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  • November 07 2014

Key opinion leaders (KOLs) have long been contracted for assistance in the development of protocols for clinical trials.  Subscribing to “in-the-field” empirical and anecdotal evidence assists in a more patient friendly research study by taking into account the many lessons learned in the treatment of patients with chronic, acute, infectious, seasonal and terminal illnesses.  The study team responsible for protocol development generally spends months in discussion with their KOLs determining the procedural and control aspects and how they play a part in data gathering and, ultimately, proving safety and efficacy.

It has been our experience, however, that all-too-often the potential for enrollment and retention of the at-large patient population is addressed after the protocol has been approved.  Furthermore, it tends to be viewed as a mathematical rather than motivation based function of the study.  Many times we have seen patient enrollment feasibility as a direct function of the number of patients required for enrollment divided by the number of sites, divided by the number of months provided for enrollment… resulting in average number of patients per site per month.  Although it is important to know what the enrollment requirements are for your sites this form of assessment is not patient enrollment feasibility.

In order to fully examine enrollment feasibility for any study it is of the utmost importance to first understand the life of the average patient, the low maintenance patient, the patient that falls into the numerical center and those in the extremes of treatment (high, low, average and mean). What is a typical day like for each of these patients and what is their probable motivation for enrolling in a clinical research study?  Are there others likely to assist in decision making for the patient’s healthcare and research needs?  What functions of a clinical study are most likely to stand in the way of general research interest, enrollment and follow-through?

Motivation comes in the form of pain abatement, easing of irritation, co-morbidity, mortality, motility and personal gratification.  De-motivating factors may include fear, ignorance, inconvenience, maintaining status-quo, disinformation (negative press), poor physician-patient communication and the ominous informed consent procedure. 

Additionally, we need to fully understand the socio-economic status, the information gathering and processing standards, the stigmatic nature of the condition and how it affects patient’s willingness to provide information at pre-screening and the social circle of information sharing between patients and caregivers. 

This is not new information here.  Abraham Maslow proffered his “hierarchy of needs” in 1954 (see diagram, below).  Fundamental to the understanding of motivation is the level at which certain factors influence our decisions.  It can be ascertained that all but the first level of Maslow’s hierarchy can apply to patient motivation in the context of the global clinical trials as a whole. This has become a standard of psychology education in the modern world and should be a standard in enrollment feasibility assessment.

Feasibility then, is a product of several aspects affecting the day-to-day life of patients within the specific protocol population.  The best sources of information of this nature are your study team, your investigators, your KOLs, and the patient population themselves.  Although much of this information may not be in the form of empirical evidence, your entire team’s experience in the particular disease state, combined with the knowledgebase accumulated through hands-on treatment, anecdotal observances and lessons learned should be the basis for determining the feasibility of the study’s enrollment objectives. The ultimate goal of any true enrollment feasibility assessment is to be able to predict which enrollment tactics will result in the most time and cost efficient solutions to your enrollment challenges. Addressing motivational factors in your recruitment, enrollment and retention tactics will yield a more effective communication model between your sites and their potential subjects, further resulting in a far greater enrollment rate and more accurate data.

Understanding the direction and rate of communication flow will help in the assessment of recruitment and enrollment tactics that fall into the categories of common sense and verifiable assessment.  It is also important to determine which inclusion and exclusion criteria will most likely result in disinterest and what points in the inquiry through evaluable patient lifecycle will result in population loss.

Successful enrollment is a function of patient communication and the sooner you address the motivation of your potential patient population the sooner you will meet your study objectives. Use your investigators, your study team, and don’t rely entirely on empirical evidence in assessing patient motivation for entering your study.  Be creative, use common sense and take a few inferential leaps when considering your enrollment objectives… your study participants will be glad you did.