It’s been almost 60 years since Bob Dylan sang “the times they are a-changin’,” and, in 2023, these words still ring out loud and true. Looking back at the past 20 years reveals just how much the world has changed from the turn of the century to a quarter of the way through it, from the spread of smartphones and internet access, to the utilization of artificial intelligence and machine learning in clinical research. Change is especially apparent for clinical trials from 2003 to now, with the addition of patient-focused electronic devices, telehealth, prescreening websites, and databases. It all adds up to a clinical trials revolution that would have seemed so futuristic just 20 years ago.
Electronic device revolution.
With 85.88% of the world’s population owning a smartphone, and 1.28 billion tablet users worldwide, the rise of powerful technology in the palm of our hands has led to new approaches in clinical research, such as the use of electronic patient-reported outcomes, or ePROs. Commonly used on a participant’s own or a supplied smartphone or tablet, ePROs such as electronic diaries (eDiaries) allow trial participants to report any side effects from their trial treatment, indicate their current health status or how they’re feeling, and answer questions about their quality of life.
For example, if a trial is researching a potential treatment option for major depressive disorder (MDD), participants may be asked to use an eDiary every day to log any MDD symptoms they are experiencing. The participant can then bring their eDiary to their study doctor to receive any additional aid as needed for their condition while also providing accurate medical information and data for the trial. This rheumatoid arthritis trial offers a great example of ePROs in action.
Telehealth and virtual visits.
Since 2000, the internet has become more commonplace, with usage increasing from 9.7% of the global population at the beginning of 2003 to 69.0% by the end of 2022. The internet’s proliferation, combined with the new highly virtual landscape brought forth by the COVID-19 pandemic, has led to the adoption of telehealth and virtual doctor’s visits for patients and medical professionals, including those taking part in clinical research.
For clinical trial visits that don’t require in-person procedures, virtual visits offer a way for participants to attend trial visits without leaving their homes. Telehealth can entice people to join clinical trials, especially if a trial is expected to last for years, as it reduces the travel and stress of getting to a trial site on time, transporting any required medical equipment, or spending money on transportation.
Easier access to trial information.
Before the prevalence of the internet, recruitment for clinical trials relied on in-person interaction between an individual and their doctor. It wasn’t until the passing of the Food and Drug Administration Modernization Act of 1997 that a mandate was created for a central database, clinicaltrials.gov, which lists enrolling, in-progress, and completed clinical trials. Since then, this database has allowed for any individual to find clinical trials within multiple parameters, such as a specific condition, age range, or sponsor that is conducting the trial. People can also read about the results of completed trials, including any adverse events that were experienced by trial participants.
Many clinical trials feature their own websites for interested individuals to see if they may qualify, read about the trial details, and find the trial site nearest to them. Physicians can also refer patients whom they feel may be good matches for a trial. And parents and caregivers can use these websites to find pediatric clinical trials if they have a child with a medical condition. The result is a resource that makes clinical trials easier to enroll in for individuals, easier to refer to for physicians, and easier for everyone to have the information they need about taking part in clinical research.