Attitudes of patients towards cancer clinical trials.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 741-741
Author(s):  
Olubukola Ayodele ◽  
Mateen Akhtar ◽  
Mathew Chad Eastwood ◽  
Aiste Linkeviciute-Koneko ◽  
Niamh M. Keegan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
University Hospital ◽  
Cancer Clinical Trials ◽  
Summary Statistics ◽  
Test Results ◽  
Exact Test ◽  
Patient Awareness ◽  
New Drug ◽  
New Treatment

741 Background: Older patients (pts) with cancer are under-represented in clinical trials (CTs). To better understand the causes for low accrual rates, the pts perspective must be explored. Objectives: To determine the attitudes of Irish pts towards enrolment into cancer CTs and in particular, the differences between the attitudes of older and younger pts. Methods: Pts with a gastrointestinal cancer, receiving treatment or in follow-up in University Hospital Waterford were eligible. Pts completed a self-dministered questionnaire comprising three sections: attitudes towards CT participation, reasons to participate, and reasons to decline participation. Pts were given three CT scenarios and were asked if they would participate: these included a cancer prevention/screening CT; a CT comparing standard to new treatment and a trial of a new drug where no standard exists. Summary statistics were used to describe the respondents. Differences between the groups were investigated using the Fishers exact test. Results: From March 2014, 69 pts were accrued, 31 <65 yrs (32-64) and 38 ≥65 yrs (65–85). Five (16%) younger and 3 (8%) older pts had been or were actively enrolled on a CT (p=0.45). An additional 4 (17%) younger and 5 (13%) older pts were invited to participate in a CT, all of whom declined. No patient in either group had actively enquired about CT availability. For the CT scenarios, 22 (71%) younger vs. 22 (58%) older pts would participate in a prevention/screening CT (p=0.32); 14 (45%) vs. 19 (50%) for standard vs. new drug CT (p=0.81), and 23 (74%) vs. 31 (82%) for a CT where no standard exists (p=0.56). The most common reasons to participate in a CT included the potential to feel better, reported in 100% of younger and older pts, the potential to live longer (100% vs. 92%) and the potential to help others (97% vs 89%). Age was deemed an important consideration in 20 (65%) younger and 25 (66%) older pts. Conclusions: The attitudes of older and younger pts to cancer CTs are similar. Physician barriers and availability of appropriate studies impact accrual of both older and younger cancer pts into trials. No patient in this study actively sought out a CT, suggesting a need for better patient awareness and education. This study is ongoing and updated results will be presented.

Efficacy of Yttrium-90 Zevalin Outside of Clinical Trials: Preliminary Results of a Retrospective Bi-Center Study

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 5015-5015
Author(s):  
Francesco Cicone ◽  
Francesco Scopinaro ◽  
Sebastien Baechler ◽  
Nicolas Ketterer ◽  
Franz Buchegger ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Setting ◽  
Patient Population ◽  
Statistical Significance ◽  
University Hospital ◽  
Low Grade ◽  
Number Of Patients ◽  
Significant Difference ◽  
Routine Clinical Setting

Abstract Background and Aim: Due to limited data regarding the efficacy of Radioimmunotherapy with 90Y-Zevalin (RIT-Z) outside of controlled clinical trials, we carried out a biinstitutional, international retrospective study to assess the efficacy of RIT-Z in a routine clinical setting. The relationship between the number of previous therapies and outcomes as well as the response to the last therapy was assessed. Possible differences in outcomes for patients treated in the two different centers were also analyzed. Materials and Methods: Forty-three consecutive patients treated at the University Hospital of Lausanne (CHUV, Switzerland) and at S. Andrea University Hospital of Rome (Italy) were evaluated, none of which had been previously included in clinical trials. Only 31 patients entered the final analysis: patients lost at follow up, undergoing autologous transplantation (ASCT), or treated within the last 3 months were excluded. Efficacy of therapy was evaluated in terms of Overall Survival (OS), Progression Free Survival (PFS), and Time to Next Treatment (TTNT). Survival curves were obtained with the Kaplan- Meier method (statistical significance = p&lt;0.05). Results: Characteristics of the patient population are listed in Table 1. Although 50% of the patients had aggressive histologies, patients treated at S. Andrea had slightly more favorable features than those treated at CHUV. Fourteen patients (45%) had received at least 4 previous treatments, and all had received Rituximab. Fourteen patients (45%) had not responded to the last therapy, while 6 (19%), all treated at S.Andrea, were considered disease-free at the time of RIT-Z, which was administered for consolidation. Median follow up time was 20 months (11.5 vs. 25 months for S.Andrea and CHUV, respectively). Median PFS and TTNT were similar. After achieving a partial response, 2 patients were referred to Rituximab maintenance after RIT-Z and remain progression-free. Median OS was still not attained. Although not statistically significant, a trend towards better outcomes for S. Andrea patients was found. In comparing patients with indolent and aggressive lymphoma, only PFS was found to be significantly different (median PFS: 10 vs. 5 months, p&lt;0.05). In patients with &lt;4 and ≥ 4 previous therapies, twenty month OS was 88% vs. 53.6% (p=0.02), respectively; median TTNT was 22 vs. 5 months (p=0.013), while differences in PFS did not attain statistical significance. The duration of response in non-responders to their last therapy was shorter than in responders: 20-month OS- 44% vs. 94% (p=0.0015), median PFS and TTNT- 3.5 vs. 15 months (p=0.0002) and 4 vs. 15 months (p=0.0001), respectively. Median PFS and TTNT after RIT-Z did not differ from those found after the last therapy. A significant difference in outcomes for heavily pretreated or refractory patients was found in those with low grade follicular lymphoma. Conclusions: Poorer outcomes were found in our patient population treated in a routine clinical setting compared to those enrolled in clinical trials. This may be related to greater heterogeneity of our study cohort which included more patients with unfavorable conditions (e.g. aggressive NHL, ≥4 treatment courses including rituximab in all, and ASCT in 25%). Our results suggest that the best benefit may be expected with RIT-Z either for consolidation or relatively earlier in the course of NHL treatment. Table 1. Total CHUV S. Andrea Population Analyzed (72%) Number of patients 43 23 20 31 Median Age 61 63 58,5 62 Aggressive Histology (FL grade 3 or DLBCL) 18 (41,8%) 8 (34,7%) 10 (50%) 11 (35,5%) Indolent Histology (FL grade 1 or 2) (%) 25 (58,2%) 15 (65,3%) 10 (50%) 20 (64,5%) Patients with ≥4 previous treatments 19 (44,2%) 12 (52,1%) 7 (35%) 14 (45,2%) Patients with previous ASCT 11 (25,6%) 6 (26%) 5 (25%) 8 (25%)

Ethical, Scientific, and Regulatory Perspectives Regarding the Use of Placebos in Cancer Clinical Trials

2008 ◽  
Vol 26 (8) ◽  
pp. 1371-1378 ◽  
Author(s):  
Christopher K. Daugherty ◽  
Mark J. Ratain ◽  
Ezekiel J. Emanuel ◽  
Ann T. Farrell ◽  
Richard L. Schilsky
Keyword(s):  
Clinical Trials ◽  
Placebo Response ◽  
Drug Approval ◽  
Active Treatment Group ◽  
Cancer Clinical Trials ◽  
Full Disclosure ◽  
Placebo Controls ◽  
Regulatory Standards ◽  
New Treatment ◽  
Oncology Drug Development

PurposeTo examine the ethical, scientific, and regulatory issues in the design and conduct of placebo-controlled cancer clinical trials.MethodsSeveral content experts contributed to this article.ResultsSpecific criteria can be applied to determine the appropriate use of placebos in oncology drug development. Placebo controls may be justified to prove efficacy of a new treatment in diseases with high placebo response rates; in conditions that wax and wane in severity, have spontaneous remissions, or have an uncertain and unpredictable course; when existing therapies are minimally effective or have serious adverse effects; or in the absence of effective therapy. Use of placebos may also be justified to assure blinding of physicians and patients regarding treatment assignment so as to minimize bias in assessment of study end points. If a trial meets these methodologic criteria, it must then fulfill additional criteria to be considered ethical. These criteria include full disclosure to patients and an assurance that participants randomly assigned to placebo are not substantially more likely than those in active treatment group(s) to die; suffer irreversible morbidity, disability, or other substantial harms; suffer reversible but serious harm; or suffer severe discomfort.ConclusionWe conclude that placebo-controlled oncology trials are scientifically feasible, ethically justifiable, and may be necessary or desirable to meet regulatory standards for drug approval. Using cross-over or randomized withdrawal trial designs, requiring inclusion of state-of-the-art palliative care, and developing valid and acceptable surrogates for survival are critical strategies to address some of the ethical dilemmas associated with placebo-controlled trials.

scholarly journals Posterior Intravaginal Slingplasty versus Unilateral Sacrospinous Ligament Fixation in Treatment of Vaginal Vault Prolapse

2013 ◽  
Vol 2013 ◽  
pp. 1-5 ◽  
Author(s):  
Virva Nyyssönen ◽  
Anne Talvensaari-Mattila ◽  
Markku Santala
Keyword(s):  
Pelvic Organ ◽  
Vaginal Vault Prolapse ◽  
University Hospital ◽  
Vaginal Vault ◽  
Sacrospinous Ligament ◽  
Vault Prolapse ◽  
Sacrospinous Ligament Fixation ◽  
Exact Test ◽  
Intravaginal Slingplasty

Objective. To investigate the differences in efficacy, postoperative complications, and patient satisfaction between posterior intravaginal slingplasty (PIVS) and unilateral sacrospinous ligament fixation (SSLF) procedures. Study Design. A retrospective study of thirty-three women who underwent PIVS or SSLF treatment for vaginal vault prolapse in Oulu University Hospital. The patients were invited to a follow-up visit to evaluate the objective and subjective outcomes. Median follow-up time was 16 months (range 6–52). The anatomical outcome was detected by the Pelvic Organ Prolapse Quantification (POP-Q) system. Information on urinary, bowel, and sexual dysfunctions and overall satisfaction was gathered with specific questionnaire. The data were analyzed using Mann-Whitney U test and Fisher’s exact test. Results. Mesh erosion was found in 4 (25%) patients in the PIVS group. Anatomical stage II prolapse or worse (any POP-Q point ≥−1) was detected in 8 (50%) patients in the PIVS group and 9 (53%) patients in the SSLF group. Overall satisfaction rates were 62% and 76%, respectively. Conclusion. The efficacy of PIVS and SSLF is equally poor, and the rate of vaginal erosion is intolerably high with the PIVS method. Based on our study, we cannot recommend the usage of either technique in operative treatment of vaginal vault prolapse.

scholarly journals 1205 Clinical Audit Demonstrating an Increase in Referrals to The Ophthalmology AMD Clinic at University Hospital Southampton

2021 ◽  
Vol 108 (Supplement_6) ◽  
Author(s):  
S Laali
Keyword(s):  
Diagnostic Accuracy ◽  
Clinical Training ◽  
University Hospital ◽  
Normative Values ◽  
Exact Test ◽  
Essentially Normal ◽  
Successful Launch ◽  
Oct Imaging ◽  
Electronic Referral

Abstract Aim To demonstrate if the introduction of OCT imaging by a national optician chain across its 740 stores in UK (followed by other chains) would increase in referrals to the wet AMD clinic. Secondly to assess if the direct increase of referrals would have an impact on the clinic workload. Method Retrospective review of all referrals made to the AMD service via optometrists/opticians throughout 2018. Total numbers of referrals that were proven to have nAMD requiring injections Inclusion; direct optician referral or GP referral via an optician. Exclusions: Ophthalmologist, Eye Casualty, other clinics and nAMD not requiring injections. Results Opticians were responsible for 62.88% (566) referrals out of 900 to the AMD service The second half of 2018 showed an increase in referrals (130 more) but with improved quality since the diagnostic accuracy of the optometrists increased from 22.94% to 37.64% The improved diagnostic accuracy of the optometrists was found to be statistically significant (Fisher’s exact test: p &lt; 0.0003) Discussion Increase in patients requiring injections directly increases clinic by initial screen and follow up injections. Medical retina departments faced an increase in false positive referrals. Potentially due to seeing essentially normal findings in a new way (B scan) that are artefacts or misinterpretation of either the image or the normative values Conclusions Upon review and presentation of the audit, NHS will invest in an electronic referral system to aid the clinic. Education and ongoing clinical training are essential to the successful launch of an OCT service in the community.

scholarly journals Inner Prepuce Preserving ‘Bird-Winged Coronal-Collar Skin ReArrangement’ Modification of Tip Urethroplasty

2020 ◽  
pp. 1-4
Author(s):  
Prabudh Goel ◽  
◽  
Jile Dar Rawat ◽  
Piyush Kumar ◽  
◽  
...  
Keyword(s):  
Ventral Surface ◽  
Control Group ◽  
Test Results ◽  
Penile Shaft ◽  
Modified Technique ◽  
Exact Test ◽  
Tubularized Incised Plate ◽  
Fischer Exact Test

Objective: To describe the ‘Bird-Winged Coronal-Collar Skin re-arrangement modification’ of the Tubularized Incised Plate (TIP) urethroplasty to preserve the inner preputial skin on the ventral surface of the penile shaft. Material and Method: Study Group: Prospective review of the results of a single surgeon with Bird-Winged Coronal-Collar skin re-arrangement modification of TIP urethroplasty (n=111; mean age 4.9 years) of distal (n=76) and mid-penile (n-35) hypospadias (mean follow-up 37 months). Control Group: Retrospective review of a single surgeon’s results of distal and mid-penile hypospadias repair with standard TIP urethroplasty (2007-11). Outcome parameters (to compare non-inferiority of the modified technique): Urethro-cutaneous fistula (UCF) at voiding trial and follow-up at 3 months, wound infection, complete dehiscence, local edema, meatal stenosis and quality of urinary stream. Statistical analysis was done with the Fischer Exact Test. Results: With this technique, the authors could provide an inner preputial cover on the ventral/ ventro-lateral aspects of distal penile shaft in all but one patient (complete dehiscence). The results of ‘bird-winged coronal-collar skin re-arrangement’ modification were not-inferior/ comparable to those of standard TIP urethroplasty. Conclusions: The modification is technically feasible and reproducible and the overall results of urethroplasty were not inferior to the standard TIPS procedure.

Association of improved survival (OS) and tumor control (TC) with interleukin-2 (IL2) with development of immune-related events (IREs): Data from the PROCLAIMSM registry.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 9528-9528
Author(s):  
Brendan D. Curti ◽  
Gregory A. Daniels ◽  
David F. McDermott ◽  
Joseph Clark ◽  
Howard Kaufman ◽  
...  
Keyword(s):  
Interleukin 2 ◽  
Rank Test ◽  
Tumor Control ◽  
Test Results ◽  
Exact Test ◽  
Log Rank Test ◽  
Kaplan Meier ◽  
Long Term Impact

9528 Background: IREs are associated with immunotherapy (IT) for cancer and while reports suggest improvement in TC and OS with induced IREs, the long-term impact is unclear. IL2 has been the major IT for patients (pts) with renal cell carcinoma (RCC) and melanoma (MM) since 1992. We evaluated IREs reports in the PROCLAIMSM data base (2008-2016) of IL2-treated pts. Methods: Reports on 614 (MM) and 843 (RCC) pts were queried for IREs. IREs were categorized as occurring before, during, or after IL-2 and related to any checkpoint inhibitor (CPI). TC (CR+PR+SD) was compared between no IRE and IRE, using Fisher’s exact test. OS curves were estimated by Kaplan-Meier method, and comparison of no IRE/before IL2 with during/after IL2, was analyzed by log-rank test. Results: With a median (med) follow-up of 3.5+ years (range 1-8+ year), 140 IREs were reported in 118 pts (9.6% of all PROCLAIMSM pts): 93 (15%) in MM; 47 (5.6%) in RCC. 25 IREs were prior to IL2; 13 IREs were during IL2; 102 were after IL2. Of the latter 102, 31 were after IL2 and after subsequent CPI; 71 were attributed to IL2 only; and in 13, IREs were due to either IL2 or CPI. TC was 73% for IRE group vs 56% for no IRE group (p = 0.0054). OS was significantly greater for IRE group during/after IL2 compared to no IRE/before IL2 in MM, med 46 months (mo) vs 18 mo (p = 0.0001) and in RCC, med 61 mo vs 43 mo (p = 0.0196), independent of CPI IREs. Med # of IL2 doses was 19 in no IRE group, 39 in IRE during IL2 group, and 25 in IRE after IL2 group. IL2-related IREs were primarily vitiligo and thyroid dysfunction (70% of IL2 IREs), with limited further impact, while CPI-related IREs were often serious, requiring intervention (hypophysitis, colitis, hepatitis, uveitis) (52% of CPI IREs) and possibly chronic management. Conclusions: IREs following IL2 are associated with improved TC and OS. IREs resulting from IL2 and from CPIs are qualitatively different and likely reflect different mechanisms of action of immune activation and response.

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.

Appropriate endpoints for superficial bladder cancer clinical trials.

1987 ◽  
Vol 5 (12) ◽  
pp. 2004-2008 ◽  
Author(s):  
L A Kalish ◽  
M B Garnick ◽  
J P Richie
Keyword(s):  
Bladder Cancer ◽  
Clinical Trials ◽  
Clinical Outcome ◽  
Superficial Bladder Cancer ◽  
Invasive Disease ◽  
Actual Data ◽  
Cancer Clinical Trials ◽  
Data Sets ◽  
End Points

Many protocols for treatment of superficial bladder cancer include periodic cystoscopic examinations with resection of visible lesions. This allows pathological restaging of the disease at each examination. For example, this type of follow-up is common in clinical trials evaluating intravesical therapies. In such trials, clinical outcome is typically summarized using end-points that measure failure to control superficial disease. Alternative endpoints measuring failure to prevent progression to invasive disease are often ignored. In this report, the rationale for ignoring the invasive disease endpoints is given and flaws in the rationale are described. Evidence from actual data sets support the view that superficial disease endpoints may not be appropriate surrogates for invasive disease endpoints. It is recommended that time to invasive disease should be considered a major endpoint when designing and analyzing trials in superficial bladder cancer.

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