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One of the key challenges that is faced by clinical trial organizations is recruitment of clinical trial participants. One major constraint in this process is that the patient must meet all the inclusion criteria in order to be consider for the trial. To achieve a

recruitment goal on-time for a clinical trial, clinical coordinators must be able to apply linear optimization process in their decision-making. Linear optimization, also called linear programming is a method used for modeling quantitative decisions so that the decision-makers can achieve the best possible outcome (Analytics Vidhya, 2023).

I work in a clinical research organization. In February of this year, the team I work with was given three clinical trial studies for hypertension,COPD and Type II diabetes. The team was required to recruit participants for these studies. Despite all the constraints we had, the goal for the team was to recruit the right participants in the time frame that was given as well as the numbers that were needed. To achieve this objective, the team formulated two strategic plans.

First, we designed a plan to work with all the physicians along with their medical assistants in the clinic. Following straight adherence of HIPPA and PHI policies, we were able to know the patient's appointment date and time with their providers. Second, we wanted to find the most efficient time-saving method for each interaction with the patients. To achieve this, wepre-identified each potential participants for each study, and then put together a brief overview of the inclusion criteria for each study and distributed them to each physician.

The physician was asked to brief the patient about the study, after their consultations. If the patient was interested in the trial, a coordinator would walk with the patient into another exam room and discuss the study objectives. If the patient still expresses interest in the study, a copy of the informed consent form (ICF) and phone number were given to the patient to take home. The patient was asked to review the ICF before the office would make a follow up call. The interactions among the physicians, medical assistants and clinical coordinators in the clinic were able to help our team to achieve our recruitment objectives within two months.

The team had two choicesrecruit patients from the community or recruit patients within the clinic by directly working with their providers. The team made a strategic decision to follow the most efficient approach. The method of choosing the best option shows that the team was implementing a linear optimization approach.

Reference, Analytics Vidhya, (2023). Linear Programming | Applications Of Linear Programming (analyticsvidhya.com)