1. PATIENT RECRUITMENT & RETENTION Presented By: Prajakta Bhole Priyal Bhoyar Priyanka Jagtap Prasad Bagave MSc.CRM PRIST(09-11)

2. CONTENTS INTRODUCTION BASIC PRINCIPLE METHODS STEPS IN RECRUITMENT PROCESS PROFESSIONAL APROACH ETHICAL ISSUES RETENTION OF STUDY SUBJECT RECENT ADVANCES CONCLUSION

3. INTRODUCTION The process of new drug development is extremely time consuming and expensive. For a new molecule that is discovered it would take approximately 10-15yrs to reach the market at cost of $500-800 million. Patient recruitment and retention are considered the “key bottle-neck” of clinical trials.

4. Patient recruitment if not adequately planned for can extend development time-lines by a number of years. Retention of patients throughout the life of a clinical trial is essential in order have complete data sets for analysis and subsequent filings. Lasagna’s law - states about the recruitment process from the initial stage upto the completion of the trial.

5. BASIC PRINCIPLES OF PATIENT RECRUITMENT Why People Participate in Clinical Trials ? (Center Watch Survey,2000)

6. SOURCES OF PATIENT RECRUITMENT Government employees Private industry Medical referrals From clinical labs Blood banks Local advertisement Mass media Special populations

7. BARRIERS TO PARTICIPATE: Risk of side effects Concern about getting placebo Center too far away Unable to find a trial Not eligible Inconvenient time Lack of information

8. What MOTIVATES Patients to participate in clinical trial? Access to promising therapy. Access to greater medical expertise. Close individual attention/care. Emotional support. Altruism.

9. METHODS: Investigator’s database Overestimate the number of patients they would be able to enroll. Look at the number of subjects with general overall diagnosis. Internet Increasingly used by patients to find health information. Internet users may be better educated, higher household incomes, and are more likely to complete a study.

10. Advertising Name and address of the clinical investigator The purpose of the study, and in summary eligibility criteria A straightforward and truthful description of the benefits (payments or free treatment) Location of the research and the person to contact for further information Direct mailing Low cost approach: reaches a large numbers of participant E-mail lists (certain colleges, health center—broadcast e-mails)

11. CLINICAL REFERRALS: Informing physicians directly via letter or phone Direct mailing to patient from clinic staff is possible if letter comes from clinic physician Includes recruitment material such as posters,flyers. Have two options: 1. Opt-in 2. Opt-out

12. THE RECRUITMENT FUNNEL: Prior to starting a recruitment campaign, an investigator need to project how many patients he would need to see. This lead to the development of “Recruitment Funnel” on the basis of which ultimate study performance would be analyzed. The Recruitment Funnel is also the basis for setting up budgets for trial.

13. STEPS IN RECRUITMENT PROCESS: Identify- Protocol suitable patients are identified by mining the investigator’s database. Approach - once identified, are approached to participate in the trial. Inform Consent and Screen- Inform consent signed by patients undergo screening. Assess- Final assessment is made when a subject is suitable for a particular protocol. Enroll-Recruited- After the above 4 steps patient is enrolled/recruited into a study.

14. PROFESSIONAL APRROACH: Planning: Recruitment should start with the initial stages of protocol design so as to make it easy for investigators to recruit patients. Budgeting: Typically 10-15% of a study budget is allocated to recruitment. Monitoring & tracking: All recruitment activities should be monitored for their effectiveness. Metrics: The collection of metrics begins with the first phone call and entailed measuring and analyzing the various recruitment method. Training: Training of the staff is shown to boost morale and improve confidence leading in the end to better performance.

15. ETHICAL ISSUES: Confidentiality and privacy of personal health information- Any information by which a patient is identified is called identifying information. Health information is kept confidential and is protected by federal law called HIPAA. Advertising for clinical trial patients – It is one of the way of recruiting protocol suitable patients in clinical trials. Various media such as newspaper, radio, television etc. can be used. should be approved by IRB/IEC before use.

16. Undue influence – Offering excessive, unwarranted, inappropriate or improper compensation as an attraction to enroll or remain compliant in a clinical trial is called using undue influence. To prevent undue influence compensation must be reasonable and must not influence a patient’s decision to enroll in a trial. Vulnerable population – Includes children, mentally disabled patients, prisoners sometimes elderly, students and employees of the investigator. For these groups informed consent form may be signed by legally acceptable representative(LAR).

17. RETENTION OF STUDY SUBJECTS : Keeping subjects in study. Harder than recruiting patients is retaining them in study. High dropout rate would make a study statistically invalid. Drop-out rates for study are approximately 25%.The rate increases to approximately 30% for phase 3 studies. Why do we care? Validity of result.

18. RETENTION IS CLOSELY RELATED TO SATISFACTION: Treating participants with respect. Communication between research staff. Communication about particular disease. Attention to factors such as transportation etc.

19. RECENT ADVANCES: Professional recruitment providers – they work with sponsors, CRO’s and SMO’s to improve recruitment. Increased use of market research – sponsors are turning towards market research strategies to increase patient recruitment. Informatics – is a database driven approach to find good potential subjects. Centralized recruiting – consist of one centralized location for all information regarding potential participants. It ensures that only suitable candidates are scheduled at various research sites. Development of metrics – The “Leaky pipe Analysis”.

20. CONCLUSION : As the number of clinical trials increases, the number of patients needed continues to increase. Traditional recruitment methods have failed to deliver recruitment goals within the specified timeframes, making sponsors look for newer innovation. Exploring the difficulties of recruitment and retention helps in growing, learning and improving on next project.

21. REFERENCES: Guide to clinical trial - by BERT SPILKER. Basic principles of clinical research - by S.K.Gupta. A Guide to Patient recruitment & retention - D.L.Anderson. Centerwatch survey 2000. www.pharmabiz.com