The adoption of real world data in clinical practice to supplement or largely replace clinical trials will remove the challenges of demonstrating the value of medicines to patients, payers and healthcare providers.
Senior digital healthcare consultant Emma D’Arcy echoed this opinion at a recent eyeforpharma Real World Evidence webinar: “Yesterday, brands told stories. Today, patients and physicians tell stories about your brands.”
Today, healthcare professionals encourage patients to share their real time health information through conversations on social media networks. In the same way, the pharmaceutical industry can use this sociable digital space to encourage a diverse range of patients to shape the development of their drugs, at all clinical stages, through their real world health stories.
The decreasing value of clinical trials was highlighted in a recent report from Medidata and Tufts University School of Medicine. Its findings demonstrated that 25% of clinical trial procedures add no value to a trial’s end-points or safety objectives. These extra procedures are focused only on regulatory approval rather than achieving reimbursement success. The solution is not to create more rigid design protocols as the tested drugs would have an even lesser value in normal clinical practice. Clinical trials will always be restricted by safety, design and other regulatory requirements meaning that no real world value will ever be given to the medicines tested in this way.
Alternatively, real world data is not currently monitored by regulators and uses an unselected sample of a whole patient population meaning that the realistic value of a new medicine can be seen. This longitudinal monitoring of medication usage in the real world is a win-win situation for all parties: the patient will get the maximum benefit from the treatment, the health care providers will derive a comprehensive knowledge about the medicine and the pharmaceutical company can continue to defend their drugs place and price in the market. Further more, R&D efforts can be targeted towards developing drugs to meet gaps in patient care. The success of real world data is demonstrated through the PatientsLikeMe initiative where different types of diabetic patients are encouraged by each other to continually share information on the management of their condition. Clinical trials would never allow this level of access to the real struggles and challenges faced by patients.
In addition to improving clinical research, R&D strategy and the economic value of medicines, real world data can gradually alter the communicative culture of a pharmaceutical company. Patients will only share information about their health consensually if pharmaceutical companies create a caring environment for them to do so. Pharmaceutical companies need to move beyond exerting all control in a clinical trial to sharing control with patients and payers in a real world environment when developing drugs if they want access to this information. Better, meaningful communication will lead to all parties have a shared responsibility for healthcare and in the long-run; patients will learn to trust the pharmaceutical industry and will ensure a commercial success that will move on with the ever-changing healthcare practice.
By now, the ineffectiveness of clinical trials has been acknowledged a countless number of times and all solutions point to a better design of RCT’s. However, a better solution would be to encourage the use of real world data as it offers the best result for patients and payers, not just pharmaceutical companies.
Through analysing this unmediated data available through an online real world environment, the pharmaceutical industry will add real value to their medicines which is the key to achieving longstanding reimbursement success.
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