For part two of our Crystal Ball series, we asked a few more of our industry experts to comment on the clinical research landscape and to share their predictions for 2021.
Rob Laurens, Principal, RSG Services
Do you think a lot of the travel services rapidly deployed in response to COVID-19 will remain in effect? Will they become part of the standard offering?
Undoubtedly, many of the extraordinary support services deployed as a means to directly respond to the impact of the COVID-19 pandemic on clinical trial participant travel not only will remain available after the distribution and anticipated positive impact of vaccines, but also will be enhanced to serve the needs of a redefined approach and capabilities for clinical trial conduct by sponsors and CROs.
It is doubtful that wholly-remote studies will become a rule, rather than an exception, as the primary motivation, generally, for clinical trial participation is the care participants receive from expert providers; however, even just the few months of 2020 beset by pandemic-related restrictions has demonstrated the value of in-home visits, medication deliveries, virtual visits, and more – both on easing the site staff and patient burden, and on maximizing budget allocations. Moreover, the impact that COVID-19 has had on sponsor companies’ comprehension of the value and importance of expert management of participant travel has been immeasurable – for patient health, retention, and compliance.
Aaron Fleishman, Director, Market Development
COVID-19 has accelerated the industry’s adoption of innovative solutions. What do you think will be important for study sponsors to consider for 2021?
While there were so many challenges to 2020, I do believe as an industry we did rally together to make the best of a tough situation. Thought leaders came together to share strategies regardless of whether they were competitors or not. We did the best we could as an industry to adapt and change. Specifically, there was a huge shift in adapting to a decentralized study model. Something that has been discussed for years, implemented from time to time, has now become a crucial component to enhancing the patient and site experience in clinical trials.
Now as we head into 2021, I think one of the things I’m interested in seeing is how we can continue to better streamline the usage of different technologies to support decentralized studies – whether it be medication delivery, pop-up sites, telehealth visits, wearable devices, eCOA, remote monitoring, etc. There are a number of companies that focus on building solutions to support one or two of these technologies. There is going to be a need for one centralized platform or company that has the ability to manage and execute a suite of solutions – whether it be decentralized services or still our bread and butter standard patient recruitment outreach. Organizing, streamlining, building efficiencies, whatever you want to call it, it’s going to be crucial to managing the needs of the healthcare consumer and their participation in clinical trials.
Because now that the door is open to the ability to have decentralized study support, potential study participants, on the patient and site side, are going to expect these options to continue to be available. So for me, that’s the key for BBK and for others in our industry, who can manage all of this and support our sponsors who want to provide solutions that make it easier for participation? Hint hint . . . wink wink . . . look no further than us. Be on the lookout for a major announcement this spring.
Danielle Frate, Art Director
Are there any creative trends that you anticipate for 2021 that will impact patient recruitment and the patient experience – particularly in the wake of COVID-19?
My feeling is that we will see the public relations around sponsor visibility and transparency into the process and progress of clinical research continue to expand even further. Considerable adaptations and efficiencies have been made in the scope of clinical research and the public has watched the industry respond to address COVID and what typically takes a minimum of eight years condense to under a year. In that expedited timeframe we’ve seen the general public get a crash course in their understanding of trial processes, involvement, and familiarity with the pharma companies involved grow significantly.
This statistic depicts the percentage of people worldwide that understood the term “clinical research study” as of 2017, by participation in clinical research. Among those that have never participated in clinical research 55 percent of respondents said that they understood somewhat well what the term “clinical research study” meant.
In a global study released in 2017 of more than 10k respondents, just under half said they did not understand the term “clinical research study.” Out of those who had participated in previous clinical research studies, still only ~60% had a broader understanding of them.
Today, high-profile trials and the sponsors organizing them are becoming household names. The key opinion leaders, researchers (even patients), and their progress in the study is regularly cited. Where caution around IRB pushback or bad press may have caused sponsors to hesitate in owning their involvement and encouragement to the public, the industry and the general public have since adapted. As potential participants – who are typically well informed about their conditions or those of a loved one – explore treatments, advocacy resources, and trial options online the networks that support these must continue to become more connected toward unified multi-disciplinary treatment initiatives.
Whether sponsor support is incorporated on study outreach and ICF aides, through study branding, advocacy group partnerships, virtual condition conference presence, addressing underrepresented patient populations, patient portal / app enhancements, or hybridized trials - it becomes more and more imperative that trial opportunities remain visible for consideration and accessible to the patients they look to serve.
Moreover, sponsor consideration of a patient and their family’s study-life balance increases enthusiasm and peace of mind. Providing services that keep participants engaged throughout the study duration are proven to reduce withdrawal rates and reduce accessibility barriers – ultimately influencing cost and drug approvals for various condition treatment options.
BBK will be staying on the pulse of emerging trends in 2021. Stay informed through our blog, our Pharma15 Live! series, our Study Voices surveys, MythBuster initiatives, and much more!