Expertise: Clinical Trials Planning, Project Management and Enrollment/Accrual Tracking
Since 2006, we have assisted organizations on clinical trial planning, enrollment tracking and project management of such trials. Our expertise is in identifying any initial barriers to enrollment, monitoring trials to gain early signals of potential problems, and creating solutions to close any enrollment gaps.
Massett H, Parreco LK, Padberg RM, Richmond ES, Rienzo, ME, Ryan Leonard CE, Quesenbery W, Killam HW, Johnson, and Dilts DM (2011) “AccrualNet: Addressing low accrual via a knowledge-based, community of practice Platform,” J of Oncology Practice, 7(6): e32-e39. PMID:22379429.
Dilts DM and Sandler AB, (2006) “The “Invisible” Barriers to Clinical Trials: The impact of Structural, Infrastructural, and Procedural Barriers to Opening Oncology Clinical Trials,” J Clin Oncol, 24(28): 4545-52. PMID: 17008693
Other Work Related to Clinical Trials Planning, Project Management and Enrollment/Accrual Tracking
2. Massett, H, Dilts DM, Bailey R, Berktold J, Ledsky R, Atkinson (2017) “Raising Public Awareness of Clinical Trials: Development of Messages for a National Health Communication Campaign,” ˆJ of Health Communications 22(5):373-385. PMID:28339327
3. Denicoff AM (plus 28 others), (2013) “The NCI-ASCO Cancer Trial Accrual Symposium: Summary and Recommendations,” J of Oncology Practice 9(6): 267-76. PMID:24130252
4. Hirsh BR, Califf RM, Cheng SK, Tasneem A, Horton J, Chriswell K, Schulman KA, Dilts DM, and Abernethy AP (2013) “Design of Oncology Clinical Trials: Insights from a Systematic Analysis of ClinicalTrials.gov,” JAMA Internal Medicine, 173(11):972-979. PMID:23699837.
5. Massett H, Parreco LK, Padberg RM, Richmond ES, Rienzo, ME, Ryan Leonard CE, Quesenbery W, Killam HW, Johnson, and Dilts DM (2011) “AccrualNet: Addressing low accrual via a knowledge-based, community of practice Platform,” J of Oncology Practice, 7(6): e32-e39. PMID:22379429.
6. Kitterman, D, Cheng, S, Dilts DM, and Orwoll, ES, (2011) “The Prevalence and Economic Impact of Low Enrolling Clinical Studies at an Academic Medical Center,” Academic Medicine 86(11): 1360-66. PMID:21952064
7. Cheng S, Dietrich M, Dilts DM (2011) “Predicting Accrual Achievement: Monitoring Accrual Milestones of NCI-CTEP Sponsored Clinical Trials,” Clin Cancer Res. 17: 1947-55. PMID:21447723
8. Dilts DM, Cheng S, Crites JS, Sander AB, Doroshow J, (2010) “Phase III Clinical Trial Development: A Process of Chutes & Ladders,” Clin Cancer Res. 16(22): 5381-89. PMID:21062928
9. Dilts DM, Sander AB, Cheng S, Crites J, Ferranti L, Wu, A, Finnigan S., Friedman S, Mooney M, Abrams J, (2009) “The Steps and Time to Process Phase III Clinical Trials at the Cancer Therapy Evaluation Program,” J of Clin Oncol, 27(11): 1761-6. PMID: 19255315
10. Dilts DM, Sandler AB, Cheng S, Crites J, Ferranti L, Wu A, Gray R, MacDonald J, Marinucci D, Comis R. (2008) “Development of Clinical Trials in a Cooperative Group Setting: The Eastern Cooperative Group,” Clin Cancer Res, 14(11):3427-33. PMID: 18519773
11. Dilts DM and Sandler AB, (2006) “The “Invisible” Barriers to Clinical Trials: The impact of Structural, Infrastructural, and Procedural Barriers to Opening Oncology Clinical Trials,” J Clin Oncol, 24(28): 4545-52. PMID: 17008693
12. Dilts DM, Sandler AB, Baker M, Cheng S, George SL, Karas KS, McGuire S, Menon G, Reusch J, Sawyer D, Scoggins M, Wu A, Zhou K, Schilsky RL (2006) “Processes to Activate Phase III Clinical Trials in a Cooperative Oncology Group: The Case of the Cancer Leukemia Group B (CALGB), J Clin Oncol, 24(28): 4553-57. PMID: 17008694
13. Yee, D, (34 others) (2012) “Adaptive trials in the Neoadjuvant Setting: A Model to Safely Tailor Care While Accelerating Drug Development,” J of Clin Onc, Letter, Dec 20; 30(36): 4584-6. doi: 10.1200/JCO.2012.44.1022
14. Dilts DM (2014) “Time has come to raise the bar in oncology clinical trials,” J Clin Onc, 30, PMID:22454422 doi: 10.1200/JCO.2013.53.8009
15. Dilts DM (2012) “Robbing Peter to Pay Paul: Financing Clinical Trial Follow-Up,” J Clin Onc, 30, PMID:22454422
16. Dilts DM, Cheng SK (2012) “The Importance of Doing Trials Right While Doing The Right Trials,” Clin Cancer Res, 18(1):3-5. PMID:22072734
17. Dilts DM, (2010) “US cancer trials may go the way of the Oldsmobile,” Nature Medicine 16(5):21. PMID:20526311
18. Dilts DM, (2010) “An Early Warning: Ailing Canary in the Mine,” J Clin Onc, 28(24): 3799-800. PMID: 20644096
19. Blajchman MA, Glynn SA, Josephson CD, Kleinman SH (2010) “Clinical Trial Opportunities in Transfusion Medicine: Proceedings of an NHLBI State of the Science Symposium,” role: contributor, Transfusion Medicine Reviews, 24(4): 259-85. PMID: 20851330
20. Massett, HA, Dilts, DM, +11 others (2016), “Will a national communication campaign to increase awareness of clinical trials work?” J Clin Oncol 34:15s (suppl; abstr: 6537)
21. Parker C, Millar JL, Dilts DM, Jefford M, Wolfe R, Snyder R (2015) “A randomized control trial (RCT) to improve enrolment to cancer clinical trials” J Clin Oncol 33:15s (suppl; abstr: 6514).
22. Massett, HA, Jaeckle, KA, Dilts DM, Denicoff, A, Souhan, E, Hopkins JR, Singh Mann, B, (2013) “Rapid online feedback to improve clinical trial accrual: CODEL anaplastic glioma (AG) (NCCTG/Alliance N0577) as a model”, J Clin Oncol 31:15s (suppl; abstr 1596).
23. Lopez-Chavez A, Thomas A, Rajan A, Steinberg SM, Dilts DM, Doyle A, Giaccone G (2013) “CUSTOM (Molecular Profiling and Targeted Therapy for Advanced Non-Small Cell Lung Cancer, Small Cell Lung Cancer, and Thymic Malignancies trial): A radical redesign of clinical trial structure–Use of mass customization and product postponement.” J Clin Oncol 30:15s (suppl; abstr 6524).
24. Cheng SK, Hirsch BR, Califf RM, Tasneem A, Schulman KA, Abernethy AP, Dilts DM (2012) “Geographic and network analysis of oncology trials: Portfolio assessment of ClinicalTrial.gov” J Clin Oncol 30:15s (suppl; abstr 6047).
25. Hirsch BR, Mitchell A, Cheng SK, Califf RM, Tasneem A, Dilts DM, Abernethy AP (2012) “Improving the impact of clinical research: A systematic analysis of kidney cancer trials” J Clin Oncol 30:15s (suppl; abstr 6051).
26. Hirsch BR, Califf RM, Cheng SK, Tasneem A, Chiswell K, Horton JR, Schulman KA, Dilts DM, Abernethy AP (2012) “The State of the Oncology Clinical Trials Portfolio: Insights from ClinicalTrial.gov”, Society of Clinical Trials Meeting (May).
27. Dilts DM, Peters, C, Stadum, S, Cheng, SK, “Where you stand depends upon where you sit: Alignment of quality measures to strategic intentions,” ASCO’s Quality Care Symposium, 2012.
28. Kitterman D, Cheng SK, Dilts DM, Orwoll ES (2011) “An etiologic survey of factors that contribute to non-enrolling clinical studies,” NCRR Clinical Research Management Workshop, Bethesda MD (Jun)
29. Kethert KH, Cheng SK, Nauman DJ, Dilts DM, Sandler AB, Chui SY (2011) “Implementation of a prospective screening tool for breast cancer clinical trial eligibility at an NCI designated cancer center,” J Clin Oncol 29:15s (suppl; abstr 6052)
30. Massett H, Parreco LK, Padberg RM, Richmond E, Dilts DM (2011) “AccrualNet: a novel approach to addressing clinical trial accruals through a knowledge-based, community of practice platform,” J Clin Oncol 29 (suppl; abstr e16621)
31. Dilts DM, Cheng SK, Wiltrout RH, Dahut WL, Bronez M, Helman LJ (2011) “Strategic alignment of clinical trials at the National Cancer Institute Center for Cancer Research: Development of the clinical mission and baseline portfolio metrics,” J Clin Oncol 29 (suppl; abstr e16619)
32. Stahl DC, Cheng SK, Lee E, Dilts DM (2011) “Benchmarking of oncology clinical trial metrics across AACI member centers,” J Clin Oncol 29 (suppl; abstr e16613)
33. Cheng S, Dietrich, M, Finnigan S, Dilts DM (2010) “Early indicators of accrual success: Time-to-first-patient and accrual performance at an anticipated enrollment milestone-A study of NCI-CTEP-sponsored clinical trials” J Clin Oncol 28:15s (suppl; abstr 6001)
34. Dilts DM, Massett H (2010) Impact of trial development time on accruals at CCOPs: The case of the MARVEL trial”. American Society of Clinical Oncology, Chicago, IL. (Abstract #e16505)
35. Cheng S, Dietrich, M, Finnigan S, Sandler A, Crites J, Ferranti L, Wu A, Dilts DM (2009) “A Sense of Urgency: evaluating the link between clinical trial development time and the accrual performance of CTEP-sponsored studies,” J Clin Oncol 27:15s (suppl; abstr 6509)
36. Dilts DM, Sandler AB, Cheng S, Crites J, Ferranti L, Wu A, Bookman M, Thomas J, and Ostroff J, (2008) “Accrual to Clinical Trials at Selected Comprehensive Cancer Centers,” 26(15S): 6543
37. Dilts DM, Sandler AB, Cheng S, Crites J, Ferranti L, and Wu A (2008), “Setups in Oncology Clinical Trials: a missing opportunity for improvement,” EurOMA 2008.
38. Dilts DM, Sandler AB, Cheng S, Crites J, Ferranti L, and Wu A (2008), “Are Cancer Clinical Trials in the USA Going the Way of Oldsmobile?,” Production and Operations Management Society 2008.
39. Dilts DM (2006) “Applications of OM Techniques in Improving Drug Clinical Trials,” Production and Operations Management Society International Conference, Shanghai, China, June.
40. Dilts DM (2006) “Applications of OM techniques in Improving the Delivery of Healthcare” (Panel presentation) Production and Operations Management Society, Boston, April.
41. Dilts DM, Elaine Chen Wang, and Barbara Murphy (2005) “Patient Obtained Medical Information used by cancer patients and their companions,” J Clin Oncol 23:16s (suppl; abstr 6056).
42. Flores, Ann Marie, Dilts DM, and Murphy, Barbara (2004) “Disparities and Unmet Needs for E-Mail Use in Cancer Patients,” J Clin Oncol 22:16s (suppl; abstr 8254).
43. (2015) “Observations on Clinical Research: Some Ideas for NHLBAC”, National Heart, Lung Blood Advisory Council, NIH,(June).
44. (2015) “Going Beyond the Norm: Some Ideas for the British Columbia Cancer Agency” British Columbia Cancer Agency Retreat, Vancouver, BC(May)
45. (2014) “The Promise and Perils in Clinical Trials,” Monash University, Melbourne, Australia(August, presented twice)
46. (2014) “Observations on Cancer Research from a Non-Medical Researcher,” keynote speech, Cancer Institute of New South Wales Annual Awards Banquet(August)
47. (2014) “Overcoming the Barriers of Transparency in Clinical Trial Data Access,” ASCO National Meeting, Chicago IL(June)
48. (2013) “Cooperative Groups, Version 3.0”, Palliative Care Research Consortium meeting, Chicago, IL(Sept).
49. (2013) “A Model for Evaluating the Efficiency and Effectiveness of Clinical Research,” Medical Executive Committee, NIH, Bethesda MD(May).
50. (2011) “Process Mapping – Purpose, Method & Expected Results,” University of Cincinnati Academic Health Center, Center for Clinical & Translational Science & Training(Sept)
51. (2011) “Clinical Research as a Complex Adaptive System,” Arizona State University Institute for Complexity, Phoenix, AZ(Mar)
52. (2010) “Clinical Trial and Regulatory Process Mapping, the Clinical Trials and Regulatory Pathways Working Group at the Center for Global Development,(Oct)
53. (2010) “Beyond Efficiency: A Strategic Approach to Clinical Research,” Keynote address, 10th Annual Oncore Users Group Madison, WI(Aug)
54. (2010) “The Science of Trial Selection, Infrastructure, and Operations,” NCI-ASCO Symposium on Accruals, Chicago IL(Apr)
55. (2009) “The Need for Operations Management in Healthcare: The Case of Oncology Clinical Trials,” Distinguished Lecture, Supply Chain Management Area, Sir Wilfrid Laurier University(Dec)
56. (2009) “Envisioning the future: Lessons from the past(& present) in Oncology Clinical Trials”, keynote speech to Johns Hopkins Sidney Kimmel Comprehensive Cancer Center strategic retreat, Baltimore MD(Mar)
57. (2008) “Building Networks: Observations from Oncology and Non-Medical Industries”, keynote address for the NHLBI Workshop on Sickle Cell Disease. Washington, DC(Oct)