I recently listened into Clinical Leader Live’s webinar Clinical Trials 2021: What Should We Expect?, which covered top questions about emerging technologies, virtual trials, and patient centricity in the age of COVID-19. It was a pleasure learning from industry experts: Michelle Longmire, CEO of Medable; Craig Lipset, founder of Clinical Innovation Partners; Debbie Profit, VP of Clinical Management and Applied Innovation at Otsuka Pharmaceutical Companies; Jeff Kasher, President of Patients Can’t Wait; and Ed Miseta, Host & Chief Editor of Clinical Leader.
Below is a recap of what I thought were the top 5 clinical trial trends we should — and will — embrace in the year ahead.
Decentralized trials are here to stay.
For years, the clinical trial process has been conducted centrally, requiring patients to travel to a single location in order to complete the research. However, that model is rapidly changing to be more modular and decentralized. COVID-19 has forced the industry to rethink the way we approach conducting clinical trials, allowing for data collection from multiple source points.
According to the FDA, decentralized clinical trials are those that leverage telemedicine, virtual visits, and mobile or local healthcare providers to complete the trial. In a press release from 2019, the FDA announced “modernizing clinical trials is an agency-wide priority.” This is exciting news for 2020 On-site in particular, as we continue to expand our Mobile Vision Clinics to support decentralized bioscience clinical trials.
Today, patients, sites, CROs, and sponsors no longer have to rely on a single location in order to complete their research. This revolution not only improves patient access to care and engagement, but it also makes conducting trials more effective, efficient, and cost-effective.
In 2021, patients can expect more convenient access to trials, which in turn will help increase trial participation and engagement. The future of medicine will give patients choice: the choice to complete their appointment in person, virtually, or at another location that works for them.
Clinical trials are adopting technology at a rapid rate.
To keep up with patient demand and new safety protocols, clinical trials have become increasingly digitized in all phases of the process. In fact, technology use in the Research & Development market is growing at a rate of over 22% per year.
Disruptive technologies like wearables, mHealth, and RWE have entered the market with more focus on the patient, decreasing patient enrollment time while casting a wider net and attracting a more diverse participant pool.
In addition to patient convenience, clinical trial technology creates more flexibility and structure in the entire process. Technology allows communication between the patient and the researchers to extend past the walls of the physical sites into patients’ homes. This creates a seamless process for the patient while also better enforcing routine trial check-ins and real-time monitoring. In fact, studies have shown patients doing at-home care are much more likely to adhere to treatments with check-ins from their physician through telemedicine than those that have no check-ins at all.
Clinical researchers can expect to see a surge of new technology enter the market in 2021 and beyond in order to empower patients and create efficiencies in the clinical trial process.
Patient centricity will be at the core of trial design.
If you haven’t noticed the trend already, patient centricity will be at the center of all trial design. From technology adoption to data security, all emerging trends in 2021 will be focused on creating a better experience for patients.
The biggest patient centric takeaway is to treat patients as partners in clinical trials, not subjects. Including patients in trial design while understanding and empathizing with their current health conditions may better protect and build trust between patients and biopharmaceutical companies. By showing more kindness and empathy, researchers will better protect patients and build trust — one of the most important elements of conducting a trial.
Additionally, patients deserve access to their own data now more than ever. COVID-19 trial subjects for vaccine research endured many months of trials that are critical for the entire world. They deserve to know more about their contributions to society, and easier access to data is one way we can provide that. By sharing data with patients, we are making them part of the research process, not just a means to an end in a trial.
Data integrity and security are critical to trial success.
With the introduction of more decentralized trials, researchers are now able to collect data points from multiple healthcare vendors that a patient may visit. This allows researchers to gather more input in their trials, however, they must now ensure patient data and personal information is secure when being sent over. This is where data mapping will come into play. Data mapping allows researchers to know where data is stored and where and when it will be distributed.
Additionally, with wearables and more high tech processes, data can now be collected outside of the trial site and throughout the entire duration of the trial. It is no longer bound by a physical space or a certain appointment time. With the adoption of data technology outside of the clinic space, the number of data points retrieved for statistical analysis can increase, give more accurate results, and improve data integrity.
The emergence of new technology has also brought increased quality of data collected in clinical trials. The old way of collecting data — by paper — has become more cumbersome, especially in a modular-based approach to clinical research. While paper data collection has historically been secure in a clinical trial process, digital collection provides real-time data and assists with version control and data back-up.
However, digital data adoption in clinical trials requires a little more planning to uphold security. While digital data can provide real-time information, improve analytics and data backup, and reduce barriers to patient care, companies may feel overwhelmed as they try to find ways to keep their data safe. That’s why there is some hesitation to embrace the change — there is still a fear of hacking and leakage of patient personal data. To help combat this risk, clinical trial design requires planning around advanced data privacy storage and security in order to maintain the integrity of the trial data and security of personal information. The biggest takeaway: with planning, data security can be attained!
Direct-to-patient care will be a new but critical need.
This last point emphasizes decentralization of clinical trials and the patient-first mentality. COVID-19 and the restrictions it brought has proved (and forced) the need for direct-to-patient care. When patients aren’t able to travel to sites or be physically present to participate, there is a huge disruption created in the entire clinical trial process.
Instead, sites, CROs, and sponsors are now presented with the opportunity to bring care and testing directly to where patients are, whether that is through telehealth, virtual visits or mobile clinical trials.
Conclusion: what you can expect from 2020 On-site in 2021
Needless to say, the year 2020 presented many challenges to the healthcare world. But those challenges have brought endless opportunities to improve the clinical trial process. This year, 2020 On-site will be heavily focused on supporting clinical sites, CROs, and sponsors in creating more efficient, decentralized processes with the patient in mind. Bringing care directly to patients is something we do best — and we’re excited to be part of this new frontier.
About Dr. Debi Sarma
Dr. Debi Sarma is a residency trained community health optometrist. She has built a career around vision health education, and is passionate about improving access to vision care for those in need. Dr. Sarma has a Bachelor of Science degree from the University of Waterloo, as well as a Doctorate degree from the New England College of Optometry. She is a seasoned lecturer on disease topics and loves connecting with people to talk about innovation, culture, and leadership in healthcare.