Patient Engagement to overcome challenges in clinical development resulting from the COVID-19 outbreak
admedicum Business for Patients organized a series of small roundtables with patient and industry experts. This is an anonymized summary of those conversations in order to help you with your own decision making. With the current challenges in the healthcare system, we believed it important to listen to patients, understand their concerns, and co-create strategies to lessen the impact of challenges imposed by COVID-19.
Issues facing patients and the industry due to COVID-19
Disruptions of regular care routines
Patient representatives taking part in the roundtables shared that their members and friends living with chronic diseases are facing disruptions to regular care routines and scheduled treatments are being canceled or postponed at hospitals.
Delayed or hampered access to care
Patients are having to change treatment formulations or delay the start of new treatment regimens. Patients taking immunosuppressants as part of care for conditions like cancer are in a particularly challenging situation. Not all care can currently be done over telemedicine, for example, how can we do an MRI check tumor growth be done virtually?
One patient representative highlighted a particularly difficult situation facing the auto-inflammatory disease community. An anti-inflammatory medication used by many people living with auto-inflammatory diseases is also being examined as a possible treatment in clinical trials for COVID-19. Patients living in Italy and Spain have already highlighted issues accessing this medication before the treatment has been investigated for COVID-19. Patients currently can not visit hospitals as normal to receive the treatment infusion and worry about access in the future.
Clinical trials suspended or postponed
From large pharma to small biotech, many clinical trials are being suspended and postponed. Patients want and need to have access to treatments that improve their quality of life or in some cases save them. Time matters. A pause in research of at least six months means increased waiting time for patients with high unmet medical needs. Our panelists pointed out that their ATMP clinical trials that may require surgery or extended hospitalization are being canceled in all EU countries.
Fundraising jeopardized or reduced
Researched focused patient charities can’t fundraise in the new pandemic environment of growing unemployment. Even gaining access to peer reviewers and ethical review boards are becoming more challenging and affecting the pace of research. Some research charities are wary that funds that were previously pledged to their clinical programs could be shifted in the future.
People are hesitant to visit the hospital
In some cases, patients view the hospital as unsafe due to their immune system issues and are avoiding going to the hospital even when care may still be available. We can expect that patients may drop out now or even when trials restart due to a reluctance to attend site visits. This may lead to protocol deviations and complications in the biostatistical analysis later in the year.
Need for support to overcome challenges
When clinical trials return to normal in the future, site staff may not have the time to help patients in normal activities like supporting families and arranging transportation to a site. Patients and their loved ones will need more support, their concerns listened to and addressed in a way that demonstrates the value of their role in research.
Prolongation of IRB and regulatory approvals
Regulators have made it clear that changes to clinical trial protocols are possible, but it takes time to get IRB approval, then to implement those procedural changes across global trial sites. By then, the situation in many countries can completely change.
Lack of reliable and valid information
The patient community feeling is not very well informed and mentions a lack of communication from hospitals.
Now that we have reflected on some of the main issues, how can we address these challenges with patient engagement?