RECRUITMENT STRATEGIES: WAYS TO FACILITATE RESEARCH

Transcription

1 RECRUITMENT STRATEGIES: WAYS TO FACILITATE RESEARCH PARTICIPANT ENROLLMENT AND RETENTION Rosleen Mansour, M.A. Research Coordinator Research Coordinator Department of Psychiatry and Behavioral Sciences September 25, 2012

2 RECRUITMENT ISSUES (SOURCE: MARITHEA GOBERVILLE, PH.D) Patient recruitment is the leading barrier in conducting studies 50% of sites enroll 1 or 0 patients 6% of clinical trials are completed on time Time to market is key concern for sponsor Can cost up to $1 million/day for delays in getting drug to market kt

3 STEP 1: STUDY DESIGN/REVIEW/CONTRACT Reviewing the protocol/contract: What is the target enrollment? N=??? Expected recruitment rate? Maximum N, minimum N? Multi site trials: Is enrollment competitive? Will the study be terminated once enrollment met? Ideal to have flexible target enrollment What are the recruitment milestones/timelines? Target population: review of inclusion/exclusion criteria What is the expected screening failure rate? What is the design of the study (e.g., Open Label vs. g y g p Placebo controlled), risks, potential benefits?

4 SAMPLE CONSIDERATIONS (CPHS) Cultural diversity is strongly encouraged Your clinical i l ti trial sample should ldbe representative tti of the local population affected by the condition in terms of: Ethnicity/Race Gender Age Economically disadvantaged subjects: costs related to research should not preclude participation p and financial remuneration, reward, or reimbursement for expenses must not be coercive to potential participants Exclusion of a particular group may only be justified in certain cases (see CPHS Recruitment guidelines)

5 STEP 2: RECRUITMENT PLAN 1. What strategies have been successful in the past? 2. What resources do you need? 3. How will you recruit? Databases Approaching existing patients in clinic Advertising (tv, radio, newspaper) Sponsor referrals Community outreach External clinics/schools/facilities Websites/internet Advisory board/focus groups/surveys on patient sources and needs? 4. How will you ensure diversity? 5. When can you start to recruit??? What do you need to accomplish before you can recruit? Contract/budget IRB Training Site Initiation visit Ordering of supplies 6. Subject renumeration, compensation, reimbursement?

6 STEP 2: RECRUITMENT PLAN: COMPENSATION? 1. Must not be coercive and must be approved by IRB 2. Compensation must be equal to all participants 3. Reimbursement for expenses 4. Compensation for time commitment 5. Compensation for inconvenience i or discomfort

7 STEP 3 BUDGET3 How much is it going to cost for you to recruit and screen? What is the sponsor contributing to recruitment? E.g., Advertising firm? National campaign, materials? Recruitment costs: Costs for advertising, flyers, website design Costs for staff time (community networking, developing recruitment materials, posting information, contacting colleagues, contact participants,) Screening costs : Telephone screening Screening failures

8 PLANNING BUDGET PERSONNEL TIME Time estimates Screen Dose Titration MAINTENANCE Timeline in Study Visit 0 Visit 1 Visit 2 Visit 12 Visit 13/Final Total/participant Item Patient Qualification/Screening Personnel Needed * Pre visit Screen Visit Baseline Week2 Week42 Week48 Recruitment SC 60 Administrative Time (reg binder, filing, billing) SC 60 Phone screening SC 30 Visit Prep/Scheduling SC Informed Consent SC 30 Inclusion/exclusion SC 30 Patient History MD 30 Physical Exam MD 20 Vital Signs MD Menarcheal status (female) MD Urine Pregnancy Test SC Serum Pregnancy Test SC/Nurse/CRU 10 Clinical Laboratory Tests SC/Nurse/CRU lead ECG SC Reading of ECG MD assessment1 SC 25 assessment2 SC 180 assessment3 SC 90 assessment4 SC assessment5 SC assessment6 SC assessment7 SC 15 assessment8 SC assessment9 MD Adverse event collection MD Prior/con meds SC IP dispensed SC/MD IP instruc/compliance/accountability SC Post Visit Processing Regulatory/Electronic t logging Scoring of measures SC Completion/collection/review of study forms SC Data entry SC Processing Lab samples SC PI review of CRFs PI Team administrative (meetings, trainings)/mo Team Total Study Coordinator (SC)Time (hr) Total Physician (MD) Time Total PI Time (hrs) Total Participant Time (hrs) Particpant reimbursement $ 130 $ 45 $ 25 $ 15 $ 65 $ 485

9 PLANNING BUDGET Principal Investigator: Study Title: SPONSOR BUDGET WORKSHEET - Costs Billable To RESEARCH Study Sponsor: Start Date: A. ***STARTUP COSTS (non-refundable): Base 30% IDC TTL Inv. Investigator Meeting IRB Fee: Awards >$50, = $2000 Protocol submission Consent development Administrative Fee: (budget, contract, recruitment, regulatory set-up) $ 3, , CRU start up Other: Long Distance SUB-TOTAL STARTUP COSTS $ 3, $ , C. PER PATIENT COSTS: Standard of Care (SOC) or Research Pre-screening Visit 0 Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 7 Visit 8 Visit 13/Final Total Research (R) Screen Visit Baseline Week2 Week4 Week6 Week9 Week18 Week24 Week48 Telephone screen Research (R) $ Informed consent Research (R) $ Physical exam/med hx Research (R) $ $ $ $ $ $ $ $ $ Assessment 1 Research (R) $ Assessment 2 Research (R) $ Clinical Laboratory Tests Research (R) $ $ $ $ $ $ $ $ $ ECG readings Research (R) $ $ $ $ $ $ $ $ $ Prizes, treats, supplies Research (R) $ 5.00 Patient Stipend Research (R) $ Patient Parking Research (R) $ SUB-TOTAL PER PATIENT COSTS $ $ $ $ $ $ $ $ $ $ Number PATIENT Telephone Screened NUMBER OF PATIENTS Screened NUMBER OF PATIENTS Enrolled 50.00N Phone screen 20.00N SCREEN 10.00N ENROLL SUB-TOTAL PATIENT COSTS $ 36, D. ***OTHER INVOICE ITEMS: TO BE INCLUDED IN CONTRACT UPON OCCURRENCE Base 30% IDC TTL Invoice Recruitment costs $ 9, $ 2, $ 11, Unscheduled Safety Visits *Total Amount to Be Unscheduled SRS FDA Audit Fee Received From Sponsor * IRB Fee - Continuing Review Amendment Querie Resolution SAE Total of Other Invoice Items (does not include "Other invoice items") Other invoice items will be invoiced as they occur *Note: Total amount to be received is based on an estimated recruitment numbers of subjects. Final total is subject to change according to actual number of participants

10 STEP 4: DEVELOP RECRUITMENT MATERIALS Flyers/Brochures/Tearsheets Templates available from CTRC: Example flyer Ads (radio, newspaper, tv): develop scripts Website content Collecting information electronically or through the web: Caution: confidentiality of participants must be protected All PHI must be kept on secure servers in zone 100

11 STEP 4: DEVELOP SCREENING MATERIALS Pre Screening participants With CPHS approval of waiver of authorization, the study team may conduct preliminary screening through research registry or conducting telephone screens Screening form, including: Inclusion/exclusion criteria Potential participant contact information Recruitment script that explains how the person s name was obtained, introduces study design, requirements, risks, benefits, study medication, location of the research Caution: No participants can undergo study procedures (e.g., discontinuation of prohibited medications until they are consented)

12 CLINICAL TRIAL WEBSITES Clinical trials.gov Online database of federal and sponsored trials Registration of certain clinical trials is mandatory Research Match: tool that helps connect volunteers with researchers. The database will sent invitation notices to potentially eligible volunteers UT Health Clinical Trials page Maintained by CTRC

13 ASSEMBLE SCREENING TOOLS Screening logs: documentation of participants screened, including dates, reason for exclusion, and if possible gender and age Waiting Lists Participant database: for future research

14 STEP 5: IRB APPROVAL All advertisements and recruitment methods/materials must be reviewed and approved by CPHS prior to implementation to assure that the information does not promise or imply a certainty of benefit beyond what is contained in the protocol/informed consent. Guidelines for Recruitment Flyers, Ads, Posters, & Brochures tmc html Recruitment Information should include some of the following elements (those in bold are mandatory): Research is specified. The ages for eligibility. Inclusion/Exclusion l i criteria i (e.g., Right handed h dparticipants i t only ). l ) The purpose of the research must be clearly stated. The amount of time required to complete the study. Any benefits (Note: a straightforward and truthful description of the benefits to the subject for participation in the study, e.g., no charge for taking part in the study, no cost health examination, or providing treatment and counseling for the drug addictions.) Any risks. (Note: If there are minimal risks other than mild boredom or mild fatigue, you may either include them or state that they will be discussed prior to the beginning of the study.) The contact person s name is identified. The institution is identified. Monetary compensation information is optional. (Note: Although the consent document must specify the EXACT amount of any financial compensation, recruitment materials should state that monetary compensation will be provided. The location of the research. Things that should be avoided: Do not emphasize monetary compensation. Do not state the amount of compensation. Do not use catchy words such as exciting, cutting edge, etc. Do not recruit children directly. Do not misstate information contained within the protocol

15 STEP 6: RECRUIT! Develop and maintain community relationships Network with other providers, schools, and groups Establish give and take relationships with the community Post Flyers in various locations Identify locations where you will find potential participants (ensure you receive approval to post) Hospitals Clinics Facilities Schools Supermarkets, libraries, employment centers, Mailouts Send letters and flyers to colleagues, support groups, past patients Advertise Start with UT Media Radio, tv, newpaper websites Presentations Start with your department, school, institution Support groups, organizations Attend Community events Fundraisers Resource fairs

16 UT RESOURCES Office of sponsored projects CTRS CPHS p// / /g / ent.html Media Relations c affairs/media relations.htm Office of communications/graphic design (websites, flyers, logos) Office of Advancement/Communications/design

17 STEP 7: SCREEN! Have staff available to take calls Train your staff GCP training? Knowledge of protocol, inclusion/exclusion Knowledge about condition and study population Confidentiality issues Communication style (a lot of information presented understandably and in a non coercive manner) Ability to establish rapport with potential participants Ability to listen, be polite, yet keep calls as a screen and redirect participants to the screening interview Cultural considerations Safety Ability to be sensitive in explaining if did not meet screening criteria Ability to refer to services if needed Continuously update the waiting list

18 STEP 8: ASSESS YOUR RECRUITMENT STRATEGIES Obtain the source of the referral when screening Evaluate recruitment milestones Revise recruitment plan as needed (with approval from CPHS) Obtain feedback from participants on reasons they did/did not participate and the screening experience in general Periodically re distribute flyers and re send ltt letters to colleagues

19 RECRUITMENT CHALLENGES Study visit burden inform participant of number of visits, length of visits and study length Inform participants of study requirements from the onset (e.g., prohibited concomitant medications, no new therapies) Assist participants p with appts/planning visits Confirm and remind for upcoming visit ( s, cards, calendars) Provide doctor excuses for missed work/school Transportation (maps, costs to travel)

20 RECRUITMENT CHALLENGES Consenting challenges Apprehension of participating i in clinical i l trial ti and taking tki new medication Fear of non FDA approved drug Fear of adverse affects Reluctance to risk receiving placebo Fear of study procedures (e.g., blood draws or other procedures) Having a well trained and understanding clinical staff and PI to help address these concerns Providing participants with the safety nets they need to feel comfortable (contact numbers, pagers, pg emergency information) Current trends in community/condition

21 RETENTION STRATEGIES Visit Experience keep visits as smooth and brief as possible by preparing ahead for participants, not over scheduling, and ensuring wait times are minimized Have waiting room materials (magazines, toys) Reduce annoyances/barriers to participant (e.g., parking convenient, wait time) Avoid and Address False Expectations Be continuously honest about study limitations Be sympathetic to concerns about lack of response/remind patients contributing to science PI should be available to address patient concerns/questions Build and maintain relationships with participants Study personnel should be professional and pleasant Use clinical skills and empathy to help participants with difficult procedures Conduct specialized training with study staff if specialized population (e.g., children, aggression, etc) Establish trust with your participants Communication/Follow up up Call participants between visits to check in (especially if long interval between visits) Confirm and remind of upcoming appointments Obtain updad contact information for participants

22 RETENTION STRATEGIES Keeping eligible participants, eligible: Re affirm/remind of exclusion/prohibited concomitant medications at each visit Anticipate i t problems/issues for each specific participant i t (e.g., cannot swallow compound, side effects, coordination of care) Counsel on strategies to improve IP compliance Remind of importance of visit windows Explain the preferred process for dropping out of the study (e.g., importance of being evaluated and returning study medication) If participant needs to be terminated from study provide follow up referrals (leave on a good note)