Adapting clinical trial protocols can help to keep participants enrolled and receiving treatments and assessments.
The integrity of more than 330,000 clinical trials listed on ClinicalTrials.gov remains threatened as the COVID-19 outbreak continues to spread globally. Further, as of March 26, at least 18 biotech or pharma companies have reported a disruption to a clinical trial as a result of this pandemic.
The biopharma industry’s shift in focus on developing vaccines and therapies in response to COVID-19 — along with the burden this crisis is placing on medical centres worldwide — is having the unintended consequence of potentially disrupting clinical trials for other diseases. Yet, keeping these trials on track is essential to bringing much needed treatments and is possible if we look to be innovative in approach.
Minimising the impact of COVID-19 on study timelines starts with identifying instances of predicted delays, and then developing study-specific plans to mitigate risks. Adapting clinical trial protocols to include direct-to-patient support, in-home and alternative site clinical services, and remote monitoring, can all help to keep participants enrolled and receiving treatments and assessments. Other services, such as FIRECREST, can offer pre-recorded investigator meetings and remote site training to ensure compliance.
Challenges facing clinical trials
For ongoing studies, the main concerns amid the COVID-19 pandemic is the safety of patients. Many people enrolled in trials, may be vulnerable to infection, and travelling to sites could be detrimental if exposed to COVID-19. Further, some patients who are receiving treatments require intensive medical assessment, which may prove difficult during the outbreak.
Another risk COVID-19 may pose to clinical trials is an unwillingness on the part of patients to enroll in new trials, patient dropout and noncompliance due to travel restrictions and quarantined areas. According to a study conducted from March 12-13 by Continuum Clinical, 39 percent of US sites surveyed said they believe patients will be much less or somewhat less likely to enroll in new clinical research trials.
Other considerations include increased patient anxiety and hesitancy to visit healthcare facilities, and the contamination risk between patients, sites and the community.
Bringing the trial to the patient
A solution to these challenges includes deploying In-home clinical services to protect the safety of patients and medical staff. In fact, regulatory agencies are supporting incorporating these services into trials. For example, the FDA published a guidance in March 2020 advising sponsors to evaluate alternative methods of patient safety assessments that can be deployed during times when travelling to sites may be restricted.
Deploying healthcare professionals that are trained to carry out a wide range of services and tests in the patient’s home can reduce anxiety, and increase comfort and convenience. In addition, in-home services reduce travel burden, ensuring compliance and data collection. Also, using in-home services can reduce the risk of patient dropout, enhancing retention.
COVID-19 clinical operations
Keeping your clinical trial on track in an evolving environment.
Adapting operations to changing conditions
ICON has adapted its services to support sponsors during this time; offering remote monitoring where on-site visits were not permitted, providing additional support to get IMP to patients and pre-recording investigator meetings because of travel restrictions.
Operationalising services to manage potential risks
Introducing in-home services benefits researchers and patients. To minimise risks to clinical trials, sponsors may need to adapt protocols to for compliance, outcomes measurement and trial recruitment. By working to sustain ongoing trials, millions of people — especially those with chronic conditions, rare diseases and cancer — can reap the benefits of a new therapy once the COVID-19 pandemic ends.
At ICON, our In-Home and Alternative Site Clinical Solutions study teams (through Symphony Clinical Research) are continuing to review how they can support clients and are working with sites and regulatory agencies to reduce the impact of COVID-19.
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