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.
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.
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.