Enrollment Best Practices

Trialfacts understands the importance of qualified and engaged potential participants in your research and have put together our Enrollment Best Practices for you to get the most out of our recruitment.

Our aim is to assist you with your enrollment being on schedule, within budget, in addition to freeing up your time to focus on your actual research. You can download our handbook here or review the videos below.

The Participant-Researcher Relationship

When you recruit patients from your own clinic, they already know you, so credibility and trust have already been established. However, when recruiting from outside sources, like Trialfacts, it’s important to understand the impact of developing these relationships. Out of the hundreds of researchers we’ve worked with over the years, we’ve noticed that the most successful researchers prioritize developing a relationship with their participants, and researchers who don’t put in these efforts struggle with recruitment.

Follow these best practices to build credibility and trust with participants to improve recruitment success.

Show Appreciation:

• One of the ways you can make participants feel valued is by showing that you appreciate their time and effort. Here are some examples of how you can show your appreciation.
  • Understand and act like they’re doing you a big favor by thanking them for their time.
  • Highlight potential benefits from your study. Learn their individual motivations for participating and share how their goals may be met during their participation in the study.
  • Help them see the value of your research and educate them on the potential impact on society and other patients with the condition in the future.
  • Whether it's a scheduled phone call or an in-person visit, being on time shows respect and builds credibility.

Get Personal

• No one likes being treated like a small cog in a big machine. Understanding why the participant responded to your study and displaying curiosity in their motivation and success, will help maintain their interest and engagement throughout the study.
  • Tailor every conversation about the study to what your participant wants to get out of it by referencing previous information they have shared to show you’re paying attention.
  • Make your organization appear human by highlighting the people they’ll be working with during the study.
  • Build a strong bond with the participants by having the same person contact them instead of multiple people. Their study team member’s contact details and availability should be easily accessible to them
  • If a participant shows any hesitancy, find out what they’re concerned about, and address this by reminding them about the benefits that are most important to them.
    • Some red flags to look out for when communicating with a participant include:
      • Sighing
      • Long pauses
      • Negative comments
      • A defensive tone or body language
      • Complaining about time
      • Noting that they want to discuss it with a friend or family member.
  • Ask them who their biggest supporters are. Suggesting bringing their spouse or loved ones into the conversation may ease their concerns and strengthen their motivation to participate.
  • Address common concerns head-on. Typical fears include:
    • Being treated like a human guinea pig
    • Receiving a placebo
    • Worry that the study treatment won’t be as effective or as safe as the standard treatment
  • Consider specific needs and concerns common within the group you’re recruiting. For example, minority groups or people afflicted by the condition you’re studying may have universal apprehensions. Be open and honest about these with your participants.
  • Be empathetic to your participants' needs, or even better identify with them! This can go a long way to building trust between you and your participants.
  • Don’t be selfish with the conversation. If they have questions, go ‘off script’ to answer them as they come up. Ask them about themselves, not just about what is needed for the study.
    • If they mention something off topic, ask more about it. (Perhaps they mentioned their dog, ask what kind of dog they have, etc)
  • Share information about yourself that could be relevant to their motivation in joining the study or just to make them feel more comfortable in sharing information with you. This will make them feel that it is a two-way street.
  • Consider the audience you’re recruiting, and tailor your conversations to their preferences.
    • For example, older populations might appreciate a more conversational approach, while younger groups may prefer more direct communication.
  • Be personable! Make the participant as comfortable as possible. Being friendly and chatty gets them to let their guard down. Sharing information about yourself makes them feel less exposed.

Be Diligent

• Persistence can sometimes feel like we’re being annoying; however, it can be disrespectful to give up too soon. Without the participant explicitly telling you they’re not interested, you are being assumptive. Remember that people are busy and they have busy lives. Last-minute obligations and issues crop up all the time. That’s why it’s important to be diligent about enrolling a participant in your study.
  • Follow up with potential participants often. We recommend attempting to contact them at least 10 times, reaching out everyday or every other day.
  • Vary your contact methods between phone calls, text messages, and email.
  • Show them you’re not giving up on them. Express concern when they don’t return your calls.
  • Be upfront about when you’re going to discontinue contacting them and how to get in touch with you should they still be interested in participating.
  • Give them an out. When leaving messages or emails, let them know that you’re committed to spending the time needed to ensure they are comfortable moving forward, but if they’ve changed their mind about participating, please just let you know.
  • Personalize every single communication attempt. Reminding them why they wanted to participate in the first place will motivate them to respond.

Make it Easy

• It is very easy for people to put even the simplest tasks in the “too hard” basket. If you ask too much too soon, you run the risk of losing them as potential participants.
  • Remain flexible to remove scheduling roadblocks.
    • Offer early morning, evening, and/or weekend appointments
    • Offer options for remote study visits when possible.
    • Offer options to combine shorter study visits or separate longer study visits when possible to allow the participant to meet the requirements of the study within their availability.
  • Learn the participant’s preferred contact method and use it whenever possible. This will maximize the chances they will respond and maintain interest.
  • Make scheduling and rescheduling appointments easy.
    • Automate reminders and use a system where the participant can add appointments to their calendar directly, ensuring they don’t double book!
    • Trialfacts’ Phone Screen Appointment System is available to our clients and provides these services.
  • Have a main line for participants where someone can answer questions or concerns should their main point of contact be unavailable.

Remember, recruiting from external sources requires extra effort to be successful. Focusing on developing a relationship with your participants in the ways we’ve discussed in this article will build lasting connections that will maximize recruitment for your studies.

Watch this video to learn more.

Contacting Volunteers

Every clinical researcher is familiar with the struggle of getting in contact with trial volunteers on the phone. However, if you employ the following tips you can maximize your rate of contact, increasing participant engagement and overall enrollment numbers.

Put the Participant’s Schedule First

• Allow the participants to choose a time they know will work for them.
• Be flexible by having appointments available throughout the day, including early mornings, evenings, and weekends.
• Call when you say you will. Asking people when they want to be contacted and not calling at that time significantly hurts your credibility.
• If you’re unable to make the appointed time, reach out to the participant and ask them to reschedule, or have backup team members who can call them in your place.
• Call them back when they’ve asked you to and provide resolutions within 24 hours. Be willing and able to hop on a call at any time to accommodate their needs.
• Ask for and use the participant’s preferred contact window. If they haven’t answered the first call, try to time your follow-ups to coincide with the preferred time.
• Leverage technology, like Trialfacts’ phone screen appointment system, to automate reminders and block out availability when phone screeners are not available.
• If the participant doesn’t answer the phone during their initial phone screen appointment time, leave a personalized voicemail message and follow up immediately with an email providing a link to reschedule the appointment.

Don’t Hesitate

• Limit the contact window to the near future (up to 3 business days)
• Gauge the participants’ interest by the length of time before their scheduled appointment, and prioritize following up with those that are farther away.
  • Generally, those who are really interested in the trial will book a call as soon as possible and won’t need as much effort to contact them. Those who schedule for further out, need more attention and may have questions or concerns that have been left unanswered.
• Call to confirm as soon as you’re able to. If you catch them and they have time, you may be able to complete their phone screening sooner than anticipated, but even if you get their voicemail, you’ll make first contact with them. Your phone number will be more recognizable, and you can introduce yourself before your call.
  • Focusing on those who book their appointment further in the future will allow them to ask any questions or voice any concerns they may have.
• Don’t delay following up with them. You should be contacting them everyday or every other day using email, text messages, and additional phone calls until you’ve gotten a response or have reached at least 10 attempts.
  • If they reach out to your team via phone or email, be sure to respond as quickly as possible. Replying to their questions quickly will minimize concerns festering which could result in reduced retention.

Get Personal

• Have one point of contact for them to get to know, like, and trust. This person should be knowledgeable of the study, have a high emotional intelligence, and be able to catch ‘flags’ that may show signs of hesitancy. (see our Phone Screening Best Practices for more on identifying red flags)
• Send personalized reminders and include information they shared to increase their interest.
• Remind them of their motivation to join the study to establish your connection, and tailor your conversations to their own experiences. Trialfacts asks why they signed up for the trial during prescreening, their answers provide great insight you can use for this purpose.
• Use real-life examples of how participation could contribute to their community.
• Do not use a blocked or private number. US-based researchers should have a local number and Australia-based researchers should use a mobile number (beginning with 04)
• Ask for the participant’s preferred method of contact, and use it along with other contact methods to maximize their response rate.
• Make sure you always put your phone number in your email signature or your texts—this gives the person a way to contact you if they have any questions.
• Avoid using bulk sending services with opt-out messages at the bottom of your texts or emails, as these give the impression that you are contacting many people in bulk, and their individual participation means little.
• Make sure your text messages and emails sound like they’re coming from an actual person. Robotic-sounding messages do not inspire trust.
• Your study team should be aware of the symptoms and struggles of people living with the condition you’re researching. Having this knowledge can help them be empathetic and reassuring when discussing the study with them.
• Be personable! Make the participant as comfortable as possible. Being friendly and chatty gets them to let their guard down. Sharing information about yourself makes them feel less exposed.

Be Persistent

• Persistence is key. If the volunteer does not pick up the phone when you call them at the designated time, be relentless in following up. Trialfacts suggests 10 contact attempts using multiple methods.
• If they do not answer the phone call, leave a voicemail and follow up with a personalized text message or email right away including your name and your reason for calling. If they still haven’t answered, leave one or at most two days before trying again. Keep calling until they have to pick up the phone.
• If the recruitment deadline is in less than a week, try once or twice a day.

Remember that it is very easy for volunteers to say they’re not interested, especially via text message. So don't make the mistake of assuming your volunteers’ level of interest until they actually tell you they’re not interested, or until you’ve called them and left text message, emails, and/or voicemails at least ten times.

Watch the video for a step-by-step run through of our method and why it works.

Phone Screening

The Phone Screening stage is your participant’s first major interaction with your study and study staff. Tailoring your communication will not only build the foundation of the participant-researcher relationship but also increase the amount of referrals willing to participate.

Here are the 5 key areas to consider when phone screening participants in order to achieve the highest rate of enrollment for your study:

Be Flexible and Accommodating 

• Respect Participant's Time:
  • Call participants at their specified times to show respect for their schedule. 
  • Be open to rescheduling calls if it's inconvenient for the participant, enhancing credibility and relationship building.
  • Begin each call by confirming if it's still a good time to talk, showing flexibility.
• Offer Remote Options:
  • Optimize convenience by offering remote participation wherever possible.
  • Clearly communicate remote participation options to reduce participant burden and encourage engagement.

Build a relationship with the participant

• Understand Participants’ Motivations:
  • Discuss the participant's interest in the study, which can be found in the "Why did You Sign Up for the Trial" column of the Trialfacts Referrals Spreadsheet.  
  • Highlight study details that align with that participant’s motivations to boost engagement and interest.
• Share Impactful Stories:
  • Explain the potential impact of participation by sharing real-life stories and examples of how the study has positively affected others. This would alleviate any doubts and illustrate the tangible benefits of their participation.

Assess interest levels

• Gauge Participant’s interest by their responsiveness:
  • Assess participants' level of interest based on their response time. A rapid response may indicate strong interest, while delayed responses suggest potential hesitations or uncertainties. 
    • In cases of slow responses, proactively follow up and promptly address any concerns they may have.
  • Minimize the window of time in which the participants can schedule their Phone Screening Appointment.
  • Promptly reach out to all participants immediately after they've booked a phone screening appointment to introduce yourself and confirm their appointment.
• Take note of vocal cues of frustration or confusion, such as sighing or long pauses. Discuss their apprehensions promptly and confirm that all of their concerns are fully addressed.

Addressing concerns

• Show Empathy:
  • Approach screening with empathy, avoiding robotic responses. Understand that discussing medical concerns may be uncomfortable for most individuals.
  • Acknowledge the participant's hesitations and fears, ensuring that they feel supported and validated.

• Educate with Understanding:
  • Provide personalized explanations about screening processes and eligibility criteria. Your participants don’t understand the purpose of the Phone Screening or why it takes so long.
  • Maintain transparency throughout the conversation, providing full and honest answers.

• Provide Immediate Answers to Questions:
  • After participants complete the screening, inform them of their success and continuously ask if they have any questions until they confirm they have none.
  • Address all questions immediately during the call to maintain an open dialogue and prioritize concerns.
  • Avoid sending additional material to answer questions, as it may lead to forgetfulness, confusion, or loss of interest. 
  • If you’re unable to answer a question, commit to finding the answer and follow up promptly.

Clarifying Next Steps

• Ensure both parties understand the next steps before ending the call, and avoid leaving responsibilities solely up to the participants.
• Schedule follow-up actions within a few days to maintain participant interest and engagement.
• When scheduling appointments, aim for dates no more than a few days away to sustain interest and commitment. 
• Leverage technology to ensure that they don’t forget the appointment by automatically adding it to their calendar.
• Confirmation of Appointments:
  • Send participants a personalized confirmation of their next appointment via text or email to acknowledge their time and commitment. 
  • Ensure that the confirmations are coming from the same person who spoke to them on the phone.

In this video, we’ve enumerated the 5 stages of phone screening you should go through in order to ensure the best possible outcome for your recruitment.

Avoiding No-Shows

We know it is frustrating and often a huge waste of resources when someone books an appointment and then doesn't show up. Maintaining a good relationship will improve communication, allowing you to inspire them to participate.

The following are some ways you can address concerns before appointments:

Limit wait times for Clinic Screenings

• Limit the time between pre-screening, Phone Screenings, and Clinic Screenings as much as possible, reducing the chances of participants being too busy, being talked out of, or just losing interest in your study.
• Coordinate recruitment activities by aligning recruitment efforts to ensure prompt scheduling and accommodate the volume of participant screenings.
• Be mindful of participants' commitments by accommodating their schedules. Offer flexible hours (including weekends and before/after typical work hours) and remote visits when possible.

Maintain Consistent Communication

• Each participant should have one point of contact following up with them throughout the study.
• Provide participants with their team member’s contact details should they have any questions or concerns at any point before or after the Clinic Screening.
• Offer an optional meet and greet to participants (either in-person or remote) to give them the opportunity to get to know the study team and research facility.
• Include expectations for the next steps at every juncture. Provide the date, time, and location of their visit, a detailed description of what the visit will entail, a map of the building, and parking instructions. If it’s a larger building, specify where to go within the building, and who they’ll be meeting with.

Continue Building the Participant-Researcher Relationship

• To minimize no-shows, maintain transparency and open dialogue with potential participants on all aspects of the study including their participation requirements.
• For example, location, frequency, duration, and number of visits as well as the purpose of the visits, and any procedures.
• During the Phone Screening inform them about the significant resources involved in setting up their first visit and kindly request that they notify you in advance if they decide not to participate. Explain that while they are free to change their mind, not showing up without notice is disruptive and costly.
• Confirm their appointment and give them an option to reschedule or cancel if they need to.
• If you have a strong relationship, they will show you the same respect you show them. Refer to our Participant-Researcher Relationship Best Practice Guide for further recommendations.

Informed Consent

• Choose the best timing and method of providing consent forms.
  • We know it's tempting to email consent forms before your potential participant comes in for an appointment, however, this runs the risk of scaring them off.
• Ensure that the informed consent process is conducted in person or over a phone call to ensure that all questions, concerns, and hesitations are addressed immediately.
  • Informed consent forms are often perceived as lengthy legal documents which intimidate many participants.
• Address any and all cultural barriers that might be posed by the Informed Consent process - including but not limited to language, literacy, and knowledge of medical/study terms.
• Include a comprehensive overview of the study, including study requirements, possible outcomes, as well as how it could help others.
• The informed consent form is full of reasons why not to join the study (commitment level, medical terminology, requirements). Putting the responsibility on the participant to review this document on their own will increase the likelihood of scaring them off because they won’t have anyone to reassure them throughout

This video covers how to avoid No-Shows.

Following Up on No-Shows

Despite meticulous planning, instances where participants fail to appear for clinic screenings can occur. Following up on no-shows is essential to maintain study momentum and achieve enrollment goals effectively.

Here are the 4 areas to consider when following up on no-shows:

Be Persistent yet Respectful

• Initiate contact with the participant promptly after the missed appointment. Delaying follow-up increases the risk of unsuccessful attempts to reconnect.
  • Continuously attempt to contact the participant while respecting their contact preferences. Trialfacts recommends 10 contact attempts before considering a participant unreachable.
  • Develop a consistent follow-up schedule (e.g. daily for the first three days, then every second day for a week, then once a week)
• Utilize phone calls, emails and text messages as primary methods of communication, use alternative contact details provided by the participant during initial screening or consent.
  • If none of these attempts are successful, leave a clear and polite message requesting the participant to contact you to reschedule or provide a reason for their absence.

Address Participant Concerns

• Immediately address any concerns or issues the participant may have regarding the absence or study itself.
  • Reassure the participant that they are welcome to reschedule the appointment if they are still interested in participating.
  • If the participant is apologetic about missing their appointment, respond with empathy and understanding.

Maintain Participant Engagement

• During the follow-up process, keep participants informed about their involvement in the study and how their contribution could help the community with the same condition.
• Provide updates on study progress and any relevant developments.
• Encourage participants to provide feedback on their experience and reasons for non-attendance.

Assess and adjust

• After a reasonable number of attempts (based on study protocols or Trialfacts’ recommendation of 10 attempts), evaluate the effectiveness of follow-up strategies. Identify points in the referral process where participants are dropping out and investigate potential root causes for these occurrences.
  • Documenting reasons for no-shows, screening failures, and lack of interest among participants will enhance the efficiency and effectiveness of this process.
• Evaluate the effectiveness of your follow-up procedures and incorporate any lessons learned into future participant engagement strategies.

Sponsor Tips for Enrollment Success

There are many things to think about when setting up your study. Determining study protocol and selecting sites are just a few pieces of the process. Thinking about the rate of successful enrollment isn’t typically high on this list, but if you’re looking to increase your chances of a successful study, perhaps they should be.

Here are 3 areas to consider when setting up your study in order to achieve the highest rate of enrollment possible:

When Possible, Reduce Participant Burden

• Offer shorter, more frequent visits and longer combined visits when possible.
  • If you have longer visits planned, give the participant options to break them up if it suits their needs. Taking multiple days off from their daily responsibilities could be more difficult than having an entire day. Conversely, it may be more convenient for them to break visits up over a few days. Leaving it open to the participant and study staff will decrease the number of individuals that decide not to participate due to the visit schedule.
• Offer Remote Options:
  • Optimize convenience by offering remote participation wherever possible.
  • Clearly communicate remote options as early as possible to increase initial interest.
• Offer reimbursement for travel, or provide transportation to the site for participation.

Select Sites With Supportive, Accessible Staff

• Select sites that can have appointments available throughout the day, including early mornings, evenings, and weekends.
• Enrolling participants takes time. Ensure sites have the team members available to dedicate time to the study. Reaching out several times to participants to phone screen them and having availability right away will increase overall enrollment rates.
• Ensure the site has staff who will be the participants’ main point of contact. This person should have the bandwidth to be available to the participants for questions and follow up with them often. They should be easy to get a hold of and very responsive.
• Ensure the site has the capacity to review the Consent Form either on the phone or in person with the participant. These legal documents can dissuade participation if not presented with someone who can explain it to them and answer any questions they may have.

Select Sites With Knowledgeable, Relatable Staff

• Staff should be knowledgeable on the study and requirements
• Staff should have high emotional intelligence and be able to identify signs of hesitancy amongst participants.
• The main point of contact should have condition competency. They should be aware of symptoms and struggles of people living with the condition you’re studying.
• If you’re working with a specific ethnicity or population subset, select sites that have staff that are aware of and sensitive to the culture you’re recruiting from.

In conclusion, when you’re designing your study, ensure that you are reducing the participant burden as much as possible. Eliminating anything that may dissuade participation will significantly increase enrollment success. Additionally, the process of site selection should include much more than determining which locations to choose. The flexibility, capacity and quality of the staff of the participating sites will play a key role in ensuring that your study enrolls on time and within budget.