Medical device developers do not always consider the process of informed consent for clinical trials, since it is often handled at the trial site. But the industry is changing, and digitizing processes such as informed consent can streamline studies to rapidly collect quality data, while reducing costs.
Patient-centric healthcare means patient-centric clinical trials
As the medical technology industry shifts toward patient centricity, novel methodologies and technologies like mobile sensors and cloud software that collects and stores data can save time, reduce costs and increase adherence to regulatory standards. In addition, these technologies can help address challenges in patient recruitment and enrollment.
This is especially true when evaluating precision medicine or therapies for rare diseases. In such cases, there are many hurdles such as shortages of specific patient populations required to complete accurate, timely trials, which is often exacerbated by the increased frequency of trials conducted in tandem. Using e-consent systems during the enrollment process can reduce the cumbersome activities associated with paper-based consent documents, leading to more efficient patient enrollment and quicker study start-ups.
E-consent is an ethical imperative
Patients comprehend the e-consent enrollment process better than paper consent forms, making e-consent a more ethical way to recruit participants. A recent pilot study found that people with a paper version recalled about 58 percent of the material in informed consent documents, while 75 percent recalled information accurately when viewed in an e-consent format.
Moreover, informed consent documents are notoriously difficult to understand. The Center for Information & Study on Clinical Research Participation published a study revealing 35 percent of potential participants dropped from a study because they couldn’t understand the informed consent documents. Due to technical terminology, participants could not understand their rights and responsibilities, and were therefore wary of participating in the study.
In contrast, a digital consent platform that tailors trail information and the way it’s delivered to a patient’s needs enables that patient to participate confidently. E-consent software accomplishes this by using multimedia tools (e.g., participant led videos, characters, virtual trial examples) that track and improve comprehension. Finally, to measure comprehension after completing the e-consent form, participants take a comprehension quiz that reveals whether the testing site staff needs to further clarify risks and benefits of the study.
Saving money and time
A software platform that digitizes the process and eliminates paper consent improves patient understanding and engagement, therefore accelerating and streamlining start-up times. It can also lead to cost and time savings.
Estimating the costs associated with informed consent can be difficult as individual CROs often tally total costs into one sum, estimating that the cost per participant can range from $50 – $1,000. But if stakeholders consider the costs associated with copying paper documents, shipping, storage, archive management, and source data validation, the value of a digital record begins to emerge.
Meeting and exceeding regulatory standards
Information compiled in an e-consent format can be tracked automatically. Participants receive immediate updates, and auditors have access to that data at any point, not just on site. Also, e-consent forms reduce participant errors, such as inputting the wrong date.
According to a Quorum report, from 2011 to 2016, the FDA reported 214 inspectional observations related to the mandate to obtain informed consent, the failure to adequately document informed consent and the failure to maintain documents evidencing informed consent. We estimate that 95 percent of those observations would be eliminated with an e-consent format versus a paper format. These benefits would allow trials to meet and even exceed regulatory standards.
What to consider when looking into digital enrollment process
When transitioning to a digital enrollment process for clinical trials, there are several considerations:
First, for e-consent to be successfully integrated into clinical trials, stakeholders need to ensure that it can be used on commercially available platforms, such as tablets and smartphones.
Second, interactive tools, such as animation or touch screen navigation, provide an active learning experience that engages the patient, improving adherence and completion. Further, look for systems that incorporate tools such as comprehension quizzes following the presentation, which can enhance understanding and allow participants the opportunity to review any confusing sections.
Third, adopting a unified enrollment system ensures consistent consent review across all sites. To help reduce monitoring and site costs, the system should:
- Include a web dashboard of consent analytics at all sites
- De-identify consent information for sponsor review
- Ensure required signatures and manage consent amendments
Finally, the system needs to comply with institutional review boards, quality assurance guidelines and regulatory standards. Such a system should prioritize risk reduction for regulatory audits and, therefore, incorporate tools including real-time enrollment statistics and traceable electronic signatures.
Investing in e-consent is no longer a luxury. Compared to traditional methods, adopting a unified platform that enables e-consent can streamline studies, while saving time and reducing costs. The healthcare market is shifting to ensure products have a patient-centric approach, and that directive must include clinical trials.
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