CRP 106 Lecture 8 Flashcards
Site Selection Visits (SSVs) purpose
-Time when the sponsor assesses the ability of the clinical research site to conduct the study in a safe, cooperative and timely manner
-Sponsor evaluates the qualifications of the study staff, adequacy of the facilities and the patient population relative to the research study needs
Part-Time Site
Community sites incl. Dr’s offices, clinics, etc.
Investigator conducts research but also maintains clinical practice
Wide spectrum of workload – investigator conducting 1 or 2 studies at a time to spending large proportion of time on research
Advantage of this type of site to sponsors:
Target population may be within practice
At completion of trial, investigator familiar with drug and may continue to prescribe for indication if approved.
Part-Time Site Advantages/Disadvantages to Monitor
Advantages
-Less experienced sites can be trained to conduct study as required by monitor
-Decreased need to change practices learned through previous experiences
Disadvantages
-Potentially less trained and experienced staff so more support needed during growth phase
-Support will need to be provided by monitor – more time commitment may be needed
-Depending on site, may be juggling several competing studies
Dedicated Research Sites
-Only conduct research – no clinical practice
-Generally experienced – less support needed from monitor as to how to conduct research in general
-Typically productive and consistent in conduct
-Main source of funding through research practice – likely more accommodating and compliant
-Experienced staff may challenge actions regarding compliance
-Sites are aware of limits – more likely to inform if not able to complete study within timelines
Academic Sites
-Located within universities and academic medical centres
-Funding from industry sponsored trials may be important in providing funding for other research activities and operations
-Therefore, may be more receptive to findings
Academic Sites Items for Consideration
-Personality of investigator
Finding time to meet with investigator to discuss study issues and progress may be challenging
-If industry sponsored research not priority, low enrollment may be observed and quality of study conduct may be low
-Inexperienced investigators may believe they can alter procedures to explore scientific ideas without regard to meeting overall study aims
-Publication may be important to investigator so be aware of guidelines prior to meeting with them
Site Management Organizations
What are they?: a group of sites linked and managed centrally
-Typically, consistent approach of research across all sites
-May provide SOPs, training on study procedures, assistance with regulatory submissions, etc.
-May provide recruitment services to attract participants to sites
-Consideration for monitoring:
-May need to alter workflow as some activities may not be handled at site but through centralized location.
-May delay monitoring activities if proper workflow and collaboration is not sought and maintained
Qualifying Investigative Sites
-Once potential investigators identified, monitor must assess ability for site to conduct study
-Initial contact via telephone or email
During initial contact assess:
-Any previous research experience?
If yes, type of project previously or currently involved with
-Current patient population
If population present, is this flow sufficient for the study
-Do they have the appropriate staff and facilities available to devote to study?
-Assess initial interest
-Confirm sponsor policy re: amount of information that can be provided prior to meeting
-If policy allows, provide information about drug and/or study to investigator for review
-If require confidentiality/non-disclosure agreement prior to sharing (most likely scenario) ensure signed prior to providing information
Site Selection Visit
-Once attending site, must review numerous items to ensure investigator can complete study
-Investigator experience and expertise
-Interest in conducting the study
-Staff and facilities to conduct the study
-Access to patient population required to conduct the study
Visit Assessment Investigator
-Qualifications
-Currently licensed?
-Specialty applicable to current study?
-Clinical trials experience
# of previous trials
# of trials conducted similar in nature to current study
-Enrollment history of previous trials (# of participants and time frame to enroll)
-Previous inspections (Health Canada, FDA, etc.) and overall findings (if available)
Visit Assessment Study Staff
-Dedicated study coordinator?
-Other specialized personnel available?
-Training in clinical trials/education
-Certification
-Licensure (eg: if RN needed for particular trial)
-Experience in clinical trials
-Staff turnover
-General interest and attitude in conducting research
Visit Assessment Facilities
-Sufficient and appropriate to conduct trial (study rooms available, storage)
-Appropriate drug storage/security and/or appropriate Pharmacy/Pharmacist to dispense
-Specialized equipment present (ie: -80ºC or -20ºC freezer, ECG)
-Active research or clinical practice
-Tour of facilities should occur to confirm information provided above
Visit Assessment Patient/Participant Population
-Proven ability to recruit within timeframe required
-Patients of investigator or obtained from other source
-If not, will other physicians be cooperative with having patients be included in study
-Advertising required to recruit participants?
-Note estimates will always be on the high side – take this into account when determining approximate timeframes to completion
Lasagna’s Law
-The incidence of patient availability sharply decreases when a clinical trial begins and returns to its original level as soon as the trial is completed
-This happens because investigators may rely on their impressions rather than actual experience or data to estimate success
Visit Assessment Research Ethics Board
-Is an REB available within institution to conduct a review?
-Frequency of meeting
-Timing of meetings
-is submission deadline influenced by timing?
-Average time to approval
-Responsiveness
-Is a centralized REB used
