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The Recruitment Innovation Center: Developing novel, person-centered strategies for clinical trial recruitment and retention
- Consuelo H. Wilkins, Terri L. Edwards, Mary Stroud, Nan Kennedy, Rebecca N. Jerome, Colleen E. Lawrence, Sheila V. Kusnoor, Sarah Nelson, Loretta M. Byrne, Leslie R. Boone, Julia Dunagan, Tiffany Israel, Casey Rodweller, Bethany Drury, Rhonda G. Kost, Jill M. Pulley, Gordon R. Bernard, Paul A. Harris
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- Journal:
- Journal of Clinical and Translational Science / Volume 5 / Issue 1 / 2021
- Published online by Cambridge University Press:
- 19 August 2021, e194
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Clinical trials continue to face significant challenges in participant recruitment and retention. The Recruitment Innovation Center (RIC), part of the Trial Innovation Network (TIN), has been funded by the National Center for Advancing Translational Sciences of the National Institutes of Health to develop innovative strategies and technologies to enhance participant engagement in all stages of multicenter clinical trials. In collaboration with investigator teams and liaisons at Clinical and Translational Science Award institutions, the RIC is charged with the mission to design, field-test, and refine novel resources in the context of individual clinical trials. These innovations are disseminated via newsletters, publications, a virtual toolbox on the TIN website, and RIC-hosted collaboration webinars. The RIC has designed, implemented, and promised customized recruitment support for 173 studies across many diverse disease areas. This support has incorporated site feasibility assessments, community input sessions, recruitment materials recommendations, social media campaigns, and an array of study-specific suggestions. The RIC’s goal is to evaluate the efficacy of these resources and provide access to all investigating teams, so that more trials can be completed on time, within budget, with diverse participation, and with enough accrual to power statistical analyses and make substantive contributions to the advancement of healthcare.
A collaborative, academic approach to optimizing the national clinical research infrastructure: The first year of the Trial Innovation Network
- Gordon R. Bernard, Paul A. Harris, Jill M. Pulley, Daniel K. Benjamin, Jonathan Michael Dean, Daniel E. Ford, Daniel F. Hanley, Harry P. Selker, Consuelo H. Wilkins
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- Journal:
- Journal of Clinical and Translational Science / Volume 2 / Issue 4 / August 2018
- Published online by Cambridge University Press:
- 27 November 2018, pp. 187-192
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Inefficiencies in the national clinical research infrastructure have been apparent for decades. The National Center for Advancing Translational Science—sponsored Clinical and Translational Science Award (CTSA) program is able to address such inefficiencies. The Trial Innovation Network (TIN) is a collaborative initiative with the CTSA program and other National Institutes of Health (NIH) Institutes and Centers that addresses critical roadblocks to accelerate the translation of novel interventions to clinical practice. The TIN’s mission is to execute high-quality trials in a quick, cost-efficient manner. The TIN awardees are composed of 3 Trial Innovation Centers, the Recruitment Innovation Center, and the individual CTSA institutions that have identified TIN Liaison units. The TIN has launched a national scale single (central) Institutional Review Board system, master contracting agreements, quality-by-design approaches, novel recruitment support methods, and applies evidence-based strategies to recruitment and patient engagement. The TIN has received 113 submissions from 39 different CTSA institutions and 8 non-CTSA Institutions, with projects associated with 12 different NIH Institutes and Centers across a wide range of clinical/disease areas. Already more than 150 unique health systems/organizations are involved as sites in TIN-related multisite studies. The TIN will begin to capture data and metrics that quantify increased efficiency and quality improvement during operations.
Contributors
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- By Lenard A. Adler, Pinky Agarwal, Rehan Ahmed, Jagga Rao Alluri, Fawaz Al-Mufti, Samuel Alperin, Michael Amoashiy, Michael Andary, David J. Anschel, Padmaja Aradhya, Vandana Aspen, Esther Baldinger, Jee Bang, George D. Baquis, John J. Barry, Jason J. S. Barton, Julius Bazan, Amanda R. Bedford, Marlene Behrmann, Lourdes Bello-Espinosa, Ajay Berdia, Alan R. Berger, Mark Beyer, Don C. Bienfang, Kevin M. Biglan, Thomas M. Boes, Paul W. Brazis, Jonathan L. Brisman, Jeffrey A. Brown, Scott E. Brown, Ryan R. Byrne, Rina Caprarella, Casey A. Chamberlain, Wan-Tsu W. Chang, Grace M. Charles, Jasvinder Chawla, David Clark, Todd J. Cohen, Joe Colombo, Howard Crystal, Vladimir Dadashev, Sarita B. Dave, Jean Robert Desrouleaux, Richard L. Doty, Robert Duarte, Jeffrey S. Durmer, Christyn M. Edmundson, Eric R. Eggenberger, Steven Ender, Noam Epstein, Alberto J. Espay, Alan B. Ettinger, Niloofar (Nelly) Faghani, Amtul Farheen, Edward Firouztale, Rod Foroozan, Anne L. Foundas, David Elliot Friedman, Deborah I. Friedman, Steven J. Frucht, Oded Gerber, Tal Gilboa, Martin Gizzi, Teneille G. Gofton, Louis J. Goodrich, Malcolm H. Gottesman, Varda Gross-Tsur, Deepak Grover, David A. Gudis, John J. Halperin, Maxim D. Hammer, Andrew R. Harrison, L. Anne Hayman, Galen V. Henderson, Steven Herskovitz, Caitlin Hoffman, Laryssa A. Huryn, Andres M. Kanner, Gary P. Kaplan, Bashar Katirji, Kenneth R. Kaufman, Annie Killoran, Nina Kirz, Gad E. Klein, Danielle G. Koby, Christopher P. Kogut, W. Curt LaFrance, Patrick J.M. Lavin, Susan W. Law, James L. Levenson, Richard B. Lipton, Glenn Lopate, Daniel J. Luciano, Reema Maindiratta, Robert M. Mallery, Georgios Manousakis, Alan Mazurek, Luis J. Mejico, Dragana Micic, Ali Mokhtarzadeh, Walter J. Molofsky, Heather E. Moss, Mark L. Moster, Manpreet Multani, Siddhartha Nadkarni, George C. Newman, Rolla Nuoman, Paul A. Nyquist, Gaia Donata Oggioni, Odi Oguh, Denis Ostrovskiy, Kristina Y. Pao, Juwen Park, Anastas F. Pass, Victoria S. Pelak, Jeffrey Peterson, John Pile-Spellman, Misha L. Pless, Gregory M. Pontone, Aparna M. Prabhu, Michael T. Pulley, Philip Ragone, Prajwal Rajappa, Venkat Ramani, Sindhu Ramchandren, Ritesh A. Ramdhani, Ramses Ribot, Heidi D. Riney, Diana Rojas-Soto, Michael Ronthal, Daniel M. Rosenbaum, David B. Rosenfield, Durga Roy, Michael J. Ruckenstein, Max C. Rudansky, Eva Sahay, Friedhelm Sandbrink, Jade S. Schiffman, Angela Scicutella, Maroun T. Semaan, Robert C. Sergott, Aashit K. Shah, David M. Shaw, Amit M. Shelat, Claire A. Sheldon, Anant M. Shenoy, Yelizaveta Sher, Jessica A. Shields, Tanya Simuni, Rajpaul Singh, Eric E. Smouha, David Solomon, Mehri Songhorian, Steven A. Sparr, Egilius L. H. Spierings, Eve G. Spratt, Beth Stein, S.H. Subramony, Rosa Ana Tang, Cara Tannenbaum, Hakan Tekeli, Amanda J. Thompson, Michael J. Thorpy, Matthew J. Thurtell, Pedro J. Torrico, Ira M. Turner, Scott Uretsky, Ruth H. Walker, Deborah M. Weisbrot, Michael A. Williams, Jacques Winter, Randall J. Wright, Jay Elliot Yasen, Shicong Ye, G. Bryan Young, Huiying Yu, Ryan J. Zehnder
- Edited by Alan B. Ettinger, Albert Einstein College of Medicine, New York, Deborah M. Weisbrot, State University of New York, Stony Brook
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- Book:
- Neurologic Differential Diagnosis
- Published online:
- 05 June 2014
- Print publication:
- 17 April 2014, pp xi-xx
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EVALUATION OF THE RE-EMERGENCE PROCESS OF PARENT ADULT DENDROCTONUS FRONTALIS (COLEOPTERA: SCOLYTIDAE)1
- Robert N. Coulson, W. Scott Fargo, Paul E. Pulley, John L. Foltz, Don N. Pope, Jim V. Richerson, Thomas L. Payne
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- Journal:
- The Canadian Entomologist / Volume 110 / Issue 5 / 01 May 1978
- Published online by Cambridge University Press:
- 31 May 2012, pp. 475-486
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The process of re-emergence of Dendroctonus frontalis parent adults was investigated using emergence traps placed systematically along the bole of infested loblolly pine, Pinus taeda. Daily collections of the traps showed the re-emergence pattern by height through time. Re-emergence/100 cm2 (Y) was described as a function of time (X) by the model Y = C(18X)B−1 exp (−A(18X)B) + ɛε for intervals along the infested bole. Peak re-emergence occurred shortly after peak attack density and continued 16–20 days. Highest re-emergence density occurred at the midportion of the infested bole and tapered to the ends. The same model was used to describe re-emergence as an average process for the entire tree. For convenience in evaluating expected re-emergence totals over a time span, the cumulative form of the model was fit to the data. The proportion of re-emergence was studied using bark samples taken at the beginning and end of the process and was found to be 97% of the attacking adult population. An empirical distribution function was developed and the probability of re-emergence described using the function Y = ABCXB−1 exp (−AXB) + ɛε, where Y = the probability of re-emergence at a time X in days given that a beetle was present on day 1 of the process. The cumulative form of this model was also provided.
Using laboratory bioassays parent adults were tested and found to respond to the attractant mixture of frontalin, trans-verbenol, and loblolly pine turpentine.
Re-emergence may play several functions in the population dynamics of D. frontalis: conditioning host trees through mass colonization; establishing brood populations through multiple re-emergence, thereby efficiently allocating egg populations; identifying new hosts and aggregating populations through pheromone production; and maintenance of continuity in pheromone production at the active portion of the infestation, thereby identifying the location of trees under colonization. The prolonged re-emergence period was suggested to be of survival value to the insect in that local short term disasters would affect only a small proportion of the re-emerging population. The number of re-emergences and proportions of re-emergence were suggested to be related to oviposition per parent adult and hence attack density.
SPATIAL AND TEMPORAL PATTERNS OF WITHIN-TREE COLONIZATION BY DENDROCTONUS FRONTALIS (COLEOPTERA: SCOLYTIDAE)
- W. Scott Fargo, Robert N. Coulson, Paul E. Pulley, Don N. Pope, Claude L. Kelley
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- Journal:
- The Canadian Entomologist / Volume 110 / Issue 11 / November 1978
- Published online by Cambridge University Press:
- 31 May 2012, pp. 1213-1232
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Within-tree colonization by Dendroctonus frontalis infesting loblolly pine, Pinus taeda L., was investigated. Two components of the colonization process were studied: the establishment of attacking adults (ATK) and the ensuing construction of egg galleries (GL). Data on the two variables were taken from standing trees beginning at the time of initial attack and continuing for 14 consecutive days.
The spatial and temporal sequence of ATK was described for 1.5 m intervals along the infested bole for the duration of the process. A three parameter nonlinear function was used to describe the data. The pattern of attack was also described as an average process for the entire tree using the same model. A frequency histogram encompassing the range in variation for peak ATK from 134 trees was prepared to provide starting values for simulation purposes.
The spatial and temporal sequence of GL construction was described using essentially the same approach as employed for ATK. The modeling process was complicated by loss or obscuring of GL from the radiograph by omission errors and foraging by Monochamus spp. and other associates. GL construction was also described as an average function for the entire tree and the rate of GL construction was defined. A frequency histogram of peak GL was prepared from data on 54 trees for use in selecting starting values for simulation purposes.
Numerical relationships between ATK and GL were defined by combining the data on ATK and cumulative expected GL.
SPATIAL AND TEMPORAL PATTERNS OF EMERGENCE FOR WITHIN-TREE POPULATIONS OF DENDROCTONUS FRONTALIS (COLEOPTERA: SCOLYTIDAE)1
- Robert N. Coulson, W. Scott Fargo, Paul E. Pulley, Don N. Pope, John L. Foltz, Audrey M. Bunting
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- Journal:
- The Canadian Entomologist / Volume 111 / Issue 3 / March 1979
- Published online by Cambridge University Press:
- 31 May 2012, pp. 273-287
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Spatial and temporal patterns of Dendroctonus frontalis emerging from loblolly pine, Pinus taeda, were studied. Daily emergence was measured at 1.5-m intervals along the infested bole on nine trees Emerging beetles from three of the trees were collected and their sex identified. Topological estimates of daily emergence on all trees were computed and the spatial and temporal patterns of emergence were described using three and five parameter models. Emergence followed the same general pattern at each of the 1.5-m sampling intervals. Peak density of emergence occurred at ca. 0.25 of the process time span (day 7) and declined thereafter. Emergence density was highest at the 3.5-m interval and tapered gradually towards the top of the tree and abruptly towards the bottom. The process took ca. 28 days for completion. Emergence partitioned by sex followed the same general pattern as observed for the combined sexes. The cumulative sex ratio of emerging beetles was essentially 1:1 at each height interval.
Since the curves at the various height intervals were similar, emergence was described as an average process for the entire tree. The essential features of the process were retained in the average analysis. A probability distribution function defined for emergence permits calculation of the distribution of beetles from host trees provided the cumulative density is known. A frequency histogram illustrating the range in observed emergence density over a three year period was also included.
Adult populations of D. frontalis available for colonization were interpreted as a single process “allocation.” The allocation process was defined by two components, re-emergence and emergence, and had the following characteristics: (1) it is continous for each tree in the infestation, (2) it is distinct for each tree, (3) it is bimodal in intensity, and (4) the components may operate together or independently. The allocation concept was used to interpret the manner in which D. frontalis infestations have been observed to develop.
EVALUATION OF PROCEDURES FOR ESTIMATING WITHIN-SPOT POPULATIONS OF ATTACKING ADULT DENDROCTONUS FRONTALIS (COLEOPTERA: SCOLYTIDAE)1
- Paul E. Pulley, John L. Foltz, Robert N. Coulson, William C. Martin
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- Journal:
- The Canadian Entomologist / Volume 109 / Issue 10 / October 1977
- Published online by Cambridge University Press:
- 31 May 2012, pp. 1325-1334
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Population data collected from 132 trees during a 3-year period were used to simulate spots of K trees (1≤ k ≤ 50) infested by the attacking adult stage of Dendroctonus frontalis Zimmerman. The total number of beetles on the K trees was then estimated by sampling k trees (1≤ k ≤ 10). The k trees were chosen at random and by selecting those of largest diameter and largest infested area. Within-tree populations were estimated at two levels of precision and within-spot populations were then estimated by scaling the sum of the k within-tree estimates according to the proportion of the tree numbers, tree diameters, or infested phloem areas included in the sample. The various combinations of tree selection, within-tree precision, and scaling produced 10 procedures which were evaluated for bias, precision, and cost as estimators of within-spot populations. Bias was calculated as the mean of the proportional errors in estimating the true numbers, and the standard deviation of the proportional errors was used as a measure of precision.
The procedures in which trees were randomly selected provided unbiased estimates of the within-spot populations. Selecting the largest trees tended to overestimate the true number with the bias diminishing to zero as k → K. However, separate analyses of trees sampled on the same date within actual spots showed no reason to reject the hypothesis of no difference in beetle density (insects/diameter and insects/area) between the largest and smallest trees.
When k = K = 1, the precision of all within-spot estimators was equivalent to the precision of the within-tree estimate. For larger k = K, the precision improved approximately as √(K). No attempt was made to derive functional relationships of precision for k < K. For each procedure, precision improved as k → K. Sampling the k trees at two sample heights (3.5 and 6.5 m, 4–100 cm2 disks/height) was more precise than single level sampling (4 disks at 5 m), but equally precise estimates could be obtained by single level sampling of just one or two additional trees in the spot. Random selection of the k trees with scaling by the number of infested trees was the least precise of the estimating procedures; scaling by diameter and by infested surface area increased the precision. Best precision was obtained by selecting the k trees of greatest infested phloem area, but selecting the largest diameter trees was nearly as precise. The least costly procedure for obtaining a desired level of precision consists of selecting the k trees of largest diameter and extracting 4 disks/tree at 5 m.