7 questions to ask before hiring a patient recruitment provider.

There are few things more important in clinical trials than filling enrollment. For many sponsors, this means success hinges on engaging the right patient recruitment company—and asking potential partners about expertise, experience, and engagement methods can help you learn quickly whether they’re the right partner for you.

7 Questions To Ask Before Hiring A Patient Recruitment Provider

1. How does your patient recruitment company ensure diversity in representation in clinical trial participants?

DEI—or diversity, equity, and inclusion—is a key component for any clinical research trial. The more diverse your participants, the more applicable your findings will be to the broader population. The U.S. Food and Drug Administration agrees, issuing new draft guidance in the hopes that it will help enroll more participants from underrepresented minority populations into clinical trials on the grounds that “despite having a disproportionate burden for certain diseases, racial and ethnic minorities are frequently underrepresented in biomedical research.” While some demographics have to fit within a specific range (such as age or locale) your next patient recruitment company should be as proactive as possible in bringing you a diverse participant pool, so make sure you ask specific questions including:

  • What are your outreach methods when it comes to underrepresented populations within the community?
  • How do you overcome certain cultural barriers, such as language or social etiquette?
  • Can you provide examples of how you’ve overcome participant diversity challenges in previous enrollment campaigns?
2. Do you have a full-funnel communication strategy to maximize patient engagement and ensure enrollees actually join the clinical study?

It’s crucial that there’s consistent communication with participants and follow-up during the entire process. Patient recruitment requires a full-funnel communications plan, and identifying a potential participant with a compelling ad is only the first step. Once a patient displays interest, following up with relevant health information, offering to answer any questions they may have about the trial itself, and friendly reminders to fill out any medical authorization forms or pre-screening documents increases the likelihood they will join your clinical study. Discover more about a patient recruitment company’s communication plan with questions such as:

  • What communication channels do you use to reach potential participants, and how do you leverage digital technologies to maximize your efforts?
  • How much time elapses between each of the steps in your patient follow-up strategy?
  • How flexible are you in modifying your communication strategies based on the progress of the recruitment process?
3. How secure is your patient data collection, and what steps do you take to ensure that you’re HIPAA compliant through the entire process?

One of the most frequent challenges we see in patient enrollment is the fear that a participant’s health data won’t be kept safe and secure. Ensuring that a recruitment company’s methods are in compliance with HIPAA is crucial for protecting the privacy of potential enrollees. Here are some questions you can ask to measure how responsibly your next recruitment partner is in gathering health data:

  • How do you gather, store, and transmit participant health data in a way that complies with HIPAA regulations?
  • What steps do you take if there’s been a security breach?
  • What do you do with patient data once the trial is completed?
4. Does your approach to patient recruitment change depending on a specific therapeutic area of study?

Your patients are online no matter what. Insider Intelligence predicts that 90% of North Americans will be internet users by the end of 2024. Patient recruitment is now therapeutic-agnostic, which means that sophisticated digital targeting strategies and compelling advertising are at a premium—as compared to expertise in a specific therapeutic area of study. Ask these targeted questions to discover if your patient recruitment company is the right fit for you:

  • What are some examples of clinical trials in diverse therapeutic areas that you have successfully recruited for?
  • What are some common challenges to patient recruitment across all therapeutic areas, and how have you overcome them in the past?
  • What processes do you have in place for regular improvement across diverse therapeutic areas?
  • Do you have previous positive results from a new translatability assessment? What elements of your strategy are repeatable?
5. What key metrics do you use in your patient enrollment?

In short, what does your patient recruitment company think success looks like? For example, if your goal is to enroll a certain number of patients in a short amount of time, you’ll want to partner with a patient recruitment company that places a stronger emphasis on average recruitment rate and efficiency. But if you have more lead time, a balanced approach with a higher initial reach, could be more helpful. In short, make sure you’re on the same page so that you’re focusing on metrics that directly affect the success of your study. Ask these questions to see if you and your potential partner are on the same page:

  • What were the specific goals of your last patient recruitment campaign, and how did you achieve those results?
  • Can you talk about a strategy or initiative you’ve recently employed that made a big difference in success rates?
  • If you had an additional 12 months to achieve the results we discussed, how would that change your campaign strategy?
  • What metrics do you evaluate to determine the health of the campaign in the first 7 days, 1 month, 3 months?

6. What is your patient screening process?

One of the most important aspects of patient-centric recruitment is effective communication. Is it as simple as ensuring that digital ads are engaging, and the pre-screening questionnaires are easy to understand? Or has the patient recruitment company found that phone calls and mailers increase the likelihood they’ll find quality enrollees? Here are some questions to ensure your partner isn’t spending unnecessary time and money attempting to engage patients:

  • Do you have a specific screening process in mind for this campaign, or do you have a general screening process across all trials?
  • Is the screening process fully automated before site referral, or do you have someone reaching out to patients with things like secondary phone screens and telehealth visits?
  • Can you provide an example of a screening process that wasn’t going according to plan and how you fixed it?
7. Do you have contingency plans in place in case we don’t hit our enrollment numbers?

Even the best patient recruitment companies can encounter unforeseen challenges, no matter how experienced they are. The National Institutes of Health reported that “more than 80% of trials fail to enroll on time” leading to costly delays. You don’t need the NIH to remind you that delays are costly, but help in avoiding them in the first place is probably welcome. That’s why learning how companies mitigate risks and navigate problems is important. How flexible are they with their processes? Are they experienced in making changes in the middle of their campaign? By asking questions that focus on their ability to overcome adversity, you can get an idea of how equipped they are to see your clinical trial enrollment through to completion:

  • How do you proactively identify and assess potential risks that could impact patient recruitment efforts?
  • Can you provide an example of when you needed to make an adjustment mid-campaign to meet an enrollment deadline?
  • What is your process in quickly ensuring that a change you want to make is in compliance with regulatory standards?

Bonus content you won’t find anywhere else!

We thought it’d be nice to give you some bonus content! Below is a helpful rubric for answering all the questions above —as well as dive deeper into additional themes and concepts that were mentioned—so that you’re even more prepared for conversations with potential providers.

How will you ensure diverse representation?

Patient recruitment companies outlining their strategy is one thing. Ensuring representation in your clinical trial is another. If you’re serious about representation, give firm targets and ask the company if they can include those in the budget. That way, the goals are clear and everyone’s on the same page.

For example…

“We need a greater than 20% share of participants from groups historically underrepresented in research. Can you provide that?”

(And by the way, if you ask 1nHealth that question, we’ll say yes—but be prepared for the budget to be higher.)

What’s your level of data security?

Anything less than a custom platform using secure cloud-based storage is likely in a gray area or worse. Ask potential providers how they store patient data, make them walk you through every step, and get specifics on all the software and solutions involved in the process.

Do you have a full-funnel communication strategy?

Imagine ordering something on Amazon and not receiving a confirmation email immediately after. You’d think something went wrong and that your purchase didn’t go through. You’d be frustrated. You’d be refreshing your inbox every 30 seconds to make sure everything’s alright. That’s how patients feel when our follow-up communication is inconsistent and infrequent. Recruitment providers should aim for zero surprises as the standard, and every step of the journey should prepare a patient for what’s coming next.

Communication should also be on the patients’ terms, which usually means texting, emailing, and then calling—in that order. Adopting an omni-channel messaging approach ensures that patients are reachable no matter what.

What’s your experience with translatability assessments?

This is less a question about experience and more about process. Recruitment companies cannot hope to cut through the clutter and noise of modern life with a generic message, so the real value they provide is the ability to constantly assess and understand the specific patient burden. That’s how you arrive at truly compelling messaging, without which a campaign will plateau and fade.

1nHealth commits dozens of person-hours at the beginning of each campaign to qualitative and quantitative review of the patient experience, as well as in-market testing to get feedback on early messaging concepts.

What metrics do you use?

Impressions and clicks are not meaningful, and form-fills are barely better. Unfortunately, “randomized per site per month” metrics can be meaningful but often lag so far that things can be dire before study teams realize there’s a problem.

Every stage of the journey should have target metrics for conversions (how many patients moved forward out of all possible participants?) and transit time (how long did a patient stay in a particular stage of the journey?).

If you break the patient journey into specific segments, recruitment vendors should be able to tell a coherent narrative. For example, going from “qualified referrals” to “pre-screened” (a status achieved after completing a secondary phone interview) to “study visit one scheduled/attended” and ultimately “consented and screen-failed/randomized” helps you identify any problem areas in the recruitment process.

If your provider can’t track this, or won’t share it with you, you’re taking an unnecessary risk.

How do you respond to adversity?

Challenges can happen at every stage of the patient journey.

At the top of the funnel, saying “there’s not enough interest” is usually traced back to poor messaging, distribution, or study framing. Interested patients failing to turn into qualified referrals suggests that the ask (“fill out this form” or “participate in this study”) isn’t aligned with the offer. This can happen because ads rely too heavily on compensation, or miss a critical element of the study design (such as an inpatient stay).

Some mid-funnel issues occur because of poor wording on screening questionnaires or simply a bad user experience on the study website. If it looks bad on a mobile device, you’re certainly missing out on the interest being driven by study ads.

Lastly, qualified referrals may not be getting to the sites for screening. This is almost always connected to process outages that cause delayed outreach, resulting in patients losing interest or becoming suspicious.

Identifying how sites and the recruitment provider can be on the same page during enrollment is a critical conversation that needs to happen as early as possible.

Can you describe your screening process?

Almost all digital providers will produce an online questionnaire and use form logic to qualify or disqualify patients based on their responses. Asking sites to follow up with every single form response is too heavy a burden in most cases. Not all sites have specific staff dedicated to recruitment, and those who do never have staff dedicated to recruitment for a specific study. Deploying a committed resource to ensure timely follow-up during screening has a transformative impact on success rate.

It’s also critical that your recruitment provider have some insight into what is happening at the site level so they can amend the screening process if needed. There’s no sense in continuing to refer patients who could easily be screened out with one or two additional questions.


There are additional considerations that would help separate two recruitment companies that have great answers for all of the above. But any team that can deliver on these benchmark features is worth working with:

Established a process for developing creative (images, headlines, copy) that resonates with patients

Understands how to evaluate funnel success by segment

Has an informed opinion on how to address any issues that may arise during recruitment, impacting one or more segments of the patient journey

Ready to learn more about how we can help you fill your next clinical trial?

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