What Is The Participant Enrollment Journey?

The Participant Enrollment Journey is the step-by-step decision-making process a participant goes through in choosing to take part in clinical research. Root Health uses a simple model of the participant journey to improve enrollment operations. Utilize this simple diagram with your study teams to track participants through their enrollment journey and identify areas for improvement! 

Why should you focus on improving the Participant Enrollment Journey?

Participant enrollment is essential to the success of pharmaceutical research, and consequently, participant care. However, according to the National Institute of Health (NIH), over 80% of clinical studies in the U.S. do not meet participant recruitment timeline goals.

 In a National Public Opinion Survey, commissioned by Research America, 80% of respondents say they have heard of a clinical study, but only 18% say they or someone in their family has ever participated in one. More than 55% of individuals say they do not participate because of a “lack of awareness and information”, followed by “too risky” (43%), “lack of information” about the process (41%), and “lack of trust” (38%). From these statistics, we can understand why only 9% of identified participants actually end up enrolling in a study. 

The leakage in the Participant Enrollment Journey has the tremendous societal cost of stagnating research by depleting resources and delaying promising medicine from those that need it most. It is important for pharmaceutical companies and Contract Research Organizations (CROs) to address gaps in their current operations.

Address Gaps In Your Enrollment Operations

The following steps can be used to address the gaps in your enrollment operations:             

1) Identify where participants are dropping out. 

2) Identify why they are dropping out. 

3) Provide participant support and address those gaps. 

While the process may seem straightforward, setting up the people, technology, and processes to address these gaps within your organization can be challenging. Finding solutions that can enhance how people work, integrate with your current technology landscape, and automate processes are important to address these gaps, and can ultimately speed up enrollment timelines. More importantly, this is an opportunity to enhance the participant experience and create advocates for clinical research with your company.

Awareness

Awareness is the first step of the participant’s journey. In this step, participants and caretakers are made aware of clinical studies as a treatment option in several communication channels. The top five sources of recruitment and enrollment information in clinical research are primary physicians, clinical registries, search engines, primary care nurses, and pharmaceutical companies. These sources of information have individual online and offline channels to refer participants to studies. This is a challenge for interoperability and seamless participant onboarding as it can be difficult to ensure that 100% of referred participants are captured. Pharmaceutical organizations and CROs should focus on intake and automate the process if possible. 

“Building data-driven personas can help you identify and support participants that are likely to enroll.”

Here are some tips we use to enhance the participant journey in awareness: 

  • Create Data-Driven Personas: A persona represents a segment of participants who exhibit similar behaviors in enrollment decisions. Identify and place participants in personas based on demographic data and motivation for participation. Add emotional and behavioral data to develop a much deeper understanding, if you have that digital capability. Investing in participant personas enables study teams to design high-quality, personalized participant experiences at all touchpoints (websites, landing pages, email, mobile, and social media channels). Building data-driven personas can help you identify and support participants that are likely to enroll. 
  • Automate Immediate Outreach: Send participants interested in enrollment an immediate communication to provide support. If participant outreach is not completed within 48 hours, the likelihood of participant enrollment drops considerably. 
  • Optimize Channels Of Awareness: Identify and optimize specific channels that generate highly qualified participants. 
  • Coordinate Awareness & Outreach:  Coordinate outreach with study-specific information and public service announcements to dramatically increase enrollment. In 2007, CISCRP launched the PSA “Medical Heroes Can Be Found in Everyday Places.When it was introduced, Eli Lilly ran the campaign and observed a 140% increase in monthly enrollment rates.

The goal of awareness is met when a participant fills out an online form to be contacted for clinical research. Therefore, a simple onboarding form is critical. While it can be tempting to request more information immediately, it is better to first understand the participant and their motivations prior to asking for that information. It is our belief that it should be extremely easy for a person who has expressed interest in clinical research to engage, even as an observer. Understanding participants and their motivations are the first steps in that process.

Consideration

Once the participant becomes aware of treatment as an option, they enter into the consideration stage. Participants will begin to start learning about the pharmaceutical company and the clinical study. This is also an incredible opportunity to learn about the participant. Provide various approved educational content, track engagement to understand the participant at a deeper level, and have a clear call to action. 

A direct communication channel is important not only to communicate information about the study but also to request more information from the participant. Asking participants questions directly can help study teams understand if the participant will qualify for the study. This allows doctors, nurses, and study teams to focus on qualified participants. 

Participants appreciate being treated as individuals. Enrollment teams should personalize engagement in both content and delivery. 

Qualification & Screening

The enrollment qualification process is confusing for the participant. They need to navigate new terminology, new faces, and new appointment locations. It is important to be transparent and communicative at this phase of the journey. The participant should be reminded about every appointment, supported through logistical challenges, and provided additional information about each procedure. Precise coordination between labs, clinical teams, researchers, pharmacists, study teams, and participants is paramount.  

Try to have the flexibility to consider individual participant circumstances with appointment rescheduling, as participants have individual lives with various priorities. If the participant is unqualified, this is also an opportunity to inform the participant and set up re-engagement points for future study participation that is right for that participant (Phase 3, Phase 4, or Registry).

Informed Consent

Now that you have qualified each prospective participant, it is time to nurture each relationship with one-on-one human conversations to help the participant understand the clinical study. This is where an open communication channel for questions and support is so beneficial. By providing support in real-time, the participant can experience more certainty about the process and fully understand the risks and benefits. By creating a supportive environment, the participant can still become an advocate for clinical research, even if they decide not to participate.

Advocacy

The relationship is not over once a participant decides to end his or her involvement with your research programs. Nurturing these relationships should be an ongoing activity in clinical research to increase advocacy for your company’s clinical studies. At the very least, all studies should disseminate study results to the community from which the study participants were from. When participants are kept informed during and after their participation, they feel positive about their study participation and can convey that their contribution was of value. Ensure you send relevant content and communication to participants on an ongoing basis to increase participant lifetime value.

Once participants become something more – “fans of the experience” – then they can become long-term advocates for your company’s clinical research. These advocates can promote your clinical research to other participants in their groups.

Improving The participant Experience

The key to improving the participant experience is to understand each participant’s interaction and engagement point, digitally or in the real world. This process is called the “Personalization Feedback Loop” and is a virtuous cycle to improve participant engagement and experience. This is where participant interaction occurs. The participant behavior and action based on that interaction are then recorded and the participant sentiment is analyzed. Consequently, the participant’s personalized profile is adapted and long-term participant engagement improves.

Overall, the goal of any study team should be to develop trust and transparency with ongoing participants. If a participant has expressed interest in your company’s clinical research, it is critical to provide high-value engagement at the right time, regardless of the communication channel.

 

“Intelligence is the ability to adapt to change” – Stephan Hawking

 

At Root Health, we aim to solve the enrollment problem in clinical studies by providing an AI Coordinator to connect study teams with more qualified participants. We use Conversational AI  to automatically engage participants through multiple channels, onboard the right participants, and retain participants with support. This allows us to build data-driven operations to predict enrollment and automate participant outreach, education, onboarding, and re-engagement.  You can learn more about us at roothealth.co/.

About the Author

Raj Sharma, MBA

CEO Co-Founder

raj@roothealth.co

roothealth.co/

Raj Sharma is the CEO of Root Health and he is on a mission to improve life-science operations. Raj has over 10+ years of operations and strategy consulting experience with Fortune 500 Pharmaceutical companies and Contract Research Organizations (CROs). Raj has deep healthcare process knowledge and has led digital transformation teams across the Healthcare and Life Sciences industry. Raj enjoys working with the Root Health team to transform clinical study operations through AI, automation, and participant-centricity.