Real World Evidence: what is it all about?

It is the evidence of the efficacy and safety of a drug obtained by collecting and analyzing Real World Data (RWD).

Real World Data are derived from observing the patient throughout the clinical practice routine.

These data are not collected through randomized or controlled studies in which strict criteria about inclusion and exclusion are established, but hail from patient observation during clinical practice.

In particular, data are mostly taken from observational studies, surveillance or records relating to a particular pathology.

Observational studies concern much less restricted series than the ones deduced through controlled studies.

Possible applications are the following:

• Health authorities may to use them to evaluate guidelines and clinical practice choices.
• Patient communities may benefit increasingly effective and safer treatments.
• Pharmaceutical companies may use them to confirm the value of their molecules at all stages of the life cycle.

OPIS proves extensive experience in prospective and/or retrospective observational studies and has been managing study populations, ranging from small to large populations.

Registry studies and Real-World Evidence studies with patients on routine therapy have become very popular especially in the indications of cardiology, oncology and infectious diseases.

OPIS in prone to assisting clients for this type of data collection, analysis and interpretation with a rigorous but innovative methodological approach.

OPIS can also offer groundbreaking technological solutions to collecting and processing patient-reported information and results.

Since the drug safety is monitored throughout the life cycle of the pharmaceutical, OPIS can also support the client in the collection and management of the adverse reactions that may occur during the clinical study.