While the COVID-19 pandemic has thrown the drug development industry for a loop in numerous ways, a recent industry survey shows biopharmaceutical companies and contract research organizations (CROs) are adapting. A survey by Life Science Strategy Group (checking in with 120 clinical development decision-makers in the US, Europe, and China) shows that industry professionals have made efforts to adapt to the new world—and that while there’s a shift back to a more traditional clinical model, decentralized trial formats are not going anywhere.
Jon Meyer, Life Science Strategy Group co-founder and principal, discussed the report with Outsourcing-Pharma and what key findings might mean for the coming months.
OSP: Could you please share some of the most notable impacts COVID-19 has had on the industry in the months since your last report?
JM: We are seeing that the scope of studies is starting to increase, after some contraction in the earlier stages of the pandemic. Also, we are seeing an uptick/increase in CRO outsourced spend in 2021.
In particular, we see the greatest gains in outsourced spend on monitoring activities and spend due to new trial starts, site activations, and trial enrollment. Use of virtual and decentralized or technology-enabled trials is also increasing at a strong pace. 42% of respondents indicate an average increase of 17%.
OSP: What looks different, comparing the trends/changes in recent months to the shifts during the early stages of the pandemic?
JM: The biggest differences are in the metrics pointing to trial site activation and enrollment. As restrictions have loosened in 2021 vs 2020 activations and enrollment are now increasing. Also, the trend to incorporate virtual/decentralized/technology-enabled trials/telemedicine/elements is increasing in 2021 over 2020, despite increases in site activity, indicating the approach is working well.
OSP: In what areas have the pharma industry and CROs made notable adaptations, and in what areas are they still struggling?
JM: The biggest adaptation is in the use of virtual, decentralized, and technology-enabled/telemedicine trials. And the adaptation appears to be successful. That, and also growth in research and new therapies/vaccines for COVID.
OSP: Regarding clinical development budget changes: could you share some of the factors contributing to these
JM: Clinical development budgets have increased each period from early 2020 to the present. Initially, this was due to new research/trials for COVID therapies and to resuscitate failing/lagging trials/low enrollment rates. Now, more so driven by expanding the scope of trials and more new starts. Also, investment in the adoption of technology/telemedicine to augment trials and more, greater CRO support for patient recruiting.
OSP: Do you expect to see a continuation at this level, or declines in the coming months?
JM: Indicators point to continued growth in 2H 2021 over 1H 2021.
OSP: Regarding outsourcing spends, could you share some of the factors contributing to these figures?
JM: Outsourced spend is growing for the same reasons as Q4. Similar to outsourced spend we anticipate continued growth in outsourcing spends, albeit at slightly lower rates vs. 1H 2020.
OSP: Could you please talk about the trends around trial starts and interruptions in recent months?
JM: From the data, trial starts while growing at a good pace (27% of respondents report an average 17% increase in starts) the trend does show some tempering over 1H 2021 (33% reported 18% increase).
Other supporting metrics – trial site activations, trial enrollment also show the same pattern. My interpretation is that after an initial decrease in activity/spending in 2020, there was a significant increase in spend/activity, which is tempering in 1H 2021. But there is still strong growth in budgets, outsourcing, and spend.
OSP: What are some of the clinical development strategies respondents plan to take on in the coming months, and how do these compare to 2020?
JM: Key clinical development strategies we see a growing focus on two things – improving trial recruiting efforts and participation rates. Sponsors report increased adoption of technology/telemedicine to trials and apps to expand patient reach/engagement.
Also, use of social media, patient advocacy groups, and advertising to drive trial enrollment and engagement. 67% and 62% of respondents are adopting technology and increasing use of CROs, respectively, to drive greater patient reach/recruiting.
OSP: Patient recruitment (certainly challenging during the pandemic) apparently is a continued concern among respondents. Could you please talk about the strategies they’re considering going into the next few months?
JM: Top strategies focus on adopting technology such as telemedicine and apps to expand patient reach and engagement. Sponsors are also increasing use of CROs to assist with recruiting. These strategies are proving to be successful with 42% and 34% of respondents indicating a high degree of success with these approaches.
OSP: Please share some insights about what respondents said regarding qualities they’re seeking in CROs.
JM: Top CRO qualities sponsors are seeking focus on three areas:
- patient recruitment (identification and selection).
- COVID-19 trial experience
- remote data collection technology.
Essentially, as more sponsors initiate trials/studies on therapies/vaccines for COVID, those CROs with experience will be in greatest demand. Further, today and pre-COVID patient recruitment continue to be a top clinical development challenge.
With the pandemic, this challenge was only amplified. As a result, sponsors are keen to drive patient recruitment and better engagement (through remote data collection/technology)
OSP: Do you have anything to add?
JM: I think the biggest “ah-ha” findings from the study are that spend/outsourcing looks strong (with a tiny bit of tempering in 2H 2021 vs. 1H 2021) and the virtual/decentralized strategies pharma adopted due to COVID and restrictions have proven successful. This longitudinal study proves the effectiveness of those strategies (remote data collection, telemedicine, etc.) and indicates the clinical development paradigm has evolved and will remain (for the immediate future) vs. pre-COVID times.
I think a big question that CROs have is will the use of these decentralized/technology-enabled/telemedicine/remote data collection strategies persists going forward or will the market revert back to a pre-COVID “in-person” model. the answer is pretty clear in this data. The paradigm has changed.
For more information or to download the report, visit LifeScienceStrategy.com