It’s hard to believe, but 2021 is coming to a close. After almost two full years of pandemic-related changes, many industries have had to adapt and evolve just to stay afloat.
Biopharma is no different. Thanks to the invention of new tools, technologies, and trial designs, research is becoming more accessible and helping solve some of the world’s greatest health threats, including certain types of cancer, cardiovascular conditions, and rare genetic disorders.
With the New Year right around the corner, we thought it would be a good time to highlight some of the clinical trial trends for 2022. From real world data collection to virtual check-ins, here’s what to expect in the coming months.
1) Real-world data collection. Real-world data (RWD) collection first gained popularity in 2016, after the passage of The 21st Century Cures Act. The law emphasized using new technologies, like computers, smartphones, and wearables to monitor patients and collect data outside the confines of a traditional clinical trial setting.
Lawmakers drafted The 21st Century Cures Act four years before the COVID-19 pandemic, but the bill’s emphasis on decentralized data collection was surprisingly prescient, and experts say the trend isn’t going anywhere.
2) Digital everything. A few years ago, every aspect of the clinical trial process occurred in person, with the assistance of manual documentation. Each trial site housed dozens of binders dedicated to specific aspects of the research process, from recruitment campaigns and trial designs, to data collection and analysis. This method of documentation was convenient in that it left a paper trail, but it was also incredibly clunky.
Enter digitization. There are now a variety of web-based tools, software programs, and apps that make it easy to track and store data while protecting patient confidentiality. What’s more, digitization extends to trial visits and check-ups. Instead of visiting a hospital or clinic in person, trial participants can now meet with their medical team or check-in virtually from the comfort of their own home.
3) Adoption of eClinical Systems. Instead of taking a patchwork approach and using several different online tools, some pharmaceutical companies and medical device manufacturers are electing to adopt and implement eClinical Systems.
eClinical Systems, or clinical trial management systems, are computer programs that assist with all aspects of the clinical trial process, including data ingestion, analytics, and tracking milestones. Because these programs are cloud-based, it’s possible to monitor a trial’s progress from anywhere, whether you’re at home, the office, or on a business trip.
4) Increased diversity in recruiting. Diversity in clinical trials is lacking. For example, one assessment of 230 oncology trials found that on average, 76.3% of participants were white. A report by Scientific American found that number to be even higher –– between 80-90%.
When a new drug or medical device hits the market, a diverse group of patients inevitably use it. Even so, that doesn’t necessarily mean it was tested across an array of racial or ethnic groups.
To enhance health equity and access to care, recruitment efforts are changing. To attract people of different races, ages, and backgrounds, trial managers are widening eligibility criteria, connecting with patient advocacy groups, and utilizing new technologies to reach people in underrepresented populations.
5) Big data. A large amount of information is collected during the clinical trial process, but not all of that data is put to good use. Often, there’s just too much of it. But that’s starting to change with the advent of big data.
Modern software applications make it easy to crunch large and complex data sets that can reveal patterns, trends, or associations. Clinical trial managers and researchers can then use that information to make stronger hypotheses or make tweaks to the trial design itself.
These are just 5 of the trends set to make an impact on clinical trials in the coming year. Would you add any items to our list? If so, we’d love to hear from you. Please fill out a comment and click the “submit” button below.