The process of enrolling patients in clinical trials and ensuring their continued participation is known as recruitment and retention, respectively. These are critical components of clinical trials that must be carried out strictly according to protocol in order to be successful. Any deviation from the protocol can lead to partial or complete failure of the trial. Despite numerous strategies for maintaining these processes, the failure rate in clinical trials remains high, with up to 86% failing during the enrollment phase and up to 15% of patients dropping out of the study.
Very well known, when assessing the expected recruitment of patients on teleconferences on current operational tasks, mention that sites represented by the main investigator give numbers for patient recruitment to get into the study, and after the start of the study, patient recruitment does not occur. In other words, the investigator is saying one thing, but in fact no one (neither the monitors nor the sponsor) expects this, that is, uncertainty remains and there is no leverage for sites to say a patient recruitment figure that is close to the truth. Even an investigator’s figure of expected recruitment must be an integral element combining his experience in many fields – treatment, clinical trials, administrative, patient’s communication etc. There is no approach that allows to transform the integral, but still subjective assessment of the patient population by the main investigator into an objective one (objectivize) and preserve integrity.
Patient enrollment in clinical trials is essential and this is one of the key factors, especially in the initial stages of a clinical trial. The consistent flow of patients into the study regardless of circumstances is essential for the sponsor, CRO, investigator, and all other parties involved in the study. We also know that while 80% of patients express willingness to participate in a study, only 10% actually do so, and 33% of sites and principal investigators are unable to enroll any patients.
The one way to boost recruitment is only to motivate sites through communication with a person who is also educated like the investigator – the medically-educated medical liaison staff of a sponsor or CRO.
We developed the next motivational tools to boost recruitment:
- Motivational visits – all sites were visited once right after the start of enrollment in order to address issues and questions;
- Physician support of some medical aspects of study-specific procedures based on experience from other sites; the sponsor assigned a separately employed physician and each site was visited by this doctor in order to address medical aspects of the protocol;
- Motivation through fee – each site was proposed to have a few gradual payments per determined period;
- Motivation through the publication or article – high enrollers were proposed to be an author of upcoming article;
- Motivation through the conferences – high enrollers were proposed to attend a medical conference per protocol nosology.
Finally, we used these tools for the 4 multinational multicenter studies in oncology and achieved success in recruitment which we elected to share in the professional community.
About the author:
Svyatoslav Milovanov, MD, PhD
Dr. Svyatoslav Milovanov has more than 15 years of Phase I-IV clinical research experience. Graduated in 2000 Dr. Svyatoslav Milovanov as a pediatrician he has been started his work in big regional hospital and worked on pediatrician positon during 7 years combining the job with university duties. In 2003 got a PhD degree. Since 2006 firstly participated I clinical trial as a sub-investigator and since 2007 fully dedicated to Clinical Trial industry on roles of Medical Monitor, CRA, Auditor, Study Physician. Has international certificates of both as a doctor (AKH, CHOP) and clinical trial professional (CRO). In 2021 certified as an oncologist. Member of many professional societies – ACRES, RQA, ESMO. Published more than 80+ scientific articles.
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