Clinical trials are expensive. The biggest expense overall is staffing, with patient recruitment a close second. Keeping these costs down is important, and remote monitoring presents an effective means of doing so. There are several added benefits of remote monitoring, one that it provides increased value to patients because it’s easier for them to participate in the trial.
In this post we explore how remote monitoring can be used by clinical researchers to improve clinical trial operations while keeping costs down.
Investigator fees account for around 40-60 percent of the total budget of a clinical trial. Remote monitoring, therefore, is a popular means of lowering this cost, explains Débora S. Araujo, founder of Clinbiz. Remote trials do not require multiple sites, which means fewer investigators are needed.
In addition to requiring fewer investigators, remote monitoring also means patients do not need to visit sites. Reimbursement for travel costs are removed, further impacting the bottom line. But more importantly, remote monitoring helps overcome the persistent problem of patient recruitment and retention.
Many trials fail to recruit suitable numbers of patients. In a study funded by Novartis Pharma, researchers found that between 50 and 60 percent of randomized clinical trials do not meet their original recruitment targets or face significant and costly delays while trying to make up the numbers. They note that patients regard the location of a trial site as very important when determining whether or not they will participate. The farther the site, the less willing patients are to commit.
Remotely monitored clinical trials removes these concerns. The study evaluated different trial settings, with patients enrolled in a site-based (conventional) trial, a mixed model trial, or a remotely monitored (decentralized) trial, using electronic informed consent forms, e-diaries, wearables and remote visits.
In the decentralized arm, 89 percent of enrolled patients completed the study while only 60 percent did so in the conventional part of the study.
Remote monitoring means that more patients will be able to participate in research, and with burdens like onsite visits removed will be more likely to stay enrolled until the study’s completion.
Remote monitoring reduces the patient burden as there are fewer site visits required and those patients with mobility issues, travel concerns and chronic and debilitating illnesses have an increased chance to participate in the research.
For similar reasons, diversity of patient populations can be improved through remote monitoring, writes Sophie Madden at HealthXL. Factors such as race, biological sex genetic makeup, age, disease and location can all be accounted for with the right processes. Madden refers to the fully site-less clinical trial by Science37, with screening and consent completed remotely and a telemedicine app provided for patients to use at their homes.
Through setting parameters to diversify the population, the study achieved a 41 percent cohort of non-Caucasion patients. Indeed, as Madden notes, remote monitoring and tech-based recruitment solutions avoid physicians’ inherent bias when it comes to selecting patients for trials. But remote monitoring also removes the physical barriers to participation.
Done right, remote patient monitoring (RPM) technology can improve study design, enrollment and patient engagement. Patients will also see improved value because of the passive reporting of data that RPM allows, says Vincent Miller, project lead for new technologies at Duke Clinical Research Institute. They will no longer need to remember to document or submit data to researchers. Additionally, research staff will be able to engage with patients in a more effective and timely fashion.
An essential component of remote monitoring is the integrity of patient health information. But it requires clear agreement on which stakeholders are party to the data, writes the team at American Heart Association.
Assuming the best solution is that data be shared among patients’ care teams that include clinicians, laboratories, hospitals, pharmacies and patients, interoperability is essential. Remote patient monitoring needs to be integrated with existing clinical workflow and services, the AHA team says.
One of the main reasons behind the move to remote monitoring is that it is more cost-effective than on-site monitoring. Consequently, regulators have relaxed the demand for 100 percent source data verification (SDV), explains the medical writing team at Quanticate.
Additionally, it’s become clearer over the years that 100 percent SDV does not ensure that all the data-related issues are picked up on.
Remote monitoring steps in, along with risk-based monitoring, to move from 100 percent on-site SDV to remote source document verification through a remote team. The benefits include increased oversight as well as reduced time in data verification from multi-site trials.
Oversight in particular comes about as a CRA will not be able to identify trends and patterns in patient behavior and data at an on-site level in the same way that a remote monitoring team can.
Devices that use machine learning and artificial intelligence technologies are already being employed by healthcare providers to remotely manage patients’ chronic conditions. However, these can also be used to gather data from trials, write Antoniu L. Fantana, Gina M. Cella, Charles T. Benson and Joseph C. Kvedar at Harvard Business Review.
And it’s the frequency of data monitoring that digital technologies bring to clinical trial operations that is so valuable. Data that can be continuously measured in an unobtrusive way is called physiological data continuomics, the researchers explains. The power of continuomics is that clinical trial participants can be monitored without any intrusiveness to their daily regimens. The quality of data is higher and researchers are better able to see how well the treatment is working.
Rather than just reducing the number of on-site staff and improving data gathering, remote monitoring also helps researchers better understand risk. First, however, researchers need to create useful key risk indicators (KRIs), writes EndoCeutics’ Adam Beauregard and Fernand Labrie, and Vadim Tantsyura. Researchers should identify KRIs, which correlate with risk factors, during the risk assessment process.
The role of remote or centralized monitors is to ensure that quantitative data as well as qualitative information gathered from on-site monitors and other key study staff is combined for a holistic view of risk. For instance, KRIs will require acceptable thresholds. When site-specific metrics extend beyond these limits, centralized monitors will analyze the data and find the root cause for that result.
Indeed, the remote monitoring process provides better perspective of the whole so that a comprehensive risk management strategy can be employed.
While there are many reasons to opt for remote monitoring, on-site monitoring remains a valuable process for clinical trial researchers. This is especially so when considering the three main purposes for any trial monitoring, which Dr. Stephanie Patchev at contract research organization GKM lists as protecting patients’ rights, ensuring compliance with the protocol and regulations, and verifying data.
Thinking about monitoring in this way, then, shows how on-site monitoring and the role of the monitor him or herself remains useful for developing relationships between the study and site teams, as well as other stakeholders.
Verifying data is another important role of the monitor. Granted, technological advances have done much for ensuring the integrity of trial data but an on-site monitor fills important gaps born from a wholly remote process, Patchev explains. These include but are not limited to:
Of course, traditional trial processes will remain valuable for many years still. And, in some cases, completely remote or virtual trials won’t be suitable for all patient populations. Nevertheless, remote monitoring can provide significant value to researchers and patients alike through more efficient processes and greater freedom to participate in research.
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