Lay summaries are a display of clinical study results intended for study participants and the general public. The aim of a lay summary is not only to enhance understanding of complex medical information, but also to increase transparency in clinical research.
Electronic informed consent (eConsent) in clinical research in Europe: opportunities and bottlenecks
While eConsent has become a reality in the US, Europe is still lagging behind in its implementation. To protect patient rights without compromising on the full potential of clinical research, flexible and dynamic consent formats will be crucial in the future.
Can they demonstrate scientific merits and align with corporate objectives? Often initiated by researchers or investigators as a part of an observation, an Investigator Initiated Trial (IIT) or Investigator Sponsored Trial is one of the kind of clinical trials that take up specific questions from clinical care, such as therapy optimization or off-label use, and are usually of no economic interest.
Digital solutions - such as online study portals – can bring patients, researchers, and industry closer together. Thereby, they can provide value to sponsors during the planning and patient recruitment stages of clinical trials or observational studies.