Updated 21-JULY-2020
In partnership with ZS Associates, we connected with 1,250 patients globally to understand the impact of COVID-19 on clinical trials. See the infographic below for a quick summary of our findings, or download the report for a deeper dive.
Updated 10-JUN-2020
Number of Clinical Research Sites Fearing Total Closure Drops by 71% in Recent Weeks; Industry Still at Risk as COVID-19 Concerns Persist
New data from an ongoing quantitative research survey conducted by Continuum Clinical in partnership with the Association of Clinical Research Professionals (ACRP) indicates 9% of clinical trial sites say it is “somewhat likely” or “very likely” that their site would need to close in the coming weeks, down from 31% in previous research.
In the new survey of 274 clinical research site staff conducted May 14-26, clinical researchers say they continue to fear clinical trial site closures in the coming weeks as a result of the ongoing COVID-19 pandemic. Though the trend has improved from research conducted April 1-4, 9% still represents a significant share of U.S. clinical trial site capacity and represents cause for continued concern, according to Jim Kremidas, ACRP’s Executive Director.
“While site staff are significantly more optimistic that they will not need to close in the coming weeks, we simply can’t afford to lose nearly 10% of U.S. site capacity at this crucial time,” Kremidas says. “The current outlook among site personnel is far more positive than just six weeks ago, but the rapidly changing nature of the pandemic underscores the need to be ready with contingency plans based on alternative scenarios.”
In the latest survey from the ACRP and Continuum, 75% of respondents said it is “very unlikely” their sites will need to close in the coming weeks. That figure is up significantly from the 36% who shared that sentiment in prior research.
“We are cautiously optimistic about the trend we see here, though any site closures are detrimental to patients who rely on clinical trials to further the development of life-saving therapies,” said Continuum Clinical president Neil Weisman. “It is more important than ever for sites and sponsors to maintain their focus on and commitment to patient centricity.”
More key findings from the latest research:
-There has been a tremendous increase in the percentage of sites conducting COVID-19 related research.
-Sites have implemented many of the newest COVID-related healthcare safety precautions for site visitors.
-The desire for operational support services remains very strong, especially telehealth.
-Sites are somewhat confident that patients will permit in-home visits by clinical trial staff.
“We are certainly pleased by the positive indicators reported by site teams,” Kremidas says. “These data reflect well on the ability of our industry to constantly adapt and thrive under extremely difficult conditions. That said, until this pandemic is in the rearview mirror we must recognize the continued threat to site capacity and remain committed to site sustainability.”
More than 25% of the survey respondents reported some of the employees at their site have been furloughed.
“Furloughs, staff layoffs, and sharp cuts to continuing education and development programs are a threat to workforce capacity and the ability to deliver important new treatments and therapies to patients in critical need,” Kremidas adds. “We must act today to support our most vulnerable clinical trial sites and to ensure their teams are ready to keep medical progress moving forward.”
To download the Executive Summary from ACRP and Continuum, please visit https://bit.ly/2YecacH.
Updated 8-MAY-2020
Japanese Survey Data Shows Most Clinical Trial Patients Intend to Continue Participation, Desire Alternatives to Hospital Visits
Continuum Clinical has a valued partnership with 3H Medi, the premier patient recruitment company in Japan. 3H recently conducted a patient survey similar to those conducted by Continuum over the past weeks. The following trends were collected from 1,255 survey respondents in Japan who are currently enrolled in a clinical trial or have participated in a clinical trial previously.
The survey indicates most patients currently enrolled in a clinical trial in Japan intend to continue their participation but would value alternatives to site visits.
80% of respondents currently enrolled in a trial intend to continue their participation
-51% cite stipend as primary motivator for continued participation
-45% intend to continue because they trust the clinical care team and feel safe participating
-35% express feelings of obligation to the trial commitment
Less than 20% say they intend to discontinue participation in current trial
-90% cite concern about visiting a hospital
-Other responses include guidelines restricting travel, and influence from friends or family
60% of respondents currently enrolled in a trial say they would value alternatives to hospital visits
-60% say they would prefer a way to record their own data via an app or device, instead of attending a site visit
-44% indicate a desire for an accessible way to reach the study site, such as a web or app-based chat function
-Other responses include virtual visits via WebEx or Zoom and a wish for electronic study communications, such as via an e-newsletter
Pamela Landau, Continuum Clinical SVP Integrated Solutions, speaks Japanese and has more than a decade of experience living and working in Japan. She notes that while there are likely cultural factors at play that result in respondents’ strong intention to continue participating in their current trial regardless of the concerns about the COVID-19, Japanese trial participants desire the same type of alternatives to hospital visits that we see in the West: Electronic health monitoring, e-diaries, and electronic communication with sites and telehealth. One difference of note is that Japanese trial participants do not welcome home visits. Landau speculates this may also have culture influences, and is worthy of further exploration.
Updated 24-April-2020
Survey shows 68% of Americans now more interested in clinical trial participation as COVID-19 news continues to boost awareness of medical research
Majority of Americans express interest in participating in a COVID-19 vaccine clinical trial
A quantitative survey conducted by Continuum in partnership with Precision Sample shows 68% of US adults diagnosed with at least one medical condition say they are more likely to consider participating in a clinical trial now than they were before the COVID-19 pandemic. More than half of respondents indicate that their awareness of clinical trials has increased as a result of news coverage of the novel coronavirus.
Interest in clinical trial participation overall increased most dramatically among men and older millennials in particular, with men and Black/African Americans indicating the largest jump in awareness of medical research.
Continuum Clinical’s Integrated Media analysts have confirmed the trend extends to online search behavior, with the number of Americans actively searching for “clinical trials” more than doubling in the past 4 months. Since February, proprietary Continuum Clinical data shows patient engagement has increased by an average of 80% across the actively recruiting clinical trial programs it supports.
Of those respondents who reported increased interest in clinical trials, nearly all pointed to a greater sense of altruism as the reason for their increased motivation to participate in medical research. And when asked about their interest in participating in research related to the current pandemic, a majority of Americans (60%) expressed interest in participating in a COVID-19 vaccine trial.
Click here for the full press release.
Updated 8-April-2020
Survey Shows One Third of Clinical Trial Study Sites Fear Total Closure; 77% Indicate at Least Some Ongoing Research Trials Have Been Impacted Due to COVID-19
The latest quantitative survey conducted by Continuum, this time in partnership with the Association of Clinical Research Professionals (ACRP), shows 31% of clinical research study sites fear total closure as COVID-19-related stay-at-home orders and patient concerns over interacting with healthcare professionals continue to increase. Nearly 80% of sites indicated at least one of their current clinical trials had been put on hold or cancelled in recent weeks.
Results from the 297 responding US sites show clinical research study sites not actively working on COVID-19-related studies have been heavily impacted by the global healthcare crisis.
Of the sites who reported patient dropouts, 80% said patients are unwilling to visit the site for study appointments, with 52% of sites indicating they believe patients fear interacting with any medical professionals who may be in contact with COVID-19 patients. Home nursing visits, recently offered by the FDA as an acceptable substitute for scheduled drug administration study visits, are also feared not practical by sites – only 19% believe patients would permit home visits by clinical trial staff.
The survey also shows investigator sites are facing serious staffing issues, with 38% reporting employees experiencing difficulties working from home and 33% reporting employees are not fully engaged due to COVID-19-related disruptions.
Click here for the full press release.
Updated 23-March-2020
US, European Site Concerns Continue to Grow
New results indicate continuing worrisome trends among both US and European clinical trial sites across the board:
Over the course of just one week, US clinical research study sites’ concern about COVID-19 impacting patient willingness to continue in clinical trials for which they are already enrolled has increased by 124%, jumping from 25% to 56%.
The newest data shows 81% of European sites indicated already-enrolled patients are “much less or somewhat less likely” to continue participating in trials.
Clinical trial sites in Europe continue to indicate a higher level of concern overall, with nearly 85% of sites indicating the pandemic will negatively impact clinical trial enrollment.
Updated 20-March-2020
Impact of COVID-19 Differs Considerably across Therapeutic Areas
Further analysis of Continuum’s site survey data shows considerable variation in site concerns driven by differences in specific areas of therapeutic focus.
Within the overall survey average of 39% of sites reporting that COVID-19 is having a “big” or “extremely big” impact on site operations, therapeutic areas ranged from a low of 27% for respiratory trials to a high of 54% for rheumatology trials. Other therapeutic areas with above-average levels of concern for disruption include cardiovascular, endocrinology, neurology, rare disease, and ophthalmology trial sites. We believe these heightened levels are primarily being driven over concerns of incidental exposure to trial patients combined with measures to protect especially vulnerable patient populations.
Compared to just last week, concern jumped the most in four therapeutic areas:
- Cardiovascular: up 26%
- Rheumatology: up 32%
- Endocrinology: up 41%
- CNS: up 52%
Rare Disease sites did not report a significant increase, but those sites were already at very high levels of concern in our initial survey on March 13 (46% reporting a big or extremely big impact).
Updated 17-March-2020
New data shows dramatic trends in US site concerns about enrollment and retention as pandemic continues
Q: Thinking about your site’s current clinical trial patients, how has COVID-19 impacted their willingness to continue to actively participate in the clinical trials they are enrolled in?
Much Less or Somewhat Less Willing to Continue Participating:
- Survey March 13: 25%
- Survey March 17: 47%
Analysis: Compared to sites that completed the survey on March 13, sites that completed the survey on March 17 are nearly twice as likely to say that COVID-19 has reduced current patient willingness to continue participating in their trials.
Q: How has COVID-19 impacted new patient willingness to enroll in clinical trials at your site?
% Much Less or Somewhat Less Willing to Enroll:
- Survey March 13: 39%
- Survey March 17: 61%
Analysis: Compared to sites in that completed the survey on March 13, sites that completed the survey on March 17 are significantly more likely to say that COVID-19 has reduced new patient willingness to enroll in clinical trials at their site.
Q: On a scale of 1 (no impact) – 10 (extremely big impact), how much of an impact do you anticipate COVID-19 will have on patient recruitment and retention at your site moving forward?
% Rated 8 out of 10 or greater; a big impact
- Survey March 13: 29%
- Survey March 17: 37%
Analysis: Compared to sites that completed the survey on March 13, sites that completed the survey on March 17 are 28% more likely to say that COVID-19 will have a big negative impact on recruitment and retention at their site moving forward.
Updated 16-March-2020
EU Results
N=52 sites
Retention of Current Patients
Q: Thinking about your site’s current clinical trial patients, how has COVID-19 impacted their willingness to continue to actively participate in the clinical trials they are enrolled in?
- Somewhat less willing: 42%
- Much less willing: 35%
Analysis: The majority of sites in Europe say that COVID-19 has reduced patient willingness to continue participating in trials they are enrolled in.
Recruitment of New Patients
Q: How has COVID-19 impacted new patient willingness to enroll in clinical trials at your site?
- Somewhat less willing: 23%
- Much less willing: 58%
Analysis: Sites in Europe are even more likely to say that COVID-19 has reduced new patient willingness to enroll in clinical trials at their site.
Updated 13-March-2020
US Results
N=170 sites
Retention of Current Patients
Q: Thinking about your site’s current clinical trial patients, how has COVID-19 impacted their willingness to continue to actively participate in the clinical trials they are enrolled in?
- Somewhat less willing: 15%
- Much less willing: 11%
Analysis: More than a quarter of US sites have experienced reduced patient willingness to continue participating in trials they are enrolled in.
Recruitment of New Patients
Q: How has COVID-19 impacted new patient willingness to enroll in clinical trials at your site?
- Somewhat less willing: 23%
- Much less willing: 16%
Analysis: Sites have experienced greater challenges recruiting new patients to enroll in clinical trials at their site.
Additional insights:
• Compared to other site types, sites at academic institutions are more likely to say that retention of current clinical trial patients has been a challenge, while sites at non-academic institutions are more likely to say that recruitment of new clinical trial patients has been a challenge.
• Sites that focus on Cardiovascular, Ophthalmology, Rheumatology, Vaccine and Rare Disease clinical trials are even more likely to say that the COVID-19 outbreak has impacted recruitment and retention at their site.
Updated 16-March-2020
This article also appears in Applied Clinical Trials here.
Measuring the Impact of the COVID-19 Outbreak on Clinical Trials
Standard enrollment metrics won’t be enough to understand and react to this “once-in-a-generation” outbreak.
The impact of the COVID-19 pandemic is already being felt in hospital emergency rooms and ICUs around the globe. Within clinical research, uncertainties about the pharmaceutical supply chain, reallocation of medical resources, and potential restrictions on patient travel have raised critical questions about the short- and medium-term implications for trial sites and sponsors:
• Will increased patient hesitancy negatively impact trial enrollment rates?
• Will enrolled patients be less likely to attend study visits?
• Will site staff experience reduced capacity for conducting trials?
As we began to parse the voluminous real-time enrollment data available to us in our ContinuVue® Reporting Platform, our trial recruitment tracking platform, it quickly became apparent that many of the usual enrollment metrics would not reflect the unique nature of the current outbreak. Accordingly, we set out to systematically identify and collect the relevant data points to help us understand the trajectory and model the impact of the current outbreak. Our COVID-19 dashboard synthesizes three key sources:
1. Real-time measures of patient engagement: Tracking changes to patients’ behavior when learning about trials online, we have identified 3 key decision points that measure patient willingness to consider visiting a research center for screening.
2. Measures of site capacity: Three (3) key metrics pertaining to site prescreening and appointment scheduling give us rapid insight into any changes in site behavior.
3. Site sentiment: We fielded a quantitative survey of representative US sites to collect direct feedback on current operations and future planning.
The results of this analysis, detailed below, indicates we have passed a probable inflection point in the outbreak that will have broad, significant impacts on clinical trial enrollment that require an immediate and fact-based response.
Changes to Patient Engagement
Patient hesitancy in the midst of the COVID-19 outbreak is most apparent when patients are provided the opportunity to connect with and visit a local research site for more information about the trial. We indexed patients’ refusal to consider a new site against pre-outbreak baseline rates for each trial, permitting us to measure changes across multiple trials (see figure 1).
Figure 1
Results and Outlook: In the early weeks of the outbreak, patient hesitancy decreased. We believe this is potentially a result of an increase in health information-seeking behaviors as pandemic information became more prevalent. Last week, however, reversed that trend, and we noted a significant increase in patient hesitancy. We believe patient sentiment may be a significant driver of enrollment rate changes and we continue to monitor this data closely.
Changes to Site Behaviors
Continuum tracks site capacity through the velocity and volume of sites’ outreach efforts to new referrals along with their rates of scheduling screening appointments. We find their short-term response metrics to be most indicative of their focus on trial enrollment against other competing priorities (see figure 2).
Figure 2
Results and Outlook: In the first two months of 2020, sites exhibited extremely consistent performance in reaching out to potential trial participants. However, the week of March 9 saw a major drop in responsiveness – well below levels of any time this year. While a single week cannot definitively indicate a trend, we believe site responsiveness to potentially be the single largest driver of short-term impact on enrollment performance.
Site Feedback
To supplement the above measurements, we deployed a survey to a representative sample of 170 US sites from March 12 to 13. The key finding from this survey is that although many sites are attempting to remain on track for “business as usual”, a clear subset are already experiencing or anticipating recruitment and retention issues.
• For patient recruitment, a full 39% of sites believe that patients will be less willing to consent to participate in a new clinical trial, with over a third of those sites stating that patients will be “much less willing” to enroll.
• For retention in existing trials, 25% of sites anticipate patients will find it difficult to maintain their visit schedules due to COVID-19-related issues.
• Overall, 29% of sites anticipated COVID-19 as having a “big” or “extremely big” negative impact on clinical trial recruitment and retention.
These results were consistent across site types: academic sites, medical centers, and private research sites reported equivalent levels of concern about recruitment and retention. Results did vary considerably by therapeutic area, with sites conducting trials in older or more vulnerable populations – including cardiology, rheumatology, and ophthalmology – having nearly double the number of sites that anticipate significant recruitment and retention challenges.
Summary and Next Steps
We believe our indices demonstrate that the week of March 9 represents a probable inflection point in patient and site behaviors in regard to clinical trials. We are currently working closely with our trial sponsors to model the impact and develop planning scenarios based on our projections of immediate impact of the pandemic. To help quantify the trajectory of patient and site change, this week we intend to:
1. Continue to refine and monitor these indices of patient hesitancy and site responsiveness
2. Field a follow-up US survey to assess changes in attitudes
3. Field an EU-focused survey to parallel the US version
As former FDA Secretary Scott Gottlieb noted just yesterday, the COVID-19 outbreak represents a “once in a generation” event, leaving us with few to no historical comparisons to understand its impact. We believe the most appropriate response for the clinical trial industry is to identify and track measures that are sensitive enough to reflect the rapidly-changing impact on trial recruitment and retention, and to build fact-based scenario plans to prepare sites and reassure patients that we are able and ready to support clinical research during these unpredictable months ahead.
Questions about COVID-19 and clinical trials?
Please contact our Vice President of Site Optimization Nariman Nasser at nnasser@continuumclinical.com.
