Enrollment of African Americans Onto Clinical Treatment Trials: Study Design Barriers

2004 ◽  
Vol 22 (4) ◽  
pp. 730-734 ◽  
Author(s):  
Lucile L. Adams-Campbell ◽  
Chiledum Ahaghotu ◽  
Melvin Gaskins ◽  
Fitzroy W. Dawkins ◽  
Duane Smoot ◽  
...  
Keyword(s):  
Clinical Trials ◽  
African American ◽  
African Americans ◽  
Cancer Patients ◽  
Study Design ◽  
Patient Population ◽  
Disease Stage ◽  
Cancer Center ◽  
Howard University ◽  
Study Population

Purpose African Americans have the highest cancer mortality rates and poorest survival and are more often uninsured and underinsured compared with other ethnic groups. Minority participation in clinical trials has traditionally been low, with reports ranging from 3% to 20%. The present study systematically assesses 235 consecutively diagnosed African American cancer patients regarding recruitment onto cancer treatment clinical trials at Howard University Cancer Center between January 1, 2001, and December 31, 2002. Our intent is to determine the rate-limiting factors associated with enrolling African Americans onto clinical trials at a historically black medical institution. Patients and Methods Two hundred thirty-five consecutively diagnosed African American cancer patients were assessed for participation in clinical trials at Howard University Hospital and Cancer Center. The study population comprised 165 women and 70 men. Results The overall eligibility rate was 8.5% (20 of 235 patients); however, among those eligible, the enrollment rate (ie, enrollment among the eligible population) was 60.0% (12 of 20 patients). Comorbidities rendered 17.1% of the patient population ineligible for the trials. Advanced disease stage, associated with poor performance status, premature death, and short life expectancy, made an additional 10% of the patient population ineligible. Respiratory failure, HIV positivity, and anemia accounted for 37.8% of the comorbidities in this population. Cardiovascular diseases and renal insufficiency represented 16.2% of the comorbidities. Conclusion It was evident that study design exclusion and inclusion criteria rendered the majority of the study population ineligible. Among African Americans, comorbidity is a major issue that warrants considerable attention.

Enrollment of lung cancer patients on clinical trials at an NCI comprehensive cancer center

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6633-6633 ◽  
Author(s):  
V. L. Keedy ◽  
L. Horn ◽  
A. Hayes ◽  
B. Spencer ◽  
G. Garcia ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
African American ◽  
Cancer Patients ◽  
Minority Groups ◽  
Performance Status ◽  
Disease Stage ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Willingness To Participate

6633 Background: Enrollment of cancer patients (pt) in clinical trials is considered essential in order to improve cancer care. However, cancer clinical trials participation remains low. Understanding barriers to pt enrollment is necessary to overcome this problem. Previous reports have identified pt age, race, and ethnicity, disease stage, performance status (PS) and relationship with their health care provider as factors that can influence the enrollment of pts in clinical trials. Methods: We conducted a retrospective review of the charts of all lung cancer pts seen in the Thoracic Oncology Clinic at Vanderbilt Ingram Cancer Center between November 2005 and November 2008. A total of 1075 lung cancer pts were seen. Results: 577 charts (of a planned 1075) have been audited to date. Pt demographics: median age = 64 yrs; male = 54%; Caucasian = 92%, African American = 4%, and Asian = 1%; NSCLC = 80%, SCLC = 17%. Male pts were more likely than females to be eligible for a clinical trial (p = 0.056). A study protocol was available for 57% of pts; 52% of pts proved eligible; 36% were entered into a study (11% total population). Significantly more protocols were available for NSCLC pts compared to pts with SCLC (p ≤ 0.001); there was also a non-significant trend towards higher enrollment of eligible NSCLC pts. There was no difference in eligibility between ethnicity; the percentage of eligible pts enrolling on trials was similar between Caucasian & African American pts (46% and 43%); no Asian pts were enrolled. The most common reasons for not enrolling included a preference for treatment closer to home (29%), patient refusal (19%), PS (19%), and co-morbidities (17%). The distance pts traveled was inversely correlated with likelihood of study participation. Conclusions: A total of 11% of lung cancer pt evaluated in our Thoracic Oncology Clinic were enrolled in clinical trials. Our data suggest additional strategies are needed to attract minority groups, increase enrollment of women and pts with comorbidities and poor PS. Travel distances influence pt willingness to participate in clinical trials. Strategies are needed to overcome this factor. No significant financial relationships to disclose.

Cancer clinical trials available in the community setting: A 5-year analysis from 1999–2004

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6056-6056
Author(s):  
J. K. Keller ◽  
J. Bowman ◽  
J. A. Lee ◽  
M. A. Mathiason ◽  
K. A. Frisby ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Community Setting ◽  
Disease Stage ◽  
Cancer Center ◽  
Newly Diagnosed ◽  
Community Based ◽  
Eligibility Criteria ◽  
Major Barrier

6056 Background: Less than 5% of newly diagnosed cancer patients are accrued into clinical trials. In the community setting, the lack of appropriate clinical trials is a major barrier. Our prospective study in 2004 determined that 58% of newly diagnosed adult cancer patients at our community-based cancer center didn’t have a clinical trial available appropriate for their disease stage. Among those with clinical trials, 23% were subsequently found to be ineligible (Go RS, et al. Cancer 2006, in press). However, the availability of clinical trials may vary from year to year. Methods: A retrospective study was conducted to determine what clinical trials were available for newly diagnosed adult cancer patients at our institution from June 1999-July 2004. The study also investigated the proportions of newly diagnosed patients who had a clinical trial available appropriate for type and stage of disease and patients accrued. Results: Over the 5-year period, 207 (82, 87, 99, 102, 117, years 1–5, respectively) trials were available. Most (50.7%) trials were for the following cancers: breast (15.5%), lung (13.5%), head and neck (7.7%), colorectal (7.2%) and lymphoma (6.8%). ECOG (53%), RTOG (26%), and CTSU (9%) provided the majority of the trials. A total of 5,776 new adult cancer patients were seen during this period. Overall, 60% of the patients had a trial available appropriate for type and stage of their cancer, but only 103 (3%) were enrolled. There was a significant upward trend in the proportions of patients with available trials over the years (60.2%, 55.9%, 59.2%, 60.7%, 63.9%, years 1–5, respectively; Mantel-Haenszel P=.008). The proportion of patients with a trial available was highest for prostate (97.3%), lung (90.9%), and breast (73.9%), and lowest for melanoma (17.1%), renal (11.6%), and bladder (7.2%). The majority of patients accrued to trials had the following cancers: breast (32%), lung (17%), lymphoma (9%), colon (7%), and prostate (5%). Conclusions: Nearly half of the newly diagnosed adult patients at our center had no trials available appropriate for type and stage of their cancers. It is likely that if strict clinical trial eligibility criteria were applied, approximately 2/3 of our patients would not be eligible for a clinical trial. No significant financial relationships to disclose.

scholarly journals Novel Method for Benchmarking Recruitment of African American Cancer Patients to Clinical Therapeutic Trials

2008 ◽  
Vol 26 (31) ◽  
pp. 5074-5077 ◽  
Author(s):  
Keith H. Morgenlander ◽  
Sharon B. Winters ◽  
Chyongchiou J. Lin ◽  
Linda B. Robertson ◽  
Dwight E. Heron ◽  
...  
Keyword(s):  
Clinical Trials ◽  
African American ◽  
African Americans ◽  
General Population ◽  
Cancer Patients ◽  
Cancer Incidence ◽  
Age Distribution ◽  
Recruitment Rate ◽  
Invasive Cancer ◽  
Therapeutic Trials

Purpose The National Cancer Institute (NCI) has historically evaluated the participation of underserved minorities within University of Pittsburgh Cancer Institute (UPCI) clinical trials in relation to the proportion of African Americans in the general population of the UPCI primary service area of Allegheny County (12%). This standard seemed to be unrealistically high as a result of a younger age distribution of African Americans within the county. Methods The proportions of African Americans within the following four separate county populations were compared using data from 2000 to 2004: general population; invasive cancer patients; invasive cancer patients diagnosed or treated at UPCI-affiliated facilities; and patients enrolled onto UPCI's clinical therapeutic trials. Results Although the proportion of African Americans within the general population was approximately 13%, only 9.8% of patients diagnosed with invasive cancers were African American. Approximately 9.5% of all cancer patients diagnosed or treated at UPCI facilities were African American, which is comparable to the county-wide percentage of African American cancer patients. Recruitment rate of African Americans to oncology clinical trials from within the UPCI patient population was 7.6%. The NCI benchmark did not reflect the actual invasive cancer incidence rate in African American patients. By comparing the percentage of African Americans contributing to cancer incidence with the percentage of African American cancer patients treated at research-affiliated institutions, a more appropriate benchmark was derived. Conclusion The method developed by UPCI is recommended as a useful mechanism for benchmarking recruitment of African American cancer patients to clinical therapeutic trials at other cancer centers.

Improving hematology/oncology clinical research recruitment via universal prescreening: The VA Connecticut (VACT) Cancer Center experience.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 79-79
Author(s):  
Jenny Jing Xiang ◽  
Alicia Roy ◽  
Christine Summers ◽  
Monica Delvy ◽  
Jessica Lee O'Donovan ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Clinical Research ◽  
Cancer Patients ◽  
Cancer Center ◽  
Cancer Type ◽  
Eligibility Criteria ◽  
Research Recruitment ◽  
Lung Cancer Patients ◽  
Study Enrollment

79 Background: Patient-trial matching is a critical step in clinical research recruitment that requires extensive review of clinical data and trial requirements. Prescreening, defined as identifying potentially eligible patients using select eligibility criteria, may streamline the process and increase study enrollment. We describe the real-world experience of implementing a standardized, universal clinical research prescreening protocol within a VA cancer center and its impact on research enrollment. Methods: An IRB approved prescreening protocol was implemented at the VACT Cancer Center in March 2017. All patients with a suspected or confirmed diagnosis of cancer are identified through tumor boards, oncology consults, and clinic lists. Research coordinators perform chart review and manually enter patient demographics, cancer type and stage, and treatment history into a REDCap (Research Electronic Data Capture) database. All clinical trials and their eligibility criteria are also entered into REDCap and updated regularly. REDCap generates real time lists of potential research studies for each patient based on his/her recorded data. The primary oncologist is alerted to a patient’s potential eligibility prior to upcoming clinic visits and thus can plan to discuss clinical research enrollment as appropriate. Results: From March 2017 to December 2020, a total of 2548 unique patients were prescreened into REDCAP. The mean age was 71.5 years, 97.5% were male, and 15.5% were African American. 32.57 % patients had genitourinary cancer, 17.15% had lung cancer, and 46.15% were undergoing malignancy workup. 1412 patients were potentially eligible after prescreening and 556 patients were ultimately enrolled in studies. The number of patients enrolled on therapeutic clinical trials increased after the implementation of the prescreening protocol (35 in 2017, 64 in 2018, 78 in 2019, and 55 in 2020 despite the COVID19 pandemic). Biorepository study enrollment increased from 8 in 2019 to 15 in 2020. The prescreening protocol also enabled 200 patients to be enrolled onto a lung nodule liquid biopsy study from 2017 to 2019. Our prescreening process captured 98.57% of lung cancer patients entered into the cancer registry during the same time period. Conclusions: Universal prescreening streamlined research recruitment operations and was associated with yearly increases in clinical research enrollment at a VA cancer center. Our protocol identified most new lung cancer patients, suggesting that, at least for this malignancy, potential study patients were not missed. The protocol was integral in our program becoming the top accruing VA site for NCI’s National Clinical Trial Network (NCTN) studies since 2019.

scholarly journals Heterogeneity of Recent Phase 3 Complicated Urinary Tract Infection Clinical Trials

2021 ◽  
Vol 8 (3) ◽  
Author(s):  
Simon Portsmouth ◽  
Almasa Bass ◽  
Roger Echols ◽  
Glenn Tillotson
Keyword(s):  
Clinical Trials ◽  
Urinary Tract Infection ◽  
Urinary Tract ◽  
Tract Infection ◽  
Study Design ◽  
Patient Population ◽  
Complicated Urinary Tract Infection ◽  
Gram Negative ◽  
Regulatory Guidelines ◽  
New Antibiotics

Abstract Background For new antibiotics developed to treat antibiotic-resistant Gram-negative infections, the US Food and Drug Administration (FDA) regulatory pathway includes complicated urinary tract infection (cUTI) clinical trials in which the clinical isolates are susceptible to the active control. This allows for inferential testing in a noninferiority study design. Although complying with regulatory guidelines, individual clinical trials may differ substantially in design and patient population. To determine variables that impacted patient selection and outcome parameters, 6 recent cUTI trials that were pivotal to an new drug application (NDA) submission were reviewed. Methods This selective descriptive analysis utilized cUTI trial data, obtained from publicly disclosed information including FDA documents and peer-reviewed publications, from 6 new antibiotics developed to treat multidrug-resistant Gram-negative infections: ceftolozane-tazobactam, ceftazidime-avibactam, meropenem-vaborbactam, cefiderocol, plazomicin, and fosfomycin. Eravacycline was not approved for cUTI and is not included. Results Microbiologic modified intent-to-treat sample size, age, proportions of female patients, acute pyelonephritis (AP), Escherichia coli and other pathogens at baseline, protocol-specified switch to oral antibiotic, and the noninferiority margin were compared. Outcome data included clinical response, microbiologic eradication, and composite outcomes, including a subset of patients with AP. Conclusions A study design can follow regulatory guidelines but still have variable populations. The proportion of AP within a study varied greatly and influenced population demographics (age, gender) and baseline microbiology. A smaller proportion of AP resulted in an older patient population, fewer females, less E coli, and lower proportions of patients achieving success. Fluoroquinolones and piperacillin/tazobactam should be reconsidered as active comparators given the high rates of resistance to these antibiotics.

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.

Pegylated Liposomal Doxorubicin (PLD), Vincristine and Reduced-Dose Dexamethasone (DVd) in the Treatment of a Predominantly African American Population with Multiple Myeloma.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 2573-2573 ◽  
Author(s):  
Ahmad Jajeh ◽  
Rosalind Catchatourian ◽  
David Osafo ◽  
Deimante Tamkus ◽  
Ghassan Zalzaleh ◽  
...  
Keyword(s):  
African American ◽  
African Americans ◽  
Patient Population ◽  
Liposomal Doxorubicin ◽  
Pegylated Liposomal Doxorubicin ◽  
Mononuclear Phagocytes ◽  
Phospholipid Vesicle ◽  
African American Patient ◽  
Minor Response

Abstract Recently there has been an important recognition of potentially different responses to pharmaceuticals based on genetic predisposition, with the first FDA advisory panel recommending approval of a heart failure drug for African Americans alone. Liposomal doxorubicin (DOXIL; PLD) is a microscopic pegylated phospholipid vesicle with a core containing conventional doxorubicin. The pegylated coat protects the liposomes from detection by mononuclear phagocytes increasing blood circulation time (t½ = 55 hours). Due to its prolonged half-life, PLD provides a similar effect to using continuous infusion doxorubicin, but administered over 1-hour, transforming the regimen into an outpatient treatment. PLD has also been shown to have a significantly better cardiac safety profile than conventional doxorubicin. A phase II trial using DVd was started in October 2000 and is still enrolling (PLD 40 mg/m2, vincristine 2 mg IVP, and dexamethasone 40 mg PO 1–4 d every 4-weeks). Twenty-seven patients have been enrolled (11 males/16 females; mean age 56 years [range 41–75]). The majority of patients enrolled in this study are African American (74%), a patient population not commonly studied. Patients presented with relatively advanced disease (stages II – III). Baseline mean serum albumin level was 3.5 mg/dL (range 1.4 to 4.4), beta-2 microglobulin 3.38 (range 1.0 – 8.97), fourteen patients had IgG Kappa, three patients has IgG Lambda, six patients with IgA, and four patients with light chain disease. Eighteen patients completed six cycles of therapy, with two patients completing five cycles. Six patients underwent autologous bone marrow transplant following their response to DVd. CR, and nCR was achieved in nine patients, partial responses were achieved in seven patients, minor response in two patients, and progressive disease in five patients, based on Blade Response Assessment. Median follow up is twenty-four months (range 3 months – 5 years). Overall medium time to progression is approximately 1 year. Twenty patients are still alive, one patient has been lost to follow up, and six deaths have occurred. Four early deaths were due to disease progression and sepsis. Two died after one year of therapy due to progressive refractory disease. One died after the second cycle because of sudden cardiac death with sepsis. Three of the early deaths had amyloidosis. No episodes of cardiac dysfunction were observed. Conclusion: African Americans have a 3-fold higher risk of cardiac toxicity with conventional doxorubicin. The use of DVd in this predominantly African American patient population was cardiac safe and provided an easy administered outpatient option, with an overall response rate of ~66% in stage II–III patients.

Pegylated Liposomal Doxorubicin (PLD), Vincristine and Reduced-Dose Dexamethasone (DVd) in the Treatment of Predominantly African American Population with Multiple Myeloma.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 5105-5105 ◽  
Author(s):  
Anshul Bamrolia ◽  
Ahmad Jajeh ◽  
R. Catchatourian ◽  
David Osafo ◽  
Deimante Tamkus ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
African American ◽  
African Americans ◽  
Liposomal Doxorubicin ◽  
Mononuclear Phagocytes ◽  
Disease Stage ◽  
Phospholipid Vesicle ◽  
American Population ◽  
African American Population

Abstract Biologic therapy is emerging as first line therapy for multiple myeloma. However, most patients will require multiple lines of treatments and chemotherapy remains a very good option. In the last few years, there has been an important recognition of potentially different responses to pharmaceuticals based on genetic predisposition, starting with the FDA advisory panel recommending approval of a heart failure drug for African Americans. Liposomal doxorubicin (DOXIL; PLD) is a microscopic pegylated phospholipid vesicle with a core containing conventional doxorubicin. The pegylated coat protects the liposomes from detection by mononuclear phagocytes, increasing blood circulation time (t1/2=55 hours). Due to its prolonged half life, PLD provides a similar effect to using continuous infusion doxorubicin, but administered over 1-hour, transforming the regimen into an outpatient treatment. PLD has also been shown to have a significantly better safety profile than conventional doxorubicin. We evaluated the efficacy and safety of DVd in a predominantly African American population. A phase II trial using DVd was started in October 2000(PLD 40 mg/m2, vincristine 2 mg IVP and dexamethasone 40 mg PO 1-4 d every 4-weeks). Thirty-four patients have received DVd (15 males/19 females: mean age 59 years [range 42–77]) (five patients were off-study but received DVd per protocol). The majority of patients are African American (70%), a patient population not commonly studied. Patients presented with relatively advanced disease (stage II–III). Baseline mean serum albumin level was 3.5 mg/dl (range 1.8 to 4.9), beta-2 microglobulin 4.09 (range 1.0–8.97). Seventeen patients had IgG Kappa, seven patients had IgG lambda, six patients had IgA and four patients had light chain disease. Twenty five patients completed six cycles of therapy, with two patients completing five cycles. Six patients underwent autologous bone marrow transplant following their response to DVd. Response was assessed on the basis of a reduction of the paraprotein in serum or urine that lasted for at least six weeks. A response was achieved in 27 patients of whom 15 had a CR or nCR. 2 patients had stable disease, and disease progressed in four patients based on Blade Response Assessment. One patient died before response could be assessed. Median follow up is 36 months (range 3 months to 5 years). Our median time to progression is approximately 1 year. Twenty four patients are still alive, one patient has been lost to follow up and nine deaths have occurred. Four early deaths were due to disease progression and sepsis. Three of the early deaths had amyloidosis. Two died after one year of therapy due to progressive refractory disease. One died after the second cycle because of sudden cardiac death with sepsis. No episodes of cardiac dysfunction were observed. For African Americans, who have a high incidence of hypertension, renal and cardiovascular disease, a cardiac safer liposomal doxorubicin may be the preferred form of anthracyline.

Ineligibility of prostate cancer patients in the VA Connecticut Healthcare System (VACHS) to participate in clinical trials due to comorbidities

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5169-5169
Author(s):  
T. M. Mayer ◽  
W. K. Kelly ◽  
J. Concato ◽  
H. Chao
Keyword(s):  
Prostate Cancer ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Healthcare System ◽  
Patient Population ◽  
Performance Status ◽  
Phase Iii ◽  
Medical Conditions ◽  
Eligibility Criteria ◽  
Major Phase

5169 Background: A large proportion of prostate cancer patients receive their care within the VA Healthcare System. As this is a population affected by complex comorbidities, they may be underrepresented in oncology clinical trials. Our objective was to quantify the frequency with which castrate resistant prostate cancer (CRPC) patients in VACHS would be excluded from major phase III randomized controlled trials. Methods: We reviewed records of all prostate cancer patients at the VACHS between 2004–2007 and identified patients with CRPC. We reviewed eligibility criteria of 24 major phase III clinical trials, from 2006 onwards, studying investigational drugs for CRPC and created a “master list” (ML) of the most pertinent criteria. We analyzed our patient population according to both the ML criteria and to the TAX327 study criteria. Results: We identified 106 patients with CRPC, excluded 7 patients with insufficient medical records, and analyzed 99 patients. Performance status and life expectancy could not be accurately assessed from most charts and were excluded as specific criteria (though reflected in other serious medical condition). Major reasons for exclusion according to ML/TAX327 criteria include: 10/10 other malignancy within 5 years; 11/14 abnormal laboratory parameters; 27/30 other serious medical conditions; 3/4 abnormal cardiac function. ML list only exclusions: 5 active angina; 1 unstable DM; 1 major GI surgery; 1 contraindication to steroids. Serious medical conditions included: active cardiac disease, dementia, serious neurologic, psychiatric, vascular, pulmonary or hematologic disease, and poor performance status or compliance. Overall, 45% (45/99) of patients were excluded when using both the ML and TAX327 criteria. Conclusions: Approximately half of CRPC patients in the VACHS between 2004–2007 did not meet eligibility criteria for major therapeutic trials for CRPC. This retrospective review demonstrates that VA patients are underrepresented in randomized clinical trials for CRPC and are a special population due to their complex comorbidities. These findings underscore the importance of designing better clinical trials for CRPC with less barriers for this underrepresented but common patient population. No significant financial relationships to disclose.

Expectations of cancer patients about clinical trials in multidisciplinary clinics

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e17563-e17563
Author(s):  
G. H. Kloecker ◽  
M. Janjua ◽  
J. Day ◽  
D. Lee
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Effective Interaction ◽  
Management Plan ◽  
Clinic Visit ◽  
Cancer Center ◽  
Academic Settings ◽  
The Difference ◽  
Multidisciplinary Conference ◽  
Multidisciplinary Clinics

e17563 Background: Progress in cancer treatment is very much dependent on the effective interaction of several specialties. To facilitate the process, more and more multidisciplinary clinics have been created over the last decade, especially in academic settings. This approach has been more established in the academic setting to help facilitate better patient accrual to clinical trials. Although there are studies confirming the effectiveness of this approach in fulfilling practice guidelines, there is however no study of patients’ expectations at a multidisciplinary clinic, especially in regard to the patients’ attitude towards clinical trials. This study examines patients’ preferences for services offered in an academic Methods: Surveys were handed to patients at the time of the first clinic visit and at time of progressive disease. The surveys were designed as a self directed questionnaire with the following questions that were rated on an ordinate scale from not at all important (score 1) to extremely important value (score 7): to see all doctors the same day; to be treated at a university-based cancer center; to have everything completely explained; to have the first appointment within 10 days; to know your cases will be discussed at conference; to have help with transportation and medical costs; and to participate in clinical trials. Results: 94 patients were surveyed at the GI and Thoracic Multimodality Clinic. Among patients the highest preference was “to have every thing explained,” score 6.7 (6.5–7.0, CI), immediately followed by the discussion at the multidisciplinary conference, score 6.6 (6.5–6.8, CI). Clinical trials ranked lowest, score 4.8 (4.4–5.2,CI). The difference was statistically significant, p = 0.012. There was no difference between GI and Thoracic Multimodality Clinic patients. Patients with progressive cancers showed a slightly higher interest in clinical trials, but still ranking trials below most other services. Conclusions: Patients value complete explanations of the disease and management plan far more than they value clinical trials. Considering that nationwide less than 5% of cancer patients are enrolled in clinical studies, it is important for physicians to explain the merit of clinical trials to patients and public. No significant financial relationships to disclose.

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