Recruitment Is Not A Priority

Is clinical trial recruitment a priority for your company?

If you’re in the clinical trial business the answer is likely yes, but I will challenge that. For many Sites, CROs and Sponsors, they may list recruitment as a priority, but don’t act like it’s a priority.

Some may disagree with me, ready to list all the things their company does to make recruitment a priority. They’re about to tell me about the amount of money that the company spends annually on recruitment. There may even be working groups at the office dedicated to recruitment, and a multitude of recruitment sessions attended at conferences.

Excellent. Now set that aside for a minute and I’ll tell you why all that is not working.

Recruitment for a clinical trial is a simple, yet complex process. It’s simple in that a person from the study team meets with a potential candidate and explains the study to them. If interested, the candidate goes through the informed consent process and is evaluated for a study. Some will be interested. Some will qualify. Others will not.

Simple. Right?

So… to recruit a certain number of participants for a clinical trial, all we need to do is get the right people connected with the study team. If we do that enough times, the study recruitment is filled, and the study moves forward.

Still simple. Right?

What makes it complex is everything occurring around that simple interaction that prevents it from happening.

Clinical trial sites, sponsors and CROs are in the business of preventing recruitment from happening and they do this by making everything but recruitment a priority.

Let’s break it down even further because it gets simpler. Get ready. This is the secret to recruitment.

1. A person with the condition who meets the criteria needs to learn about the study.
2. Well trained site staff need to have the time to meet with that person.

That’s all that’s needed. If we do those two things enough times, we’re done.

The problem is not with 1. or with 2. The problem is that everyone in clinical research doesn’t make them a priority at the same time. 1 may be a priority for the advertising agency but they may do it in a way that makes 2 impossible.

People may learn about a clinical trial in several ways. They may hear about it from their doctor’s office or may see an ad on social media. They may be googling their condition in search of answers. Millions of dollars are spent in recruitment campaigns to have more people learn about the study. That’s fantastic, but all falls apart if the study coordinator doesn’t call them back right away because they’re too busy.

It falls apart when the coordinator is inundated with referrals that don’t have the condition being studied. It falls apart because 1 was a priority to one group, but 2 was not a priority at the same time.

I know that ensuring site staff have time to meet with candidates is not a priority for sites, sponsors and CROs because everyone is doing everything possible to prevent the site staff from having the time to meet with the participants.

It’s not intentional, but it occurs just the same. Site staff simply don’t have the time to do all the things necessary to get to the point where they’re meeting with the candidates.

The strategies we need to employ to make recruitment a priority for all, will be different for each company. Some of the strategies your company needs to implement may not directly benefit your company but are necessary to achieve success for others.

Clinical trial sites, sponsors and CROs are in the business of preventing recruitment from happening and they do this by making everything but recruitment a priority.

How Sponsors make recruitment a priority:

• It starts far before the study is conceived. It starts with your company and your molecule. Does your company have a good story? Does your molecule? Are you ready to share those stories with the sites you intend to approach for the study? A compelling story goes a long way to motivating the investigators that will want to take on your study.
• Did you build a good protocol? Please know that the more you try to build into your protocol and the more complex it is, the more it will negatively affect your recruitment.
• Who are the vendors considered for participation in the study and how do you assess site satisfaction with them? One bad vendor in a study can tank recruitment. If the study coordinator is spending hours on the phone with IT support, then guess what they’re not doing. They’re not recruiting.
• The next big issue concerns feasibility, communication, and timelines. Share accurate information in feasibility and set realistic start times. If a site plans for start-up on a certain date and there is a delay, they may lose all the candidates who were interested. Your site that could have enrolled 10 is now sitting and waiting for the advertising campaign to start hoping to replace the candidates they lost in the delay.  
• The more tech and portals you have in your study, the more complex the start-up is. Sites are then spending more time on those things instead of recruitment.
• Ensure the central advertiser is going to communicate directly with the sites to determine the best time to start, pause, (start again, pause again…) the ads.
• Ensure the central advertiser has a good plan that includes pre-screening the interested candidates to provide better, pre-qualified leads to sites.
• Provide an optional resource that will work with sites to teach them how to recruit. Everyone thinks that sites automatically know the ins and outs of recruitment, and some do, but many could use the extra help. Some need to be told the basic information that when a referral comes in, the sooner the site responds and contacts the person, the higher the likelihood that they will be interested. If they’ve let it go 24 hours, the person has likely lost interest.
• Make the time sites spend on recruitment a priority in the study budget. Sure, provide a local pass-through advertising budget, but that’s not what is referred to here. Pay for time spent by study staff to answer the phones, review the database, pre-screen candidates. Be generous here. Thing about it, if your company compensates well for pre-screening, going through medical records, and coming up with other recruitment strategies, and your competitor doesn’t, who’s study do you think the site will focus on?
• Provide free of charge access to a third-party app that helps manage and track recruitment for all the site’s studies.
• Become the sponsor that everyone wants to work with. There are endless things that you can do here, but here’s one to consider. Develop long term relationships with the sites. How would you treat someone if you wanted them to desire to do your studies for the next ten years?
• Do the little things. There’s a sponsor we work with that sends key sites plaques to hang on the wall recognizing the quality of their work. Those get put up with pride.

How CROs can make recruitment a priority:

• Fight and plan for funding in the site budget for a site’s recruitment activities. Trying to nickel and dime on an hourly rate for this will get you nothing. These budgets must be high. This is a high skill task and should be compensated as such. I don’t want to hear about the nonsense of fair market value when millions are going to the recruitment agencies.
• What type of relationship do you have with your sites? Is it a collaborative one where everyone is viewed as all on the same team? Or, is your culture one where the CRAs think they’re in charge and the site has to do everything they say? Guess which one works better?
• Sites are seeing an increase in delays between the SIV and getting the green light to start screening. This directly causes loss of candidates that were lined up to be screened. All supplies, access, training, approvals must be in place with the goal to enable the site to screen a candidate the same day as the SIV.
• Problems with site personnel obtaining access to vendor portals is on the rise. This can delay study start and take time away from recruitment.
• Asking a site for a meeting to discuss their recruitment plans only succeeds in one thing – resentment for wasting the site’s time. These meetings are not productive and should be axed.
• Likewise, the failed concept of requesting recruitment updates and screening logs do nothing to boost enrollment. Somewhere, someone thought that it would increase engagement. They’re wrong. It increases wasted time by the site.
• Limit emails, requests, and phone calls to sites during the recruitment period. If it isn’t going to help recruitment, does it need to be sent this instant or can it be consolidated with other items later?
• Cut down on the unnecessary questions in the feasibility questionnaire. Sites drop everything to get a FQ back quickly. This can cut into recruitment time for other studies.
• Respond quickly to site requests. If they have to follow-up, recruitment time just shrunk.
• Send short newsletters that highlight the high recruiting sites. Celebrate the sites that are doing well. They’ve worked really hard, and you want to show appreciation for that.

How Sites can make recruitment a priority:

• Does your community know that the clinic conducts clinical trials? Is research messaging included on your signage, in the clinic, and on your website? Do all the referring physicians know the clinic does research?
• Does everyone one at the site know what making recruitment a priority means? Do they all know what the expectations are for their role? Everyone has a part to play in the recruitment process – even if it is just making the candidate feel welcome when they arrive at the clinic.
• It takes courage to respond to an ad and show interest in a clinical trial. Let’s not ruin that by making candidates feel like we’re not interested in them by not getting back to them immediately. Remember, even if they’re not a candidate for this study, they or their friend might qualify for the next one.  
• Designate time and responsibilities
  • Whose responsibility is it to respond to all advertising referrals within 24 hours of receipt? (BTW – if you can respond even quicker, the potential for success increases)
  • Whose responsibility is it to communicate with the advertising vendor? Coordinate when the campaign should run, pause, restart etc.
• If recruitment is a priority, set aside time for it every day. Once set, protect that time. If there are no leads to follow up on, then spend the time reviewing charts, sharing study information with referring clinics, sending thank you notes to clinics that referred, creating awareness in the community, preparing information to share…
• Has the site spent time learning how to recruit? Is everyone comfortable answering the difficult questions in an honest, balanced manner? Are the people that contact the candidates great at customer service?
• Do you reach out to other sites and share ideas and compare successes?
• Ask for recruitment funding in the budget to help cover staff time spent on these activities.
• The PI needs to personally connect with colleagues in the community – other physicians, nurse practitioners, pharmacists, specialty clinics… If the PI can’t make time for this, then recruitment is not a priority for them.
• Make sure your staff isn’t spending time on unnecessary requests from sponsors and CROs. A lot of time can be frittered away with requests that don’t need to be completed by sites. Sites are not being paid to do them, and they’re not really required for a clinical trial.

Is clinical trial recruitment a priority for your company? To answer that honestly, you need to have the courage to ask and answer some tough questions.

Clinical trial recruitment is a simple activity that our industry has made complex. Let’s start peeling back the complex layers and focus more on two activities:

1. What can our company do to help a person with the condition learn about the study?
2. What can our company do to help well trained site staff have the time to meet with that person?

If we all start thinking about what we can do to help others be successful, we may actually make progress on a very complex and challenging crisis in clinical trial recruitment.