By Liisa Eisenlohr & Gurjit Singh Bansel
In the drive to bring new therapies to market, life sciences companies justifiably focus on efficacy and safety data as the foundation for gaining regulatory approval. Increasingly, however, regulatory bodies and the healthcare industry are recognizing the importance of input from patients throughout the development of medical products.
The narrow focus on clinical study endpoints that demonstrate superiority of one medical product over another as required by regulatory bodies may not be of primary importance to patients. Furthermore, companies developing medical products have historically relied on consultations with healthcare professional KOLs who provide input from a clinical perspective but in most cases do not cope with the disease or condition personally as patients do. As a result, life sciences companies — usually inadvertently — have overlooked or disregarded the real-world situations and exeriences of intended patients.