To demonstrate how new technology can be used to develop econsent to allow a patient centric approach to obtaining informed consent.
Method
To improve patient understanding and compliance in Clinical Trials we developed a new patient centric approach. All required information according to GCP and local requirements is provided in an interactive format. Technology ensures a full audit trail and appropriate documentation of the process.
Results
A traditional Informed consent template containing all the required components both from GCP and local regulation was broken down into a multi-media format allowing the patient to focus on the areas of the consent process which was most relevant to them. A mixed approach ensured patients could have the option to consult face to face with a physician or using telemedicine. An interactive format ensured patients understood the information being provided to them and gave the consulting physician an opportunity to understand where the patient was lacking information. A high demand for participation was seen suggesting that patients appreciate this novel form of informed consent.
Conclusion
New technology can be used to develop econsent to allow a patient centric approach to obtaining informed consent. This process not only ensures optimised understanding of the study and procedures but also allows regulators and sponsors to clearly identify that all regulations have been followed and no study procedures can be started prior to the signature being given. A high demand from patients suggests this approach is appreciated
