hourly or every several hours for secondary time period.

During each blood collection event, additional data on various physical responses to the vaccine is also collected (blood pressure, heart rate, etc.). Depending on the method of vaccine administration, other observations are recorded, such as injection site redness, heat, and pain if administered via injection, or coughing rate and breaths per minute if administered via breathing. These observations demand close attention from the researcher and increase the stress level the researcher experiences during data collection.

Historically, vaccine studies are costly because the researchers-to-subjects ratio of at each data collection event is low to allow enough time to collect the data. Development of an electronic data capture system that streamlines the process can increase the accuracy of data collection, and allow for more subjects to undergo the vaccine therapy simultaneously, ultimately lowering costs, decreasing data collection time, and reducing time to market.

Solution

Prelude Dynamics proposed to utilize Prelude EDC to develop an electronic data system for vaccine trials that:

• Includes an integrated time management system that prompts the researcher to administer the doses or collect specific data within designated timeframes.
• Expedites data entry of dosing or blood draw by collecting researcher information, data and time stamp for each data collection event with one button click.
• Standardizes data collection by allowing researchers to select designated options rather than writing out observations.
• Allows researchers to augment the clickable answers with additional details when pertinent.
• Alerts researchers immediately of missing required data to ensure the data is collected prior to the data collection event.
• Integrates lab analysis into patient files, including notifying researchers of the receipt of lab results and flagging outlying results based on designated lab normal values.
• Allows monitors and sponsors to view data collection in real-time even when they are located remotely so that if data needs to be queried, it can occur quickly.
• Allows sponsors and researchers to examine demographic results of the data collected to date to allow mid-study monitoring.

Prelude EDC contains administrative panels that allow the sponsor to determine the frequency of vaccine dosing and challenge dosing and blood draws. Acceptable timeframe deviation ranges can be entered into this panel. When site personnel or researchers initiate the time clock for the case by clicking the “now” time button, Prelude EDC automatically starts the countdown to the next event and displays any data that must be collected in the interim. When the “now” button is clicked, the user’s ID, date, and time stamp are recorded in the system, eliminating time to write the dame and time, reducing future data entry costs, and increasing the accuracy of data collection. Once the researcher clicks “save,” the data entered is hidden. When it is time for the next event (blood draw, dosing, etc.), the system alerts the researcher on the screen and displays the data to be collected for that event. Because Prelude EDC is an online data collection system, field researchers are able to access the study and enter data on any mobile device.

These features allow for dosing and blood draws to occur for multiple cases in a tiered fashion, which maximizes the researchers’ time without compromising data integrity. When multiple cases are being entered simultaneously, switching between patients can be done either through the list page or by entering the case ID and hitting the search button. The system is constantly communicating with the researcher what needs to occur next and what data needs to be collected.

The additional data to be collected between doses or draws is standardized in order to allow entry through selection from a drop down menu of choices, radio buttons or checkboxes. When additional information needs to be added, comments or notes can be added directly to the pertinent field. Additionally, if needed, free text fields can be provided for entry of comments or in response to certain questions. Edit checks that fire when the form is saved alert the researcher to missing or out-of-range information. Prelude EDC collects a full audit trail of all data recorded in the system, and each data point is stamped with who entered the data when (date/time).

While lab analyses do take time, Prelude EDC allows the labs to enter data directly into the system, and the researcher receives an email notification of the lab data arrival. The lab results are automatically compared with the designated lab normal ranges and out-of-range data is flagged to allow the researcher to determine if it is clinically significant.

Remotely located sponsors or other researchers can access data in real-time, which allows queries to appear in the system at the site during data collection. Site or field personnel respond within the system to the queries, and can collect additional data immediately.

For vaccines using injections as the administration route, digital photos can be captured and uploaded into the system. An additional module allows measurements to be collected.

Prelude EDC also contains pre-existing summaries which assist in monitoring the data collected at the patient level, at each site or for the study as a whole. Using Prelude EDC’s search and filter capacity allows these summaries to display data for only cases fitting the search criteria. Additionally, designated users can create ad-hoc reports to monitor additional criteria and answer important research questions. The data within the system is available for export 24/7/365 with the appropriate user permission. Export features the ability to export in multiple formats, including SAS-ready format.

Results & Benefits

During the initial testing of the system, researchers collected data both on paper as well as within Prelude EDC. Within minutes, it was obvious that the Prelude EDC solution was far superior, reduced time and data entry errors, and was well liked by the researchers. In fact, the users were so impressed with Prelude EDC that they called upper level management to come observe the difference at the last minute. Upper management was also very impressed at the capacity of Prelude EDC to streamline the process, and agreed there were cost savings and efficiency benefits to their studies.

Real-time data is entered into Prelude EDC and has eliminated the need for paper CRF collection. Researchers spend less time entering data and the data entered is standardized as they select from designated options. In cases where text entry fields are available, as items are entered, they become available for future selection in a drop down menu adding real-time standardization to data entry.

Additionally, data is accessible in real time for review, analysis, export, or additional data entry. Users have access to all digital photographs, and labs are compared to designated lab normals and outliers flagged for analysis. Users report the streamlining of the process has helped reduce errors and improved efficiency.

They are currently working on standardizing additional data collection forms so that they can be used as templates for future studies further standardizing their studies. Meanwhile, Prelude is working on developing a way to provide them with the ability to pick the forms they want to use from their existing library of forms via an administrative panel so they can design future studies faster and at a lower cost. Additionally, within each form, they will have the ability to select what modules of information they desire to use on the form for that particular study.

About Prelude Dynamics & Prelude EDC

Prelude Dynamics is a global provider of customized web-based software systems for data collection, analysis and management of clinical trials, studies and registries. We streamline eClinical operations through our unique and innovative Prelude EDC software system, which allows us to rapidly configure data collection solutions for pharmaceutical, CRO, medical device, animal health, and university organizations.