Technology’s Role in Improving Clinical Trial Equity
Wednesday, August 24, 2022
Source: MedTech Intelligence
It has been reported that as few as 2% to 3% of patients enroll in clinical trials.[1] When we consider that a 2020 Health Information National Trends Survey found that 85% of U.S.-based adults utilize health or wellness applications, and 80% are willing to share data from at-home devices,[2] it suggests that technological advancements in clinical studies are the cornerstone to decentralizing the clinical research journey and expanding clinical trial equity.
Technological advancements in all aspects of work and life are moving at lightning, and the ophthalmic clinical research space is following suit to improve processes for sponsors, investigators and patients. Improved quality of imaging and diagnostic modalities, as well as tools that allow for entirely novel measurements to be taken are only a few examples of the ever-developing advancements in clinical research tools.
There is excitement surrounding the trajectory of product sponsors, contract research organizations (CROs) and clinics in advancing clinic trial processes to bring potentially life-changing therapies to patients in need. With this, the importance of decentralizing clinical studies to obtain more robust data points and reduce patient burden is essential in pushing clinical research forward successfully. Addressing the growing need to develop clinical studies that assess patients’ signs and symptoms and track drug regimen compliance in a more effective manner should be a major focus.
In many areas of the world today, including developed countries, patients do not have access to health care, including investigative therapies that could change their lives and, in the case of ophthalmology, their vision. One major restraint for patient participation in desired studies includes transportation barriers.[3] Some patients do not have access to adequate means of transport or live far from the nearest clinical research site. The importance of remote technologies comes into play here, enhancing clinical research access and outreach for these patients.
Technology Is Key to Decentralizing the Clinical Trial Landscape
It is crucial that remote technologies produce quality data of a similar, non-inferior nature to tests performed in the office—or more optimal quality. Furthermore, it would be particularly beneficial if technologies produced repeated measures in one quick and easy process. For example, devices capable of measuring ocular redness, tear film instability, including tear break up time (TBUT), and areas of fluorescein staining on a single examination could be extensively beneficial to clinical trials in the dry eye or ocular allergy space.
Enhancing accuracy within clinical studies should be a major consideration in the development of remote technologies to decentralize ophthalmic clinical trials. Measurements taken by participants in their homes should be time-stamped to ensure precision of data points. Reminders for drop regimens and other measurements that enhance patient compliance should also be considered when creating these remote devices. With consistent reminders for patients to take photos, videos or enter their signs and symptoms into a device diary, many more data points can be obtained in a clinical study. This in turn increases the statistical power of a clinical trial (Figure 1), allowing for greater understanding of how a drug works throughout the course of the day and aiming to bring therapies to market more effectively.