Overcoming Complexity on a Phase 2 Glaucoma Study The Specific Situation • A Phase I/II multi-site study needed to enroll more than 100 patients across three distinct cohorts on an exceeding complex protocol: • The Sponsor implemented 7 protocols amendments over 13 months. How could the sponsor find enough patients who could meet the stringent enrollment standards and stick with the program? THE KEY QUESTION: Key Words: Ophthalmology, Ocular Hypertension (OHT), Primary Open-Angle Glaucoma Designed Around You • Multiple pre-dosing IOP measurements required for eligibility. • Strict inclusion based on best-corrected visual acuity (BCVA), cup-to-disc ratio, central corneal thickness; exclusion for recent ocular surgery any history of laser or instrumental orbital surgery, and • Patients subjected to major lifestyle and dietary restrictions during study participation: no exercise, use of contact lenses, caffeine, chocolate, alcohol, tobacco, vitamins nor analgesics. • Limited use of oral calcium channel blockers and beta blockers. • Twice-daily office visits requiring multiple procedures, overnight IOP assessments and detailed daily diaries.

Overcoming Complexity on a Phase 2 Glaucoma Study · Phase 2 Glaucoma Study The Specific Situation • A Phase I/II multi-site study needed to enroll more than 100 patients across

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Overcoming Complexity on a Phase 2 Glaucoma Study

The Specific Situation

• APhaseI/IImulti-sitestudyneededtoenrollmorethan100patientsacrossthreedistinctcohortsonanexceedingcomplexprotocol:

• TheSponsorimplemented7protocolsamendmentsover13months.

Howcouldthesponsorfindenoughpatientswhocouldmeetthestringentenrollmentstandardsandstickwiththeprogram?

THE KEY QUESTION:

Key Words: Ophthalmology, Ocular Hypertension (OHT), Primary Open-Angle Glaucoma

Designed Around You

• Multiplepre-dosingIOPmeasurementsrequiredforeligibility.• Strictinclusionbasedonbest-correctedvisualacuity(BCVA),cup-to-discratio,central

cornealthickness;exclusionforrecentocularsurgeryanyhistoryoflaserorinstrumentalorbitalsurgery,and

• Patientssubjectedtomajorlifestyleanddietaryrestrictionsduringstudyparticipation:noexercise,useofcontactlenses,caffeine,chocolate,alcohol,tobacco,vitaminsnoranalgesics.

• Limiteduseoforalcalciumchannelblockersandbetablockers.• Twice-dailyofficevisitsrequiringmultipleprocedures,overnightIOPassessmentsand

detaileddailydiaries.

Page 2: Overcoming Complexity on a Phase 2 Glaucoma Study · Phase 2 Glaucoma Study The Specific Situation • A Phase I/II multi-site study needed to enroll more than 100 patients across

North&LatinAmerica:+14239689533AsiaPacific&Europe:+44(0)1753512000

[email protected]

www.chiltern.com

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A B C D E F G H I J K L M N O

Days to IRB Approval

Days to Fully Executed Contract

Days to Activation

A Customized Solution

• Conductin-depthfeasibilityassessmenttoensurethatsiteshavethestaff,facilities,equipment,motivationandexperiencetosuccessfullyconductthetrial.

• Providedetailedpatient-specificschedulestositestoaidinsubjectvisittrackingandprocedurescheduling;updatewitheachprotocolamendment.

• Fosteranenvironmentofopenandfrequentcommunicationamongsitestaff,CRAs,andtheprojectmanagementteamthroughscheduledwebmeetings,teleconferencesandweeklycorrespondence;answerquestionsquicklyandprovidesitetoolstomanageafrequentlychangingprotocol.

• Closenon-producingsitesandaddadditionalsitesquicklyinordertomaximizeuseofresources.

• Providesiteswithsmallgifts(food,officesupplies,holiday-themeditems)ofappreciationforextraefforttomotivateresearchstaffandkeepthestudyattheforefrontoftheirdailyactivities.

The Positive Outcomes Bycarefullyvettingsites,maintainingclearcommunicationandemphasizingstaffmotivation,Chilternwasabletosystematicallyovercomesubjectidentificationandretentionchallenges,andenablethesponsortomeetallrecruitmentgoals.

• Effectiveimplementationensuredpromptsitestartupfor24sitesduringan18-monthperiod.(seechart)

• 137patientsweresuccessfullyrecruitedwithinthetimeframe,despitechangesandalterationsnecessitatedby7protocolamendmentswithin13months.

• Chilternbuiltandmaintainedaproductiveandongoingrelationshipwiththesponsorleadingtosuccessivepivotalprogram.

Key Words: Ophthalmology, Ocular Hypertension (OHT), Primary Open-Angle Glaucoma

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