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Dr Y S Sumathy Module 2 Assignment.pptx
- 1. PATIENT RECRUITMENT AND RETENTION Dr Y S Sumathy CRD Batch-II Bangalore Bioinnovation Centre
- 2. RECRUITMENT: Is getting the attention of, and attracting potential research participants. RETENTION: Research participants remaining in the study for its duration, to provide valuable data and attain study objectives. It is also referred to as “Attrition” (participants leaving the study prematurely and/or being “lost to follow up”). Introduction
- 3. Research participant recruitment and retention is essential for conducting a successful trial. Introduction
- 4. VARIOUS STEPS INVOLVED IN RECRUITMENT PROCESS • Inclusion/Exclusion criteria • Adequately explaining the study • Recruiting an adequate and representative sample • Obtaining true informed consent • Maintaining ethical standards • Retaining participants until study completion • Minimizing cost-benefit ratio and Compensation
- 5. VARIOUS METHODS OF PATIENT RECRUITMENT • Advertisements • Honest Broker System • Recruitment letters and/or scripts • Research registry • “Dear Doctor” Letters to encourage clinician referrals • General public interest news items on diseases or conditions -not study specific • Recruitment advertising that is intended to be seen or heard by prospective subjects to solicit their participation in a study • Newspapers, local papers, publications for parents, etc. • Television and radio • Posters, flyers: post around campus, in public spaces with permission if necessary. • Random digit Dialing (RDD) used in surveys and polling • Pop-Ups, banner Ads with required IRB approval
- 6. STRATEGIES TO FACILITATE RETENTION: • Inquire the patient about barriers to participation “Why…and is there anything we can do?” • Flexible visit schedules like early morning, evenings and weekends • Access visit windows • Atmosphere of visit length of time spent in clinic • Diversions–magazines, DVDs and refreshments • Study staff and clinic staff interaction • Develop tools for your team and make it as easy as possible to conduct the study procedures especially for clinical staff • Communication with participants: honest and frequent education enables an informed decision • Develop trust with the patients • Reminder phone calls and e-mails • Appreciation cards like –birthday cards, study anniversary cards and study tokens • Thank you letters at study close and share results if allowed
- 8. BARRIERS OF RECRUITMENT AND RETENTION • Subject-related barriers Long waiting times Inconvenient scheduling of appointments Unrealistic expectations of Subjects • Investigator-related barriers Investigator’s underestimation of the workload Lack of time and resources • Protocol-related barriers and Overly complex study designs • Other barriers negative influence of the media delay in ethical approval poor choice of study site by the sponsor
- 9. CHALLENGES IN CLINICAL TRIAL PATIENT RECRUITMENT AND ENROLLMENT • Sponsor perspective Those who design the study plan must specify a larger number “N” in the protocol than the number of participants expected to be evaluated at study closure. • Principal Investigator perspective Commonly drug companies and contractors offer large payments to doctors, nurses and other medical staff to recruit patients, some getting finder’s fees for merely referring patients to the study. This activity is strongly frowned upon in academic institutions and absolutely discouraged. • Clinical research volunteer perspective lack of awareness of clinical trials, lack of access to trials,distrust or suspicions of research,practical or personal obstacles,Insurance or cost problems, Unwillingness to go against personal physician’s wish,long-standing fear, apprehension and skepticism. People from various cultural or ethnic backgrounds hold different values and beliefs that may be different.
- 10. RECENT ADVANCES • Professional recruitment providers • Increased use of market research • Informatics • Centralized recruiting • Development of Metrics
- 13. MOST EFFECTIVE RECRUITMENT STRATEGIES 0 2 4 6 8 10 Use of existing database Targeted specific clinic Use of study flyer Word of mouth/snowball Newpaper ads Community outreach/field- based
- 14. RECRUITMENT BARRIERS 0 1 2 3 4 5 6 7 8 9 Misinformed Lack of health insurance No contact information Prejudice of study medication Distance to study site Personal health issues Privacy/confidentiality concerns Missed appointment Time commitment Lack of interest Lack of transportation Low level of education Lack of study partner Low compensation Uncomfortable/Distrust
- 15. BARRIER REDUCTION STRATEGIES 0 2 4 6 8 Accommodate schedule Provision of study/program… Community outreach Rapport building Privacy/Confidentiality… Fair compensation Explanation of study procedures Exhibiting caring attitude Pre-study information session Question & answer sessions Sharing study newsletter Displaying respect
- 16. RETENTION STRATEGIES 0 5 10 15 20 25 Explanation of study and… Community outreach Provision/study resources Occasional Contact Taking advantage of patient visits Holding annual events Pre-visit telephone calls Being respectful Being sensitivity Being attentive/listening Frequent reminders Scheduling flexibility Fair compensation Post-visit telephone calls Rapport (keeping in touch)