It’s hard to believe as we reflect over the past year but virtually everything has changed in healthcare. What once was considered leading edge – such as decentralized clinical trials – has started to become the norm. As we slowly move to a “new normal” (whatever that may be), many in the industry are asking what’s next? What’s going to stay, evolve or revert to the way it was pre-pandemic?
One issue has become clear, decentralized clinical trials can play a tremendous role in facilitating research.
An important contributor to making both virtual and in-person visits work for clinical trials has been the advent and evolution of digital imaging. Digital imaging for wound care/dermatology trials uses a mobile e-clinical platform that offers a seamless and integrated experience that facilitates images, video, and data capture remotely.
Here are six ways digital imaging facilitates wound care/dermatology clinical trials during lockdowns and beyond.
- It is simple for trial sponsors to implement and maintain. Optimal digital imaging platforms should be cloud-based and require no expensive or cumbersome hardware. It should also be intuitive so any user can readily use, check progress and communicate with team members and participants.
- Helps you remain connected to trial participants. Clinical trials need to be simple for participants and keep them engaged and connected. Over the past year, we’ve learned that a decentralized approach is ideal for engaging patients. Because of its benefits, remote options will remain an important element of clinical trials post-lockdown.
- Provides the latest in 2D-3D Mobile Imaging. When monitoring wounds or dermatological conditions remotely, exceptional digital imaging is critical. Look for software that allows your team to capture any wound/lesion with precision and accuracy, including wound/lesion dimensions and perimeters. There is no room for errors with wound/skincare so also make sure the accuracy rate of your partner is exceptional.
- Is compliant with all regulatory guidelines. Remaining compliant with the many, and often changing regulatory guidelines is a challenge! 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.
- Can be utilized across a broad range of potential clinical research settings. Because digital imaging tools are used across many care settings, they can be used for clinical research in many settings as well including medical device, pharmaceutical, academic hospitals, contract research organizations (CROs).
- Offers a range of features. While the field for decentralized wound care/dermatology trials is small, it is growing. As a plan sponsor, you have many options. Look for partners that provide the following features: smartphone technology that is iOS/Android compatible, 2D/3D Mobile Imaging, eConsent and eCRF, Secure Messaging, Reminder/Alerts to keep participants informed and engaged.
While we aren’t quite sure when the pandemic will officially end, what we have learned over the past year is that the U.S. healthcare system is innovative and will always look for ways to adapt. The benefits shown by decentralized clinical trials highlight that it’s a methodology that will remain a vital component of wound care/dermatology clinical trials well into the future.
Find out more about the future of wound care clinical trials. Ask for a free demo here.