Digital clinical trials

The implementation of digital technologies and tools can open the door to new models that allow closer proximity to patients and their real-life conditions. For industry stakeholders, this allows an easier recruiting process of participants, inclusion of under-represented or isolated populations, and the ability to provide a study setting that more closely resembles real-life usage of healthcare products.

What are the subgroups or representative populations to include? What are the endpoints that should be measured? Notably, how can more patient-reported outcomes (PROs), such as patient quality of life, be incorporated to closely reflect their real-life conditions? How can digital methods be employed to improve the patient experience in clinical phase evaluations?

Digitization of therapeutic trials is a lever for reducing greenhouse gasses, especially those that result from participant travel, therapeutic research associates in site selection, and other involved players. However, digitization can also have an environmental impact, for example through the production of medical devices, storage of collected information, and through other means.

Which steps can be digitized, and what is the associated environmental benefit? How can we minimize the impact of digitizing clinical phase evaluations?

After a digital clinical trial, industry professionals have at their disposition a program that allows them to follow their patients over a long period of time, as well as a database for the data collection to be kept for regulatory purposes. The challenge for these professionals is therefore to determine how to use this program to follow the patient beyond the clinical trial, or how to analyze the gathered information to derive value from them, for example in research and development.

How can one successfully valorize the collection of information compiled during therapeutic research? How can the monitoring program be valorized for the real-world use of a product?

Digital technologies can be used to facilitate the measurement of clinical variables in patients, such as the treatments’ efficacy, with a higher frequency than during visits to investigative centers. However, the collected information must meet certain quality criteria, and the production, storage and analysis of these data must be planned and scaled in advance.

What is the necessary quantity of information, and at what frequency should it be measured? What nature of data can and should be collected in order to respect regulations? What system or platform should be put in place for data transfer between patients, health professionals, and the industry, as well as for data storage in the short, medium, and long-term?

The generation of sensitive data requires adequate preparation to ensure patient security and facilitate the acceptance of this new mode of conduct. This includes, among other things, obtaining informed consent from participants regarding the measured information and its uses, as well as the creation of a safety system to avoid data leaks.

How can patients be reassured about the new format and have a clear understanding of measured information? What systems and information exchange protocols can sufficiently protect the participants and their information?