From The Editor | January 7, 2021

Pandemic Accelerates The Evolution Of Clinical Trials

Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical

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How much has the COVID-19 pandemic accelerated the evolution of clinical trials? A new report from Oracle Health Sciences and Informa Pharma Intelligence attempts to answer that question. The companies surveyed 252 professionals around the world who are involved in clinical trials at biopharmaceutical and med device companies as well as CROs. The goal was to determine how the pandemic was changing clinical trial operations and identify the key challenges and opportunities surrounding those changes.

It should come as no surprise to anyone in the industry that the pandemic forced innovation upon sponsor companies. Leading the way was decentralized trials. Some drug developers spent a good portion of the year trying to incorporate virtual technologies into their trials. What was once a vision of the future of clinical trials suddenly became a reality.

The pandemic, along with new guidance from the FDA, resulted in large numbers of companies opting to adopt remote approaches. The survey found that 76 percent of respondents noted at least some of their trials are decentralized, while 38 percent of respondents noted more than half of their trials were decentralized.

The Impact of COVID-19

Survey respondents were asked how the pandemic was impacting their ongoing trials. The top three responses were longer enrollment times (49 percent), amended protocols (45 percent), and paused protocols (41 percent). Other notable impacts were amendments to how data is collected, patient retention issues due to fear and lockdowns, increased deviations to data not collected per protocols, and delayed IRB reviews. All were noted by more than 25 percent of professionals surveyed.

As COVID was impacting trials, it was also impacting strategies for running clinical trials. The biggest strategy change involved virtual trials. The survey found 46 percent of respondents were implementing or planning to implement decentralized trials. New clinical supply, logistics, and administration vendors were being considered by 44 percent of respondents, while another 36 percent were considering new geographies for trial location. Seventy-six percent noted they are accelerating their adoption of decentralized trial methods.

There are many steps involved with a move to decentralized clinical trials. The most common step being taken by companies is the adoption of patient-facing technologies or alternatives, which was cited by 64 percent of respondents. That was followed by protocol redesign (63 percent), adoption of investigator-facing technologies or alternatives (53 percent) and rewriting of standard operating procedures (SOPs) (48 percent).

Virtual Trials Create Challenges

The move to decentralized trials, while easing the burden on patients and investigators, will also create operational issues for companies. Respondents noted ensuring compliance (56 percent), effectively tracking data (44 percent) and the ability to integrate new technologies with other platforms (40 percent) as the factors most likely to impact their technology requirements and current environment. But there are other challenges companies will face.

When adopting decentralized trials, patient engagement was cited as the main challenge that would be faced. It was noted by 59 percent of survey respondents. That was followed by ensuring data reliability and quality (50 percent), data collection (45 percent), and comparative lack of regulatory guidance (33 percent). Another 33 percent cited comfort level and ease of use by patients.

Remote data collection goes hand-in-hand with decentralized trials. The majority of respondents, 67 percent, noted they have already implemented remote data collection or are planning to do so. The means of implementing remote data collection varies, with 57 percent noting they are using patient apps, 49 percent citing ePRO, 45 percent using wearables/devices, and others mentioning monitors and mHealth. Twenty-four percent say they are already using wearable and remote monitoring technologies. Another 13 percent plan to do so in the next 6 months.

The Benefits Of Remote Monitoring

Of course, the main reason for implementing wearable and remote monitoring technologies is the benefits they bring to a trial. The main benefit seems to be convenience for the patient, which was cited by 64 percent of the survey respondents. That was followed by real-time data and insights (52 percent), time and resource savings for site staff (45 percent), convenience for site staff (30 percent), and time/resource savings for sponsors (28 percent).

Respondents also noted disadvantages of wearables and remote monitoring, with approaches to reviewing/managing/interpreting data, cost, and regulatory considerations all being mentioned by more than 40 percent of respondents.

The primary concern around remote data collection is the quality of data, followed by data protection/privacy, lack of standardization in data, and lack of harmonization of data.

While COVID has accelerated the adoption of decentralized trials, concerns about the model still exist. Forty-two percent of respondents still cite regulatory concerns as a reason why the adoption of decentralized trials has not accelerated in their organizations. Approximately half of all respondents (48 percent) do not believe current regulatory guidance surrounding decentralized trials and data collection is clear. Other concerns include rewriting SOPs, protocol redesign, logistical issues, and a lack of consistent leadership alignment.

The entire research report, titled The Accelerated Evolution of Clinical Trials in a Pandemic Environment, can be accessed here.