The success or failure of a trial strongly lies in the recruitment achievements. Although clinical trials has been conducted in more than few decades, the recruitment continues to be an immerse challenge for most trials. Investigators enthusiasm for ambitious recruitment targets is often misguided. This is called as “Lasagna Law” where by, investigators overestimate the pool of available patients and at the end of the study fails to deliver the promised target.
Failure in achieving recruitment targets will affect the below:
- Jeopardize the quality of a study.
- Causing study delays and data analysis which eventually delays in marketing the investigational product.
- Skewed statistical results
- Decline confidence in investigators
- Increase in resources use and costs
- Potential loss of revenue
- Lost in patient confidence
- Risk of future trial participation with sponsor
We need to understand that each trial is unique and depending on who is being recruited, each trial faces unique challenges and opportunities. Similarly, individual sites for the same study are very different in patient recruitment and retention approaches. Strategies that are used to recruit for the same population may or may not be successful at another site. Thus it is very important that site team especially investigators invest time in planning and executing the strategies.
Investigators are crucial leaders in recruitment. Those sites with successful recruitment rates normally consist of investigators who are active in recruitment and they are the influential people in building the relationship and confidence in patients. When you ask most of the patient, they value the time spend with the doctor as they get increased attention and care.
Example of recruitment strategies:
- Investigators own patient database
- Need to choose patients who are likely to comply with study visits and medications
- Referral from nearby clinics, hospitals and network of colleagues in a society
- Pamphlets and poster distribution within the hospital, nearby health clinics and private hospitals
- Media Advertisement – Radio, TV, newspaper or through social media
- Have promotional campaign/booth to promote on clinical trial and studies
- Present the study at local/regional/national related therapeutic meetings, CME courses, department meetings
- Engaging departments such as pharmacy, counselling or dietician depending on trial nature on distributing pamphlets or identifying potential patients from their database
It is important to layout the strategies and discuss with team on the execution of the strategies and the needed resources. Preferably this discussion should be initiated once the site is selected and alert the monitor and sponsor on the required resources. Many meetings/ discussion will only enhance the quality of recruitment strategy. At the end of the day, this will help in site preparation, minimal wasting of time in obtaining the appropriateregulatory approval and it reflects well on the site in terms of commitment and planning. Some of the tools might be a bit resource intensive and some costly. That being said, these are the most effective strategies for most of the trials.
Even though the recruitment layout might look promising in achieving the targets, it is good to anticipate problems and quickly recognize when a recruitment strategy fails or target goals are behind the schedule. Discussion within the team and monitor or sponsor will help in ensuring site-specific enrolment barriers are overcome.
Study coordinators plays significant role in patient recruitment and retention as well. They are the key connectors between the subjects and trial. The communication and relationship between the study coordinators and patients is a vital role as well in retaining the patients in the trial. They need to make every attempts in contacting or identifying potential patients and discuss with investigators if need to revise the recruitment strategies.
Let’s look at some of the tips that might be useful for both Investigators and Study Coordinators during recruitment and retention:
- Always explain the pros and cons of their participation in the study. Make them sense the big picture and they are part of it even when the study does not have any intervention approach, convey your beliefs in the potential
- Be excited about the study
- Highlight the scientific rationale of the study and impact of their participation could have – Convey in a lay friendly language where patient can relate to
- Prepare power point slides to present the study to potential patients
- Always available if patients want to contact you due to any concern or questions
- Have more in person communication – help to build relationship and address any immediate concerns
- Create a database of patients who express interest in research participation
- Once patient participates in the trial, make compliance and visit reminders
- Always keep the patient updated on the progress of the study, their personal health and discussion of their test results taken for the trial – Feedback provided sensitively and quickly
- Payment for trial participation “Travel Reimbursement” is given swiftly
- Discuss the trials visits – To ensure patients compliance and what to be prepared for during the next visit
- Provide educational support that might be helpful for patients or any disease related brochure that might enhance their knowledge on their disease
- Be flexible, be timely, and appreciate their time commitment
The complexity of trial and expectations are constantly challenged at site. We all should take the responsibility of contributing to recruitment strategies, barriers and in achieving the targets. Sharing experience or lessons from a successful recruitment site will inspire and guide other sites and also factoring learning lessons from others’ failure might be useful in planning effective tools. Always brainstorm new approaches with the team and revisit these ideas regularly. It is recommended to intercept potential dropout rate when recruiting a population.
PLAN in advance, ADOPTION of innovative methods, COMMITMENT of team members, EXECUTION and SUSTAIN quality.
By Kalpana Devi a/p Balagangatharan, Associate Regional Manager (Northern B), Clinical Research Malaysia.