Did you know? A study found that 19% of clinical trials were closed or terminated due to failure to recruit enough participants, and 86% did not meet their recruitment targets within prespecified timelines, as discussed here.
Clinical Trial Managers (CTMs) deal with many challenges throughout each clinical trial, and study recruitment is widely considered to be among the most taxing and stressful responsibilities.
Study recruitment is crucial because a study can only move forward with participants. Finding enough willing and eligible participants can be challenging, depending on the study. That is where a Clinical Trial Manager comes in.
This article talks about the CTM role and, specifically, how CTMs manage study recruitment.
What is a Clinical Trial Manager?
Clinical Trial Managers (CTMs) are typically involved with every aspect of a clinical trial, from Start-Up to Close-Out. Usually employed by a Clinical Research Organization (CRO) or Sponsor, aka a Pharmaceutical Company, the CTM leads all activities that are part of a research study and is accountable for the study’s success (or failure).
CTMs generally oversee and work directly with their assigned Clinical Research Associates. Clinical Trial Managers also work cross-functionally with other team members, are the main point of contact for the Sponsor, and work with site teams and vendors. CTMs drive timelines to keep the study on time, within budget, and with high-quality results.
What is Study Recruitment?
According to this article on the SOCRA website, “study recruitment is the process which aims to identify and enroll representatives of the target population in sufficient numbers to fulfill the sample size and demands of the study.”
Study recruitment is when Sponsors, sites, or recruitment companies try to connect with patients who may be eligible for their clinical trial.
Recruitment is a long process that generally takes more time than any other step of the trial. It begins with an Investigator and Study Coordinator mapping their patient outreach plan. That can include reviewing medical charts, calling their patient database or contacting their colleagues for referrals. It continues by connecting with potential participants, determining if they are interested and eligible, and moving forward with the consent process followed by study procedures.
But recruitment doesn’t stop there! Instead, it proceeds for the length of the study as the research team works to keep the patient actively involved and retained in the study through regular communication and check-ins.
This free downloadable guide teaches more about patient recruitment, including ten recruitment and retention tips.
What does a CTM do for Study Recruitment?
We know that study recruitment can be a long, challenging process and is a big part of the Clinical Trial Manager’s role, but what does a CTM actually do for study recruitment?
- Create a Site Specific Recruitment Plan
A Site Specific Patient Recruitment Plan is a great tool to keep a research site team on the same page with everything recruitment-related. The CTM creates the template and each site completes the Site Specific Recruitment Plan typically at the Site Initiation Visit (SIV).
It helps sites understand and initiate their recruitment efforts, and it helps the CTM and Clinical Research Associate (CRAs) track recruitment statistics and activate action plans when needed.
Every site’s recruitment plan should start with the obvious, where will potential patients come from for their site – their database, advertisements, or referrals? Then it should outline how many patients the site plans to screen or enroll per month.
Then, additional sections can be added to the recruitment plan, including:
- How many patients the site plans to screen or enroll over the course of the enrollment period.
- Marketing strategies and outreach methods the site intends to use:
- Do they need materials such as posters, ads, and Dear Dr. Letters?
- Will they use social media ad campaigns?
- Will they use email campaigns?
- People with whom to connect for referrals:
- Healthcare providers
- Non-profit organizations
- Patient advocates
When done well, a Site Specific Patient Recruitment Plan becomes a helpful reference to help a site stay on target for their recruitment goals.
- Activate the Recruitment Plan
Once a Recruitment Plan has been communicated to all research site members involved with patient recruitment, it is time to get started!
Based on the plan’s timeline, the research sites move forward with their recruitment efforts. CRAs review the site’s recruitment numbers during monitoring visits and may meet with the site team to discuss changing or implementing new strategies. Sites are expected to provide recruitment numbers to the CRA or CTM.
Recruitment statistics are important! CTMs should keep track of patient recruitment and compare it with the recruitment goals and the overall study budget and timeline. These statistics may dictate if a new plan of action is needed.
The CTM is responsible for sharing overall recruitment status reports with the Sponsor, vendors, sites and study team.
- Communicate Regularly with Investigators and Site Teams
Frequent communication with Investigators and site teams (some may require more contact than others) is essential. Keeping site teams informed about the study and any significant changes encourages them to be involved and committed to the study and the patient participants.
Many Clinical Trial Managers host monthly, bi-monthly, or quarterly teleconferences for Investigators and Study Coordinators. This is a great way to encourage open dialogue, address questions, share best practices, provide study updates, and discuss challenges and mitigation strategies.
Study recruitment is an active process that CTMs prioritize for the duration of each clinical trial. But even with proven plans and procedures, recruitment can be a struggle. Here is a video from Dan Sfera, The Clinical Trial Guru, about clinical trial recruitment challenges and opportunities.
What Study Recruitment strategies are used by CTMs?
If a research team does not recruit enough patients for their clinical trial, it could delay the study and cause it to go over budget. Along with the issues this causes for the Sponsor or CRO, it also means that the drug or treatment will not be available to the general public for a longer time.
That is why Clinical Trial Managers use various tools and tactics to boost study recruitment. There are many study recruitment strategies – here are 3 of them:
- Focus on feasibility!
Feasibility is an integral part of the site selection process – and there is a good reason for it. Sites are asked to project the number of patients they are likely to contribute to the study during recruitment, as well as any barriers the Investigator may see with enrollment. This projection and answers to many other critical study-related questions are requested within the Feasibility Questionnaire.
CTMs want to work with sites with a database of potential patients they can efficiently recruit. This consistent access to possible study participants helps aid recruitment from the start. Also, it helps with patient retention, as patients are more compliant when participating in a study for their primary doctor. Sites relying solely on referrals may have a slower patient accrual rate as they wait for patients to be referred to them to determine if they qualify.
A detailed Site Recruitment and Retention Plan created for each site can provide study-specific information and strategies, evaluation techniques, and resources to strengthen recruitment and maximize retention. PRO TIP for CTMs: Find (or create your own) Site Recruitment and Retention Plan template to use for each study. You can then use the same template for each new study you manage, just update the study specifics.
PRO TIP for SITES: If your site believes that recruitment could be an issue, it is advantageous to decline the trial and wait for another trial with a patient population that would not be a challenge to recruit. This will help leave you in good standing with a Sponsor or CRO and leave the opportunity to work with those companies in the future.
Advertising is similar to creating a marketing plan. It is essential to know the targeted demographic when determining how and where to focus marketing and advertising efforts. A clear, consistent, compelling message is key! Remember all patient facing material requires Institutional Review Board (IRB)/Ethics Committee (EC) approval!
Depending on the targeted patient population, a marketing campaign could include printed materials, radio ads, television ads, social media, email campaigns to patient databases, and notice boards in hospitals and medical offices.
Meeting with and educating healthcare providers, non-profit organizations, patient advocacy groups, support groups, and others from the “connections” list on the Recruitment Plan may be helpful. Networking may encourage these individuals to recommend the study to patients who may be eligible.
- Clinical Trial Recruitment Companies
Many different companies focus on clinical trial recruitment. These companies take that responsibility from the site teams and, ultimately, from the CTM.
There are benefits to outsourcing Study Recruitment. These companies often have extensive databases and access to technology that makes recruitment easier. Also, they consider themselves “experts” in recruitment, which adds value. Additionally, this saves time for the research team, allowing them to focus on other priorities and tasks.
However, outsourcing study recruitment does come at a cost. Sites also miss out on the opportunity to build relationships with the patients from the beginning.
These are just a few study recruitment strategies that Clinical Trial Managers use. Of course, there are many more successful recruitment tactics!
Where Can I Get More Study Recruitment Tips?
Study Recruitment is a topic that is discussed in greater detail in the ClinEssentials CTM Training Course. Participants receive more specific information about how a Clinical Trial Manager is involved with patient recruitment and retention – and will learn specific strategies that lead to successful study recruitment.
Also, the course goes over what CTMs can do when study recruitment and retention are not going well.
Many topics about what a CTM does, from Study Start-Up to Study Close-Out and much more, are covered in CTM Training!