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
Visit Assessment Laboratory
-Is a local laboratory accessible?
-Can lab conduct the tests required for this study?
-Turn around time on requested tests
-Certified and accredited
-Experience with clinical trials or sending samples to centralized lab
Visit Assessment Other Factors
-Other clinical trials being conducted or to be conducted at site?
-Other nearby sites doing similar type of study
-May influence recruitment
-Use clinicaltrials.gov as a resource
-How many trials ongoing at site?
-Will sufficient attention be provided to current study?
Investigator Experience, Expertise and Interest
-Review CV to gain understanding of experience or expertise
-Follow-up with in-depth in person discussion regarding
-Research experience in general and in therapeutic area of interest
-I.e.: have they conducted a study with a similar design or similar class of drug if applicable
-Interest in conducting this study
-if there is little to no interest this will carry over to the team and will likely have difficulty with the site
-Attempt to assess schedule of investigator, how involved will they be at the site?
-Observe functioning of the team during your visit, does PI pay attention to site’s activities?
Protocol Adherence
-Does the physician object to the completion of any tasks listed within the protocol
-Do they agree to comply with protocol
-Are they comfortable with administration of placebo
-Do they believe equipoise exists for this condition
Pre-Study Visit
-If significant delay between initial visit and time study is to begin, follow-up visit may be required to confirm conditions remain adequate
-Confirm investigator is still able and willing to conduct study
-Review inclusion/exclusion criteria to confirm population is still present
-Ensuring contract is proceeding and site is taking steps to begin
Investigator’s Meetings and Site Initiation Visits purpose
-To ensure appropriate training and education is provided to investigators and their staff regarding study conduct and procedures
-Ensure study sites have obtained all approvals to conduct study
-Ensure all study supplies and investigational product are available
Investigator’s Meeting
-For larger, multisite studies many sponsors hold investigator’s meetings
-If exceedingly large study with many sites, may be divided into smaller meetings held regionally to make travel more convenient.
-Attendees include investigators from each site, their coordinators, and sponsor representatives
-Monitors commonly involved in these meetings and may be required to present certain information
Purpose of Investigator’s Meeting
-Review study procedures and conduct
-Provide introduction between study staff, sponsor staff and other sites
-Allows questions and discussion regarding study to be addressed
-Functions to ensure critical staff involved in the study are properly aware and trained regarding all aspects of the study
Timing of Investigator’s Meeting
-Sites should be very close to being ready to begin the study at the time of the meeting
-Significant delays between investigator’s meeting and start of study will prevent benefit from being fully obtained as much of the information presented will be forgotten
