Why do Recruitment Efforts Fail to Enroll Enough Participants?

Kristina Lopienski
November 7th, 2017

Patient accrual remains a huge challenge in clinical research, despite heavy spending on recruitment. According to a 2011 Tufts Center for the Study of Drug Development (CSDD) report, two-thirds of sites don’t meet the enrollment requirements for a given trial. Failing to meet these goals causes delays in clinical trials that end up costing even more money.

According to a 2011 Tufts Center for the Study of Drug Development (CSDD) report, two-thirds of sites don’t meet the enrollment requirements for a given trial.

This issue, which affects both sponsors and sites, is caused by a variety of factors. Here are some reasons why patient recruitment efforts aren’t effective at enrolling enough patients.

The protocol is too complex

No matter how beautifully recruitment materials are designed or how perfectly strategies are executed, if the protocol is too complex the study won’t apply to a significant portion of the patient population. With too many inclusion/exclusion requirements, willing volunteers often aren’t able to participate because they don’t qualify. According to a 2012 Tufts CSDD study, the total number of eligibility criteria for the typical Phase III protocol has jumped from 31 to 50 from 2002-2012. Increasing complexity can also cause confusion for prospective volunteers. If people don’t understand the protocol, they likely won’t participate.

Dozens of patients can be screened, but if they aren’t eligible or lose interest in a study, it’s back to square one. A protocol should be designed incorporating the patient’s perspective to help anticipate enrollment and realistically reach the available population.

Not being well prepared

Every study needs a recruitment plan that fits the budget and is ready on time. It’s not always realistic to have all materials created, submitted, reviewed, and approved in advance. Simply having generic templates that are customizable is better than starting from scratch each time.

Being proactive with the creation of recruitment materials is one part of a well-coordinated campaign. It’s also important to be prepared for the inquiries that result from the promotion of those materials. For example, if a commercial airs and no one is available to take incoming calls, callers may become frustrated and give up. Making it as easy as possible for participants to speak directly with an actual person and find the answers to their questions will increase the likelihood of ever hearing from them again. Also, the importance of an online presence can’t be ignored, knowing that most people first go online to find information.

Recruitment materials don’t reflect the motivations of participants

Knowing why people do and don’t enroll for clinical trials is important to understand, but it’s not always information that can be used in ad copy. Recruitment materials need to reflect the intent of the study – presenting it in an easy to understand and honest way. A huge challenge remains in creating collateral without being able to directly speak to all motivations.

A 2013 Perceptions & Insights study from the Center for Information and Study on Clinical Research Participation (CISCRP) asked 5,701 respondents what they think the top reason is that people choose to participate in clinical trials. The report found 33% of respondents said to advance medicine, 29% said to help improve or save lives, and 15% said to help improve their condition. The top perceived benefits of participation have an altruistic and/or hopeful outlook, but these ideas can’t be used to encourage participation. An IRB won’t approve an ad it if it implies a specific end result or is considered promissory.

Even though the content created for patient recruitment is limited in what can be said, demographic information can be used to decide how and where it’s said. The tone should target the right person, whether that’s the patient or caregiver, using the right channel. Not every message will resonate with everyone, but it should concisely explain what a potential participant might want to know about the study to help them decide if what’s in it for them is the right opportunity.

Not trying new methods of recruitment

Technology has had a significant impact on marketing communications, which has great potential for patient recruitment. In an industry that’s generally slow to adopt new methods, it can be easy to stick with the familiar – especially if it has been successful. What was effective years ago may or may not be working as well today. With the ability to fast-forward through commercials and ignore advertisements, it’s becoming more difficult to break through the noise to reach an audience. Luckily, there are new opportunities and channels to reach people.

In March 2014, ISR published a whitepaper titled, “The Expanding Web of Clinical Trial Patient Recruitment” that surveyed 102 mid-large sponsors, 28% of which cited using a diverse range of recruitment outlets as the number one best practice. Diversifying patient recruitment efforts can include incorporating modern approaches, such as targeted advertising on social media, or simply trying something new, like getting physicians involved by providing them with simple inclusion/exclusion cards or posters. Of course, all communications need to first be IRB-approved.

Not tracking results of recruitment efforts

One of the biggest mistakes that can be made in patient recruitment is not tracking the results. It’s important to ask each volunteer how they heard about the study and document that information. Sites can use metrics and analytics as hard data to justify why they need an increased advertising budget. Examining what was effective and what didn’t work helps plan future recruitment, knowing what to continue doing and to avoid making the same mistakes.

One of the biggest mistakes that can be made in patient recruitment is not tracking the results.

Patient accrual in clinical trials relies heavily on effective patient recruitment, but enrollment goals aren’t met for a variety of reasons. No matter the cause, delays in clinical trials affect sponsors, CROs, and sites. Making improvements to recruitment efforts and working more as a team can increase the efficiency of clinical trials to keep studies on track.

This article was originally published on May 9, 2014.

20 Comments

20 thoughts on “Why do Recruitment Efforts Fail to Enroll Enough Participants?

  1. Would be interesting to find data on two important points: the recruitment methods used by the research sites, as many only use database and referring physicians and secondly the refusal of CROs and sponsors, that knowing the results of the goals recruitment, consistently refuse to negotiate improvements at this point in the budget. They claim that investment in recruitment methods is only part of the researcher of their own money.

  2. It really comes down the skill and quality of the staff you hire and train. Are they dedicated, are they committed to serving the patient community from which you draw participants. No real reason for falling short on accrual goals, most of the teams I’ve led, or worked with, usually met or exceeded the goals given, and quite often, we did it ahead of schedule.

    1. So very true Stanley, I attended a very recognized convention and I kid you not, I had more insight on recruitment than some of the speakers! Its not a issue you can throw money at, you have to have good, trained charismatic staff members in place. Our site network has an inhouse recruitment department which are trained to handle inbound and outbound calls, prescreen and schedule pre qualified candidates.

  3. After 25 years in clinical research, I can say that PI involvement is paramount. An engaged investigator will usually meet or exceed the enrollment goal.

  4. After recruitment materials are approved by the IRB for a study, is there a source you recommend to increase online presence with social media? I am particularly interested in the step by step application of doing so.

  5. Thanks for the comments and sharing your experiences! Any recommended strategies that have helped with your success?

    I’m sure there are plenty of articles out there, but on the topic of optimizing your online presence using social media we have a few resources:

    -A free on-demand webinar, “Optimize Your Online Presence for Patient Enrollment” – http://info.forteresearch.com/optimize-online-presence

    -Social Media Success: Three Facebook Pages Doing it Right – http://forteresearch.com/news/social-media-success-three-facebook-pages-right/

    -Optimizing Your Online Recruitment Strategies – FAQs – http://forteresearch.com/news/optimizing-your-online-recruitment-strategies-faqs/#sthash.Si1brjyb.dpuf

    Hope that helps!

  6. The industry is always grateful for insight and Ms Lopienski offers reinforcement of the complex challenges. Her company’s eBook may give us more ways to solve these persistent issues. Her points indicate an overarching challenge: inadequate steps taken by sponsors (or CRO) regarding the feasibility and viability of their protocol. In many cases, no one wants to know they have an un-deliverable study, they could lose their job if the study is cancelled. There are no metrics upon which to properly judge the cost and duration of the enrollment effort. Plus, even if there were, the compound development team determines the completion date and cost. The sites are asked to perform a miracle, the patients are asked to take a huge leap of faith.

    We must develop a better way to plan enrollment strategies.

  7. This information is extremely helpful. Recruiting for complex therapy trials can be very frustrating. Equally frustrating is explaining to Pis reasons why recruitment is so difficult. I have worked for PIs who do not totally understand the recruitment process. Great information.

  8. Thanks everyone, for joining the conversation. Your comments are all on point. I’m glad you found the article helpful!

  9. The factors listed are all important but there is an even bigger gorilla in the room which I did not see mentioned. Patients abhor randomization. It is the second-highest reason patients refuse to sign up. The most significant reason is that clinicians fail to mention the trial to patients in the first place.

      1. I only have an anecdote – it applies to a close friend with advanced lung cancer who desperately wanted to get into a clinical trial at an academic medical center that would have allowed her to receive immunotherapy.

        When she found out she was eligible, but randomized to the standard of care, she was devastated. The PI had made it clear to her from the beginning that she might not get the experimental drug, however my friend had become convinced this new drug, which she read about in the news, was sure to cure her. After finding out she would not receive the investigational treatment, my friend decided not to participate in the study.

        Almost eight weeks had gone by during the determining eligibility period (e.g. imaging, biopsies, genetic marker tests), delaying her treatment with her regular oncologist, because having been on chemo within a certain timeframe would have made her ineligible.
        The tumor had grown significantly during the eight weeks she was off treatment and she passed away within a few months.

        Hope this story helps explain the previous commenter’s remarks about patients abhorring randomization. Perhaps the story is only relevant to oncology, where patients envision entering a clinical trial as being a life or death situation.

  10. Very good article. Use of metrics is very important so you are not continuing to throw money at something that is not working. Also, thinking outside the box for advertising can make your dollar go further. Instead of spending a thousand dollars on newspaper ads in a market, try a billboard, or lawn signs/banners. Having coordinators/marketing at local events to hand out study branded materials and study brochures can build awareness in the community and spread the word about a study easily.

  11. Recruitment time also a crucial point. Summer time people travel a lot and do not care about study participation. So if you start screening on Jun/July then you definitely miss your target.

  12. I have a special point to follow. In Mexico (as in other Third World´s Countries)the social media use to be less used by the kind of population who entry in a clinical trial. Do you have any recomendation for our countries?

    1. Hi Reyna,

      Social media is only being used to recruit patients in about 11% of all trials. http://csdd.tufts.edu/news/complete_story/pr_ir_mar_apr_2014

      For developing countries, or for any trial that’s trying to reach a specific population that isn’t as present online, probably more traditional methods of recruitment would be more successful.

      We don’t specialize in global recruitment, but here are a few resources that might be of value:

      http://www.centerwatch.com/news-online/article/6559/the-pulse-on-global-trials#sthash.EqYqiq4m.dpbs
      http://www.pmlive.com/pharma_intelligence/clinical_trial_regulation_in_mexico_477081

  13. You are appointed as the regional CTM on a global study of a chronic disease. Enrollment started very well, and the target randomization rate was being achieved. Over the past 4 weeks, there has been a noticeable slowdown, and there are no holidays, vacation seasons or other extraneous reasons for the decline. Although subject randomization is continuing, the randomization rate is 20% slower than originally projected and experienced for the initial part of the project. Based on the current randomization rate, as well as reports from the CRAs, you now project that the LPI date will be delayed by six months. The critical date for the sponsor is delivery of the final TLGs, and a delay in receiving the TLG will likely cause a delay in their next trial’s starting timelines. This is a fixed fee contract, and the sponsor is extremely reluctant to acknowledge any need for, let alone sign off on change orders. Site identification and selection were joint activities with the sponsor providing all of their Phase II sites, and insisting at least 60% of them participate in this trial. Please describe your action plan.

    1. Launch a Facebook advertising campaign. Tetra Discovery Partners did, and filled a phase 1 trial in 7 weeks, recruiting healthy elderly volunteers (39 people).

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