Melissa Rosales
Director General
RM Pharma
Expert Contributor

Improving Recruitment and Retention in Clinical Trials

By Melissa Rosales | Fri, 12/18/2020 - 14:17

Patient recruitment is widely recognized as a key determinant of success for clinical trials. Yet a substantial number of trials fail to reach their recruitment goals, a situation that has important scientific, financial, and ethical implications. Despite efforts over multiple decades to identify and address barriers, recruitment challenges persist.

Most people being treated for a disease or condition are not aware that they might be eligible for a clinical trial, or that trials are conducted where they are receiving treatment. Education and communication are paramount. 

There are factors that potentially contribute to recruitment success. These include trial design, study staff, recruitment strategies, patient care, targets and timelines. The scope of factors that affect recruitment to clinical trials suggests a fundamental need for more inclusive and proactive approaches that extend beyond common study-specific strategies.

Other factors also play a role, including:     

  • Access or proximity of clinical trials to minority communities;
  • Readability and length of informed consent forms;
  • Provider bias in offering clinical trials or assumptions made about interest, and how people are approached; 
  • Eligibility criteria and other aspects of the trial design;
  • Patient did not want to participate because he or she does not understand the protocol, they do not want to receive a placebo, because of the inability to take time off work to attend follow-up visits or just because of the fear of unknown; 
  • The challenge for all research staff is to effectively communicate the purpose, technical aspects, and implications of trials to patients and to assist them in decision-making, providing full and unbiased information about options, benefits, and risks, while considering the participants’ cultural traditions, personal preferences and values, family situations, social circumstances, and lifestyles; and 
  • Quality health education plays an important role in patient-centered communication in clinical trials.

While there is a lot of information on the barriers, there is very little written about the solutions. RM Pharma constantly is improving recruitment strategies and has met the target recruitment in 90 percent of our clinical trials. In about 50 percent of the trials, we have exceeded the number of patients assigned. 

To reach our target numbers, we have a year-round program in which the first medical evaluation is free. If any of those patients meet inclusion criteria for any ongoing or future clinical trials in any of our therapeutic areas of expertise, such as rheumatology and immunology, cardiovascular and metabolic diseases, dermatology, pediatrics, otolaryngology, gerontology, gynecology and ophthalmology, they are included in the database and invited to participate. 

In November 2014, RM Pharma organized the 1st Clinical Research Race with the objective of providing information to people about clinical trials. It consisted of a 6km race and 3km walk. Many of our patients and their families participated along with members from the Clinical Research Organization (CRO) and sponsors. From 2015 to 2018, the community outreach regarding clinical research has included medical conferences, purposeful community engagement and education, which have helped demystify clinical trials, address realistic expectations, and build trust between researchers and culturally diverse communities.
In November 2019, we organized a workshop for our patients called “ Designing a Full Life,” in which we also invited health ambassadors to be part of our program to encourage patients to become involved in clinical trials, sharing their experiences participating in studies and how trials can improve quality of life, sharing the importance of clinical research, the work done by our institution in provide cutting-edge care, the possibilities of having additional options for care by choosing to get care within the context of a clinical trial, and the extra monitoring and attention participants receive during a clinical trial. 

In some trials, the sponsor made agreements with clinical trial patient recruitment companies that use a range of methods, from digital advertising to community partnerships, to find the right patients for the trial. Those are helpful but in the end, the researchers and site staff made the difference. 

When the recruitment goal has been reached and one our participants leaves a trial before it is completed, it means that the site and sponsor resources, such as staff time, materials and medical research, are wasted because the data is incomplete. Therefore, it is critical to find ways to promote appointment adherence, treatment compliance, and patient safety.  

While not all dropouts are preventable, making sure that patients feel appreciated, that their expectations are met, and that their questions are addressed have boosted our retention numbers. Family members are important too, so we address their questions and concerns just as much as we do with the patients. Most of the sponsor trials include reimbursement of travel costs, which also greatly helps with retention.  

We’ve also implemented a quick satisfaction survey that a patient completes after the first or second visit in order to value their input. It also allows us to see both the negative and positive trends more easily.

We try to stay top of mind for patients, which means contacting them as soon as the initial outreach has been done. If a patient shares their email address, but doesn't respond to a phone call, we send a follow-up email. Many of our patients in trials are busy people so we ask permission to set up text message or whatsapp and/or phone call reminders about upcoming appointments to help increase attendance and overall trial retention.

As clinical trials have continued through the pandemic, some patients have wanted to come into the office even when they do not have to. Patients like interacting with site staff. 

My point of view is that research should be designed to fit the patient, not the other way around. We now have the opportunity to further improve research recruitment and retention in Mexican clinical trials, taking COVID 19 vaccines as examples. 

Photo by:   Melissa Rosales