Invisible Barriers to Clinical Trials: The Impact of Structural, Infrastructural, and Procedural Barriers to Opening Oncology Clinical Trials

2006 ◽  
Vol 24 (28) ◽  
pp. 4545-4552 ◽  
Author(s):  
David M. Dilts ◽  
Alan B. Sandler
Keyword(s):  
Clinical Trials ◽  
The United States ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Community Practice ◽  
Home Office ◽  
Scientific Review ◽  
Oncology Research ◽  
Oncology Clinical Trials ◽  
The Impact

Purpose To investigate the administrative barriers that impact the opening of clinical trials at the Vanderbilt-Ingram Cancer Center (VICC) and at VICC Affiliate Network (VICCAN) sites. Methods VICC, a National Cancer Institute–designated comprehensive cancer center, and three VICCAN community practice sites were studied. Methodology used was identification and mapping of existing processes and analysis of historical timing data. Results At course granularity, the process steps required at VICC and VICCAN main office plus local sites are 20 v 17 to 30 steps, respectively; this gap widens with finer granularity, with more than 110 v less than 60 steps, respectively. Approximately 50% of the steps are nonvalue added. For example, in the institutional review board (IRB) process, less than one third of the steps add value to the final protocol. The numbers of groups involved in the approval processes are 27 (VICC) and 6 to 14 (VICCAN home office and local sites). The median times to open a trial are 171 days (95% CI, 158 to 182 days) for VICC and 191 days (95% CI, 119 to 269 days) for the VICCAN sites. Contrary to expectations, the time for IRB review and approval (median, 47 days) is the fastest process compared with the scientific review committee review and approval (median, 70 days) and contracts and grants review (median, 78.5 days). Opening a cooperative group clinical trial is significantly (P = .05) more rapid because they require fewer review steps. Conclusion There are numerous opportunities to remove nonvalue-added steps and save time in opening clinical trials. With increasing numbers of new agents, fewer domestic principal investigators, and more companies off-shoring clinical trials, overcoming such barriers is of critical importance for maintenance of core oncology research capabilities in the United States.

scholarly journals Institutional Scientific Review of Cancer Clinical Research Protocols: A Unique Requirement That Affects Activation Timelines

2017 ◽  
Vol 13 (12) ◽  
pp. e982-e991 ◽  
Author(s):  
Ning Ning ◽  
Jingsheng Yan ◽  
Martin F. Dietrich ◽  
Xian-Jin Xie ◽  
David E. Gerber
Keyword(s):  
Clinical Trials ◽  
Value Added ◽  
Research Quality ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Process Time ◽  
Scientific Review ◽  
Medical Specialties ◽  
Median Process ◽  
Oncology Clinical Trials

Purpose: The National Cancer Institute (NCI) requirement that clinical trials at NCI-designated cancer centers undergo institutional scientific review in addition to institutional review board evaluation is unique among medical specialties. We sought to evaluate the effect of this process on protocol activation timelines. Methods: We analyzed oncology clinical trials that underwent full board review by the Harold C. Simmons Comprehensive Cancer Center Protocol Review and Monitoring Committee (PRMC) from January 1, 2009, through June 30, 2013. We analyzed associations between trial characteristics, PRMC decisions, protocol modifications, and process timelines using the χ2 test, Fisher’s exact test, Wilcoxon rank sum test, Kruskal-Wallis test, and logistic regression. Results: A total of 226 trials were analyzed. Of these, 77% were industry sponsored and 23% were investigator initiated. The median time from submission to PRMC approval was 55 days. The length of review was associated with trial phase, timing of approval, and number of committee changes/clarifications requested. The median process time was 35 days for those approved at first decision, 68 days for second decision, and 116 days for third decision ( P < .001). The median process time was 39 days if no changes/clarifications were requested, 64 days for one to three changes/clarifications, and 73 days for four or more changes/clarifications ( P < .001). Requested changes/clarifications had a greater effect on industry-sponsored trials than on investigator-initiated trials. Conclusion: NCI-mandated institutional scientific review of oncology clinical trials contributes substantially to protocol activation timelines. Further evaluation of this process and the value added to research quality is warranted.

Impact of Safety Concerns of Erythropoiesis-Stimulating Agents (ESAs) and Regulatory Changes on the Use of ESAs and Red Blood Cell (RBC) Transfusions at a Comprehensive Cancer Center

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 1300-1300
Author(s):  
Saroj Vadhan-Raj ◽  
Victoria E. Hawkins ◽  
Xiao Zhou ◽  
Kurt Sizer ◽  
Lincy S. Lal ◽  
...  
Keyword(s):  
Hematological Malignancies ◽  
Black Box ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Safety Concerns ◽  
Regulatory Changes ◽  
Time Period ◽  
Number Of Patients ◽  
Oncology Clinical Trials ◽  
The Impact

Abstract Safety signals raised in the recent oncology clinical trials have led to various regulatory restrictions including FDA black-box warning, National Coverage Determination (NCD), and updated ASCO/ASH guidelines in 2007. The purpose of this study was to determine the impact of these changes on the utilization of ESAs and on transfusion (Tx) of RBCs in 2006 (prior to changes) and 2007. We identified the total number of unique patients that received any treatment including chemotherapy, radiation, transfusions, or any treatment in the out-patient and in-patient settings during this 2 year time period. All the data on the ESA doses dispensed by the hospital pharmacy and all the RBC transfusions dispensed by the Blood bank were also analyzed. The ESA units were calculated by converting 40,000 units of epoetin alfa or 100 mcg of darbepoetin alfa to one unit of ESA. When comparing 2007 to 2006, the number of patients that received ESAs decreased by 26% and the total ESA units decreased by 30%. The overall usage of ESAs decreased by 55%, from 2398 units in 1/2006 to 1080 units in 12/2007. However, the number of pts that received RBC transfusions increased only by 6% and the total number of RBC units transfused by 2% (from 38,218 units in 2006 to 38,948 units in 2007). The median Hgb on the day of transfusion was same for each year (Hgb 8.2 g/dL for both 2006 and 2007), suggesting that the lack of impact on RBC Tx may not be due to a change in Tx threshold. The total number of unique patients referred and treated at MDACC during 2007 (24,356) increased by 13% from 2006 (21,619), not accounting for a lack of impact on transfusions. We therefore examined Hgb at the initiation of ESAs in a subset of pts (n=212) that had not received ESA for at least 3 months. The median Hgb/HCT values at the initiation of ESAs were 9.5 g/dL/27.4. The most frequent utilization of ESAs and transfusions was in patients with hematological malignancies. Conclusion: These findings indicate that the recent ESA safety concerns and related regulatory changes have significantly affected the ESA utilization. The lack of significant impact of reduced ESA usage on RBC transfusions may be related to a lower Hgb threshold used at initiation of ESAs and/or the targeted patient population (less likely to respond) treated with ESAs. Further research is needed to establish the factors contributing to the lack of correlation and to optimize the use of ESAs.

Health care worker attitudes about clinical trials at a comprehensive cancer center.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20633-e20633
Author(s):  
Erica Leigh Campagnaro ◽  
Seunghee Margevicius ◽  
Barbara J. Daly ◽  
Jennifer Rachel Eads ◽  
Tyler G. Kinzy ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Self Efficacy ◽  
Small Sample Size ◽  
Educational Interventions ◽  
Small Sample ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Normative Beliefs ◽  
The Impact

e20633 Background: Cancer patient (pt) participation in clinical trials (CT) is low. Little is known about the beliefs and attitudes of health care workers (HCW) and how they impact intention to discuss CT with pts. The overall goal of this project was to develop a conceptual model to guide future interventions to enhance communication about CT between HCW and cancer pts. Methods: Two email surveys of non-physician HCW at an NCI-designated comprehensive cancer center were conducted. The first was sent to a random sample of 150 HCW. The second was sent to 80 who completed the first survey. Based on our prior work (Eads et al. ASCO 2011) and Ajzen’s Theory of Planned Behavior, domains of the first included CT knowledge (19 items, agree/disagree) and attitudes (27 items, 5-point Likert); the second included normative beliefs about institutional attitudes toward CT (6 items, 5-point Likert), self-efficacy about engaging in discussion about CT (14 items, 5-point Likert), and intention to discuss CT with pts (4 items, 7-point Likert). Results: 41 HCW completed both anonymous surveys; 27 could be matched by demographics. Median age of matched respondents was 44.3 yrs (range 24-63), 26 female, 22 caucasian, 9 nurses. Overall, CT knowledge was high (median 17/19 items correct). There were strong associations between attitudes and self-efficacy (Spearman r=-0.425, p=0.03), as well as perceived normative beliefs and self-efficacy (r=0.651, p=0.0002). These associations were strong amongst nurses (r=-0.818, p=0.007 and r=0.656, p=0.05, respectively), with a particularly strong correlation between self-efficacy and intention to discuss clinical trials with pts (r=0.891, p=0.001). Conclusions: In spite of a small sample size, these pilot data strongly support a behavioral framework to understand and address the impact of HCW attitudes and beliefs about CT on discussions of CT with pts. Insofar as HCW (especially nurses) have substantial pt contact, and serve as a resource for pts regarding treatment decisions, educational interventions to address HCW barriers to discussing CT with pts (i.e. attitudes, beliefs, and self-efficacy) could positively impact pt attitudes and improve decision making.

Bridging the gaps between tertiary and community care networks: Results from a southern California survey research analysis.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1538-1538
Author(s):  
Alex Chehrazi-Raffle ◽  
Nicholas Salgia ◽  
Joann Hsu ◽  
Zeynep Busra Zengin ◽  
Sabrina Salgia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Los Angeles ◽  
Southern California ◽  
Medical Center ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Community Practice ◽  
Electronic Data Capture System ◽  
Tertiary Center

1538 Background: Although many tertiary cancer centers offer access to myriad research protocols, the majority of patients nevertheless receive treatment at community practices. We sought to examine the barriers that hamper clinical collaboration between tertiary and community practice environments in Southern California. Methods: A 31-item survey was distributed to community and tertiary oncologists using REDCap, a browser-based electronic data capture system. Survey questions assessed the following attributes: demographics and features of clinical practice, referral patterns, availability and knowledge pertaining to clinical trials, strategies for knowledge acquisition, and integration of community and tertiary practices. Results: The survey was distributed to 98 oncologists, 85 (87%) of whom completed it in full. The most common institutional affiliations were City of Hope Comprehensive Cancer Center (58%), University of California, Los Angeles (10%), and Cedars Sinai Medical Center (8%). In total, 52 (61%) respondents were community practitioners and 33 (38%) were tertiary oncologists. A majority (56%) of community oncologists defined themselves as general oncologists whereas almost all (97%) tertiary oncologists reported a subspecialty. Clinical trial availability was the most common reason for pt referrals to tertiary centers (73%). The most frequent barrier to tertiary referral was financial considerations (59%). Clinical trials were offered by 97% of tertiary practitioners as compared to 67% of community oncologists (p = 0.001). Of note, while a majority of tertiary center providers (52%) described the primary value of community practices to be a source of referrals for clinical trials, most community oncologists (82%) reported only a minimal-to-moderate understanding of clinical trials available at regional tertiary centers. Conclusions: Community oncologists refer patients to tertiary centers primarily with the intent of clinical trial enrollment; however, significant gaps exist in their knowledge of trial availability. Our results identify the need for enhanced communication and collaboration between community and tertiary providers to expand patients’ access to clinical trials.

Attrition rates, reasons, and predictive factors in supportive/palliative oncology clinical trials at a comprehensive cancer center.

2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 108-108
Author(s):  
Isabella Claudia Glitza ◽  
David Hui ◽  
Eduardo Bruera ◽  
Gary B. Chisholm
Keyword(s):  
Clinical Trials ◽  
Confidence Interval ◽  
Sample Size Calculation ◽  
Symptom Burden ◽  
Attrition Rate ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Study Duration ◽  
Palliative Oncology ◽  
Oncology Clinical Trials

108 Background: Attrition is common among supportive/palliative oncology clinical trials. Few studies have documented the reasons, and predictors for dropout. We aimed to determine the rate, reasons, and factors associated with attrition both before reaching the primary endpoint (PE) and the end of study (EOS). Methods: We conducted a review of all prospective interventional supportive/palliative oncology trials in our department between 1999 to 2011. Patient and study characteristics and attrition data were extracted. Results: 1,214 patients were included in 18 clinical trials. The median age was 60, performance status ≥3 41%, median fatigue 7/10, and median dyspnea 2/10. The attrition rate was 26% (95% confidence interval [CI] 23%-28%) for PE and 44% (95% confidence interval 41%-47%) for EOS. Common reasons for EOS dropout were patient preference (N=93, 17%), symptom burden (N=87, 16%), death (N=45, 8%), and hospital admission (N=43, 8%). At the patient level, EOS attrition was associated with Hispanic race (OR=1.88, 95% CI 1.27-2.78), higher baseline intensity of fatigue (odds ratio [OR]=1.09 per point, 95% CI 1.02-1.16), and dyspnea (OR=1.06, 95% CI 1.02-1.11) in multivariate analysis. At the study level, longer study duration (Spearman correlation 0.59, P=0.01) and outpatient studies (47% vs. 6%, P=0.05) were also associated with higher EOS dropouts. Higher dyspnea, fatigue, and longer study duration were associated with PE attrition. Conclusions: The attrition rate was high amongsupportive/palliative oncology clinical trials, and was associated with various patient characteristics and high baseline symptom burden. These findings have implications for future study designs including eligibility criteria and sample-size calculation.

Institutional scientific review of cancer clinical research protocols: Impact of requirement on activation timelines.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18224-e18224
Author(s):  
Martin Frederik Dietrich ◽  
Ning Ning ◽  
Jingsheng Yan ◽  
Xian-Jin Xie ◽  
David E. Gerber
Keyword(s):  
Clinical Trials ◽  
Value Added ◽  
Research Quality ◽  
Comprehensive Cancer Center ◽  
Scientific Review ◽  
Medical Specialties ◽  
Process Duration ◽  
Investigator Initiated Trials ◽  
Board Review ◽  
The Impact

e18224 Background: The National Cancer Institute (NCI) requirement that clinical trials at NCI-designated cancer centers undergo institutional scientific review in addition to Institutional Review Board review is unique among medical specialties. We evaluated the impact of this process on protocol activation timelines. Methods: We analyzed oncology clinical trials that underwent full board review by the Harold C. Simmons Comprehensive Cancer Center Protocol Review and Monitoring Committee (PRMC) from January 1, 2009, through June 30, 2013. We analyzed associations between trial characteristics, PRMC decisions, protocol modifications, and process timelines using Chi-square test, Fisher’s exact test, Wilcoxon rank-sum test, Kruskal-Wallis test, and logistic regression. Results: A total of 226 trials were analyzed. Of these, 77% were industry-sponsored and 23% were investigator-initiated. While only 40% of trials were approved initially, 97% of trials were eventually approved after a mean of 0.6 protocol changes were requested and a mean of 0.5 protocol changes were implemented. Protocol changes were more likely to be requested ( P< 0.001) and implemented ( P= 0.008) for investigator-initiated trials. Median time from submission to PRMC approval was 55 days. The longest component interval was from submission initiation to completion of required documents by the study team (median 29 days). Total process duration depended on approval timing: median 35 days for first review, 68 days (2nd review), and 116 days (3rd review) ( P< 0.001). Similarly, process duration was also associated with the number of changes/clarifications requested: median 39 days for none, 64 days for 1-3, and 73 days for ≥4) ( P< 0.001). Requested changes/clarifications had greater impact on timelines for industry-sponsored trials than for investigator-initiated trials. Conclusions: NCI-mandated institutional scientific review of cancer clinical trials contributes substantially to protocol activation timelines. Further evaluation of this process and the value added to research quality is warranted.

scholarly journals Cancer-Related Internet Use and Online Social Networking Among Patients in an Early-Phase Clinical Trials Clinic at a Comprehensive Cancer Center

2018 ◽  
pp. 1-14 ◽  
Author(s):  
Goldy C. George ◽  
Adrianna Buford ◽  
Kenneth Hess ◽  
Sarina A. Piha-Paul ◽  
Ralph Zinner ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Internet Use ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Cancer Information ◽  
The Internet ◽  
Phase I Clinical Trials ◽  
Experimental Drugs ◽  
The Impact

Purpose We examined patterns, correlates, and the impact of cancer-related Internet use among patients with advanced cancer in a phase I clinical trials clinic for molecularly targeted oncologic agents. Methods An anonymous questionnaire on Internet use for cancer-related purposes that incorporated input from phase I clinical trial oncologists and patients was self-administered by patients age ≥ 18 years in a phase I clinic. Multivariable modeling was used. Data were analyzed for the overall sample and by generation, which was defined by year of birth. Results Of 291 patients (52% women, 82% non-Hispanic white, 50% age ≤ 60 years), 62% were cancer-related Internet users (CIUs). Cancer-related Internet use was associated with an income of ≥ $60,000 (odds ratio, 2.42; P = .004). CIUs used the Internet to learn about their cancer (85%), treatment adverse effects (65%), clinical trials (52%), new alternative treatments (42%), and symptom management (41%). CIUs most frequently used the hospital Web site (70%) to learn about clinical trials, followed by ClinicalTrials.gov (42%) and search engines (41%). The emotional impact of Internet-derived cancer information on CIUs varied—56% felt empowered, 34% anxious, 29% relieved, and 17% confused. Cancer-related Internet information made 51% of patients from the Millennial (born after 1990) and Generation X/Y (born 1965 to 1990) CIU populations anxious compared with < 29% of CIUs from older generations (born 1964 and before). Most CIUs desired more online information about new experimental drugs (91%) and US Food and Drug Administration–approved drugs for cancer (72%). Conclusion As most phase I patients use the Internet for cancer-related purposes, the Internet overall and hospital Web sites should provide more extensive, pertinent, and helpful information on clinical trials and cancer treatment to phase I patients.

scholarly journals The Impact of Insurance on Access to Cancer Clinical Trials at a Comprehensive Cancer Center

2010 ◽  
Vol 16 (24) ◽  
pp. 5997-6003 ◽  
Author(s):  
Justin F. Klamerus ◽  
Suanna S. Bruinooge ◽  
Xiaobu Ye ◽  
Mandi L. Klamerus ◽  
Dorothy Damron ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Cancer Clinical Trials ◽  
The Impact

National survey on the effect of oncology drug shortages in clinical practice: A Hematology Oncology Pharmacy Association (HOPA) survey.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13609-e13609
Author(s):  
Sarah Hudson-Disalle ◽  
David L. DeRemer ◽  
Larry W Buie ◽  
Mark Hamm ◽  
Jeffrey Pilz ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Supportive Care ◽  
Cancer Patients ◽  
Medication Errors ◽  
The United States ◽  
Adverse Outcomes ◽  
Common Disease ◽  
Drug Shortages ◽  
Oncology Drug ◽  
The Impact

e13609 Background: Drug shortages are a clear and growing challenge. Prominent shortages included oncology medications and supportive care products essential for the care of cancer patients. Oncology drug shortages often result in disruptions in the timing of chemotherapy treatments, alterations in the dose or regimen administered, or even missed doses when alternative agents are unavailable. The purpose of this survey was to characterize the impact of oncology drug shortages across the United States, including the experiences of health care organizations, resource implications, and the impact on patient safety, patient care, and clinical trials. Methods: A 34-item online survey was distributed to HOPA membership of the Hematology Oncology Pharmacy Association to gather information on shortages of oncology drugs (i.e., all drugs essential in the care of cancer patients, including supportive care agents. Results: Sixty-eight organizations completed the survey; almost all completed by pharmacists, and analysis completed. Sixty-three percent of institutions reported one or more drugs shortages a month, with a 34.33% increase in 2019 from 2018. Sixty four percent of responded had incurred increased costs from oncology drugs shortages, with 7% noting reimbursement issues when switched to brand name therapies due to shortages. Treatment delays, reduced doses or alternative regimens were reported by 74.63% of respondents. The most common disease states which causes a dose delay of treatment included Acute Lymphocytic Leukemia, Lymphoma and Multiple Myeloma with dose reductions noted in 36.36%, 36.36 and 15.91%. The top five oncology drugs on shortage included epirubicin, flutamide, decitabine, mechlorethamine, dactinomycin with the top 5 supportive care drugs on shortage being noted as hydrocortisone, bivalirudin, promethazine, mycophenolate sodium and scopolamine. Respondents noted medication errors related to oncology drug shortages at 4.48%, with noted errors including incorrect conversion from iv to oral etoposide and incorrect EMR drug builds. Oncology Drug shortages impacted clinical trials in 13.4% of respondents in which 54.55% of respondents noting patients not being enrolled in clinical trials. Conclusions: A survey of US oncology pharmacists and technicians indicated that oncology drug shortages occurred frequently in 2020. Shortages led to delays in chemotherapy and changes in treatment or omission, complicated clinical research and increased the risk of medication errors and adverse outcomes.

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