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The digitization initiatives are focusing on e-consent to collect quality data efficiently and cost-effectively.
FREMONT, CA: The process of informed consent for clinical trials is still not adopted by many of the medical device developers. But the trend is changing, and the digitization initiatives are enabling informed consent to collect quality data and reduce costs.
Moving toward Patient-Centric Trials
As the medical industry is increasingly shifting their focus toward patient centricity, technologies such as cloud and mobile can significantly save time as they help in collecting and storing data. Moreover, technologies will also positively impact patient discharge and enrollment processes.
While evaluating medicines or precision therapies for rare diseases, there are numerous hurdles such as lack of specific patient populations, accurate and timely trials that often gets projected during the increased frequency of trials conducted in tandem. With the aid of e-consent systems, rigorous paper-based consent activities can be eliminated, allowing quicker study start-ups and efficient patient enrollment.
Comprehending an e-consent is better than paper consent forms thereby making it a more ethical method of patient admission. As per the study conducted by the Center for Information & Study on Clinical Research Participation, 35 percent of potential participants decided not to be a part of the study. The lack of participation highlights the complexity of the informed consent documents. Thus, moving on to an e-consent is more logical.
Cutting Down Time and Cost
Digitizing the process with the help of a software platform that eliminates paper consent improves patient engagement and understanding. It helps in streamlining and accelerating start-up times. Further, it also saves time and money.
It is easier to track the information compiled in an e-consent format automatically. Further, participants can receive instant updates while auditors can access data at any point in time. E-consent form also reduces participant errors.
Considerations while Transitioning to a Digital Enrollment Process
Numerous overheads must be addressed before transitioning to a digital enrollment process:
• The stakeholders must ensure that the e-consent that needs to be integrated into clinical trials is compatible with the commercially available platforms, such as smartphones and tablets.
• Opting for interactive tools such as touch screen navigation or animation provide a powerful learning experience that enhances understanding of the patients and allows the participant to review any confusing section.