As a company that offers clinical trial management solutions, we have our own checklist of items that should be accounted for before sponsoring a clinical trial. These items make sure that the largest areas of focus are addressed: enrollment, engagement and education. By covering all areas of focus, the clinical trial has a greater advantage and will advance data collection, bring in more qualified candidates and reduce drop out rates, saving sponsors money, as a result.
- The trial has transparency: While the sponsor may be aware that the trial has been assessed for risks and the reasons that it’s been approved for human trials, those points need to be presented to potential patients. It’s the ethical approach to take and transparency in clinical trials will put more trust between the patient and the provider; it’s also a great opportunity to educate the patient. In the long run, it’s going to produce more viable patients and will increase retention rates.
- eQualification and eConsent have been integrated into the recruitment process: EQualification and eConsent ensure that the trial has transparency. For patients that are recruited online, they should have the ability to enroll directly into the trial; they can do so through a series of questions in the eQualification process. While qualified candidates have the option to immediately enroll, it’s our expectation that the candidate takes the time to read through the eConsent with their family or friends and understands what it means to enter the trial. We want the patient to be fully aware of the commitment that they are making. By utilizing eConsent, patient candidates can access a resource of education on the trial and even reach out to the provider with questions and concerns. The eConsent process brings in a qualified pool of patients that are more likely to continue with the trial because they have been educated on requirements and expectations.
- Utilizing patient organizations and advocacy groups: A successful trial begins by being patient centric. Patients are demanding more communication from sponsors, so it’s important to listen to their needs and use patients as a resource for disease-related information. By understanding common questions that patients have, it creates a feedback loop, allowing the industry to design better patient experiences and ultimately increasing enrollment in future studies. Patient education can be accommodated in a mobile solution that provides all trial details, as well as video tutorials, surveys and an eDiary.
- Accommodating a wide geographic area of patients: Gender bias has been a large concern in the past for patient recruitment. Utilizing digital recruitment tools to find niche patient groups will help eliminate gender bias and provide more valuable data to physicians. This data will catch adverse events sooner and keep the trial more aligned with time and budget expectations. Having a digital recruitment strategy already in place will make this process more seamless.
- Providing a clinical trial management solution: Offering a clinical trial management system that allows patients and physicians to report trial progress through a mobile app, will offer two-way communication between the patient and physician and deliver real-time insights to sponsors and CROs. Clinical 6 is an all-encompassing solution for digital recruitment and clinical trial management. To learn more about Clinical 6’s benefit to sponsors and CROs, contact us today.