For more insights on how the clinical trial space is changing in light of COVID-19, take a look at more of our findings here.

1. IMPACT OF COVID-19 ON
CLINICAL TRIAL RECRUITMENT

2. NOTES TO CONSIDER
Although search terms related to COVID-19 were removed, it is still a major topic of conversation. The term may still have been
included in links to news stories and PR, despite the author not directly quoting the condition.
Due to the volume of online mentions, the search terms have been limited to 30 days (March 2020).
Without mentions of
“Coronavirus OR COVID-19”
Searches on mentions of patients and Clinical
trials and recruit / enrolment
Total Mentions Mentions/Day Average Unique Twitter Authors
5.32k
1.66k
184
57
378
368
+ 1475%
+ 1837%

3. TOP-LEVEL ANALYSIS
The majority of online discussions at the moment about clinical trials revolve around the latest developments in COVID-19
trials.
Universities, pharmaceutical companies and technology firms are contributing to helping solve the problems posed by this
global pandemic.

4. TOP-LEVEL ANALYSIS
One of the most common emotions revealed in the analysis was fear. This reflects that everybody has been impacted by the
uncertainty of the pandemic, which is overwhelming for many.
Emotional Comparison
35
30
25
20
15
10
5
0
Joy Fear Surprise Anger Love Sadness

5. WIDESPREAD DISRUPTION TO TRIALS
The ongoing pandemic is impacting clinical trials regardless of the indication. This spans recruitment and immediate patient care, as
well as data collection and analysis.
The FDA has encouraged trials to halt, unless they serve an immediate benefit to the population.
“To maximize public health benefits, creativity and persistence are required, especially during these unprecedented and uncertain
times.”
Many have recognised the impact COVID-19 has had on clinical trials and drug development

6. SOME TRIALS ARE MOVING FORWARDS WHERE POSSIBLE
The organisers of a Parkinson’s Disease study, Rapsodi, are utilising saliva collection kits that can be used by patients at home and
returned to researchers in the post.
As participants are able to provide their DNA samples safely at home, enrolment is still encouraged.
*Despite the pandemic
*

7. BUT COVID-19 HAS THE ABILITY TO DISRUPT TRIALS…
…at every point of the journey.
+ During trial enrolment, patients are unable to visit sites for regular check ups, or screening for trial participation.
+ Some clinicians, where possible, are also working from home four days a week to minimise contact with vulnerable
patients
+ Research groups that routinely recruit volunteers and run lab-work are being told to pause operations to devote
resources to Covid-19
+ Hospitals banning site visits will likely impact monitoring clinical trials, ultimately slowing down data collection and
analysis.
+ Covid-19 testing is not part of trial protocols, and this may get complicated from a regulatory and data integrity point
of view. Patients may need to be removed from the study population for safety purposes, thus reducing sample sizes
and statistical significance.

8. PATIENTS FACE MANY CHALLENGES AHEAD
Adjustments to their usual treatments and clinical trials are worrying and causing anxiety
“Must admit I am not looking forward
to going to the hospital as I believe
they could be riddled with covid 19.”
“I was told off my consultant to self isolate
for 12 weeks. I have no letter off the
government my husband my carer he is
terrified when he is out and [that he’ll] pass it
on.”
– MS patient – Respiratory patient
Regular infusion appointments at hospitals
are a source of concern
Communication is key to allaying fears
with accurate, up-to-date information

9. PEOPLE ARE LESS LIKELY TO PARTICIPATE IN TRIALS
ONE US CLINICAL TRIAL SURVEY FOUND:
+ An increased hesitancy when potential clinical trial participants are provided the opportunity
to visit a local research site for more information about the trial.
+ 39% of sites believe that patients will be less willing to consent to participate in a new clinical trial.
+ Over a third of those sites also stated that patients will be “much less willing” to enrol.
+ 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” impact on
clinical trial recruitment and retention.

10. PHARMA POSTPONES ONGOING TRIALS
Pharma companies have announced delays of ongoing clinical trials, especially those with vulnerable patients who may be more
susceptible to the virus.
Gilead announced that enrolment into
their highly anticipated RA treatment
filgotinib trials were also being paused
until further notice.
Eli Lilly
"By delaying most new
study starts and pausing enrolment
of new patients or healthy volunteers
in most ongoing studies, we hope to
ease the burden on participating
healthcare facilities and allow
physicians to focus more of their
efforts on combatting COVID-19."
resTORbio
“We want to ensure the
safety of our clinical trial
participants, many of whom are older
adults at high risk of COVID-19
morbidity and mortality. Therefore, we
have postponed enrolment in the
fifth cohort of our ongoing Phase
1b/2a clinical trial of RTB101 in
patients with PD.”

11. MEASURES TO MAINTAIN INTEGRITY OF EXISTING TRIALS
Responses vary from suspension of research (except when this increases risk to participants)
to relying on principal investigator discretion.
JAMA has reported on the following solutions to minimise disruption of ongoing randomised clinical trials, and ensuring participant
health and safety:
1. Assessment of outcome data – primary outcome has highest priority
2. Alternative methods of data collection – protocols should be modified accordingly
3. Remotely collecting outcomes – self-administered, online or collected by telephone should be continued
4. Questionnaires conducted in person are to now be conducted over the phone or by mail
5. When feasible and safe, objective outcomes can be collected at home
6. When a high-priority outcome cannot take place at home, consideration can be given to collection
off-site, in an areas where exposure to potential infection is minimal

12. CONCLUSION
FUTURE IMPLICATIONS
COVID-19 has forced the pharmaceutical industry to step
up, expedite processes
and re-evaluate priorities.
Considerable efforts by clinical trial teams will be needed to
ensure that participants feel safe and comfortable making
site visits in the future.
Short-term adjustments to site protocols may become
commonplace, with benefits of virtual visits, reduced risks of
exposure and further features proving more patient-centric.
WHAT WE HAVE FOUND
The majority of clinical trials have been paused or
postponed until participants and researchers are no
longer self-isolating, facing travel restrictions or social
distancing.
Trials where there is minimal contact required, and that
are feasible and safe, may still proceed but at the
discretion of the trial investigators.
Many companies have diverted resources where possible
to contribute their research efforts towards COVID-19
trials.

13. This report (including any attachments) has been prepared for the exclusive use and benefit of the addressee(s) and solely for the purpose for which it is provided.
All report information is correct as of April 2020. Unless COUCH Health provide prior written consent, no part of this report should be reproduced, distributed or communicated to any third party. COUCH Health do not accept
any liability if this report is used for an alternative purpose from which it is intended, nor to any third party in respect of this report.
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