Remote environments often create logistical challenges for trial developers. How can researchers ensure the data collected is accurate? How can they know if patients followed directions in administration and reporting? Alongside these questions, there are security concerns. Clinical research organizations (CROs) and sponsors need to protect the privacy of their patients and prevent their organizations from being hacked by cybercriminals.
Here are some of the challenges facing CROs and sponsors as they work with patients in remote trial environments.
The main concern that researchers are working on is the use of new technology in a remote environment. Trial developers increasingly need to add patient technology training to their research timelines to ensure the devices are used correctly. While many patients have smartphones and can log data on an iPad, there are some tools that aren’t familiar to them.
According to a survey of 93 readers of Clinical Trials Arena, a Verdict network site, only 28 percent of respondents knew that telemedicine is currently used in clinical trial development. Additionally, respondents weren’t very familiar with wearable devices, digital biomarkers or biosensors.
Not only are researchers concerned about accurate medical information and reporting, but they also need to know that patients are receiving their trial medication and taking it correctly. Andrea Zobel, senior director of personalized supply chain at World Courier, says only five percent of drugs were shipped directly to patients before the COVID-19 pandemic. This number increased dramatically as trial leaders switched to decentralized operations. Zobel estimates that direct-to-patient shipments have increased fourfold as a result of the pandemic.
While the use of technology and direct-to-patient medication come with risks, there are potential benefits to moving trials to a remote environment.
Remote trials can have significant positive effects on the budgets and scalability of clinical trials. As an example, Cynthia Matossian, an ophthalmologist in Pennsylvania who regularly conducts dry eye disease trials, recently started trials with five groups using remote patient monitoring. This format means patients no longer have to travel to the clinic and can complete observation forms online. This saves time and money for both patients and sponsors.
The rise of remote trial environments is driving more researchers to reconsider patient privacy rules. Patients need access to their medical records and deserve to become advocates for their treatment. At present, this is difficult with the current medical privacy guidelines.
“A more nuanced approach to privacy may be needed after the pandemic to support telehealth expansion,” writes Carmel Shachar, executive director of the Petrie-Flom Center at Harvard Law School, along with Jaclyn Engel and Glyn Elwyn at the Dartmouth Institute for Health Policy and Clinical Practice. “Privacy concerns should not interfere with the actual need of patients to receive care on a timely basis. HIPAA regulations may need to be revisited, so patients could be given the responsibility and ability to share their health information with clinicians who require that information.”
The Department for Health and Human Services (HHS) is already looking to adjust HIPAA laws in 2021 and recently closed a comment period on their revised guidelines in May 2021. These efforts all point to the same goal: how trial leaders can protect patients without blocking them from valuable access and information about their care.
Even if researchers develop clinical trials with simple technology and clear privacy guidelines, both parties still face significant risks in the form of cyberattacks. The COVID-19 pandemic has driven cybercriminals to go after healthcare providers and organizations that work with sensitive patient information.
“Suffering a data breach can cost a company $3.8 million per incident,” writes Daniel S. Brettler, SVP and life science practice leader at Conner Strong & Buckelew. Even with a robust response plan, a research organization would have to pay significant sums. “This, however, does not capture the reputational damage that can result from being associated with a cyber event.”
When a company is in the news for a cyberattack, its reputation can be stained for several years. Unfortunately, these attacks are often out of the company’s control, even if they use the best digital security tools.
“Apart from clinical trials, ransomware gangs have targeted other healthcare providers with devastating effects,” reports Alicia Hope, staff writer at CPO Magazine. Ventilator manufacturers, health service providers, and individual hospitals have all fallen victim to cybercriminals looking to make money or disrupt the development of medical resources.
Even the United Nations isn’t safe from cybercriminals. In March 2020, the World Health Organization (WHO) announced that it had noticed a significant uptick in attack attempts because of its efforts to fight the COVID-19 pandemic.
“There has been a big increase in targeting of the WHO and other cybersecurity incidents,” says Flavio Aggio, chief information security officer at the WHO. “There are no hard numbers, but such compromise attempts against us and the use of [WHO] impersonations to target others have more than doubled.”
Moving to a digital clinical trial environment means cybercriminals have more touchpoints to hack and to gain access to an organization’s data or funds.
While the challenges facing companies developing remote trials might seem overwhelming, it is only because these systems are mostly brand new. Many organizations embraced remote trials less than a year ago at the start of the pandemic. They are just now switching from a reactionary stance to a proactive planning environment.
“While I think FDA was terrific and speedily tried to provide some guidance that would be helpful to sponsors who were dealing with this change, there’s still some lack of clarity...particularly around the data collection efforts,” says Richard Moscicki, chief medical officer at the Pharmaceutical Research and Manufacturers of America (PRMA).
While the FDA continues to improve its guidelines on remote trials, speed bumps are natural. However, the potential benefits of this trial option significantly outweigh any risks and questions facing researchers.
“Increasing [remote patient monitoring] uptake will also drive a surge in other emerging industry trends such as patient empowerment, telemedicine, electronic health records, real-world evidence and decentralized clinical trials,” says Urte Jakimaviciute, senior director of market research at GlobalData Healthcare. “The accelerated expansion of these trends will be further sustained by increasing technological advancements, the need to improve healthcare access in rural areas, the increasing aging population, and growing burden of chronic diseases.”
Leaders in the clinical research field are continually working to address concerns about cybersecurity, patient privacy, and remote trials. In fact, they are speeding up their work as more researchers rush to embrace remote monitoring in the wake of the pandemic.
“These are very difficult issues, but it is our role to question the system and to ensure not only that it works well, but also that physicians and all healthcare providers are well informed about the regulations to ensure state-of-the art treatment and care of their patients,” says Hein Heidbuchel, professor and past president of the European Heart Rhythm Association.
CROs, sponsors and trial developers need to focus on patient privacy and security throughout the testing process. Not only will this help their organizations stay safe from cybercriminals, but these careful considerations will create better patient experiences and build trust with trial participants.
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