clinical trials

The anatomy of a decentralized clinical trial

by Jayneel Patel

It goes without saying that the in-person option for clinical trials scheduled during the past two years offered everything but, well, the people. 

But if the pharma industry relied on technology to build a new way to connect with trial participants, would they come? More importantly, would the collected data be valid despite the lack of in-person testing sites? 

To illustrate how technology can sustain the integrity of pharma research, let’s consider the transformation of clinical trials in response to the pandemic. 

In 2021, there were around 362,511 global registered studies. By the beginning of 2022, over 5,000 additional clinical trials were added to the total number of registered studies. 

“As health-system resources became consumed by COVID-19-related care and travel became limited by physical distancing, patients’ access to trial sites was reduced by 80 percent,” reported researchers at McKinsey and Company. “The number of monthly trial starts declined 50 percent from January 2020 to April 2020, and 60 percent of investigators reported a significant reduction in trial activities in May 2020.”

Historically, it hasn’t been easy for researchers to build a diverse population segment. Experts estimate that a lack of enrollment delays about 80 percent of clinical trials, and out of those who participate, around 70 percent live more than two hours from proposed trial sites. 

With persistent challenges (some occurring pre-COVID) facing in-person testing sites, some pharma companies started using a virtual or hybrid model to gather data from trial participants. 

“To meet patient needs, new digital features like online enrollment, electronic consent, and more made their way into the mix,” explained Jennifer Turcotte, Director, Global Life Sciences Industry at Salesforce. “These pivots proved the viability of remote options.”

 

Two challenges facing pharma research

The two main components that pose a challenge for clinical trials are accessing a sizeable test group of a targeted population and maintaining the integrity of collected data. 

The human aspect is essential.  And now that numerous trials are conducted virtually, how can pharma companies connect with people when they’re not coming into the testing sites?

 

Salesforce Health Cloud offers a solution

The virtual clinical trial model allows for testing kits to be sent directly to trial participants, for instance. Under the direction of the trial coordinator, the data is collected cohesively. 

Health Cloud has played a role in collecting that data virtually through the member portal that collects and organizes patient data based on the clinical trial purposes. 

Through thresholds defined within Health Cloud, trial coordinators can monitor and see how the patient has been feeling as part of a clinical trial. The thresholds also trigger the next steps or the best actions for the clinical trial coordinator on what to do if somebody were to feel a certain way. 

An emerging challenge with traditional trial practices is to ensure your population is truly diversified, so you’re not just testing the drug on certain types of people, but you’re testing the drug on all people who are likely to use use it. So you want to get a proper sample size of the demographic that really represents the population that is designed to consume the drug. To reach desired population segments, Salesforce Marketing Cloud can help customize those populations.  

 

Marketing Cloud adds value to the trial population

The first benefit is using technology that decentralizes trial access to reach a larger number and potentially a more diverse pool of patients. Then, segmentation and targeting help make sure that researchers have an accurate sample size of the true demographic that represents the population to run a clinical trial that is genuine, complete, and accurate.

Decentralization can also reduce the workload for trial coordinators since traditional site activities (such as drug administration, test assessments, and verifying data) are performed remotely by others or by trial participants themselves. And that self-reporting option creates an additional advantage: real-time data. 

 

Real-time data

Ranging from wrist straps to jackets, “wearables” are electronic devices that track, analyze, and transmit personal information. In 2020, wearable technology was used in almost 500 studies. But as wearable technology improves, experts predict that wearable technology will appear in nearly 50 percent of clinical trials by 2025. 

Unlike other self-reporting trial kits, wearable devices can connect to Salesforce Health Cloud. This means participants don’t even have to report the outcome. Instead, test results are automatically reported and submitted into Health Cloud to trigger the next steps

The face of the clinical trial is changing. As decentralization opens up new opportunities for pharmaceutical research, Salesforce Health Cloud and Marketing Cloud ensure those new connections are accessible to a broader audience, accurate in data collection and analysis, and aligned with the research goals of the pharmaceutical industry. 

To learn more about ways Salesforce Health Cloud can transform your clinical trial research, let’s talk. 

 

Jayneel PatelJayneel is VP, Healthcare & Life Sciences, here at Simplus. With a Ph.D. in engineering and MBA from Duke and over 15 years of experience, Jayneel designs and delivers empathy-driven innovative solutions in healthcare. He has developed digital strategies to reduce risk, increase visibility, and improve patient and member satisfaction. His passion is to enable better care through technology.

[email protected]

 

 

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