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Welcome. Follow us and stay connected through social media :. @mySCRS and #SiteSolutionsSummit. Site Solutions Summit Networkers Group. Disclaimer. Check with your professional consultants (legal, financial, HR, etc.) to obtain specific information pertaining to your company.

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slide2

Follow us and stay connectedthroughsocial media:

@mySCRS and #SiteSolutionsSummit

Site Solutions Summit Networkers Group

disclaimer
Disclaimer
  • Check with your professional consultants (legal, financial, HR, etc.) to obtain specific information pertaining to your company.
  • This information is not meant to direct you on how to address any specific issues.
  • Antitrust–compliance policy adherence.

http://myscrs.org/24-revision-v1/policies/antitrust-compliance-policy/

beach rules
Beach Rules
  • Picnic lunch on the beach
    • Sponsor & CRO representative at each table
    • Table 45 changed to Eli Lilly
    • Map in your program – pg 8 & 9
  • Roundtables
    • 1:45 – 2:30
    • 2:45 – 3:30
    • 3:45 – 4:30
  • Receptions & Eagle Award Gala
  • Meet up for breakfast 8 – 9:20am
goggle was originally named
Goggle was originally named?
  • Find It
  • Sum Up
  • Back Rub
  • Dig It
slide6

Successful people are always looking for opportunities to help others. Unsuccessful people are always asking, “What’s in it for me?”

- Brian Tracy

what we all know
What We All Know
  • Too Long
  • Too Expensive
  • Too Unpredictable
slide8

What We All Want

Time

Predictability

Cost

Quality

what we all need
What We All Need

Quality Data

Reliability

Speed

Enrollment

cycle time for multisite clinical trials in the united states
Cycle Time for Multisite Clinical Trials in the United States
  • Retrospective study
  • 19 organizations submitted data
  • 5,396 studies were submitted
  • 10,673 line of data submitted
  • About ½ of the data unusable
    • despite some steep intervention

CTTI – Diana Abbott, Robert Califf, Briggs Morrison, Jean Bolte, Swati Chakraborty

conclusion
Conclusion
  • We are not collecting standardized measures of cycle times … to support evidence-base health care, standard measures should be developed…
where we all need to go together
Where We All Need To Go - Together
  • Establish Global Industry Standards
    • Sites and the Rest of You Too
  • Determine What’s Important
    • Compliance & Business Operations
    • Relationship of the metrics
  • Then we’ll talk about all the rest…
    • i.e. accreditation, etc.
site terminology metrics
Site Terminology & Metrics

Business Foundation

  • Human Resource
  • Facility & Equipment
  • Business Development & Marketing
  • Quality
  • Finances
  • Commitment
site terminology metrics1
Site Terminology & Metrics

Opportunity

  • First learn of the study – study decision for your site
    • Feasibility
    • Pre-site Visit
site terminology metrics2
Site Terminology & Metrics

Pre-Study

  • Site Selection – Study Activation
    • Budget & Contract
    • Regulatory Submission
    • Recruitment Plan
    • Training
    • PI Meeting
    • Source Document Development
    • Equipment/Supplies/IP Management
site terminology metrics3
Site Terminology & Metrics

Enrollment

  • Site Activation-Study Enrollment Ends
    • Screening
    • Consenting
    • Randomization
    • Retention
    • Data Management
    • Control of
      • Supplies/inventory
      • IP
      • Regulatory Management
site terminology metrics4
Site Terminology & Metrics

Follow-Up

  • Enrollment Ends – LPLV
    • Retention
    • Data management
    • Control of inventory
    • Control of IP
    • Regulatory management
site terminology metrics5
Site Terminology & Metrics

Close-Out

  • LPLV - Study Close Our Visit
    • Data Management
    • Control/Return of Inventory/IP
    • Regulatory close out
    • Achieved
5 standard site terms
5 Standard Site Terms
  • Opportunity
  • Pre-Study
  • Enrolling
  • Follow-Up
  • Close-Out
summit survey demographics
Summit Survey Demographics

Academic Sites 8%Hospital Sites 29%Private Practices 39%Sand-alone research centers 25%

______________________________________________________________________________________

Investigators 39%Site Manager/Director/VP 26%Coordinators 19%

geographic distribution
Geographic Distribution
  • North America 54%
  • Europe 30%
  • South America 8%
  • Asia-Pacific 3%
  • Other 5%
summit survey results
Summit Survey Results

354 sites

  • 29% SCRS members
  • 20% Summit attendees, but not SCRS members

Statically, SCRS members have sites that have been in business for more years than non-SCRS members (χ²: 7.89; p=0.05)

business foundation step 1
Business Foundation – Step 1
  • Human Resource
  • Facility & Equipment
  • Business Development & Marketing
  • Quality
  • Finances
  • Commitment
interviewing practice
Interviewing Practice

Alwayscheck references

  • 78%
  • 60%

Site Solutions Summit Survey 2012 n = 142 & Site Solutions Summit 2013 n=146

now that they re hired
Now That They’re Hired

2012 2013

Have a formal orientationprogram 62% 51%

Do not always follow theorientation program 22% 73%

Site Solutions Summit Survey 2012 n = 142 & Site Solutions Summit 2013 n = 146

certification of site staff
Certification of Site Staff

Site Solutions Summit Sponsor/CRO Survey 2011 n = 35, 2012 n=151 & Site Solutions Summit Site Survey 2011 n = 141 & Site Solutions Summit 2013 n = 129

sites that have a qa auditing process
Sites That Have a QA, Auditing Process
  • 74%

QA ongoing studies

37% Always

29% Often

23% Sometimes

11% Rarely

1% Never

Site Solutions Summit Survey 2012 n = 115

best describes your qa system
Best Describes Your QA System
  • 37% Staff review each others work
  • 24% One designated person
  • 14% Work closely with the CRAs
  • 6% Want to, but can’t fine the money
  • 4% Hire an outside firm

Site Solutions Summit Survey 2012 n = 115

percent of sites you work with that you think are audit ready
Percent of Sites You Work With That You Think Are Audit Ready?
  • <25% 32%
  • 26-50% 32%
  • 51-75% 29%
  • 75%+ 7%

Sponsor/CRO Site Solutions Summit Survey 2012, n=149

opportunity step 2
Opportunity – Step 2
  • First learn of the study – study decision for your site
    • Feasibility
    • Pre-site Visit
emr realties
EMR Realties
  • 51% Have an EMR system
  • 78% Use it during the feasibility process to identify potential subjects
    • 96% SCRS Members use it during feasibility
  • 44% Flag identified potential records
    • 27% don’t have that capabilities
    • 22% do not flag charts
    • 8% are unsure if they do
    • 67% SCRS members flag charts

Site Solutions Summit 2013 n=181

feasibility investment
Feasibility Investment

Site Solutions Summit 2013 n =181

conversion rate
Conversion Rate

2013 80% of studies pursued were awarded

2012 70% of studies pursued were awarded

Site Solutions Summit Survey 2012 n=119, 2013 n = 181

study load
Study Load

Statistically, a greater number of SCRS member sites were likely to be involved in higher study loads (>11) than non-SCRS members (χ²: 11.98, p<0.05)

Site Solutions Summit 2013 n = 181

pre study step 2
Pre-Study – Step 2
  • Site Selection – Study Activation
    • Budget & Contract
    • Regulatory Submission
    • Recruitment Plan
    • Training
    • PI Meeting
    • Source Document Development
    • Equipment/Supplies/IP Management
cycle times days
Cycle Times (days)

*Unclear if the IRB contact is submission or approval, those that reported the name of the IRB mostly listed central IRBs

2013 SCRS Survey

summary irb site activation visits
Summary: IRB, Site Activation, Visits
  • Statistically, SCRS members were more likely to be quicker from IRB contact to site activation than non-SCRS members (r=0.65, p<0.05)
  • Statistically, there was no difference in the cycle times between SCRS and non-SCRS members for other aspects of site action and patient visits. (r=0.12, p>0.05)
multi tasking budget contract reg docs simultaneously
Multi Tasking Budget, Contract & Reg Docs Simultaneously
  • Yes 61%
  • Sometime 31%
  • No 8%

Site Solutions Summit 2013 n =108

on average how many working days does it take a site to return a budget contract sponsors cros only
On average how many working days does it take a site to return a budget & contract? – Sponsors & CROs Only
  • 0-5 days
  • 6-10 days
  • 11-15 days
  • 16-21 days
  • 21+ days
budget contract cycle time
Budget & Contract Cycle Time

Site Solutions Summit 2013 n = 108

implication of cross indemnification
Implication of Cross Indemnification
  • No extra time required 47%
  • More than 2 weeks 32%
  • More than a month 9%
  • Deal breaker, won’t sign 12%
    • SCRS Members 19%
    • Non member 8%

Site Solutions Summit 2013 n=108

accepts first study budget offer
Accepts First Study Budget Offer

Site Solutions Summit 2013 n=106

what do you think best negotiation tips
What Do You Think?Best Negotiation Tips
  • Provide additional justificationof costs
  • Provide additional justificationofstaff costs
  • Escalate to a more senior staff person
  • Have the PI involved & escalate the issue
  • Provide past performance metrics
  • Walk away (or indicate strongly you will)
how are your negotiation skills
How Are Your Negotiation Skills?

Site Solutions Summit n=141

successful negotiation actions
Successful Negotiation Actions
  • 51% Provide additional justification of costs
  • 17% Provide additional justification of staff costs
  • 13% Have the PI involved & escalate the issue
  • 11% Provide past performance metrics

Site Solutions Summit 2013 n = 181

non refundable payment why
Non-Refundable Payment,Why?
  • Lack of monthly paymentandthis is a way to frontloadcash requirement
  • To recuperate start up costs
  • Seldom request it because we can never get it
now the truth non refundable payment
Now The TruthNon-Refundable Payment

64% To recuperate start up costs

18% Lack of monthly payment and this is way to front load cash requirement

8% Seldom request, we can never get it

SCRS Members 5%

Non members 11%

Site Solutions Summit n=108

first payment
First Payment
  • 57% non-refundable/administrative fee
  • 24% have “refundable” advances

CFS Financial n = 11,472 studies

non refundable start up received
2006 $2,367

2007 $1,381

2008 $2,550

2009 $2,740

2011 $3,205

2013 $2,927

SCRS Member $3,323

Non-Member $2,927

Non-Refundable Start Up Received

Site Solutions Summit Survey 2007, 2008, 2009 & 2010, n=1,260 studies, 2011 =800 studies, 2013 Summit Survey n= 1,181 studies

average cost per visit across 10 different therapeutic categories
Average Cost per Visit across 10 different therapeutic categories
  • $809 (includes vaccines)
  • $880 (excludes vaccines)

Both exclude screen failures and discontinues

invoicing practices
Invoicing Practices

Of interest – the sites in business the most years, with the highest GR and doing the most studies, invoice the least.

26% all payments processed are invoiceable items & not driven by EDC

~5 different invoiceable line items on average per CTA

~ $1,168 per study

2013 CFS Clinical n = 11,427 studies

2012 Site Solutions Summit Survey n= 125 sites

Site Solutions Summit 2012 n=125

enrollment step 3
Enrollment – Step 3
  • Site Activation-Study Enrollment Ends
    • Screening
    • Consenting
    • Randomization
    • Retention
    • Data Management
    • Control of
      • Supplies/inventory
      • IP
      • Regulatory Management
enrollment cycle times
Enrollment Cycle Times

2013 SCRS Survey n= ~2,000 studies

summary enrollment cycle
Summary: Enrollment Cycle
  • SCRS members enrolled more patients (Mean=50.24, SD=12.46) than non-SCRS members (Mean=30.48, SD=14.34). This difference was statistically significant (p=0.024)
  • SCRS members utilized a lower number of days to meet randomized goal from study activation (Mean=180.20, SD=140.36) than non-SCRS members (Mean=201.09, SD=203.49). This difference was statistically significant (p=0.048)
  • There was no difference between SCRS and non-SCRS members over %times randomized goals met, exceeded and % exceeded by
agree neutral disagree
Agree Neutral Disagree
  • Site pay greater attention to enrollingstudies that have monthly payment terms.
  • Slow payment terms & withholdingmoney earned places our site infinancial stress.
  • When the contract states the sites is paid on a ratio of screen failure to randomize subjects and the site has not had great success in randomization g a number of consented subject they will stop screening.
is it time to look at lackluster enrollment from a different perspective
Is It Time To Look at Lackluster Enrollment from a Different Perspective?

Site Solutions Summit 2013 n =108

data entry
Data Entry

Site Solutions Summit 2013 n=146

timeliness improves as study progresses
Timeliness Improves as Study Progresses

Source: Medidata Insights Metrics Warehouse 2013-SEP and Medidata analysis

slide62

“Correlation Does Not

Imply Causation”

But it might make us think!

ecrf entry timeliness higher enrollment
eCRF Entry Timeliness => Higher Enrollment …

Mean eCRF Entry Cycle Time vs. Total Enrolled Patients

Total Patients Enrolled

Mean eCRF Entry Cycle Time (Days)

Source: Medidata Insights Metrics Warehouse 2013-SEP and Medidata analysis

1 pain point for any business cash management
# 1 Pain Point for Any Business CASH Management

Payment Terms

2012 2013

Monthly 25% 39%

Every Other Month 9% 1%

Quarterly 46% 37%

2012 Site Solutions Summit Survey 2012 n=840 studies

scrs supports ciscrp the study for information study on clinical research participation
SCRS Supports CISCRPThe Study for Information & Study on Clinical Research Participation
  • Educate the general public about clinical research
  • “Aware for All” Days
  • Hero Campaign
  • Pamphlets
scrs believes in ciscrp s mission
SCRS Believes in CISCRP’s Mission
  • We have donated over
  • 40K in 4 years
  • SCRS will continue to match 100% of all donations
  • Box at registration desk
  • Contributions are tax deducible donation
  • Cash, credit cards, checks
follow up step 4
Follow-Up – Step 4
  • Enrollment Ends – LPLV
    • Retention
    • Data management
    • Control of inventory
    • Control of IP
    • Regulatory management
subject retention metrics
Subject Retention Metrics

There was no significant difference between SCRS and non-SCRS members for screen failures, completion and dropped rates (p>0.05)

2013 SCRS Survey

close out step 5
Close Out – Step 5
  • LPLV - Study Close Our Visit
    • Data Management
    • Control/Return of Inventory/IP
    • Regulatory close out
    • Achieved
withholding trends
2006 12%

2007 13%

2008 13%

2009 11%

2013 48% of CTA have holdbacks

2013 12%

Withholding Trends

Site Solutions Summit 2007, 2008, 2009 & 2010, n=126, * CFS Financial n= 11,427 studies

profit margins
Profit Margins

Percent

Site Solutions Summit 2013 n=141

a request to industry
A Request to Industry

56% A post study site report card would be extremely valuable

Receiving a post study site report card would..

28% Definitely change the conduct of our work

67% Probably change the conduct of our work

Site Solutions Summit Survey 2013