Clinical Trials Patient Recruitment and Management

Assistance:
The team at Medcom Kinetics has assisted clients with clinical trial recruitment for more than 15 years. We have experience assisting with patient recruitment for trials of all types and sizes, including pediatric trials, trials for rare and orphan diseases, and trials for acute and chronic disorders. In helping our clients with clinical trial recruitment, we have focused on the following primary goals:

• Educating patients and, when appropriate, parents and other caregivers about diseases, clinical trial opportunities, and clinical trial specifics
• Supporting patients through the recruitment and early study phases of clinical trials
• Educating investigators, study coordinators, nurses, and other healthcare professionals about clinical trials
• Supporting study coordinators and study sites in their recruitment efforts
• Screening and acquiring patients
• Managing the recruitment process

Study Awareness:
The team at Medcom Kinetics has succeeded in assisting clients in their recruitment efforts by employing various advertising channels to spur study awareness in members of the target population. Each trial's protocol is analyzed to help determine the most effective channels for the advertising campaign. Below are a few of the channels we have utilized to improve response rates.

• Online patient and caregiver advocacy groups
• Print, eg, take-one displays at pharmacies, clinics, and doctor's offices, and VALPAK inserts
• Television and radio
• Consumer-focused medical websites, eg, WebMD
• Banner ads on health plan websites
• Direct mail
• Point of purchase

Diverse Populations:
The team at Medcom Kinetics knows how to speak to and engage with subjects and respondents in diverse populations. We have developed solutions and collateral materials that have helped to improve randomization and retention rates. Below are a few of the languages we have developed materials for and communicated in.

• French (Belgium)
• Dutch (Belgium)
• Dutch (Netherlands)
• US Spanish
• EU Spanish
• French (France)
• French (Canada)
• German
• Russian
• Ukraine (Ukrainian)
• Ukraine (Russian)
• Mandarin (Chinese - Standard)
• Mandarin (Chinese - Simplified)
• Japanese
• Thai
• Korean

HCP Support:
Healthcare Professional Support - contains typical support material, such as inclusion-exclusion criteria details, study information guides, and coordinator teleconference reminders. We have found that coordinator teleconferences can help with difficult-to-recruit trials by allowing coordinators to share and discuss successful and unsuccessful recruitment efforts

Screening:
For screening and acquiring patients, we develop patient self-screening web portals. In addition to study education and information, these portals contain questionnaires, based on the study protocol, that allow potential study subjects to assess their eligibility. Questionnaires can be multi-branching and automatically track respondents' eligibility after every question to ensure we know both if and why a respondent disqualifies for a formal screening. If eligible, the qualified respondent is directed to their nearest study site to schedule a formal screening, and their information is forwarded to the site and our RecruitmentTracker™ system.

Our self-screening portals can be localized and developed in a variety of languages. Patients are directed to these sites through awareness, advertising, and education materials and via other online advertising campaigns which can be tracked to determine reach, effectiveness, and ROI. These portals have proven to be very successful and can be the cornerstone of a recruitment effort.

Self-screening Portals:

Tracking Success:
RecruitmentTracker™ - an online application and database that allows study site coordinators to manage their qualified respondents and other aspects of their recruitment efforts. RecruitmentTracker also allows our clients to monitor and review recruitment data for all sites in a study, including LTFU tracking and reasons. The tool is very powerful and can generate all necessary reports to evaluate study sites and overall trial recruitment, including qualified respondent-to-randomized subject conversion rates.

All data collected from our self-screening portals and call centers are automatically fed into our RecruitmentTracker database, and alerts are automatically sent to the corresponding clinical study sites for all qualified respondents for follow-up and formal screening.

Medcom Kinetics' recruitment services and tools adhere to Good Clinical Practice and comply with HIPAA and other privacy policies. Medcom Kinetics also has experience with Safe Harbor compliance for global recruitment programs.

Patient Materials:
For education and support efforts, we develop materials for delivery in a variety of ways, such as print, downloadable PDF files, and website content. Patient Education and Study Awareness - includes study information guides and trial referral cards. We can develop content in many languages, as seen with the PRECISION Study information samples below, including Asian languages such as Japanese, Cantonese, Thai, and Mandarin.

Patient Materials - Newsletters:
Newsletters - provide study and disease education while helping to keep the study top-of-mind. All of our material developed for patients is written at the appropriate grade level.

Patient Support:
Patient Support - includes various pieces to support patients' efforts, such as study participation guides, enrollment material, and study reminders

Advertising:
Study Awareness and Advertising - samples of study awareness campaign materials

Mobile Apps:
Medcom Kinetics also creates mobile apps (Android and iOS) as well as mobile-ready webapps: materials