Ruth Carrico PhD RN FSHEA CIC Associate Professor Division of Infectious Diseases

Review basic elements of screening and recruitment that support a non-biased approach Identify some similarities in screening and recruitment strategies that cross a variety of research areas

EnrollScreenRecruit Validity of the study depends upon recruitment of adequate numbers of a representative population, retention of those subjects, ensuring the protocol is followed

Patient Concerns about risk and safety, community standard, publicity, abilities to meet study requirements, financial constraints, loss of interest, language or culture, transportation Research team Pressure to recruit, inclusion/exclusion criteria; variable recruitment planning, costs to recruit Study sponsor Unaware of patient attitudes, costs associated with recruitment

Identifying, recruiting then enrolling is the most challenging part of the trial Rates as low as 3%-20% of screened subjects Fear of losing autonomy and decisions-making Fear of being treated like “guinea pig” Fear doctor will not be able to provide ideal treatment Fear of receiving a placebo

Recruit with the end goal of enrollment Focus on increasing awareness of the health topic being researched, potential impact of participation on the their health, engagement in the learning process.(Caldwell 2013) Truly consider patient’s willingness to participate Try to know the patient’s interests and motivations to participate Explore the abilities of the patient to complete the study milestones Avoid coercive conversations or actions Caldwell PHY, Hamilton S, Tan A, Craig JC (2010) Strategies for Increasing Recruitment to Randomised Controlled Trials: Systematic Review. PLoS Med 7(11): e doi: /journal.pmed

“…the procedure for recruiting subjects is not coercive and does not state or imply a certainty of favorable outcome or other benefit beyond what is outlined in the consent document and protocol.” “No claims should be made, either explicitly or implicitly, that the drug, biologic or device is safe or effective for the purpose under investigation…” “Advertisements should not promise free medical treatment, when the intent is only to say (the) subject will not be charged for taking part in the investigation.”

Review basic elements of screening and recruitment that support a non-biased approach Identify some similarities in screening and recruitment strategies that cross a variety of research areas

Plan: Identify target research population Develop recruitment timeline and milestones Develop profile of potential subjects Identify potential sources of subjects Determine method of approaching each source Identify recruitment advertising IRB Questionnaire Plan for moving from recruitment to screening phase

Methods: Flyers Media (newspaper, radio, TV, billboards) Professional networks Clinics Referral Existing databases (check with IRB first!)

Are eligibility criteria met Are inclusion criteria met Has the patient been screened for social barriers to participation/retention Can/Does your study support recruitment and screening of vulnerable populations Staff attitudes and communication skills Open communication with subjects. What do they need in order to be retained in the study

Establishing personal relationships, when possible and when appropriate Engage with subjects to promote retention Address retention issues at the time of screening to ensure subject understands what their involvement in the study means to them Remember that the subject has the right to refuse