The COVID-19 pandemic changed the way that we people live and work.
Everything went online, from ordering groceries to remote collaboration with coworkers. The vaccines from Pfizer/BioNTech and Moderna have a lot of promise, making a world without COVID-19 seem on the horizon. But the reality is that it will be some time before we reach a point where our lives represent anything like “before.”
For clinical trials, the restrictions of COVID-19 have presented challenges. Unlike other industries that responded rapidly, clinical trials have been slower to adapt.
Trials mostly rely on in-person doctor’s visits and in-person patient monitoring. This means that COVID-19 has resulted in a dramatic slow-down in research. This could have an impact on the medical community for years.
As researchers look at how to move forward, remote patient monitoring can be the solution. Clinical project managers can keep critical parts of the trial moving from anywhere. The result will be a streamlined and accelerated process.
Challenges of Traditional Monitoring for Clinical Trials
The COVID-19 pandemic exacerbated some of the challenges of traditional clinical trials. Participants often spend hours completing doctors’ visits. They must maintain paper diaries about their treatment compliance.
Patient safety became of increasing concern in the COVID-19 pandemic, in a way that it hadn’t been before. With no real way to respond to the concern, many clinical trials were temporarily paused or delayed. This resulted in enormous costs and delays in getting the therapies into the hands of patients.
Some of the disruptions in clinical trials have included:
- Closed clinical trial sites due to COVID-19.
- Patients are unable to reach trial sites due to travel restrictions.
- Economic strain means patients cannot take time off for doctor’s visits.
- Lower recruitment for trial participants from primary care physicians.
- Difficulty in clinical trial patients reporting results.
Some of the challenges existed before COVID-19. Clinical trials have become increasingly complex and rely on a timely exchange of data. There is increasing pressure for real-time oversight.
Large data sets and caseloads cause strain in traditional monitoring. The clinical study could face delays as a result.
Another important consideration is that younger generations are less likely to take part in clinical trials. They may not have a primary care physician who can recruit them. They may also see the trial as “inconvenient” or too much of a burden.
Researchers need to overcome this barrier. Having a representative population is necessary for clinical trials. Some of these challenges will not go away with COVID-19 and will only increase over time.
Benefits of Remote Monitoring for Clinical Trials
Clinical trial sites should be assessing patient access and patient monitoring during the COVID-19 pandemic. However, they should be considering permanent changes in conducting trials. Sponsors can ensure patient safety and have just as much – if not more – visibility into site activities.
The Pfizer COVID-19 vaccine proved that remote monitoring could be successful. Swiftly conducted clinical trials that use innovative technology can see similar results. Trials of the future will have improved speed and accuracy.
Regulators are recommending – and pushing – for remote monitoring. There are significant benefits to digitizing and streamlining the clinical trial process.
More Access to Patients
If clinical trial participants are not limited by geography, primary care providers can recruit them from more locations. Decentralized trials can rely partially or fully on telehealth.
Connected devices, mobile apps, and other technology make patient participation easier. Trials can continue without patients leaving their homes.
Improved Data Quality
The paper documentation for a clinical trial can be substantial. Clinical research associates (CRAs) may be manually reviewing hundreds of files and keying in data. This leaves room for error or inconsistencies in source data verification.
A clinical trial management system (CTMS) can provide a means of automating data collection, monitoring, and reporting. Integrating subject data can reduce errors. Audit trails can show actions taken on different records for integrity and accountability.
While the patient data is part of the equation, the other part is the overall clinical study and its metrics. A CTMS can provide valuable insights such as KPIs, cycle times, and more. A CTMS can also identify trends or bottlenecks that need attention.
By eliminating paper, CRAs can spend less time collecting and organizing paper files. While some research communication has moved to email, this is still mostly decentralized. CRAs may also be tracking attachments and phone calls.
A CTMS will improve collaboration, centralize communication, and create paperless trial management. Workflows, milestones, and activities can all be automated and tracked on a project calendar. Information is more standardized in its collection and reporting.
Clinical trials are expensive overall, and some of the costs are directly related to onsite monitoring. Transportation costs of CRAs alone can be significant. There are also site costs related to office space and computer equipment.
Costs will also go down if CRAs spend less time managing paper and trial data. This can either mean fewer staff needed or speeding up the trial timeline. Time savings and cost savings can mean bringing more therapies to patients more quickly.
Turnover and burnout of CRAs are also a frequent problem with clinical trials. Less dependence on travel and less tedious data entry will reduce turnover. This will add to the cost savings.
Implementing Remote Clinical Trial Monitoring
Remote monitoring can better achieve study goals. It provides value to those contributing to the clinical trial. Teams will be able to respond more quickly to a constantly changing world.
Moving to remote clinical trial management and remote monitoring are necessary. When considering a remote launch, there are some things to consider.
1. Controlled Document Management
Replacing paper files is essential for moving to remote clinical trial monitoring. Study teams can make the transition with tools that allow for secure document collaboration and FDA 21 CFR Part 11 signing. Systems that support FDA compliant eSigning makes monitoring quick, easy, and convenient.
2. Remote Access to Source Documents
A cloud-based platform can allow monitors to remotely access source documentation. Documents can be reviewed in an electronic trial master file (ETMF) and reviewed from anywhere.
Travel restrictions and social distancing are no longer a setback. Trial stakeholders can access the information they need at any time.
3. Remote Collaboration
Web conferencing and video technology make it easier to conduct remote monitoring. Site monitoring and collaboration with site personnel can take place via secure web conferencing. Even site visits can be done remotely with a virtual tour of the facility.
With improved communication, it can be easier to find, locate, and use the collected information.
4. Monitor Protocols and Safety
COVID-19 has been one instance where deviations or procedural changes may have occurred. However, COVID-19 is not the only instance where protocols may have to change due to patient safety or other considerations.
As activities are reviewed, deviations can be agreed upon and documented within a centralized system. Clinical trial protocols and procedures going forward should account for remote monitoring. Observations will become part of the process.
Deviations from SOPs need to be caught and addressed to remain compliant. This also mitigates any risks to patient safety, data integrity, and regulations.
5. Control and Compliance
Having continuous control over documents is critical to management. Fax, email, and shared document systems all have inherent risks. Part of the accountability is determining who should have access to documents, at what time, and for what purpose.
Until now, having 21 CFR Part 11 Compliant eSigning has not been possible. Paper documents have continued to be the main method. Trials already take long enough without the added lag time of paper documents.
Using a platform that meets FDA compliance means speed. Paperless signing and document sharing can happen in seconds, not days.
6. Document Routing
Duplicate work has always been an issue. The site, sponsors, and clinical research organizations are all processing information and data differently.
A CTMS can gather data and securely obtain signatures for documents. It can also serve as secure document storage and complete document routing. Documents can be reviewed and routed based on policies so that they reach the right person for approval.
The Right Tools for Clinical Trial Remote Monitoring
The benefits of remote monitoring are clear. The industry has been primed for changes for years. With support from regulators, the COVID-19 pandemic has forced the adaptation of remote monitoring.
The technology already exists and is ready for adoption and implementation. A clinical trial management system will deliver improved access and efficiency.