While Randomized Clinical Trials (RCTs) are a preferred method of investigating the efficacy of new interventions, recently, observational studies have gained increasing importance. They can complement and build upon the evidence and data procured from RCTs and are frequently conducted when RCTs are considered unfeasible or unethical. Although observational studies cannot replace a well-designed RCT, they can be used to prove the validity of its results.
Observational studies are a form of real-world evidence that explore how a given treatment will work and impact the daily life of a patient. In observational studies, phamax carries out retrospective reviews of existing data with patient-level data analytics and patient chart reviews, and prospective studies by investigating real-life evidence outside the limitations of clinical trials: product registries, and standard of care assessment.
Observational studies play a key and, at times, complementary role in supporting and providing evidence for new drugs and therapies. Observational studies have numerous advantages compared to RCTs, such as the proximity to real-life situations and lower cost. They often play a significant role in investigating treatment outcomes, and providing information on the tolerability profile of a particular medicine. They can also shed light on the unexpected outcomes or side-effects of a given treatment, as well as on drug adherence and patient preferences.
Let us help you demonstrate the real-world value of your product. Contact us now, and we will develop a free concept note for you, outlining the design, timelines and cost of a potential RWE project.
Simply enter your details in the form and one of our experts will be in touch with you to discuss further.