scholarly journals NCI–Clinical Trial Accrual in a Community Network Affiliated with a Designated Cancer Center

2020 ◽  
Vol 9 (6) ◽  
pp. 1970 ◽  
Author(s):  
Daniel J. Kim ◽  
Dan Otap ◽  
Nora Ruel ◽  
Naveen Gupta ◽  
Naveed Khan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Treatment Options ◽  
Tertiary Care ◽  
Racial Diversity ◽  
Cancer Center ◽  
Main Campus ◽  
Therapeutic Trials ◽  
Clinical Trial Accrual ◽  
Community Site

Most cancer care is delivered in the community, while most clinical trials exist in academic centers. We analyzed clinical trial accrual of a tertiary care cancer center and its affiliated community sites to better understand what types of trials accrued at the community sites and whether community accrual increased ethnic diversity. The institutional clinical trial database was searched for solid tumor accruals during 2018–2019. Patient’s race was abstracted, and trial’s funding source, phase, and disease type/stage were tabulated. Of 3689 accruals, 133 were at community sites, representing 26 unique trials while the main campus accrued to 93 unique trials. Community site accruals were highest for breast and colorectal cancer, but patients with less common cancers such as renal, nasopharyngeal, and gastric cancer were also accrued at community sites. Accruals occurred to randomized trials, as well as phase Ib and translational biomarker studies. Minority patients constituted 20.0% and 32.5% of community site accruals for therapeutic and non-therapeutic trials respectively, compared to 20.6% and 29.8% of main campus accruals for therapeutic and non-therapeutic trials, respectively. We conclude that community sites affiliated with an academic cancer center can accrue to a broad spectrum of clinical trials while enhancing racial diversity in participation of clinical trials. Further expansion of access to clinical trials in community sites is necessary to broaden patient access to state-of-the-art and next-generation treatment options.

Cancer communication in the social media age: Could Twitter help clinical trial accrual?

2016 ◽  
Vol 34 (7_suppl) ◽  
pp. 194-194
Author(s):  
Mina Samir Sedrak ◽  
Roger B. Cohen ◽  
Raina M. Merchant ◽  
Marilyn M. Schapira
Keyword(s):  
Lung Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Content Analysis ◽  
Significant Proportion ◽  
Cancer Clinical Trials ◽  
Specific Content ◽  
The Public ◽  
Therapeutic Trials ◽  
Clinical Trial Accrual

194 Background: Twitter, a social networking site, is transforming communication. Effective use of Twitter might be one way to communicate with the public about cancer clinical trials and increase awareness and perhaps enrollment. We conducted a content analysis of tweets about lung cancer, describing dialogues specific to lung cancer clinical trials and seeing where embedded-links in tweets about therapeutic trials are leading the public. Methods: We used the Twitter search engine to identify a cohort of 26,059 tweets with the keyword “lung cancer” from January 5 - 21, 2015. Tweets were captured and prepared using Nvivo qualitative data analysis software. Duplicate and non-English tweets were excluded. Of the remaining 15,346 unique tweets, 1,516 (10%) were randomly selected for detailed content analysis (kappa = 0.71). Tweets related to clinical trials underwent further analysis to categorize the trial type and embedded-links. University of Pennsylvania IRB exempted this study from review. Results: Most, 83% (1,260/1,516) of tweets in our sample contained lung cancer-specific content and 17% (256/1,516) were categorized as miscellaneous (e.g., extraneous content, non-sequiturs). Table 1 shows the distribution of content categories of lung cancer related tweets by frequency. Most of the tweets focused on support or prevention. Among the lung cancer related tweets, 18% (221/1,260) related to clinical trials. Of clinical trial tweets, 83% (183/221) concerned therapeutic trials, 13% (28/221) non-therapeutic, and 4% (10/221) basic research. Among the therapeutic clinical trial tweets, 79% (144/183) concerned immunotherapy and 86% (158/183) had embedded-links directing users to news articles. Only 1 tweet linked to a patient recruitment website. Conclusions: A significant proportion of lung cancer tweets are about clinical trials, but virtually none direct patients to enrollment sites. Twitter is a new communication medium for the cancer community, and further research is needed to test its potential to promote clinical trial accrual. [Table: see text]

The impact of the COVID-19 pandemic on oncology clinical trial recruitment in an Irish cancer center.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18756-e18756
Author(s):  
Ronan Andrew McLaughlin ◽  
Valerie Madigan ◽  
Maureen O'Grady ◽  
Thamir Andrew Mahgoub ◽  
Roshni Andrew Kalachand ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Informed Consent ◽  
Treatment Options ◽  
Cancer Clinical Trial ◽  
University Hospital ◽  
Cancer Center ◽  
Cancer Clinical Trials ◽  
Number Of Patients ◽  
The Impact

e18756 Background: The COVID-19 pandemic has created unprecedented disruptions to cancer clinical trial research across the world due to a temporary global suspension of patients’ recruitment to cancer clinical trials. Access to clinical trials permits better treatment options and best clinical practice standards for patients with cancer. We present the impact of the COVID-19 pandemic on cancer clinical trial activity at the Cancer Clinical Trials Unit (CCTU) at the Mid-Western Cancer Centre, University Hospital Limerick (UHL). Over the last 4 years 28 clinical trials, both interventional and translational, have opened here, across a variety of primary disease sites, with 5 trials opened in 2017, 11 in 2018, 7 in 2019 but only 2 in the first 10 months of 2020 until 3 further trials were opened in December. Methods: CCTU records were reviewed to identify the number of patients screened and consented to participate in cancer clinical trials at UHL in 2020, which were compared directly with corresponding numbers for 2019. Results: In 2019, 17 clinical trials were open and recruiting at the CCTU, UHL. During 2020, 19 trials were recruiting although during the 1st surge of the COVID-19 pandemic recruitment was essentially suspended and CCTU staff were redeployed throughout the hospital. 1st Six months 2020 vs 2019 In the six months from January 2020 until the end of June 2020, 99 patients were screened and only 15 (15.2%) signed informed consent to participate in a cancer clinical trial. When these figures are directly compared with the first six months of 2019, there is a 33% reduction in patients screened for participation (147 vs 99) and a 60% reduction in patients consented (37 vs 15) to clinical trials. 12 Months 2020 vs 2019 In total during 2019, 376 patients were screened for inclusion to participate and 49 (13%) patients signed informed consent to participate in a clinical trial within CCTU at UHL. In 2020, 914 patients were screened for participation with 51 patients consented to participate (5.6%). The majority (45/51 (88%)) of patients consented to cancer clinical trials in 2020 at the CCTU, UHL were recruited to translational based studies and only 6 (12%) consented to interventional studies compared with 2019 when 30/49 (61%) consented to translational and 30/49 (39%) to interventional studies. Conclusions: During the COVID-19 pandemic, the percentage of patients consented to participation in a clinical trial reduced significantly, as compared to the previous year (5.6% vs 13%). Fewer interventional studies have recruited patients during 2020. As we enter the third surge of COVID-19 infections in Ireland, we must continue to monitor and identify effective strategies to navigate the ever-changing situation for cancer clinical trials, in an attempt to maintain access to high quality cancer clinical trial opportunities for our patients.

Accrual of Black participants to cancer clinical trials following a five-year prospective initiative of community outreach and engagement.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 100-100
Author(s):  
Carmen E. Guerra ◽  
Vicki Sallee ◽  
Wei-Ting Hwang ◽  
Brenda Bryant ◽  
Armenta L. Washington ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Catchment Area ◽  
Community Outreach ◽  
Fold Increase ◽  
Cancer Center ◽  
Black Communities ◽  
Cancer Clinical Trials ◽  
Black Patients ◽  
Clinical Trial Accrual

100 Background: Accrual of Black participants to cancer clinical trials remains a major challenge across the country. Here, we report the outcomes of a five-year initiative of community outreach and engagement to improve enrollment of adult Black participants to clinical trials at the Abramson Cancer Center (ACC) at the University of Pennsylvania. Methods: Primary metrics were the percentage of Black patients among all cancer cases in our catchment area, the percentage of adult Black patients cared for at the ACC, and the percentage of adult Black participants enrolled on the three types of NCI-defined clinical trials. Results: In 2014, at baseline, Black residents comprised 19% of the population and 16.5% of cancer cases in our catchment area surrounding Philadelphia, but only 11.1% of ACC patients were Black. The percentages of Black participants accrued onto treatment, non-therapeutic interventional, and non-interventional trials were 12.2%, 8.3%, and 13.0%, respectively. We then established a center-wide program with community guidance to address these gaps. Key elements of the program included: 1) culturally tailored marketing strategies for cancer clinical trials; 2) plans for each protocol to facilitate Black participant enrollment; 3) new partnerships with faith-based organizations serving Black communities to conduct educational events about clinical trials; 4) pilot programs with Lyft and Ride Health to address transportation barriers; 5) patient education by nurse navigators regarding cancer and clinical trials; and 6) an improved informed consent process. These efforts reached more than 10,000 individuals in venues including churches, neighborhoods, community parks and centers, and health centers with formats ranging from educational forums to wellness fairs. Reassessing metrics in 2018, we found that the percentage of Black patients seen at ACC had increased to 16.2%, matching the percentage of Black cancer patients among all cancer cases in our catchment area (16.5%). Total cancer clinical trial accrual had increased from 9,308 participants in 2014 to 13,170 in 2018 (41.5% increase). The percentages of Black participants accrued onto treatment, non-therapeutic interventional, and non-interventional trials were 23.9%, 33.1%, and 22.5%, respectively – a 1.7- to 4.0-fold increase in five years and higher than the percentage of Black patients seen at the ACC. Conclusions: Our multifaceted, community-based engagement initiative to encourage clinical trial enrollment was associated with improved accrual of Black participants to cancer clinical trials. These findings also suggest that gaps in access to cancer centers are a key factor driving access to clinical trials. Medicaid expansion occurred concurrently in all states in our catchment area and its impact on accrual merits further research.

Overcoming clinical trial accrual barriers at UPMC: A successful experience.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14152-e14152
Author(s):  
Vincent Edgar Reyes ◽  
Terry L. Evans ◽  
Robert Alan VanderWeele ◽  
Christopher Ritchie Marsh ◽  
Sajid M. Peracha ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Oncology ◽  
The United States ◽  
Cancer Center ◽  
Therapeutic Trial ◽  
Interventional Trial ◽  
Community Oncology ◽  
Community Physician ◽  
Clinical Trial Accrual

e14152 Background: UPMC Hillman Cancer Center Medical Oncology Network is one of the largest integrated community oncology network in the United States. A large gap exists between trial participation rates and the willingness of patients and physicians. There are numerous barriers to clinical trial accrual in the medical oncology community. UPMC identified and created solutions to overcome barriers, and thus dramatically increase clinical trial accrual in 2019. Methods: A physician led advisory board was created to identity problems and find solutions to increase clinical trial accrual in the community. Processes that were implemented in the community to increase physician engagement included identifying more community friendly clinical trials, highlighting high impact clinical trials, and reprioritizing available clinical trials. Also, community physician champions were selected and directly linked with the academic faculty by disease site at UPMC Hillman Cancer Center. Other marketing tools were utilized like a newly developed mobile clinical trial app, community physician dedicated clinical trial retreat, and clinical trial newsletter. High volume community sites were identified as flagship clinical trial accrual centers. Results: With the implementation of physician led initiatives, total (interventional + non interventional) clinical trial accrual increased in the UPMC medical oncology network from 216 in 2018 to 660 in 2019. In 2019 there were 631 interventional trial accruals and 363 therapeutic trial accruals. In 2018 there were only 186 interventional trial accruals and 46 therapeutic trial accruals. Conclusions: The community oncology-directed initiatives created a culture change among the community physicians. UPMC implemented new processes in the medical oncology network that significantly increased clinical trial accrual. [Table: see text]

Prospective Evaluation of Cancer Clinical Trial Accrual Patterns: Identifying Potential Barriers to Enrollment

2001 ◽  
Vol 19 (6) ◽  
pp. 1728-1733 ◽  
Author(s):  
Primo N. Lara ◽  
Roger Higdon ◽  
Nelson Lim ◽  
Karen Kwan ◽  
Michael Tanaka ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Private Insurance ◽  
Cancer Clinical Trial ◽  
Cancer Center ◽  
Trial Participation ◽  
Cancer Clinical Trials ◽  
Eligibility Criteria ◽  
Clinical Trial Accrual ◽  
Patient Accrual

PURPOSE: Well-conducted cancer clinical trials are essential for improving patient outcomes. Unfortunately, only 3% of new cancer patients participate in clinical trials. Barriers to patient accrual in cancer clinical trials must be identified and overcome to increase patient participation. MATERIALS AND METHODS: We prospectively tracked factors that potentially affected patient accrual into cancer clinical trials at the University of California Davis Cancer Center. Oncologists seeing new outpatients were asked to complete questionnaires regarding patient characteristics and the physician’s decision-making on patient eligibility, protocol availability, and patient opinions on participation. Statistical analysis was performed to correlate these parameters with subsequent protocol accrual. RESULTS: There were 276 assessable patients. At the initial visits, physicians did not consider clinical trials in 38% (105/276) of patients principally because of a perception of protocol unavailability and poor performance status. Physicians considered 62% (171/276) of patients for participation in clinical trials. Of these, only 53% (91/171) had an appropriate protocol available for site and stage of disease. Seventy-six of 90 patients (84%) with available protocols met eligibility criteria for a particular study. Only 39 of 76 patients (51%) agreed to participate in cancer clinical trials, for an overall accrual rate of 14% (39/276). The remainder (37/76, 49%) declined trial participation despite meeting eligibility criteria. The most common reasons were a desire for other treatment (34%), distance from the cancer center (13%), patient refusal to disclose reason (11%), and insurance denial (8%). Patients with private insurance were less likely to enroll in clinical trials compared to those with government-funded insurance (OR, 0.34; P = .03; 95% CI, 0.13 to 0.9). CONCLUSION: Barriers to cancer clinical trial accrual can be prospectively identified and addressed in the development and conduct of future studies, which may potentially lead to more robust clinical trials enrollment. Investigation of patient perceptions regarding the clinical trials process and the role of third party–payers is warranted.

Removing barriers to clinical research in community hospitals—The Fox Chase Cancer Center Partners experience

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6614-6614 ◽  
Author(s):  
M. A. O'Grady ◽  
S. J. Cohen ◽  
P. A. Keeley ◽  
E. Sein ◽  
B. J. Miller ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Median Number ◽  
Cancer Center ◽  
Community Hospitals ◽  
Research Programs ◽  
Regulatory Burden ◽  
Clinical Trial Accrual ◽  
Research Nurses

6614 Background: Although the majority of cancer patients are treated in community hospitals, resources to support community clinical trials are often limited. The Fox Chase Cancer Center Partners (FCCCP) initiative is a large academic and community based oncology program in the Delaware Valley. We hypothesized that a detailed clinical research assessment within the 18 main community cancer research programs of the FCCCP would result in improved clinical trial accrual. Methods: The FCCCP clinical team completed research assessments at 10 affiliated community hospitals during 2004–2006 to evaluate active trials, research nurses and data managers, and research barriers. Institutions were benchmarked for staffing, processes, outreach, and quality improvement. Results were presented to administration at each hospital and impact on research accrual recorded. Results: In 2004, 371 patients were treated on clinical trials at 18 FCCCP community research programs. The median number of data managers, research nurses, and open protocols per site was 0.7, 1.6 and 48 respectively. The most common perceived barriers to accrual by investigators and research staff were regulatory burden, time, and awareness. Recommendations included: improved tumor registry identification of clinical trial candidates, increased staffing, improved web-based outreach, and targeted research affiliations. With regulatory burden a significant research barrier, the following IRB streamlining processes were recommended: NCI Central IRB, for-profit IRBs, IRB reciprocity, and centralized health system IRBs. With implementation of recommendations, 10/18 IRBs have transferred to the NCI-Central IRB for phase III cooperative group studies. The median number of data managers and research nurses per site increased to 1.25 and 1.7 respectively. Although the median number of open trials per site remained at 48, accruals to clinical trials increased to 805, representing a 116% increase. Conclusions: Research assessments are feasible in a large academic-community hospital partnership program and result in best practice recommendations with increased clinical trial accrual. Larger scale implementation of research infrastructure in community oncology programs is warranted. No significant financial relationships to disclose.

397 Intra-tumor immunotherapy injections utilizing image guidance in interventional radiology: clinical trial experience at a tertiary care cancer center

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A422-A422
Author(s):  
Ravi Murthy ◽  
Rahul Sheth ◽  
Alda Tam ◽  
Sanjay Gupta ◽  
Vivek Subbiah ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Interventional Radiology ◽  
Real Time ◽  
Image Guidance ◽  
Tertiary Care ◽  
Cancer Center ◽  
Imaging Guidance ◽  
Image Guided ◽  
Real Time Image ◽  
Time Image

BackgroundImage guided intra-tumor administration of investigational immunotherapeutic agents represents an expanding field of interest. We present a retrospective review of the safety, feasibility & technical nuances of real-time image guidance for injection & biopsy across a spectrum of extracranial solid malignancies utilizing the discipline of Interventional Radiology.MethodsPatients who were enrolled in image guided intratumoral immunotherapy injection (ITITI) clinical trials over a 6 year period (2013–19) at a single tertiary care cancer center were included in this analysis. Malignancy, location, imaging guidance utilized for ITITI & biopsy for injected (adscopal) & non-injected (abscopal) lesions were determined and categorized. Peri-procedural adverse events were noted.Results262 pts (146 female, 61 yrs median) participating in 29 immunotherapeutic clinical trials (TLR & STING agonists, gene therapy, anti CD-40, viral/bacterial/metabolic oncolytics) met study criteria. Malignancies included melanoma 88, sarcoma 32, colorectal 29, breast 23, lung 17, head & neck 15, ovarian 8, neuroendocrine 7, pancreatic adenocarcinoma 6, 3 each (cholangioCA, endometrial, bladder, GI tract), 2 each (RCC, thymicCA, lymphoma, merkel cell, prostate) & others 1 each (CUP, GIST, dermatofibrosarcoma, DSRT, neuroblastoma, thyroid). All 169 & 93 patients received the intended 1371 ITITI in parietal (abdominal/chest wall, extremity, neck, pelvis) or visceral (liver, lung, peritoneum, adrenal) locations respectively; 83 patients received lymph node injections within either location. Imaging guidance was US in 68% of the cohort (US 161, CT+US 19); CT was used in 30% (81) & MRI in 1 patient. Median diameter of the ITITI lesion was 32 mm (8–230 mm). Median volume of the ITITI therapeutic material/session was 2 ml (1–6.9 ml). Lesions were accessed using a coaxial technique. ITITI delivery needles used at operator preference & tailored to lesion characteristics were either a 21G/22G Chiba, 21G Profusion (Cook Medical), 22G Morrison (AprioMed), 25G hypodermic (BD) & 18G Quadrafuse (Rex Medical). 2840 core biopsies (>18G Tru-cut core, Mission, Bard Medical) were performed in 237 patients during 690 procedures; biopsy sessions were often concurrent & of the ITITI site. 137 patients also underwent biopsy of a non-ITITI site (89 parietal location). Dimensions of the non-ITITI lesion were median 10 mm (7–113 mm); US image guidance was used in 97 patients (72%) to obtain a total of 1257, >18G Tru-core samples. 1.3% of injections resulted in SAE (NCI CTC AE >3) and 0.5% of 4097 biopsies developed major complications (SIR Criteria); both categories were manageable.ConclusionsUtilizing real time image guidance, ITITI to the administration of a myriad of investigational immunotherapeutic agents with concomitant biopsy procedures to date are associated with a high technical success rate & favorable safety profile.AcknowledgementsJoshua Hein, Mara Castaneda, Jyotsna Pera, Yunfang Jiang,Shuang Liu, Holly Liu and Anna LuiTrial RegistrationN/AEthics ApprovalThe study was approved by Institution’s Ethics Board, approval number 2020-0536: A retrospective study to determine the safety, feasibility and technical challenges of real-time image guidance for intra-tumor injection and biopsy across multiple solid tumors.Consent2020-0536 Waiver of Informed ConsentReferenceSheth RA, Murthy R, Hong DS, et al. Assessment of image-guided intratumoral delivery of immunotherapeutics in patients with cancer. JAMA Netw Open 2020;3(7):e207911. doi:10.1001/jamanetworkopen.2020.7911

scholarly journals Therapeutic clinical trials to combat COVID-19 pandemic in India: analysis from trial registry

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Angelika Batta ◽  
Raj Khirasaria ◽  
Vinod Kapoor ◽  
Deepansh Varshney
Keyword(s):  
Clinical Trials ◽  
De Novo ◽  
Treatment Options ◽  
Drug Repurposing ◽  
Trial Registry ◽  
Therapeutic Treatment ◽  
Clinical Trial Registry ◽  
Clear Cut ◽  
Therapeutic Trials ◽  
Microsoft Office

AbstractObjectivesWith the emergence of Novel corona virus, hunt for finding a preventive and therapeutic treatment options has already begun at a rapid pace with faster clinical development programs. The present study was carried out to give an insight of therapeutic interventional trials registered under clinical trial registry of India (CTRI) for COVID-19 pandemic.MethodsAll trials registered under CTRI were evaluated using keyword “COVID” from its inception till 9th June 2020. Out of which, therapeutic interventional studies were chosen for further analysis. Following information was collected for each trial: type of therapeutic intervention (preventive/therapeutic), treatment given, no. of centers (single center/multicentric), type of institution (government/private), study design (randomized/single-blinded/double-blinded) and sponsors (Government/private). Microsoft Office Excel 2007 was used for tabulation and analysis.ResultsThe search yielded total of 205 trials, out of which, 127 (62%) trials were interventional trials. Out of these, 71 (56%) were AYUSH interventions, 36 (28.3%) tested drugs, 9 (7%) tested a nondrug intervention, rest were nutraceuticals and vaccines. About 66 (56%) were therapeutic trials. Majority were single-centered trials, i.e. 87 (73.7%). Trials were government funded in 57 (48.3%) studies. Majority were randomized controlled trials, i.e. 67 (56.8%). AYUSH preparations included AYUSH-64, Arsenic Album, SamshamaniVati etc.ConclusionsThe number of therapeutic interventional clinical trials was fair in India. A clear-cut need exists for an increase in both quantity and quality of clinical trials for COVID-19. Drug repurposing approach in all systems of medicine can facilitate prompt clinical decisions at lower costs than de novo drug development.

scholarly journals Key Barriers to Clinical Trial Enrolment: A Survey of Clinical Trial Staff at an NCI Designated Cancer Center

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5864-5864
Author(s):  
Amany R. Keruakous ◽  
Adam S. Asch
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cultural Bias ◽  
Cancer Center ◽  
Exclusion Criteria ◽  
Strict Inclusion ◽  
Trial Protocols ◽  
Trial Staff ◽  
Disease Site ◽  
Patient Enrolment

Background: Clinical trials, key elements of the processes that account for many of the recent advances in cancer care, are becoming more complex and challenging to conduct. The Stephenson Cancer Center (SCC) has been the lead accruer to NCI-LAP trials over the past three years, and in addition, fields investigator initiated and industry sponsored trials. To identify opportunities for continued improvement in clinical trial enrolment, we sought to identify the obstacles encountered by our clinical trial staff in these activities. Method: We conducted a survey of our research staff including all research nurses and disease site coordinators who participate in recruitment, screening, consenting, data collection and compliance. The survey, sent by email to the clinical trial list-serve at SCC (90 staff member), invited respondents to enumerate obstacles to patient participation in clinical trials. We then performed a follow up meeting with our research coordinators to clarify responses. A total of 26 responses from 90 respondents were received and tabulated by disease site. Results: The most commonly reported obstacles to enrolment were, in descending order: communication/language barriers, cultural bias, time/procedure commitment, and complexity of the trial protocol, financial logistics, comorbidities, and stringent trial criteria. Respondents identified 83 obstacles as frequently encountered obstacles to enrolment. The 83 reported obstacles were classified into 9 categories and organized by disease site as presented in tabular format (below). The most commonly identified obstacles to patient enrolment were communication and language barriers. In patients for whom Spanish is the primary language this was a universal obstacle, as there is a lack of consistent Spanish consents across the clinical trial portfolio. Cultural bias, as an obstacle was manifested as a general mistrust by prospective trial participants of experimental therapies and clinical trials. After communication and cultural bias as barriers, travel requirements and the associated expenses playing a role in patients from rural areas were identified as the most commonly encountered barrier. The complexity of trial protocols and the associated large number of clinic visits, frequent laboratory and imaging tests were also identified as common obstacles. Clinical trial complexity with strict inclusion and exclusion criteria and trial-specified biopsies were frequently cited. Implications: In this descriptive study, common barriers to patient enrolment in clinical trials were identified by clinical trial staff. Assessing barriers encountered by clinical trial staff is infrequently used as a metric for improving clinical trial enrolment, but provides important perspective. In our study, some obstacles are inherent in our patient populations, others appear to be actionable. Development of Spanish language consents and specific programs to overcome negative bias regarding clinical trials are potential areas for improvement. The complexity of clinical trial protocols and the increasingly strict inclusion/exclusion criteria, are issues that will require consideration and action at the level of the cooperative groups and industry. Disclosures No relevant conflicts of interest to declare.

Evaluating the Financial Impact of Clinical Trials in Oncology: Results From a Pilot Study From the Association of American Cancer Institutes/Northwestern University Clinical Trials Costs and Charges Project

2000 ◽  
Vol 18 (15) ◽  
pp. 2805-2810 ◽  
Author(s):  
Charles L. Bennett ◽  
Tammy J. Stinson ◽  
Victor Vogel ◽  
Lyn Robertson ◽  
Donald Leedy ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Pilot Study ◽  
Medical Care ◽  
Phase Ii ◽  
Third Party ◽  
Disease Stage ◽  
Cancer Center ◽  
Policy Debate ◽  
Economic Analyses

PURPOSE: Medical care for clinical trials is often not reimbursed by insurers, primarily because of concern that medical care as part of clinical trials is expensive and not part of standard medical practice. In June 2000, President Clinton ordered Medicare to reimburse for medical care expenses incurred as part of cancer clinical trials, although many private insurers are concerned about the expense of this effort. To inform this policy debate, the costs and charges of care for patients on clinical trials are being evaluated. In this Association of American Cancer Institutes (AACI) Clinical Trials Costs and Charges pilot study, we describe the results and operational considerations of one of the first completed multisite economic analyses of clinical trials. METHODS: Our pilot effort included assessment of total direct medical charges for 6 months of care for 35 case patients who received care on phase II clinical trials and for 35 matched controls (based on age, sex, disease, stage, and treatment period) at five AACI member cancer centers. Charge data were obtained for hospital and ancillary services from automated claims files at individual study institutions. The analyses were based on the perspective of a third-party payer. RESULTS: The mean age of the phase II clinical trial patients was 58.3 years versus 57.3 years for control patients. The study population included persons with cancer of the breast (n = 24), lung (n = 18), colon (n = 16), prostate (n = 4), and lymphoma (n = 8). The ratio of male-to-female patients was 3:4, with greater than 75% of patients having stage III to IV disease. Total mean charges for treatment from the time of study enrollment through 6 months were similar: $57,542 for clinical trial patients and $63,721 for control patients (1998 US$; P = .4) CONCLUSION: Multisite economic analyses of oncology clinical trials are in progress. Strategies that are not likely to overburden data managers and clinicians are possible to devise. However, these studies require careful planning and coordination among cancer center directors, finance department personnel, economists, and health services researchers.

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