When it comes to clinical trials for wound care, researchers and trial administrators constantly look for those secret ingredients that will lead to success.
Those ingredients vary by any number of factors. However, there are fundamental elements that can help manufacturers of wound care products, devices, and technologies, and industry researchers secure optimal outcomes from clinical trials. It all starts with finding the right clinical trial partner. To get that answer, here are five key questions to ask.
- Are you targeting the right physicians and patients for the trial? Getting the right patients for a trial begins with identifying the physicians who can connect you with those participants. Providers with Long-Term Care and Skilled Nursing Facilities recognize how important new products and services can be for their patients’ treatment. They can help identify the ideal patients for specific clinical trials. Data from specialized electronic health records (EHRs) further enable rapid identification of providers and patients and aid in gathering and disseminating data.
- Does your partner include both virtual and in-person options for the trial? In the months after the pandemic hit, there was a rush to move to decentralized clinical trials. But that’s not always the solution, especially for wound care. The key is a hybrid or decentralized approach, combining virtual care and in-clinic visits, to make participation easier for patients and to accurately monitor the participant’s progress.
- Does your partner incorporate digital technology into the monitoring process? Technology empowers sponsors, researchers, and providers to stay connected to trial participants. Look for partners who offer a seamless experience for capturing images, video, and data measurements. Platforms that leverage smartphone devices to document wound evaluations, analyze wound measurements, and capture tissue composition are especially beneficial for clinical trials.
- Can your clinical trial partner ensure you meet regulatory and compliance guidelines? Compliance is always one of the more time-consuming and worrisome aspects of a clinical trial. Your partner should meet the necessary certification to serve as an eCRF and ePRO for clinical trials, including HIPAA, the FDA (21CFR Part11) and the EU General Data Protection Regulation (GDPR). Make sure they will also provide an audit of Certified Quality Systems (CQS) if requested.
- What will your partner do to keep patients engaged in the trial? One of the primary challenges faced by wound care researchers is patients who disenroll in the trial. This leads to delays in study timelines and increases in costs. Keeping patients engaged begins with caring providers who answer questions, communicate often, and encourage ongoing participation. Technology, including secure messaging, reminders and alerts, also helps keep patients enrolled in trials.
To find out more about the ingredients necessary for a successful clinical trial, visit us at https://www.nethealth.com/solutions/clinical-research/#.