Patient's perspectives
Patient organisations represent some of the most vul-
nerable patient groups in this pandemic: many have
chronic conditions, are at a higher risk for illness and
death from COVID-19, and may experience substantial
disruptions to ongoing care and treatment due to the
pandemic. Raising awareness of these issues is one focus
of patient organisations during the pandemic. In Decem-
ber 2020, the Swiss patient organisation SPO wrote an
open letter (in German) to the Swiss Federal Council and
representatives of the cantons calling for more solidarity
with ill and elderly people as well as healthcare workers.
This was, however, one of the rare initiatives from Swiss atient organisations to our knowledge. Rare Diseases
Europe (EURODIS), an alliance that gives voice to over
30 million Europeans affected by rare diseases, initiated
a survey of almost 7000 people with rare diseases in 36
countries across Europe to ascertain how COVID-19 has
impacted them. The survey shows that the pandemic
has not only caused severe disruptions to care for people
with rare diseases, but it has also increased their levels
of uncertainty and anxiety. The survey also reveals posi-
tive developments, for example that the pandemic has resulted in more people using online health services.
The suspension or termination of human
research during the pandemic
Patient organisations have been following and responding
to the pandemic’s effects on human research. As the result
of COVID-19 becoming the focus of much research (i.e.
the “covidisation” of research), attention and resources
have been diverted from other research projects. Early
on in the pandemic in May 2020, BioPharma Dive shared
details on the disruption of clinical trials: three out of
every four clinical trials worldwide had to be ended
prematurely or put on hold. Later, studies performed in
August 2020 identified the persistent impact of COVID-19, with over 60% reporting an “average” or greater level
of impact on ongoing trials and the initiation of new
trials. Respondents specifically highlighted challenges in
patient enrolment and recruitment (see article in Applied
Clinical Trials from October 2020). Those obstacles drove
a discernible shift toward conducting decentralised trials
and using telemedicine and mobile technologies in order
to reduce contact with patients – and thus potentially
lowering research costs.
Slowing down or stopping clinical research has resulted in
both a disruption to care for patients receiving treatment
in affected trials and a delay in the development and
authorisation of the tested treatments for the whole
group of patients. In an open memo to the health indus-
try, the European Patients Forum (EPF), which represents
patient organisations throughout Europe and over 150
million Europeans who are affected by chronic conditions,
advocates for patients to be informed in a timely manner
and supported if clinical trials are changed, suspended, or
terminated. The EPF’s memo also highlights the need for patients to continue receiving treatment if needed. In an open letter to policy makers, EURODIS draws attention
to the fact that there are no effective treatments for most
rare diseases and emphasises the importance of continu-
ing research and clinical trials related to rare diseases,
even during the pandemic. As a way to avoid prematurely
ending non-COVID-19 clinical trials and to keep them
from being put on hold, the clinical research service
provider WIRB-Copernicus Group (WCG) proposes using
independent sites that do not treat COVID-19 patients for
clinical trials (see article on WCG’s website).
Coronavirus vaccine development,
testing, and authorisation
The development, testing, and authorisation of corona-
virus vaccines has occurred at an unprecedented pace.
While there is a great urgency to develop and approve
effective vaccines against the coronavirus, patient
organisations have been advocating for patient safety
to remain the top priority throughout all steps of the
process. In a statement on patient safety as it relates to
coronavirus vaccines, the EPF asserted that “regulatory
‘shortcuts’ must not lead to lowering standards of safety
or efficacy that should remain under the strict control of
EMA [European Medicines Agency]”.
In addition to advocating for patient safety, patient
organisations are calling for transparency in the vaccine
development and authorisation processes in order to
foster the public’s trust in these processes, pharma-
ceutical companies, and the authorities. This trust will
in turn increase the acceptance of approved vaccines.
Together with the EPF, EURODIS successfully encouraged
the EMA to hold public stakeholder meetings on the
development and authorisation of COVID-19 vaccines and
on the approval and roll-out of vaccines. During these
meetings, the EMA provided the public and stakeholders
with information on its processes and collected feedback
from participants. The EMA also adapted its processes for
more transparency.
Many of the patients represented by patient groups are
at higher risk of becoming seriously ill or dying from
COVID-19, so they are some of the first people who are
able to receive coronavirus vaccines. Although these
vaccines have gone through rigorous testing and approval
processes, certain adverse effects may only become clear
when the vaccines have been administered on a large
scale for a longer period of time. In its statement on
patient safety, the EPF calls for “an even greater level
of vigilance and protection of patients’ rights in case
of adverse reactions”. The EPF also asserts that corona-
virus vaccines need to be subject to the same liability
regulations as other vaccines and recommends creating
a mechanism that ensures prompt compensation to
vaccinated people who develop severe adverse reactions.
Conclusion
Throughout the coronavirus pandemic, patient organisations have
made sure patients’ voices and concerns are heard. In addition, they
have drawn attention to the disruption to patient care resulting
from the suspension or termination of research projects during
the pandemic. And while patient organisations have welcomed
the fast development and authorisation of vaccines, they have also
emphasised the need for transparency and a focus on patient safety
in those processes.
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