What Are Clinical Trials?

Clinical trials are health research studies conducted in a medical setting to aid the development of novel medicine, vaccines, and treatments by gathering important physiological data. Without clinical trials, we would not have over-the-counter pills, antibiotics,¹ or even the COVID-19 vaccine! Because clinical trials help us all achieve an improved quality of life, science needs diverse and inclusive participation to advance healthcare. However, only 10% of the global population participates in research, leaving 90% of the world underrepresented.²

The fear associated with research participation runs deep from historically unethical human research. Fortunately, today, there are laws and regulations in place, as well as rigorous review processes, to ensure that present day clinical trials are conducted ethically, for the benefit of health advancement.

Present day clinical trials are typically run with a dedicated care team at a trial site with close monitoring of the delivery of any medication or use of medical technology, to ensure the participant’s safety. However, to many, traditional clinical trials are invasive to their day-to-day lifestyle which present barriers to participation, such as:

• Geographical restrictions: Traditional clinical trials are geographically restricted; you must be in the local area or be able to travel to a trial site to participate. Travelling became more difficult than ever because of COVID-19 restrictions preventing people from going to trial sites and public transport became more difficult to access. Even without COVID, travelling can be difficult for people with certain conditions, making travel a barrier to participation.
• Fear of labs & the unknown: Despite better information sharing and transparency between researchers and participants about the requirements for clinical trials, there is room for improvement to help participants feel comfortable. Going into a lab remains intimidating and uncomfortable.
• Time commitment: Scheduling time in our busy lives when we have so many other responsibilities can seem like a hassle for anyone. In particular, for those with illnesses, scheduling time for clinical participation can be a barrier for the entire family as multiple people may need to make time in their schedules to go to appointments and follow-ups at a trial site.

And challenges don’t just exist for participants, but also for researchers for scheduling and quality data collection. For the same reasons that it makes it hard for participants to attend research sessions, researchers often struggle to agree on times with participants. Moreover, data that is collected in a lab setting at a trial site might be different from a real world setting and limit our knowledge of how the test product is used in an uncontrolled, everyday environment.

Limitations and challenges of in-person clinical trials mean that there is a smaller population of people who are willing to participate, which delays recruitment and results in non-representative data.

One way that researchers are combating these challenges and making clinical trials more convenient for participants is to opt for decentralized clinical trials.

What Are Decentralized Trials?

Decentralized clinical trials make it easier for you to participate in health research remotely by eliminating the need to go into a physical location.³ Ultimately, decentralized trials bring research participation closer to your home by removing the transportation burden, and make clinical trials less intimidating and less time consuming.

It’s easy to see why decentralized trials are becoming an increasingly popular topic; just look at some of the advantages that decentralized trials provide:

• Eliminates the need to go into a physical location, participants can conduct the trial from home
• No intimidation of a lab setting, complete the trial with the support of your family members
• Removes the burden of taking time out of your day for travel, you can simply participate from home
• Removes the controlled lab setting, making real-world data collection possible from your natural, comfortable environment

Researchers are incorporating technology and protocol changes to slowly achieve fully decentralized trials.

However, even though there are some big advantages to trial decentralization, there are still major concerns that need to be addressed. Some disadvantages of decentralized trials are:

• Difficulty accessing medical care teams in a remote setting. Decentralized trials will use methods such as video calls to provide a care team, however, it is more difficult to provide the same monitoring as traditional clinical trials.
• Inability to collect certain data that is normally collected at a clinical trial site, for example, blood samples.
• Difficulties assessing if patients are following study protocols effectively.
• If a study uses technology (e.g. sensors, monitoring devices), challenges include providing technology that participants know how to use, providing technical support, and providing technology that isn't ineffective or outdated.

Even though technology can have its drawbacks, technological advancements have a huge role to play in supporting decentralized trial processes because they can help researchers collect data remotely and give you increased access to participate in research. Take a look at some of the tech-enabled strategies that are making decentralized clinical trials easier than ever for you!

Tech-Enabled Strategies to Support Trial Decentralization

Providing Monitoring Devices to Collect Participant Data from Home

Providing medical devices such as wrist watches, skin patches, oximeters, and clothing with embedded sensors, to research participants allows researchers to monitor participants from home and lets participants integrate the trial more comfortably into their lives.⁴

This model is great because it removes time and travel burdens for you and also gives researchers valuable data for their studies. We have even seen this strategy being used!

For example, Pfizer was able to monitor patients’ eczema-related scratching at night by providing them a wearable motion tracker.⁵ Eczema patients can experience intense itching, which may flare up at night.⁵ By providing the wearable motion tracker, Pfizer is tracking patients’ conditions from the comfort of their own homes.⁵  

Another technological advancement that can help researchers monitor participants remotely is continuous glucose monitoring technology. This is the first technology that can track blood glucose trends 24/7.⁶ This technology could be used to track blood sugar levels for diabetic and non-diabetic patients that participate in clinical trials from their homes⁶ without needing to draw blood for testing blood sugar levels, making participation easier for you!

Providing Smart Devices to Observe Vitals Over Time

Smart devices like fitness trackers are widespread and can provide a large range of data like step counts, calories burned, heart rate and sleep activity.⁷ It can allow users and researchers alike to observe vital measurements over time with ease.

This technology has proven to be helpful in clinical trials. For example, one recent study found that fitness trackers can be a valuable tool for assessing the daily functioning and quality of life of cancer patients.⁷ This is a huge development because one big challenge in treating cancer patients is getting up-to-date and accurate data about their health, according to Andrew Hendifa, MD and medical director for pancreatic cancer at the Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute.⁷

Another type of smart device is an ingestible sensor (ingestibles). Ingestible sensors are smart devices that consist of a pill, a sensor patch and a software that helps track whether an individual has taken their pill.⁸

One example of an ingestible consists of a pill that has a one-square-millimetre sensor; when you take the pill, it transmits a signal to a patch worn on the stomach and sends the data to a smartphone using Bluetooth technology.⁹ Ingestibles could be a strategy to track medication use in clinical trial populations, making research more comfortable in its setting.¹⁰

Challenges of Tech-Enabled Decentralized Trials

Even though technology enables improved real-world data collection for clinical trials and removes some challenges presented by decentralized clinical trials, there are still limitations, such as:

• Ethical & privacy concerns: While there exist implications for data sharing, consent, and data processing,⁴ our data is still being collected everyday by social media companies and search engines for free; why not consider earning rewards and contributing anonymous data to a good cause? Clinical trials go through rigorous approvals for their studies to ensure that your data won’t be abused, which diminishes some of the concerns around ethics and privacy. Additionally, your individual data from clinical trials is never used on its own; it is anonymized and aggregated with other clinical trial data as part of the study average.
• Reliability of data: Not all devices are made equal. There are medical-grade devices that can be used to support clinical trials but if consumer-grade devices, like many smart devices, are also being used, more research is needed to prove the reliability and validity of the data they collect.¹¹ Additionally, devices vary in their level of complexity; a participant must be properly trained to use a monitoring device at home so that the data captured is reliable. Monitoring devices should be discussed in the clinical trial protocol as this will help prevent confusion with how the devices are to be used.¹²
• Cost of Technology: Consumer-grade monitoring devices, such as smartwatches, are quite expensive. It is important to consider whether a participant needs to own a device before they join a study; if this is the case, the participant pool will be restricted to those who own the required technology and may be biased towards a higher socio-economic class. Although budgets may not always allow researchers who can provide devices for the study would massively increase sample size and widen data inclusion.
• Providing monitoring devices & maintenance: If the device is provided to participants, how will they know how to use it, and what happens if it breaks down or the battery continually dies? The cost of shipping devices to participants, making sure that they are being used and functioning properly are all factors to be considered. However, it may come at a bonus of saving on other resources that would typically be used in person.
• Quality of technology: Technology is improving every day but these advancements are still not at the level needed for completely decentralized trials. Data collection tools and technology at trial sites are used by trained medical staff; how can we achieve the same accuracy with portable technology on people who may not have any experience using it? For example, medical staff know the correct protocol for using an oximeter, but a participant may need to be trained to properly measure oxygen saturation levels to capture accurate data. As technology improves, our ability to capture accurate health data in a remote setting may become more accurate and convenient, changing how health research data is collected to create optionality for trial design.

Technology is helping healthcare become more effective and convenient for people everyday and will play a huge role in the future for decentralized trials. In the spirit of capturing data more comfortably, check out this study which incorporates decentralized trial aspects!

Honeybee

Connects the community with research. Honeybee is a web and mobile app to participate in research, discover yourself, and earn cash and rewards.

References

1.         Clinical Trials: A Winning Step Toward Medical Breakthroughs. Accessed July 9, 2021. https://www.clinicalleader.com/doc/clinical-trials-a-winning-step-toward-medical-breakthroughs-0001

2.         EDITORS T. Clinical Trials Have Far Too Little Racial and Ethnic Diversity. Scientific American. doi:10.1038/scientificamerican0918-10

3.         Decentralized clinical trials need collaboration to achieve wider use. STAT. Published January 29, 2021. Accessed July 9, 2021. https://www.statnews.com/2021/01/29/decentralized-clinical-trials-more-collaboration-needed-to-expand/

4.         Izmailova ES, Wagner JA, Perakslis ED. Wearable Devices in Clinical Trials: Hype and Hypothesis. Clin Pharmacol Ther. 2018;104(1):42-52. doi:10.1002/cpt.966

5.         How Pfizer Is Using Wearables To Understand The Patient Experience. Accessed July 9, 2021. https://www.clinicalleader.com/doc/how-pfizer-is-using-wearables-to-understand-the-patient-experience-0001

6.         Schnell O, Barnard K, Bergenstal R, et al. Role of Continuous Glucose Monitoring in Clinical Trials: Recommendations on Reporting. Diabetes Technol Ther. 2017;19(7):391-399. doi:10.1089/dia.2017.0054

7.         Fitness trackers prove helpful in monitoring cancer patients: Study shows wearable devices can help assess quality of life and daily functioning during treatment. ScienceDaily. Accessed July 9, 2021. https://www.sciencedaily.com/releases/2018/07/180724174304.htm

8.         Ingestible Sensors Market: Rising awareness among the general population is expected to drive the market. BioSpace. Accessed July 9, 2021. https://www.biospace.com/article/ingestible-sensors-market-rising-awareness-among-the-general-population-is-expected-to-drive-the-market/

9.         September 26, 2014. How ingestible sensors and smart pills will revolutionize healthcare - MaRS. MaRS Discovery District. Accessed July 9, 2021. https://www.marsdd.com/news/ingestibles-smart-pills-revolutionize-healthcare/

10.       A Review Of Digital Technologies Used In Decentralized Clinical Trials. PRA Health Sciences. Accessed July 9, 2021. https://prahs.com/insights/a-review-of-digital-technologies-used-in-decentralized-clinical-trials

11.       Wearable technologies for active living and rehabilitation: Current research challenges and future opportunities - Mary M Rodgers, Gad Alon, Vinay M Pai, Richard S Conroy, 2019. Accessed July 9, 2021. https://journals.sagepub.com/doi/full/10.1177/2055668319839607

12.       Clinical Trial Protocol Development. Clinical Research Resource HUB. Accessed July 9, 2021. https://hub.ucsf.edu/protocol-development