Executive Director of Digital Strategy, Elligo Health Research

Raj Sharma

According to a 2021 Pharma Intelligence survey, only 5% of Americans consent to participate in clinical research. But 81% of survey respondents who had never participated in a clinical trial indicated they would be likely to participate should the right situation arise.

These statistics indicate the current clinical research paradigm is not ideal for maximum patient participation. What are we doing wrong? How can we increase patient participation in clinical trials?

Financial and logistical barriers significantly contribute to low clinical research participation.

 Patients often have high out-of-pocket medical expenditures related to their condition and usually face high out-of-pocket costs when participating in a trial.

 For example, many studies create additional participation costs by requiring testing not covered by insurance and travel to and from specific study sites for procedures and other protocol-related tasks.

 One analysis of a cancer study revealed 99% of patients were covered by insurance, but more than 30% still reported financial concerns surrounding participation.

 When existing expenses related to their condition are combined with additional spending related to trial participation, the cost simply becomes too great for many patients.

Decentralized clinical research promises to alleviate a portion of these patient burdens and provide broader geographic access to increase overall trial participation; however, decentralized or site-less trials pose participation barriers. In decentralized designs, the first touchpoint with patients is often virtual, which leads to challenges in managing and owning the participant’s experience. Patients may face challenges and require technical support when using decentralized clinical trial technologies.

One participant in a COVID-19 vaccine recently publicly commented, “The trial’s [e-diary] has been such a hassle to deal with. The site couldn’t figure out how to get it to log in, IT couldn’t help, the vendor couldn’t even get it to function! We ended up having to email in the responses daily. We also received calls from the [clinical research coordinator] daily with new troubleshooting steps, which never worked.”

Those who suffer from cognitive decline and those with vision issues may require additional assistance. Patients having to navigate complex platforms or unfamiliar technology to complete trial protocols are less likely to participate. Barriers also include communication, such as language differences, low literacy, and mistrust. More than 30% of the US population has basic or below basic health literacy. This number is likely higher in clinical research, as many studies and their related information are complex.

 If patients do not fully understand the how and the why of a trial, they will be less inclined to participate.

The NIH states the principal challenges of clinical trial recruitment remain, “the lack of awareness and education about clinical trials, availability, and how to participate.”

 Our historical engagement models have fallen short of meeting the needs of individuals interested in clinical research. The common barriers to trial participation are significant. When patients consider enrolling in a study, they weigh the cost- versus-benefit ratio of participation. The substantial costs often win out because there isn’t enough engagement to personally connect individuals with the benefits of participation.

This lack of patient engagement spells disaster for studies: 80% of clinical trials experience setbacks because of enrollment challenges, leading to $600,000 to $8 million in lost revenue every day a pharmaceutical drug or medical device is delayed to market.

 Insufficient patient engagement and the resulting enrollment issues also lead to problems with site coordination and start-up. Like patients, sites need to be ready to go for the start of a trial. However, if there are no patients, the sites sit empty after activation, wasting time, effort, and even more money.

Research from the NIH suggests indifferent or negative attitudes toward participation can improve through education and discussion.

 Therefore, increased education and discussion can potentially lead to higher participation levels. Virtual waiting rooms provide a unique opportunity to do just that.

A virtual waiting room is a virtual location where patients who have expressed interest in clinical research can learn more about clinical studies, manage their enrollment activities, and speak with patient concierge specialists. But, despite the name, virtual waiting rooms do not involve much waiting; patients can express interest in research or specific therapeutic areas of interest independently of site activation or protocol optimization timelines. They combine the function of a patient database with education and engagement, offering participants background information on studies, essential details about participation, and updates leading up to the trial launch. Virtual waiting rooms provide more time for patients to ask questions like “How do clinical trials work?” or “How do you protect my data?” The virtual rooms also enable two-way engagement to explain to interested individuals how best to find a study or answer questions for caretakers.

Virtual waiting rooms have several structural functions that meet the tenets of patient engagement. First, they offer multichannel communication modalities, including phone calls, chat, and email. Multichannel engagement allows patients to receive health information through a communication channel of their preference, thereby increasing the exchange of health information and the accessibility of clinical research. Secondly, they enable patients to intake from various sources into one convenient database, ensuring they are not lost but are converted from interested to engaged. Finally, virtual waiting rooms allow patients to connect with a human to get their questions answered and obtain desired additional information, further boosting engagement.

The most innovative virtual waiting rooms use advanced data-science tools to identify patients through electronic health record (EHR) data. The identified patient’s treating physician contacts them about trial participation, and the patient can express interest and enter the waiting room. There is considerable evidence that clinician recommendations play an important role in helping patients consider clinical trial participation; such engagement can increase the likelihood that patients enrolled in the virtual waiting room will agree to research participation.

For patients, joining a virtual waiting room is as simple as ordering from their favorite local restaurant. Patients text a keyword to a phone number, click a link, or scan a QR code with a mobile device. They are then introduced to the waiting room through an AI-driven virtual assistant, like Elligo’s RootSM or another digital companion. Patients can text questions to the digital assistant about upcoming trials in various therapeutic areas and even receive study enrollment support when the inclusion-exclusion criteria are finalized. If the patient has any issues, they can ask their digital assistant to schedule an appointment with a patient concierge specialist at their convenience.

The virtual waiting room is an effective mechanism for supporting patients from the point of study awareness to consent.

For example, without the virtual waiting room, a patient interested in participating in urinary tract infection (UTI) research would have to search the internet to find a potential study, fill out a lengthy questionnaire, and then wait days or weeks for a call from the site. Once the patient gets a call, the site coordinator asks them additional questions and uncovers that the patient is not qualified for the study because they have not had an acute symptom within 48 hours of study activation. This experience can leave the patient disappointed, frustrated, and perhaps less likely to participate in clinical research in the future.

But with the virtual waiting room, the patient can have a much better experience. Because the patient is already in the waiting room, they can quickly and easily find an appealing UTI study. The patient can scan the study QR code with their smartphone and answer short, carefully written questions designed to reduce dropout and save time. While waiting for the study to start, the patient can read educational materials, ask the concierge questions, and generally feel prepared for participation. Once the study is live, the patient can use the virtual waiting room to inform the site when an acute symptom arises, meeting their enrollment timeline, allowing for participation, and improving the overall study experience.

Virtual waiting rooms also allow patients to become fully educated on the research process. An Antidote Technologies survey found 77% of respondents want the clinical research industry to make it easier to find, learn about, and understand trials, a desire that virtual waiting rooms can efficiently fulfill.

 Virtual waiting rooms offer actionable, regionalized materials at the proper reading level for each patient’s consumption. They provide opportunities for patients to ask questions and engage in clinical
research and their therapeutic areas of interest, helping them become enthusiastic trial participants.

The virtual waiting room helps sponsors efficiently complete clinical enrollment by increasing referral to randomization rates and reducing the cost per randomization as well as overall study spending. They also provide one virtual location for referrals from all partners and ensure no individual is lost in their clinical study journey. Because patients can access virtual waiting rooms from anywhere, they expand sites’ geographical reach and allow for more diversity and trial-participation access.

The prioritization of the patient experience through the virtual waiting room can also diminish site burden and infrastructure, identification, and enrollment costs. Virtual waiting rooms boost site enrollment capacity and support coordinated efforts throughout the enrollment, further streamlining the study and reducing spending. Because waiting rooms allow patients to become fully educated on the research process and further evaluated on likely screen-fail issues, they also improve patients’ likelihood of randomization and retention throughout the trial.

Most importantly, virtual waiting rooms offer early patient engagement to educate and retain patients. The earlier and more comprehensive engagement is, the earlier patients can ask questions about the study, understand what to expect from the protocol, a then make a cost-vs.-benefit decision of participation.

Elligo Health Research provides a virtual waiting room model and is currently running a study to demonstrate that patients presenting to the screening visit and consenting process after spending time in the virtual waiting room are more likely to agree to the research requirements and to adhere to the protocol procedures and timeline. While the study is not yet complete, the early results hold promise that virtual waiting rooms are a solution to patient engagement and, therefore, research participation.

, Executive Director of Digital Strategy, Elligo Health Research

Pharma Intelligence. Patient Perspectives on Clinical Trial Participation Report. Accessed through: Informa Business Intelligence. Patients Rate their Clinical Trial Experience Positively, but Trial Locations Still Pose Barriers to Enrollment. Accessed April 11.2022.

Zafar SY, Peppercorn JM, Schrag D, et al. The financial toxicity of cancer treatment: a pilot study assessing out-of-pocket expenses and the insured cancer patient’s experience. 

 2013;18:381-390. Accessed March 28, 2022.

Narang AK, Nicholas LH. Out-of-pocket spending and financial burden among Medicare beneficiaries with cancer. 

. 2016;3:757-765. Google Scholar. Accessed March 28, 2022.

Nipp RD, Powell E, Chabner B, Moy B. Recognizing the financial burden of cancer patients in clinical trials. 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4571792/

Stump TK, Eghan N, Engleston BL, Hamilton O, Pirollo M, Schwartz JS, Armstrong K, Beck JR, Meropol NJ, Wong Y-N. Cost concerns of patients with cancer. 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3770507/

Van Norman GA. Decentralized Clinical Trials: The Future of Medical Product Development? 

. 2021;6(4):384-387. Published April 27, 2021. Accessed April 14, 2022.

Crane Cutilli C, and Bennett IM. 2010. Understanding the health literacy of America: Results of the National Assessment of Adult Literacy. Orthopaedic Nursing 28(1):27-34. 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2668931

National Institutes of Health. NIH Clinical Research Trials and You – Opportunities for Education and Awareness. 

https://www.nih.gov/health-information/nih-clinical-research-trials-you/opportunities-education-awareness

Desai M. Recruitment and retention of participants in clinical studies: Critical issues and challenges. 

. 2020;11(2):51-53. Accessed April 15, 2022.

Hargreaves B. Clinical Trials and Their Patients: The rising costs and how to stem the loss. 

http://www.pharmafile.com/news/511225/clinical-trials-and-their-patients-rising-costs-and-how-stem-loss

Clark LT, Watkins L, Piña IL, et al. Increasing diversity in clinical trials: overcoming critical barriers. 

 2019;44:148-172. Accessed April 7, 2022.

Antidote Technologies, SCORR Marketing. 2018. 

https://www.antidote.me/blog/what-role-does-health-literacy-play-in-clinical-trial-participation#:~:text=In%20addition%20to%20health%2Drelated,to%20participate%20in%20clinical%20trials

Articles

Exploring their unique opportunity in increasing study enrollment levels.

Raj Sharma

Articles

A Primer on Clinical Trial Virtual Waiting Rooms