Res esea earch ch S Site P e Per erspecti ctives Chan anges es i in S Site a e and P Patient B Burden en David P. Walling, Ph.D CNS Network, LLC. Long Beach, CA
COST PER CONSENT COST PER CONSENT 1/ 1/ 16 $1,886 1 / 1 / 1 6 $2,184 $1,728 $2,537 3/ 1/ 16 $1,584 3 / 1 / 1 6 $1,699 $1,341 $1,301 5/ 1/ 16 $1,431 5 / 1 / 1 6 $1,448 $1,420 $1,196 7/ 1/ 16 $1,154 7 / 1 / 1 6 $1,005 $1,770 $1,901 9/ 1/ 16 $1,447 9 / 1 / 1 6 $2,220 $1,659 $2,542 11/ 1/ 16 $2,536 1 1 / 1 / 1 6 $1,696 DEPRESSION $1,992 $2,084 MIGRAINE 1/ 1/ 17 $3,732 1 / 1 / 1 7 $2,400 $1,841 $1,931 3/ 1/ 17 $2,338 3 / 1 / 1 7 $2,021 $6,227 $2,367 5/ 1/ 17 5 / 1 / 1 7 $1,639 $5,187 $2,074 $1,823 7 / 1 / 1 7 $3,659 7/ 1/ 17 $2,201 $2,062 $1,714 9 / 1 / 1 7 $1,793 9/ 1/ 17 $1,662 $1,173 $2,076 1 1 / 1 / 1 7 $1,373 11/ 1/ 17 $1,568 $2,830 $2,011 1 / 1 / 1 8 $15,020 1/ 1/ 18 $1,878 $1,366 $1,349 3 / 1 / 1 8 $2,717 3/ 1/ 18 $1,843 $1,713 $1,723 5 / 1 / 1 8 $1,187 5/ 1/ 18 $1,347 1,203 1,198 7 / 1 / 1 8 2,070 7/ 1/ 18 2,751 9 / 1 / 1 8 9/ 1/ 18 1 1 / 1 / 1 8 11/ 1/ 18 COST PER CONSENT COST PER CONSENT 1/ 1/ 16 $3,315 1 / 1 / 1 6 $1,027 Cost P Co $4,795 $661 3/ 1/ 16 $4,402 3 / 1 / 1 6 $761 $3,795 $800 5/ 1/ 16 $2,820 5 / 1 / 1 6 $915 $1,589 $781 7/ 1/ 16 $2,465 7 / 1 / 1 6 $596 $2,573 $964 9/ 1/ 16 $2,629 9 / 1 / 1 6 $811 SCHIZOPHRENIA $5,624 $865 Per Co 11/ 1/ 16 $9,351 1 1 / 1 / 1 6 $815 $3,089 $789 1/ 1/ 17 $4,256 1 / 1 / 1 7 $1,073 BIPOLAR $2,007 $947 3/ 1/ 17 $2,071 3 / 1 / 1 7 $985 $1,611 $1,049 r Consent 5/ 1/ 17 $2,651 5 / 1 / 1 7 $960 $2,145 $1,174 7/ 1/ 17 $1,984 7 / 1 / 1 7 $815 $2,310 $789 9/ 1/ 17 $2,781 9 / 1 / 1 7 $1,073 $4,127 $947 11/ 1/ 17 $791 1 1 / 1 / 1 7 $985 $1,104 $1,049 1/ 1/ 18 $1,871 1 / 1 / 1 8 $848 $1,337 $616 3/ 1/ 18 $5,540 3 / 1 / 1 8 $718 $1,147 $361 5/ 1/ 18 $1,529 5 / 1 / 1 8 $1,217 1,534 1,111 7/ 1/ 18 1,790 7 / 1 / 1 8 9/ 1/ 18 9 / 1 / 1 8 11/ 1/ 18 1 1 / 1 / 1 8 COST PER CONSENT COST PER CONSENT 1 / 1 / 1 6 $8,551 1/ 1/ 16 $4,485 $3,323 $10,177 3 / 1 / 1 6 $1,482 3/ 1/ 16 $3,722 $1,716 $7,637 5 / 1 / 1 6 $3,000 5/ 1/ 16 $2,402 $3,002 $4,343 7 / 1 / 1 6 $1,008 7/ 1/ 16 $1,788 MULTIPLE SCLEROSIS $1,656 $2,176 9 / 1 / 1 6 $2,628 9/ 1/ 16 $2,056 $2,085 $2,522 ALZHEIMER'S 11/ 1/ 16 $2,924 1 1 / 1 / 1 6 $7,773 $3,423 $4,314 1/ 1/ 17 $3,089 $6,702 1 / 1 / 1 7 $3,858 $4,797 3/ 1/ 17 $3,826 3 / 1 / 1 7 $3,017 $9,332 $2,692 5/ 1/ 17 $4,462 5 / 1 / 1 7 $842 $9,143 $5,076 7/ 1/ 17 $5,789 $1,704 7 / 1 / 1 7 $6,887 9/ 1/ 17 $7,671 $4,001 $2,424 9 / 1 / 1 7 $3,642 11/ 1/ 17 $5,183 $4,198 $2,838 1 1 / 1 / 1 7 $4,161 1/ 1/ 18 $5,820 $1,168 $3,170 1 / 1 / 1 8 $3,917 3/ 1/ 18 $1,532 $2,899 $4,308 3 / 1 / 1 8 $2,190 5/ 1/ 18 $6,329 2,333 $1,859 7/ 1/ 18 2,575 5 / 1 / 1 8 $2,046 6,675 9/ 1/ 18 7 / 1 / 1 8 7,090 11/ 1/ 18 9 / 1 / 1 8 1 1 / 1 / 1 8
Mor ore C Com omplex x Prot otocols • Increased time needed to adequately plan and prepare • Increased need for protocol clarifications • More stringent inclusion/exclusion criteria • Greater number of procedures at each visit • Increased number of vendors • More time spent in training • Increased number of emails, phone calls, etc.
Add dditional Site B e Burden en • Sites required to contract with more outside vendors • Sites required to purchase additional supplies • Decreased time for study start-up • Increased amount of mandatory study specific training • Greater number of staff required to complete training • Mandatory vendor training • Pre-randomization forms now becoming common – often duplicating data
Technological C Considerations • Technology vendors require increased training • Tablets often slow down patient visits thereby frustrating both patients and staff • Coordinators have to track the subject’s compliance with devices at home
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