Clinical Trial Performance Measurement

Complete this survey and you will receive a slide presentation of the findings of this research upon completion of this study.   The survey must be fully filled out, including target goals and actual performance metrics, to receive any findings. If you have any questions while completing this survey, please contact Shaylyn Pike at either Shaylyn_Pike@cuttingedgeinfo.com or 919-433-0385.

Your Information (This will remain confidential)

Name

Company

Title

Phone

Email

In responding to this survey, please consider two trials that you have recently completed.  Respond for the first trial in the initial set of questions and the second in the following question set.

Trial 1

Background

Q1	For which development phase did this trial take place?
	Phase 1
	Phase 2
	Phase 3
	Phase 4

Q2	To which of the following therapeutic areas did this trial belong?
	Autoimmune
	Cardiovascular
	CNS/Psychology
	Dermatology
	Endocrinology
	Gastroenterology
	Hematology
	Immunology
	Infectious Diseases
	Musculoskeletal
	Oncology
	Ophthalmology
	Pain
	Respiratory
	Urology
	Women's Health
	Medical Devices
	Other

	Please specify.

Q3	In which country was this trial located?

Q4	Approximately how many patients were enrolled in the trial?

Q5	How many investigator sites were needed for the trial?

Q6	In the original protocol, how long did you estimate this trial would take (in weeks)?

Q7	How long did it actually take to complete the trial (in weeks)?

Q8	Which of the following Key Performance Indicators did you measure during this trial?

	Time to complete protocol		Time to close database		Randomization rate per site
	Time to initiate first investigational site		Time from database lock to statistical tables complete		Investigator recruitment rate
	Time to enroll target number of patients		Time from LPO to statistical tables complete		Patient retention rate
	Time to randomize target number of patients		Time from statistical tables complete to trial report done		Site retention rate
	Time from protocol completion to FPI		Time from trial completion to regulatory filing		CRFs collected per CRA day
	Time from FPI to first patient first visit (FPFV)		Number of sites per CRA		Number of blank data fields per CRF page
	Time from FPI to first patient first dose (FPFD)		Cost per patient enrolled		Number of queries per 1000 data points
	Time from FPI to LPI		Cost per patient randomized		Number of report errors per page
	Time from LPO to database lock		Budget to completion of trial		Cost per data error
	Time from LPI to last patient last visit (LPLV)		Cost per clean CRF page		Other
	Time from LPI to last patient last dose (LPLD)		Number of protocol amendments		Other
	Time from LPI to LPO		Enrollment rate per site		Other

	Please specify

Q9	For the KPIs selected in the previous question, please indicate the goals specified in the trial protocol and the actual results calculated at the end of the trial.

Target Goal                                          Actual Result

Time to complete protocol			weeks		weeks
Time to initiate first investigational site			weeks		weeks
Time to enroll target number of patients			weeks to enrollment goal		weeks to enrollment goal
Time to randomize target number of patients			weeks		weeks
Time from protocol completion to FPI			weeks		weeks
Time from FPI to first patient first visit (FPFV)			weeks		weeks
Time from FPI to first patient first dose (FPFD)			weeks		weeks
Time from FPI to LPI			weeks		weeks
Time from LPO to database lock			weeks		weeks
Time from LPI to last patient last visit (LPLV)			weeks		weeks
Time from LPI to last patient last dose (LPLD)			weeks		weeks
Time from LPI to LPO			weeks		weeks
Time to close database			weeks		weeks
Time from database lock to statistical tables complete			weeks		weeks
Time from LPO to statistical tables complete			weeks		weeks
Time from statistical tables complete to trial report done			weeks		weeks
Time from trial completion to regulatory filing			weeks		weeks
Number of sites per CRA			sites/CRA		sites/CRA
Cost per patient enrolled			USD		USD
Cost per patient randomized			USD		USD
Budget to completion of trial			USD		USD
Cost per clean CRF page			USD		USD
Number of protocol amendments			amendments		amendments
Enrollment rate per site			patients/week		patients/week
Randomization rate per site			patients/week		patients/week
Investigator recruitment rate			investigators/week		investigators/week
Patient retention rate			% retained		% retained
Site retention rate			% retained		% retained
CRFs collected per CRA day			CRFs/CRA day		CRFs/CRA day
Number of blank data fields per CRF page			blank fields/CRF page		blank fields/CRF page
Number of queries per 1000 data points			queries/1000 data points		queries/1000 data points
Number of report errors per page			errors/page		errors/page
Cost per data error			USD/error		USD/error
Q8.t1.other.1
Q8.t1.other.2
Q8.t1.other.3

Trial 2

Background

Q10	For which development phase did this trial take place?
	Phase 1
	Phase 2
	Phase 3
	Phase 4

Q11	To which of the following therapeutic areas did this trial belong?
	Autoimmune
	Cardiovascular
	CNS/Psychology
	Dermatology
	Endocrinology
	Gastroenterology
	Hematology
	Immunology
	Infectious Diseases
	Musculoskeletal
	Oncology
	Ophthalmology
	Pain
	Respiratory
	Urology
	Women's Health
	Medical Devices
	Other

	Please specify.

Q12	In which country was this trial located?

Q13	Approximately how many patients were enrolled in the trial?

Q14	How many investigator sites were needed for the trial?

Q15	In the original protocol, how long did you estimate this trial would take (in weeks)?

Q16	How long did it actually take to complete the trial (in weeks)?

Q17	Which of the following Key Performance Indicators did you measure during this trial?

	Time to complete protocol		Time to close database		Randomization rate per site
	Time to initiate first investigational site		Time from database lock to statistical tables complete		Investigator recruitment rate
	Time to enroll target number of patients		Time from LPO to statistical tables complete		Patient retention rate
	Time to randomize target number of patients		Time from statistical tables complete to trial report done		Site retention rate
	Time from protocol completion to FPI		Time from trial completion to regulatory filing		CRFs collected per CRA day
	Time from FPI to first patient first visit (FPFV)		Number of sites per CRA		Number of blank data fields per CRF page
	Time from FPI to first patient first dose (FPFD)		Cost per patient enrolled		Number of queries per 1000 data points
	Time from FPI to LPI		Cost per patient randomized		Number of report errors per page
	Time from LPO to database lock		Budget to completion of trial		Cost per data error
	Time from LPI to last patient last visit (LPLV)		Cost per clean CRF page		Other
	Time from LPI to last patient last dose (LPLD)		Number of protocol amendments		Other
	Time from LPI to LPO		Enrollment rate per site		Other

	Please specify

Q18	For the KPIs selected in the previous question, please indicate the goals specified in the trial protocol and the actual results calculated at the end of the trial.

Target Goal                                          Actual Result

Time to complete protocol			weeks		weeks
Time to initiate first investigational site			weeks		weeks
Time to enroll target number of patients			weeks to enrollment goal		weeks to enrollment goal
Time to randomize target number of patients			weeks		weeks
Time from protocol completion to FPI			weeks		weeks
Time from FPI to first patient first visit (FPFV)			weeks		weeks
Time from FPI to first patient first dose (FPFD)			weeks		weeks
Time from FPI to LPI			weeks		weeks
Time from LPO to database lock			weeks		weeks
Time from LPI to last patient last visit (LPLV)			weeks		weeks
Time from LPI to last patient last dose (LPLD)			weeks		weeks
Time from LPI to LPO			weeks		weeks
Time to close database			weeks		weeks
Time from database lock to statistical tables complete			weeks		weeks
Time from LPO to statistical tables complete			weeks		weeks
Time from statistical tables complete to trial report done			weeks		weeks
Time from trial completion to regulatory filing			weeks		weeks
Number of sites per CRA			sites/CRA		sites/CRA
Cost per patient enrolled			USD		USD
Cost per patient randomized			USD		USD
Budget to completion of trial			USD		USD
Cost per clean CRF page			USD		USD
Number of protocol amendments			amendments		amendments
Enrollment rate per site			patients/week		patients/week
Randomization rate per site			patients/week		patients/week
Investigator recruitment rate			investigators/week		investigators/week
Patient retention rate			% retained		% retained
Site retention rate			% retained		% retained
CRFs collected per CRA day			CRFs/CRA day		CRFs/CRA day
Number of blank data fields per CRF page			blank fields/CRF page		blank fields/CRF page
Number of queries per 1000 data points			queries/1000 data points		queries/1000 data points
Number of report errors per page			errors/page		errors/page
Cost per data error			USD/error		USD/error
Q17.t2.other.1
Q17.t2.other.2
Q17.t2.other.3

Q19	Rate the following trial tasks individually in terms of how much they slow trial timelines. (On a scale of 1 to 10, with 1 representing tasks that do not slow trials at all and 10 representing tasks that are major bottlenecks to trial completion.)
		1		2		3		4		5		6		7		8		9		10
	Trial development/design
	Protocol writing
	CRO/vendor selection and contract negotiation
	Site selection
	Investigator recruitment
	Patient enrollment
	Data cleaning
	Statistical analysis
	Final report writing

Q20	Are performance management/measurement activities conducted in-house or outsourced?
	In-house
	Outsourced
	Combination of both

Q21	What kind of system does your company have in place to track and compile performance metrics?
	Internally-created spreadsheet or database
	Purchased out-of-the-box software
	Purchased customizable software
	Other

	Please specify brand.

	Please specify brand.

	Please specify.

Q22	Why do you track and analyze performance metrics?
	Improve forecasting ability
	Provide basis for policy change
	Identify bottlenecks
	Improve on-time performance
	Determine fair employee/investigator compensation
	Justify staffing/budgetary support to certain departments
	Manage CRO relationships
	Other
	Other

	Please specify.

Q23	How often do you analyze collected performance metrics?
	Never
	Monthly
	Quarterly
	Semi-annually
	Annually
	Other

	Please specify.

Thank you for participating in our survey.

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