eConsent: Using Metadata to Support Study Oversight and Enhance Informed Consent

Mika Lindroos
Signant Health

Neetu Pundir
Signant Health

Jenna McDonnell
Signant Health

lectronic Informed consent (or eConsent) refers to using electronic systems and processes that may employ multiple electronic media to convey information related to the study as well as to obtain and document informed consent. eConsent offers so much more than simple confidence in the clinical trial consenting process. The metadata it collects provides deep insights and transforms processes around recruitment, retention, and compliance as well as improving documentation and education materials.

Industry-leading data analytics tools can rate site performance by identifying training needs, spotting potentially fraudulent enrollment, or flagging data integrity issues by simply viewing an online dashboard.

As the shift towards eConsent gathers pace, we expect exponential growth in the ways we use data collected during the consenting process, allowing us to build the patient-centric, robust, compliant clinical trials of the future.

Metadata Analysis – From Consent to Insight

As with most aspects of clinical trial management, informed consent is going through something of a digital revolution. Sponsors are moving the process from paper to an intuitive, interactive, collaborative online platform. Its multimedia approach incorporates pictures, videos, and graphics to convey study information in an accessible way, before obtaining and documenting truly informed consent from engaged patients.

While paper-based consent forms have traditionally been the go-to solution, paper fails to enable other metadata describing the consenting process (such as completion times, time spent per section, commonly questioned areas, etc.) to be collected reliably and made available. Thus, sponsors and sites receive scant details regarding the true enrollment process and miss out on key opportunities for oversight.

Sources of Data

In contrast, eConsent provides a full set of consistent documents from all sites, across protocols, programs, and even therapeutic areas. Records of patient interactions with the system, quantitative insights on site activities, study-specific site enrollment, and performance metrics can all be captured and, with the right tools and expertise, interrogated. In addition, metadata datasets can be segmented and analyzed, side-by-side, allowing sites and sponsors to mine the minutiae of enrollment, consent, and re-consent on one hand, while simultaneously overseeing the “bigger picture.”

Patterns that may otherwise have gone unnoticed can be spotted and rectified before causing expensive study delays or costly regulatory issues. There is also unprecedented opportunity for study teams to understand and anticipate the behavior of trial participants. Capturing data on patients’ responses to the enrollment process, for example, can help organizers of increasingly global trials to ensure that all information provided is culturally sensitive and caters to all levels of health literacy.

Overall, the collection and utilization of eConsent metadata leads to the optimization of trials, which may shorten the time to bring new medicines to the people who need them.

A Deep Dive Example: Metadata in Action

Let’s imagine a global, three-year, phase 3 prostate cancer trial that includes 350 patients across 50 sites in 20 countries.

In this example, the study comprises one main eConsent form and one optional sub-study form for each of the 50 sites as well as 75 translated form versions across the sites, for a total of 175 site-level eICF form versions. This was done, theoretically, to record consent for the collection of biosamples to be used in a study on the drug’s effect on a specific genotype. However, patients are not enrolling in the study, and in order to determine why, sponsors review data collected during the consent process.

Information Needs

In this example, a high number of patients residing in a European country cited side effects fears as a reason to not enroll. Interrogation of the metadata also found that the time investment in the study was perceived to be too high, and that there was a lack of understanding of the sub-study.

These insights could lead to revision of materials to ensure that explanations of these components is well-written and not ambiguous to enable a better understanding for potential participants as they make enrollment decisions.

Potential fraud

Reviewing the average time it took patients to go through the consenting process proved insightful. The average consent time for the main study was 35 minutes; yet one site recorded times of just three minutes, while a different center took an average of two hours and ten minutes to complete the form. These statistics alerted study organizers to potentially fraudulent enrollment at one site, and a possible training need in the other.

Optimization

eConsent systems also provide important feedback for sites and sponsors—an option that simply doesn’t exist with paper-based systems.

Content flags, which allow potential candidates to “flag” areas of the form where they have concerns, or queries, can be used to continually ensure that consent documents are optimized and fit-for-purpose.

In the prostate cancer trial example, 10 percent of patients at one site flagged content relating to side effects, suggesting the need for better information on the ICF and equipping sites to respond effectively to questions about this aspect of the study.

In the same example, 15 percent raised concerns about genotype sampling, prompting a review of educational materials, whereas 80 percent flagged content on visiting schedules and dosing requirements, triggering a deeper look at enrollment, retention, and study design.

Localization and Health Literacy

A common issue for sponsors working in multiple countries concerns potential participants receiving information in a way that is understandable, engaging, and culturally sensitive. Analyzing quiz data can help here, with the metadata showing which questions patients are getting right and wrong.

In this example, 12 out of 15 patients at one site answered all the side effects questions incorrectly and across the entire study, 90 percent did not understand a particular procedure. Findings like these provide an opportunity to revise materials to ensure more effective communication.

Investigating Patterns

Study enrollment speed and efficiency data can also unlock insights. The sites involved in the study example recruited an average of two people a week. But, as ever, the outliers are what’s interesting.

Let’s imagine several different outlier sites: One enrolled 20 patients in one week, while another met 10 percent of its recruitment target in the first three months. In a different country, a center had not enrolled a single patient six months after the “go live” date. Equally concerning was a different site that enrolled 98 percent of all patients they saw.

Of course, the metadata cannot tell study organizers the “why.” But it can suggest a review of the information, education or training provided, or even an investigation into potentially fraudulent or inappropriate recruitment.

The Benefits of Metadata

While much is written on the advantages of eConsent, the power of its insights and previously unavailable levels of oversight is less documented. eConsent metadata can optimize trials based on information captured at any point in the consent and re-consent process. Here, data can help ensure site staff have all the information they need to enroll patients, and that patients have all the information they need to make an informed decision. It can advise on amendments to protocols that will minimize risk and uncertainty, and help sites revise internal standard operating procedures to ensure trials run as efficiently and as compliantly as possible.

As more sponsors move to eConsent, the potential for better datasets, processes, and technique evolves, creating a feedback loop that allows for even better data collection using more sophisticated techniques.

Towards Patient-Centric, Optimized Trials

Data is often called the most valuable commodity of the 21st century; its real value lies in what it can tell us. Industry-leading data capture, analytics and visualization tools and techniques can, through eConsent, guide the continual improvement of informed consent processes while optimizing studies overall.

By converting metadata into actionable insights, these can shorten trial duration, ensure compliance, and drive return on investment. This helps achieve the industry’s overriding goal: to get the life-changing medicines of tomorrow to the people who so desperately need them, as quickly as possible.

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