The document outlines a trial enrollment strategy and patient recruitment plan for a clinical trial comparing ZOCOR and Lipitor in patients with high cholesterol. The trial is currently under-enrolled, with only 2 patients enrolled out of a goal of 10. Various recruitment methods like advertising and outreach are proposed to boost enrollment. Barriers to recruitment and retention like patient burden and lack of communication are identified, along with strategies to improve participation like transportation assistance and regular contact with patients.

1. Trial Enrollment Strategy: Patient Recruitment & Retention Plan Protocol 96267-MRK 12-week, randomized, open-label, parallel group study of ZOCOR®, 40 mg QD compared to Lipitor®, 20 mg QD in patients with primary hypercholesterolemia Marwah Zagzoug CRA 106 October 31, 2006 - Session 8

2. Recruitment & Retention Strategy Timely enrollment of patients is critical to the trial’s success. The 96267-MRK study is currently experiencing a shortage in enrollment. Each site has allotted $5000 which will be used for solutions to increase patient recruitment & retention. Site holds a patient database of 4000 Expected enrollment: 10 patients Currently enrolled: 2 patients and one lost to follow up Recruitment campaigns and advertising will be initiated to boost enrollment. Dear doctor letters Advertising: brochures, referrals, TV, radio, newspapers, internet, etc.

3. Obstacles Preventing Successful Recruitment & Retention Patient loses interest in the trial Trial becomes too burdensome Spending too much time at the clinic Having to spend a long time in the waiting area Patients feeling uncomfortable or intimidated during any aspect of their involvement in the trial Afraid to ask or not given an opportunity to ask questions Not being asked how they are feeling or how the study is going for them. Lack of courtesy and respect from any staff member towards patients Little or no communication with patient Rushed or hurried through their appointment Patients feel the investigator does not want to see them and they become reluctant to continue with participation Investigator shows little interest in patients or study Being seen by someone other than the investigator or Being seen by a different person at each visit, which prevents the patient from being at ease while in the study

4. Successful Methods for Maximized Recruitment & Retention Provide additional services for patients Reminder calls the day before each visit Send a taxi, shuttle, or other transportation service for pick up if needed Notes and cards for participation and completion of study Thank you notes Holidays Birthday cards Give out special study gifts for participation T Shirts Mugs Tote Bags Inform patients that their contribution is significant to the trial. Make patients feel appreciated Discuss what happens during their visits Have patient concerns allayed & their questions answered Communicate openly and respectfully with patients and help them understand that their partnership and cooperation is vital to the success of the trial. Obtain IRB approval beforehand Obtain IRB approval beforehand

5. Sample Advertisement All office visits, medical evaluations and investigational medications related to this study will be provided to you at no cost. For further information on this study and how you can participate, please contact: Dr. Mike Lipid Phat Pharma 100 Low Density Lane Fat Globules, CT 06877 203-798-VLDL Do You Have High Cholesterol? The researchers at Phat Pharma need your help. Males and females, age 18 or over with high cholesterol are needed for a study to compare the effects of higher doses of ZOCOR® (simvastatin) and Lipitor® (atorvastatin). This study will last for 12 weeks and participants will be closely monitored to ensure safety. This research study has been approved by the Institutional Review Board under federal regulations.