The health regulators have started to accentuate the importance of patient-centered drug development and enhance patient engagement for the trials.
FREMONT, CA: Today patients are empowered with technology, so they understand and expect more from the clinical trial procedures. The health regulators have also started to emphasize the necessities of patient-centered drug development and are taking initiatives to increase patient engagement by pressurizing the sponsors to elevate patient involvement for trials.
Improvement of patient involvement is advantageous for the clinical trial procedures because better patient treatment will lead to an increase in the participation. Many sponsors do not use the usual methods for engaging a patient for studying design and conduct. Here are three key learnings that sponsors can use to engage patients in the design and execution of the trials.
1. Integrate With Patients and Patient Advocates
One of the essential parts of the process is to collect information for the patients directly while drafting a patient engagement plan. There are many ways in which this can be conducted, for example, sponsors can engage through the patient platform and network, conduct one-on-one interviews with patients, hold patient focus groups, or work with patient advisory boards to gather real-time feedback. During the development of the Patient Experience Initiative toolkit, it is vital to have a patient advisor on the development team so that the patient’s input is integrated from the very beginning.
2. Take Time to Understand the Current Landscape and Regulations
Like any other major project, it will be helpful if the process is started with primary research. The research will include information from every part of the industry, like resources for engaging patients as partners, materials that outline the current regulatory landscape, and even guidance for patients on how they can become ready for partnership.
3. Build Long-Term Trust
To successfully produce a meaningful tool for the patients, it is necessary to share a certain level of alignment, clarity, and respect between the invested groups. Once there is unity among the group, then they can elevate transparency by assigning roles and responsibilities to the stakeholders. Throughout the entire process of developing better patient engagement, there must be trust and mutual respect among the stakeholders and sponsors.