Managing work flow in high enrolling trials: The development and implementation of a sampling strategy in the PREPARE trial
David PogorzelskiUyen NguyenPaula McKayLehana ThabaneMegan CamaraLolita RamseyRachel B. SeymourJ. Brett GoodmanSheketha L. McGeeJoanne FraifoglAndrea HudginsStephanie L. TannerMohit BhandariGerard P. SlobogeanSheila SpragueGerard P. SlobogeanSheila SpragueJeffrey WellsMohit BhandariGerard P. SlobogeanMohit BhandariSheila SpragueJean-Claude D’AlleyrandAnthony HarrisDaniel C. MullinsLehana ThabaneJeffrey WellsAmber WoodGregory J. Della RoccaAnthony HarrisJoan HebdenKyle J. JerayLucas S. MarchandLyndsay M. O’HaraRobert ZuraMichael J. GardnerJenna BlasmanJonah DaviesStephen Y. LiangMonica TaljaardP.J. DevereauxGordon GuyattLehana ThabaneDiane Heels‐AnsdellDebra MarvelJana PalmerJeffrey WellsJeff FriedrichDaniel C. MullinsNathan N. O’HaraMs. Frances GrissomGregory J. Della RoccaI. Leah GitajnKyle J. JeraySaam MorshedRobert V. O’TooleBradley PetrisorMegan CamaraFranca MossutoAnthony HarrisManjari JoshiJean-Claude D’AlleyrandJustin FowlerJessica C. RiveraMax TalbotSheila SpragueMohit BhandariShannon DoddsAlisha GaribaldiSilvia LiUyen NguyenDavid PogorzelskiAlejandra RojasTaryn ScottGina Del FabbroOlivia Paige SzaszDiane Heels‐AnsdellPaula McKayGerard P. SlobogeanNathan N. O’HaraAndrea HoweJoshua RudnickiHaley K. DemyanovichKelly LittleC. Daniel MullinsMichelle MedeirosEric KetteringDiamond HaleRobert V. O’TooleJean-Claude D’AlleyrandAndrew EglsederAaron J. JohnsonChristopher G. LanghammerChristopher LebrunTheodore T. MansonJason W. NasconeEbrahim ParyaviRaymond A. PensyAndrew N. PollakMarcus F. SciadiniGerard P. SlobogeanYasmin DeganiHaley K. DemyanovichAndrea HoweNathan N. O’HaraKatherine JosephJoshua RudnickiMegan CamaraBrad PetrisorHerman JohalBill RistevskiDale WilliamsMatthew DenkersKrishan RajaratnamJamal Al-AsiriJordan LeonardFrancesc Marcano-FernándezJodi GallantFederico PérsicoMarko GjorgjievskiAnnie GeorgeRoman M. NatoliGreg E. GaskiTodd O. McKinleyWalter W. VirkusAnthony T. SorkinJ. SzatkowskiJoseph R. BaeleBrian MullisLauren C. HillAndrea HudginsPatrick M. OsbornJustin FowlerSarah N. PierrieEric MartínezJoseph KimmelKyle J. JerayJohn D. AdamsMichael L. BeckishChristopher C. BrayTimothy R. BrownAndrew W. CrossTimothy DewGregory K. FaucherRichard W. GurichDavid E. LazarusS. John MillonM. Jason PalmerScott E. PorterThomas M. SchallerMichael S. SridharJohn SandersL. Edwin RudisillMichael J. GarittyAndrew S. PooleMichael L. SimsClark M. WalkerRobert CarlisleErin Adams HoferBrandon S. HugginsMichael D. HunterW. A. MarshallShea Bielby RayCory D. SmithKyle M. AltmanJulia C. BedardMarkus F. LoefflerErin R. PichiotinoAustin A. ColeEthan J. MaltzWesley ParkerT. Bennett RamseyAlex BurnikelMichael ColelloRussell J. StewartJeremy WiseMarion MoodyStephanie L. TannerRebecca G. SniderChristine E. TownsendKayla H. PhamAbigail MartinEmily RobertsonSaam MorshedTheodore MiclauUtku KandemirMeir MarmorAmir MatityahuR. Trigg McClellanEric MeinbergDavid ShearerPaul ToogoodAnthony DingErin DonohueTigist BelayeEleni BerhaneselaseAlexandra R. PaulKartik GargJoshua L. GaryStephen J. WarnerJohn W. MunzAndrew M. ChooTimothy S. AchorMilton L. Chip RouttMayank RaoGuillermo PecheroAdam S. MillerJennifer E. HagenMatthew PatrickRichard VlasakThomas KrupkoKalia SadasivanChris KoenigDaniel P. BaileyDaniel WentworthChi VanJustin T. SchwartzNiloofar DehghanClifford B. JonesJ Tracy WatsonMichael D. McKeeA KarimMichael TalericoDebra L. SietsemaAlyse WilliamsTayler DykesWilliam T. ObremskeyA. Alex JahangirManish K. SethiRobert BoyceDaniel J. StinnerPhillip M. MitchellKaren TrochezAndrés RodríguezVamshi GajariElsa RodriguezCharles PritchettChristina BoultonJason LoweJason R. WildJohn T. RuthMichel TaylorAndrea SeachSabina SaeedHunter CulbertAlejandro Francisco‐CruzThomas R. KnappColin HurkettMaya LowneyMichael J. PraysonIndresh VenkatarayappaBrandon HorneJennifer JereleLinda ClarkFrancesc Marcano-FernándezMontsant Jornet-GibertLaia Martínez-CarreresDavid Martí-GarínJorge Serrano-SanzJoel Sánchez-FernándezMatsuyama Sanz-MoleroAlejandro CarballoXavier PelfortFrancesc Acerboni-FloresAnna Alavedra-MassanaNeus Anglada-TorresAlexandre BerenguerJaume Cámara-CabreraAriadna Caparros-GarcíaFerran Fillat‐GomàRuben Fuentes-LópezRamona Garcia-RodriguezNuria Gimeno-CalaviaGuillem Graells-AlonsoMarta Martínez-ÁlvarezPatricia Martínez-GrauRaúl Pellejero-GarcíaOna Ràfols-PerramonJuan Manuel PeñalverMònica Salomó DomènechAlbert Soler-CanoAldo Velasco-BarreraChristian Yela‐VerdúMercedes Bueno-RuizEstrella Sánchez-PalominoErnesto Guerra-FarfánYaiza GarcíaNicholas M. RomeoHeather A. VallierMary A. BreslinJoanne FraifoglEleanor S. WilsonLeanne K. WadenpfuhlPaul G. HallidayDarius G. ViskontasKelly ApostleDory BoyerFarhad MoolaBertrand H. PereyTrevor StoneH. Michael LemkeMauri ZomarElla SpicerChen “Brenda” FanKyrsten PayneKevin D. PhelpsMichael J. BosseMadhav A. KarunakarLaurence B. KemptonStephen H. SimsJoseph R. HsuRachel B. SeymourChristine ChurchillClaire BartelRobert Miles MayberryMaggie BrownriggCara GirardiAda MayfieldRobert A. HymesCary C. SchwartzbachJeff E. SchulmanArjan MalekzadehMichael A. HolzmanLolita RamseyJames S. AhnFarhanaz PanjshiriSharmistha DasAntoinisha D. EnglishSharon HaaserJaslynn CuffHolly PilsonEben A. CarrollJason J. HalvorsonSharon BabcockJ. Brett GoodmanMartha B. HoldenDebra BullardWendy R. WilliamsThomas F. HigginsJustin M. HallerDavid L. RothbergAshley NeeseMark RussellI. Leah GitajnMarcus P. CoeKevin DwyerDevin S. MullinClifford A. ReillyPeter DePaloAmy E. HallMarilyn HengMitchel B. HarrisR. M. SmithDavid W. LhoweJohn G. EspositoMira BansalPatrick F. BerginGeorge V. RussellMatthew L. GravesJohn MorellatoHeather K. ChampionLeslie N. JohnsonSheketha L. McGeeEldrin BhanatSameer MehtaDerek J. DoneganJaimo AhnAnnamarie D. HoranMary DooleyAshley KuczinskiAshley IwuDavid A. PotterRobert VanDemarkBranden PfaffTroy HollinsworthMichael J. WeaverArvind von KeudellMichael F. McTagueElizabeth AllenTodd JaeblonRobert BeerHaley K. DemyanovichMark J. GageRachel M. ReillyCindy Sparrow
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Abstract:
Pragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow.Given the broad eligibility criteria and high fracture volume at participating clinical sites in the PREPARE trial, a pragmatic sampling strategy was needed. Using data from PREPARE, descriptive statistics were used to describe the use of the sampling strategy across clinical sites. A Chi-square test was performed to explore whether use of the sampling strategy was associated with a reduction in the number of missed eligible patients.7 of 20 clinical sites (35%) elected to adopt a sampling strategy. There were 1539 patients excluded due to the use of the sampling strategy, which represents 30% of all excluded patients and 20% of all patients screened for participation. Use of the sampling strategy was associated with lower odds of missed eligible patients (297/4545 (6.5%) versus 341/3200 (10.7%) p < 0.001).Implementing a sampling strategy in the PREPARE trial has helped to limit the number of missed eligible patients. This sampling strategy represents a simple, easy to use tool for managing work flow at clinical sites and maintaining the integrity of a large trial.Keywords:
Odds
Patient recruitment
Clinical trials continue to grow in complexity and, in turn, the cost of running a clinical trial is ever-increasing. Improving the Probability of Success (POS) for a clinical
trial should be at the forefront of every trial manager’s focus. Delays, whether in terms of missed recruitment targets or data collection inefficiencies, must be proactively
addressed in order for trial funds to be budgeted in the most effective manner. Data solutions such as electronic Case Report Forms (eCRFs) or social media subject
recruitment tools oftentimes carry high upfront or fixed costs but can lead to faster trials with fewer errors that are more likely to reach recruitment and other milestones.
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The Clinical Research Information Service (CRIS) in South Korea provides a clinical trial registry platform in which all clinical trials should be mandatorily and prospectively registered. However, to date, the registration status of clinical trials in the field of dentistry has not been investigated. Therefore, this study aimed to provide an overview of the methodological design and trends of the registered clinical trials over a period of nine years. Information about registered clinical trials in the field of dentistry from the CRIS was comprehensively collected from 2013 to 2021. The details assessed from the collected trials include: type of sponsors, recruitment status, study design, randomization, allocation concealment, single or multi-centric, retrospective or prospective registration, and publication status. A total of 65 registered clinical trials were identified. The number of clinical trials in dentistry in South Korea was found to be less; however, an increasing trend was observed in the recent three years. A majority of the trials were interventional (81.5%), single-centered (86.2%), and conducted on patients (81.5%) and in private hospitals (55.4%). A considerable number of trials had an unclear phase, were retrospectively registered, and rarely published. Regarding the quality, most trials have inadequately reported the method of randomization and allocation concealment. The number of clinical trials in dentistry is still low in South Korea, and most of them were registered retrospectively. A poor-quality reporting of methods at several specific areas was observed. It is necessary for dental investigators to raise awareness of the need to register clinical trials.
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6521 Background: Clinical trials are essential to the advancement of clinical therapies. However, only 5% of cancer patients enroll in clinical trials (CTs) due to limited accessibility. Given that greater participation in CTs is associated with better patient outcomes, patients from smaller centres are at a disadvantage. The Clinical Trials Navigators (CTN) program was established by Hamm (2022) to help patients in smaller communities navigate and enrol in CTs, resulting in clinical trial enrolment of 7% of patients. This study will provide updated results on the impact of the CTN program as it has expanded. Methods: Between March 2019 to September 2022, 241 patients were enrolled in the CTN program. Five Clinical Trials Navigators (CTNs) receive referrals from various sources: physicians, patients, and patient support groups. CTNs review medical information submitted and search five CT registries. Eligibility criteria is scrutinized. A second review of the CT list is conducted by two physicians to ensure accuracy. The number of potential trials is recorded at each step of review. Data collected includes: patient disease, stage, and number of prior therapies, time from referral to death, number of potential trials, number of trials that were phase I or phase II / III / IV, number of outgoing referrals, locations of the identified trials, and successful enrolment onto CTs. Patient information and results were inputted and analysed using REDCap. REB Category A approval has been granted on August 31, 2022. REB approval number is 22-439. Results: 41 Canadian cancer patients used the CTN program. The updated study found that 75.9% of patients were in stage IV of their disease, and 51% had at least two prior lines of therapy. 61.4% of patients deceased at last follow up, with a range of 0.3-37.5 months from CTN program referral to death, and a median of 5.9 months. CTNs identified a range of zero to 26 trials for each patient with a median of three trials: a range of zero to 10 phase I trials were found, and a range of one to eight phase II / III / IV trials were found. 25.5% of patients referred to a CT enrolled onto the recommended trial. The expanded CTN program resulted in CT enrolment of 8.5% of patients that follow-up information is available for. Conclusions: One quarter of patients referred to a CT by the CTN program were successfully enrolled, highlighting the CTN program as a successful tool to identify CTs for cancer patients and improve CT accrual. 8.5% of all patients with available follow-up information that participated in the CTN program were enrolled onto clinical trials. Further investigation into reasoning for early high mortality rates should be assessed. New initiatives to improve uptake of the CTN program are ongoing.
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