Remote Clinical Studies: The Future of Medical Research

While medical breakthroughs may seem to happen overnight, it can take years of research to develop, refine, and test new drugs, surgical techniques, and medical interventions before they are made available to the general public. A novel, promising discovery in a scientist’s lab may be exciting, but it is just the beginning of the research process. It’s only after positive research findings that researchers may reach the next step, that of conducting a clinical trial or study.

Clinical studies and trials play an essential role in the development of diagnostics and treatment for diseases including cancer. Researchers conduct them to determine whether an intervention or treatment (such as a new cancer drug or diagnostic test) is effective and safe for people.

While patients have typically come to clinical sites to enroll and participate in studies, COVID-19 is pushing researchers to explore the option of harnessing technology to conduct remote studies and trials.

The first randomized clinical trial was completed in 2011 by Pfizer, which recruited and enrolled patients via the web and smartphones and collected data from patients remotely.^[1] Today, ongoing research such as Natera’s BESPOKE colorectal cancer clinical study is being conducted remotely so that patient access to innovative cancer care remains uninterrupted.

Advantages and drawbacks of remote studies

Remote studies and trials can offer numerous benefits over traditional trials, including:

• Lower costs: Remote studies and trials can be less expensive to conduct because they require fewer staff members and may reduce the overall number of sites needed for a multisite trial.
• Greater ease attracting patients: Patients may be more likely to agree to remote studies or trials because they participate from home, without having to visit a trial site.
• Better overall retention: Because it’s easier for patients to participate, patients are more likely to remain in the study or trial. This means more data for researchers from more participants.

There are potential drawbacks to remote studies and trials. Patients may fail to report results, for example, or sensors or other equipment used at home may fail, interfering with data collection. Also, advanced technology isn’t for everybody and might not be adopted in some populations.

Moving to remote settings: Signatera BESPOKE study for colorectal cancer

The Signatera BESPOKE clinical study is examining the impact Signatera can have on treatment decisions for people with cancer. “For example, if a patient with stage III [colorectal cancer] has a negative result with Signatera, based on past studies, a clinician might recommend not as much chemotherapy. Conversely, if a stage II patient receives a positive result, a clinician might recommend chemotherapy,” said Sarah Sawyer, senior clinical trial manager at Natera. Because of COVID-19, the study is now being conducted remotely.

“Currently, clinics are reducing the number of live visits from external companies, and in some cases, study staff are working remotely. . . . Meeting remotely lets us continue to move forward with our study of Signatera and lets us help patients in this climate,” said Sawyer. “When we conduct our site initiation visits and meet with the lead investigators to conduct protocol training and training about other study material, we’re doing that remotely.”

“Once a site is trained on the study, they may approach patients about the study remotely, and if they are interested in contributing to our research, patients also have the option of e-consents,” said Sawyer. “They can talk to the study coordinator by phone to learn more about the study and then sign an e-consent [without having to leave home].”

Because of the COVID-19 crisis, many patients are worried about going to the hospital for their planned follow-up visits with doctors. “We hope to carry over this type of remote clinical study model to future studies. This could be a new way of doing clinical studies,” said Sawyer.

Patients can also opt for mobile phlebotomy and have their blood drawn at home. Conducting the study remotely should also impact patient retention.

“For this study, we are capturing patient-reported outcomes, which involves participants answering questions about their cancer anxiety, their fear or recurrence, and how Signatera helps with treatment decisions,” said Sawyer. “Having the patients report outcomes electronically means patients can contribute to the study remotely.”

As awareness of remote studies and trials grows, it’s likely that more researchers will choose this option. In today’s environment, making clinical studies and trials remote can help ensure that new treatments and drugs will continue to be tested, leading to more options for patients now and in the future.

Read more about the BESPOKE study of ctDNA-guided therapy in colorectal cancer here.

References:

^[1]Benefits and challenges of virtual clinical trials. Clinical Research Society. July 17, 2019. Accessed April 22, 2020. https://www.clinicalresearchsociety.org/benefits-challenges-virtual-clinical-trials/