Until now, companies have considered RWE studies useful mostly for post-approval safety; there are some big opportunities on the Real-World Evidence horizon that industry and regulators will be considering and implementing soon.

We are referring to the possibility of expanding the indication for a drug already available on the market. A recent example is the breast cancer drug Ibrance, which has received secured approval for a new indication: Pfizer, in partnership with FDA, has gained the authorization to extend it to male patients, thanks to the evidence obtained from data collected from EHR’s (Electronic Health Records) and other Real-World tools.

The regulatory field has already started to evaluate the intrinsic possibility within RWD (Real World Evidence Data), both in the USA and Europe (FDA and EMA). We recently mentioned the MyStudies App case, an important action taken by FDA to incorporate RWD (Real World Data) into the regulatory field. This is a significant decision, although it requires other steps to guarantee specific guidance for companies working on innovative medicines. This is a major opinion in the industry: a call to do more, and fast.

Indeed, it is crucial to identify the best partner in order to improve your company’s opportunities. Thanks to the international, multidisciplinary network of experts and the co-existence of the Real-World and Clinical Platform, Evidilya offers tangible solutions and reliable results in the field of disease prevention and supporting therapies.

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