This year has ushered in the third year of the COVID-19 pandemic. While the virus is something we’re all tired of hearing about, its lingering effects on drug research and development can’t be overstated.
PPD, the clinical research branch of Thermo Fisher Scientific, recently surveyed more than 150 biopharma and biotech leaders on their predictions for trends in the drug development industry. You can read the full report here, but we highlight several of the most notable projections below.
1) Digitization will make clinical trials increasingly efficient
More and more clinical trials use hybrid models or are increasingly decentralized. Though convenient for trial participants, the lack of a “home base” can make it difficult to collect and record data accurately.
According to PPD, 62% of industry leaders say they plan to invest more heavily in digital tools this year. Technologies such as cloud computing, artificial intelligence, and data analytics can improve trial efficiency, ensure compliance, and help studies stay on track.
2) An increased recruitment focus on racial and ethnic diversity
Clinical trial patient recruitment and retention are two of the greatest pain points for biotech and biopharma companies. In fact, 55% of those surveyed by PPD said it was their number one challenge.
Much progress is anticipated in this area over the next year. The FDA’s recent industry guidance, recommending that all studies include a “Race and Diversity Plan,” helps trial sponsors, CROs, and patient organizations design and execute trials that recruit diverse patient populations.
In the coming months, many experts predict increased collaboration between biopharmas, biotechs, advocacy groups, and community organizations. The latter two institutions regularly interact with members of the public and may be able to streamline the patient enlistment process.
3) Wearables and other remote monitoring technology will continue to increase in popularity
Wearable devices, such as smart watches, biosensors, and blood pressure monitors, have transformed the way sponsors collect and document patient data.
Instead of scheduling in-office check ups once a week or several times a month, remote trial participants can go about their normal routine. Wearable devices automatically store and transmit information to the cloud, allowing researchers to monitor the success of treatment in real time.
Wearable technology increases data accuracy, saves sponsors time, and boosts participant retention by allowing for greater flexibility.
4) An increased focus on adaptive clinical trials
Adaptive clinical trials are unique in that they don’t stick to a traditional, fixed design. Instead, the trial’s parameters change based on an analysis of the data at predetermined points.
By analyzing the data at specific intervals –– instead of only once, at the end of the trial ––it’s possible to identify errors, save money, and improve the accuracy of research results.
The PPD survey found that 64% of biotech and biopharmas already use adaptive clinical trials and that number is expected to grow even more in 2023, with an increase in the amount of complex and specific clinical trials taking place.
5) A greater reliance on outsourcing to CROs and FSPs
Clinical trials are becoming increasingly complex and drug development timelines continue slowing down. These factors, compounded by recruiting and retention challenges, often result in the need for outside help.
In the past few years, particularly since the start of the COVID-19 pandemic, biopharma and biotech leaders have increasingly sought outsourced help with their critical operations, such as data management, clinical trial management, and biostatistical analyses. Historically, these tasks were outsourced primarily to CROs but research shows more and more sponsors are partnering with FSPs to complement their clinical trial operations, which allows for more flexibility, control and greater access to highly specialized experts than the traditional full service approach.
What’s Trending in the Biopharma and Biotech Industries – Takeaways
No one has a crystal ball, but many in the biopharma and biotech industries expect major changes in the coming year. With improved access to affordable digital technologies and a regulatory emphasis on diversity in patient recruitment, there’s a lot on the horizon for 2023!