A paradigm shift may be imminent concerning the development and commercialization of pharma products and new medicines, according to Ulrich Neumann of Eyeforpharma. Neumann discusses the idea that the clinical trial process to bring new drugs to market should become more patient-centered rather than scientific explorations that collect data.
The pharma industry is realizing the power that the customer wields. According to Neumann, the Tufts Center for the study of Drug Development suggests that late-stage clinical trials, which cost over $1 million on average, serve no purpose other than to provide peripheral scientific data. Increased patient involvement in drug development could significantly reduce the time-to-market for new medicines.
- Over 90 percent of pharma executives consider that patient-centricity is essential to reduce costs and hasten effective trials. As future customers, patients must be incorporated into the drug development process as valuable providers of feedback, not merely sources of data. Patients as research partners will result in superior market-oriented products, tailored to the end-user.
- New models should deliver more patient-friendly clinical trials. Clinical trial changes include better communication with volunteers. Video presentations, collaborative informed consent, and consideration of volunteer needs such as Wi-Fi in waiting rooms, or the costs of taking time off work are factors that could enhance the patient’s experience.
- Increased home monitoring of volunteers could be instituted once a drug’s safety is approved to reduce the current controlled, sterile settings of clinical trials. Bringing the studies to more convenient patient settings will improve enrolment and retention rates.
- A project leader for Novartis Consumer Health suggests that later studies should reach as yet untapped community patient groups, working through charities and independent pharma groups, thus providing a collaborative and marketing element.
Novartis and Walgreens are partnering to base trials at pharmacies. However, the use of social media as a tool to recruit volunteers for clinical trials has not shown significant signs of success. Eli Lilly, Novartis, and Pfizer partnered in November 2013 with the online registry clinicaltrials.gov. The site’s use of electronic health records is eventually expected to match patients to trial inclusion criteria, although data privacy is a concern and may slow progress in this area.
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