Patient Centricity in the Pharmaceutical Industry
Patient Centricity is about designing a service around the patient. In recent years, it has become highly prioritised in the clinical trial process to highlight the needs of the patient and get a study up and running. However, there are many factors to take into consideration, in regards to regulations, logistics, the mindset of the participants and more. This article will be discussing the new EU Regulation, the need for the pharmaceutical industry to be a part of this movement, and methods companies can follow.
EU Regulation 536/2014
As mentioned in a previous article, the EU Regulation 536/2014 is due to come into effect in 2019 and there are plans to have more protection in place for patients. They will be in regards to insurance coverage, marketing authorisation, and informed consent to name a few. Patients will have their final word in the clinical trial evaluation stage, which means the public will hear first-hand from the patients if the drug actually works. They will also have a more organised process for the recruitment, with an online portal managed by the European Medicines Agency (EMA) for a simpler and safer procedure.
Why the Pharmaceutical Industry needs to be part of the Patient-Centric Movement
The purpose of the pharmaceutical industry is to develop medicines for the prevention and treatment of diseases. This is impossible without the collaboration of patients throughout the entire scientific process. Pharmaceutical companies need to make profit, and by prioritising patient centricity they establish credibility with external stakeholders such as the media, regulators, and patients. In return, the opportunity arises to invest in new drugs, recover costs from R&D and make more profit. Considering the EU Regulation 536/2014 will prioritise patients, pharmaceutical companies will need to build a good rapport with patients in order to gain that advantage.
How the Industry can become Patient-Centric
· Feedback from Customers
In order to gain an understanding of patient perspectives, key performance indicators should be adapted through structural changes to capture this shift in cultural mindset. These KPIscould include data from patient input, for example, a feedback form that includes the risks and benefits of a treatment, as well as the type of information available to patients.
· Building Trust
A rapport can be built between the pharmaceutical industry and the public through clear communication about the drug development process as well as the risks and benefits. One of the best approaches for recognition, is having the backing of Government and Regulatory agencies like the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and health institute organisations. This way, the public understand the company and products are thoroughly examined and tested by a trustworthy and impartial organisation.
As previously mentioned, companies can add more credibility to their name through the approval and endorsements of regulatory agencies and respected health institutes. There is an ongoing collaboration between the FDA and EMA on patient involvement, known as the FDA/EMA Patient Engagement Cluster, which enables them to share best practices for patient selection and training throughout drug regulatory life cycles. As a result, this can help pharmaceutical companies reduce barriers to patient engagement.
The possibilities are endless to what you can discover at the 20th edition of the Clinical Trial Supply Europe conference! Some of our key sessions include how to design a patient-centric clinical trial supply chain by Arena Pharmaceuticals Executive Senior Director of Clinical Operations and Patient Engagement, Mimi Choon-Quinones. For more information, please visit http://www.arena-international.com/ctseurope/ or alternatively email us at: firstname.lastname@example.org
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