The clinical study industry today is undergoing a major transformation. To succeed, a clinical research organization and pharma company need to look for and implement effective and innovative Veristat methods to accelerate drug launches in the market. Clinical trial companies today are more open and do not see patients as “subjects” who are data sources. Instead, patients are now considered informed collaborators whose participation is central to the trial’s success. This has led to the rise of the concept of “patient-centric” clinical trials. This article reveals why focusing on patients in your clinical trial improves its effectiveness.
Seeking patient input informed consent forms (ICFs) increase participation
The Food and Drug Administration (FDA) offers draft guidelines for creating informed consent forms. However, ensuring the ICFs are patient-centric is key to improving participation. For example, using the simplest language possible that patients can easily decipher establishes expectations regarding unforeseen and foreseen risks. As a result, potential participants can make an informed decision, reducing skepticism and improving participation. Additionally, clearly defining the clinical trials study’s goals and providing a comprehensive summary in the informed consent form can retain patients’ interest. In other words, short, precise ICFs that aren’t too scientific hold the attention of the to-be participants.
To make your ICFs concise and patient-centric, consider having a non-expert review them. That way, you ensure the content is not too scientific which would confuse potential participants instead of clarifying the study’s objectives, protocols, and risks. The review by the layman will shed light on confusing sections in the informed consent forms to help you make amendments in the earlier stages of protocol development. Generally, getting clarification from patients on their understanding of the trial’s protocol provides insights on building ICFs that a larger patient population would accept.
Building patient-friendly protocols improve retention
When designing your trial’s protocols, ensure you understand the patient population’s lifestyle. As a result, you become sensitive to patients’ needs and comforts, which helps increase patient retention in your study. To build patient-friendly protocols, real-world patients should provide their input in the design process. That is the best way to design a trial closer to life experiences, cost-effective, and patient-centric. For example, developing flexible visit schedules is patient-centric. It ensures the study doesn’t adversely interrupt the patient’s daily activities. Generally, you should be careful to provide an environment and facilities conducive to patients, especially if the study involves pro-longed on-site visits. Patient-centric protocols improve retention.
Educating potential patients improves enrollment
Before participating in trials, patients today look for information online regarding the disease of interest, the trial drug’s mechanism for a cure, and the results from similar clinical trials. And finally, patients look for other clinical-trial-related information that influences their decision to enroll in a trial. If your clinical trial company comes forward and avails such information to potential patients (e.g., through blogging), you accelerate the enrollment process. For example, most patients want to make informed decisions when considering joining a trial. If you educate them on the factors to consider before participating in a clinical trial, you tackle the barriers that make them hesitate to enroll in your clinical research.
In other words, educating potential patients reduces the frictions that make people skeptical about joining trials by helping them make informed decisions.
