Identification of cancer care and protocol characteristics associated with recruitment rate in breast cancer clinical trials in Ontario

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 17042-17042
Author(s):  
J. Lemieux ◽  
P. J. Goodwin ◽  
K. Pritchard ◽  
K. Gelmon ◽  
L. Bordeleau ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Multivariate Analysis ◽  
Relative Risk ◽  
Cancer Care ◽  
Time Frame ◽  
Recruitment Rate ◽  
Pharmaceutical Companies ◽  
Cooperative Groups ◽  
Number Of Patients

17042 Background: Recruitment rate (RR) in clinical trials (CT) has been recognized to be low. Poor accrual may lead to premature closing of CT or decrease of the planned power to detect an effect if present. Methods: Objectives were primarily to identify characteristics of cancer care settings and clinical trials protocols associated with low RR and secondarily (1) to determine the RR and (2) to compare the RR between years. A cross-sectional design was used. Poisson regression was used for multivariate analysis. RR was calculated by CT, hospital and year in Ontario between 1997 and 2002. Number of patients recruited in each CT was obtained from cooperative groups and pharmaceutical companies. Number of patients with breast cancer (BC) was obtained from the Ontario Cancer Registry. Prevalence of women with metastatic BC was calculated from the British Columbia Breast Cancer Outcome Unit database. Characteristics of cancer care and protocols were collected. Results: Response rates were 84% (66/79) for hospitals, 69% (9/13) for cooperative groups and 80% (8/10) for pharmaceutical companies. Recruitment rates varied between 1.3% and 5.5% (median, p=0.0003). Characteristics of cancer care were not associated with RR (number of oncologists, breast oncologists, breast surgeons, investigators, clinical research associates and being a cancer centre or an academic centre). Among protocol characteristics, the following were associated with RR in univariate analysis: phase, randomization, type of intervention, placebo, extent of the trials (local vs. national vs. international), number of sites, population (adjuvant vs. metastatic), menopausal status, premature closing of the trial, time frame for enrolment, extra baseline and follow-up testing. In multivariate analysis, type of control arm and time frame for enrolment were significant. CT using placebo compared to an active control arm were less likely to recruit patients (relative risk 0.57, p=0.0144). CT with a time frame for enrolment greater than 9 weeks were more likely to enrol patients (relative risk 1.43, p=0.0020). Conclusions: RR is very low. No easily modifiable factors have been identified. This project was funded by the Canadian Breast Cancer Foundation, Ontario Chapter. [Table: see text]

Identification of Cancer Care and Protocol Characteristics Associated With Recruitment in Breast Cancer Clinical Trials

2008 ◽  
Vol 26 (27) ◽  
pp. 4458-4465 ◽  
Author(s):  
Julie Lemieux ◽  
Pamela J. Goodwin ◽  
Kathleen I. Pritchard ◽  
Karen A. Gelmon ◽  
Louise J. Bordeleau ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Care ◽  
Primary Objective ◽  
Cancer Clinical Trials ◽  
Cooperative Groups ◽  
Number Of Patients ◽  
Trial Protocols ◽  
Few Data

Purpose It is estimated that only 5% of patients with cancer participate in a clinical trial. Barriers to participation may relate to available protocols, physicians, and patients, but few data exist on barriers related to cancer care environments and protocol characteristics. Methods The primary objective was to identify characteristics of cancer care environments and clinical trial protocols associated with a low recruitment into breast cancer clinical trials. Secondary objectives were to determine yearly recruitment fraction onto clinical trials from 1997 to 2002 in Ontario, Canada, and to compare recruitment fraction among years. Questionnaires were sent to hospitals requesting characteristics of cancer care environments and to cooperative groups/pharmaceutical companies for information on protocols and the number of patients recruited per hospital/year. Poisson regression was used to estimate the recruitment fraction. Results Questionnaire completion rate varied between 69% and 100%. Recruitment fraction varied between 5.4% and 8.5% according to year. More than 30% of patients were diagnosed in hospitals with no available trials. In multivariate analysis, the following characteristics were associated with recruitment: use of placebo versus not (relative risk [RR] = 0.80; P = .05), nonmetastatic versus metastatic trial (RR = 2.80; P < .01), and for nonmetastatic trials, protocol allowing an interval of 12 weeks or longer versus less than 12 weeks (from diagnosis, surgery, or end of therapy) before enrollment (RR = 1.36; P < .01). Conclusion Allowable interval of 12 weeks or longer to randomly assign patients in clinical trials could help recruitment. In our study, absence of an available clinical trial represented the largest barrier to recruitment.

scholarly journals Online Patient Recruitment in Clinical Trials: Systematic Review and Meta-Analysis

10.2196/22179 ◽  
2020 ◽  
Vol 22 (11) ◽  
pp. e22179
Author(s):  
Mette Brøgger-Mikkelsen ◽  
Zarqa Ali ◽  
John R Zibert ◽  
Anders Daniel Andersen ◽  
Simon Francis Thomsen
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Cost Effectiveness ◽  
Meta Analysis ◽  
Recruitment Rate ◽  
Wilcoxon Test ◽  
Patient Recruitment ◽  
Conversion Rates ◽  
Number Of Patients ◽  
Online Recruitment

Background Recruitment for clinical trials continues to be a challenge, as patient recruitment is the single biggest cause of trial delays. Around 80% of trials fail to meet the initial enrollment target and timeline, and these delays can result in lost revenue of as much as US $8 million per day for drug developing companies. Objective This study aimed to conduct a systematic review and meta-analysis examining the effectiveness of online recruitment of participants for clinical trials compared with traditional in-clinic/offline recruitment methods. Methods Data on recruitment rates (the average number of patients enrolled in the study per month and per day of active recruitment) and conversion rates (the percentage of participants screened who proceed to enroll into the clinical trial), as well as study characteristics and patient demographics were collected from the included studies. Differences in online and offline recruitment rates and conversion rates were examined using random effects models. Further, a nonparametric paired Wilcoxon test was used for additional analysis on the cost-effectiveness of online patient recruitment. All data analyses were conducted in R language, and P<.05 was considered significant. Results In total, 3861 articles were screened for inclusion. Of these, 61 studies were included in the review, and 23 of these were further included in the meta-analysis. We found online recruitment to be significantly more effective with respect to the recruitment rate for active days of recruitment, where 100% (7/7) of the studies included had a better online recruitment rate compared with offline recruitment (incidence rate ratio [IRR] 4.17, P=.04). When examining the entire recruitment period in months we found that 52% (12/23) of the studies had a better online recruitment rate compared with the offline recruitment rate (IRR 1.11, P=.71). For cost-effectiveness, we found that online recruitment had a significantly lower cost per enrollee compared with offline recruitment (US $72 vs US $199, P=.04). Finally, we found that 69% (9/13) of studies had significantly better offline conversion rates compared with online conversion rates (risk ratio 0.8, P=.02). Conclusions Targeting potential participants using online remedies is an effective approach for patient recruitment for clinical research. Online recruitment was both superior in regard to time efficiency and cost-effectiveness compared with offline recruitment. In contrast, offline recruitment outperformed online recruitment with respect to conversion rate.

scholarly journals Cancer Patient Management during COVID-19 Pandemic: An Audit of a Single-Surgeon Unit in a COVID-Hotspot

2021 ◽  
Vol 10 (01) ◽  
pp. 39-41
Author(s):  
Laleh Busheri ◽  
Smeeta Nare ◽  
Rituja Banale ◽  
Ashwini Bapat ◽  
Moushumi Nagarkar ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Care ◽  
Patient Management ◽  
Clinic Visit ◽  
Breast Cancer Treatment ◽  
Phone Call ◽  
Guiding Principle ◽  
Number Of Patients ◽  
Risk Of Exposure ◽  
Made In

AbstractThe report evaluates the effect of coronavirus disease (COVID-19) pandemic on breast cancer treatment and management at a single-surgeon cancer care unit in one of the hotspots of COVID-19 in India. In response to the pandemic, the adjustments were made in the clinical practice to accommodate social distancing. Patient consultations were done over phone call or in-clinic visit with prior appointment to reduce the risk of exposure to COVID-19. Total number of patients that were treated at the clinic and the essential surgeries performed during the pandemic phases are summarized in the report. The methodology adopted here for care and management of the cancer patients can serve as a guiding principle for cancer care units in the country.

scholarly journals Clinical Trials of Oncolytic Viruses in Breast Cancer

2021 ◽  
Vol 11 ◽  
Author(s):  
Mary E. Carter ◽  
André Koch ◽  
Ulrich M. Lauer ◽  
Andreas D. Hartkopf
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Neutralizing Antibodies ◽  
Viral Gene Expression ◽  
Oncolytic Viruses ◽  
Viral Gene ◽  
Clinical Activity ◽  
Routes Of Administration ◽  
Number Of Patients ◽  
New Treatment

Breast cancer is the second most common kind of cancer worldwide and oncolytic viruses may offer a new treatment approach. There are three different types of oncolytic viruses used in clinical trials; (i) oncolytic viruses with natural anti-neoplastic properties; (ii) oncolytic viruses designed for tumor-selective replication; (iii) oncolytic viruses modified to activate the immune system. Currently, fourteen different oncolytic viruses have been investigated in eighteen published clinical trials. These trials demonstrate that oncolytic viruses are well tolerated and safe for use in patients and display clinical activity. However, these trials mainly studied a small number of patients with different advanced tumors including some with breast cancer. Future trials should focus on breast cancer and investigate optimal routes of administration, occurrence of neutralizing antibodies, viral gene expression, combinations with other antineoplastic therapies, and identify subtypes that are particularly suitable for oncolytic virotherapy.

scholarly journals Access to Breast Cancer Care in Jos, North Central

2020 ◽  
pp. 1-7
Author(s):  
Alexander Femi Ale ◽  
Mercy Wakili Isichei ◽  
Michael Ayedima Misauno
Keyword(s):  
Breast Cancer ◽  
Health Care ◽  
Cancer Care ◽  
Demographic Data ◽  
Descriptive Statistics ◽  
University Teaching ◽  
Treatment Modalities ◽  
Breast Cancer Care ◽  
Number Of Patients ◽  
Health Care Centers

Aims: This paper seeks to evaluate the extent to which breast cancer patients from two tertiary health care centers in Jos were able to access the different components of breast cancer care. Background: Breast cancer in low- and middle-income countries is associated with poor outcomes when compared with high-income countries. Numerous studies have identified factors responsible for this, one of them being a lack of access to the various components of breast cancer care. Breast cancer care requires a multimodal approach involving prevention, early detection, diagnosis and treatment, rehabilitation and palliative care. Access to the various modalities of care is key to a good outcome. Study Design: This study is a retrospective study. Place and Duration of the Study: The study was carried out at Jos University Teaching Hospital, and FOMAS Hospital which are both tertiary health care centers located in the city of Jos, Plateau State, Nigeria. The study spanned January 2016 to June 2019.We applied descriptive statistics for data analysis. Methodology: We included all patients who were diagnosed with breast cancer between January 2016 and December 2017. Patients were followed up for a minimum of one and a half years (from January 2018 to June 2019). The project team performed a review of medical records and charts for data elements which included; sex, age, site of tumor, stage of tumor at presentation, and access to the different treatment modalities. Data was entered into a pre-designed proforma and analyzed on the SPSS 20 Chicago, Illinois. We applied descriptive statistics to the demographic data and clinical information of patients. Results: The total number of patients was 110. Forty-four (40%) patients had access to immunohistochemistry (IHC). Eighty-nine (81%) patients were eligible for chemotherapy. Twenty-one (19%) patients were not fit for chemotherapy. Ten (9%) patients received radiotherapy.  A total of 73 (66%) patients had different forms of breast surgeries. Three (3%) patients declined surgery, while 34 (31%) were not fit for surgery. Thirty-four (31%) patients were treated with hormonal therapy. Conclusion: This study examined access to the various components of breast cancer care within two tertiary health centers. It shows that in our environment, there is limited access to immunohistochemistry, chemotherapy, radiotherapy and targeted therapy.

scholarly journals The risk of development of multiple primary malignant tumors involving the thyroid gland

2012 ◽  
Vol 93 (4) ◽  
pp. 616-623
Author(s):  
Z A Afanas’eva ◽  
S F Bakunin
Keyword(s):  
Breast Cancer ◽  
Prostate Cancer ◽  
Thyroid Cancer ◽  
Relative Risk ◽  
Skin Cancer ◽  
Thyroid Gland ◽  
Malignant Tumors ◽  
Uterine Cancer ◽  
Second Malignancy ◽  
Number Of Patients

Aim. To determine the relative risk of developing other malignant tumors in patients with thyroid cancer and and the risk of developing thyroid cancer in patients with other malignancies. Methods. A retrospective analysis of 116 patients with multiple neoplasia including thyroid gland involvement was conducted for the period from 1973 to 2010. In order to estimate the relative risk of development of multiple neoplasias including thyroid gland lesions used was the following formula: relative risk = [a / (a + b)] / [c / (c + d)], where a is the number of patients with thyroid cancer with a second malignancy; b is the number of patients with thyroid cancer without a second malignancy; c is the number of patients in the population affected by the same malignant disease, as patients in group a; d is the number of people in the population without any cancer-related pathology. Results. In patients with carcinomas of the thyroid gland the relative risk is higher than in the general population for developing metachronous lymphoma (41.8 for men, 31.7 for women), renal cell carcinoma (55.6 for men, 18.5 for women), prostate cancer (35.7), lung and bronchus cancer (18.8 for women), melanoma (17.1 for women), colon cancer (16.7 for women), cervical cancer (15.8), uterine cancer (11.8), breast cancer (11.5 for women), skin cancer (9.5 in women) and the simultaneous development of renal cell carcinoma (33.8 for men and 46.3 for women), prostate cancer (24.4), melanoma (20.6 for women), cancer of the esophagus (19.4 for men, 17.8 for women), colon cancer (19.0 for men), lymphomas (12.8 for men), cervical cancer (11.3), breast cancer (11.0 for women), skin cancer (8.5 for women). The relative risk of developing metachronous cancer of the thyroid gland is higher than that in the population in patients with melanoma (108.0 in men, 50.4 for women), with malignant neoplasms of the lymphoid tissue (40.2 for men, 40.8 for women), uterine cancer (11.8), skin cancer (8.7 in women), breast cancer (8.0 for women). Conclusion. During preventive medical examinations of patients with thyroid cancer the relative risk of developing subsequent cancers must be taken into account for early diagnosis of multiple neoplasias.

scholarly journals Online Patient Recruitment in Clinical Trials: Systematic Review and Meta-Analysis (Preprint)

2020 ◽  
Author(s):  
Mette Brøgger-Mikkelsen ◽  
Zarqa Ali ◽  
John R Zibert ◽  
Anders Daniel Andersen ◽  
Simon Francis Thomsen
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Cost Effectiveness ◽  
Meta Analysis ◽  
Recruitment Rate ◽  
Wilcoxon Test ◽  
Patient Recruitment ◽  
Conversion Rates ◽  
Number Of Patients ◽  
Online Recruitment

BACKGROUND Recruitment for clinical trials continues to be a challenge, as patient recruitment is the single biggest cause of trial delays. Around 80% of trials fail to meet the initial enrollment target and timeline, and these delays can result in lost revenue of as much as US $8 million per day for drug developing companies. OBJECTIVE This study aimed to conduct a systematic review and meta-analysis examining the effectiveness of online recruitment of participants for clinical trials compared with traditional in-clinic/offline recruitment methods. METHODS Data on recruitment rates (the average number of patients enrolled in the study per month and per day of active recruitment) and conversion rates (the percentage of participants screened who proceed to enroll into the clinical trial), as well as study characteristics and patient demographics were collected from the included studies. Differences in online and offline recruitment rates and conversion rates were examined using random effects models. Further, a nonparametric paired Wilcoxon test was used for additional analysis on the cost-effectiveness of online patient recruitment. All data analyses were conducted in R language, and <i>P</i>&lt;.05 was considered significant. RESULTS In total, 3861 articles were screened for inclusion. Of these, 61 studies were included in the review, and 23 of these were further included in the meta-analysis. We found online recruitment to be significantly more effective with respect to the recruitment rate for active days of recruitment, where 100% (7/7) of the studies included had a better online recruitment rate compared with offline recruitment (incidence rate ratio [IRR] 4.17, <i>P</i>=.04). When examining the entire recruitment period in months we found that 52% (12/23) of the studies had a better online recruitment rate compared with the offline recruitment rate (IRR 1.11, <i>P</i>=.71). For cost-effectiveness, we found that online recruitment had a significantly lower cost per enrollee compared with offline recruitment (US $72 vs US $199, <i>P</i>=.04). Finally, we found that 69% (9/13) of studies had significantly better offline conversion rates compared with online conversion rates (risk ratio 0.8, <i>P=</i>.02). CONCLUSIONS Targeting potential participants using online remedies is an effective approach for patient recruitment for clinical research. Online recruitment was both superior in regard to time efficiency and cost-effectiveness compared with offline recruitment. In contrast, offline recruitment outperformed online recruitment with respect to conversion rate.

scholarly journals Regulatory delays in a multinational clinical stroke trial

2021 ◽  
pp. 239698732110048
Author(s):  
Jeroen C de Jonge ◽  
Hendrik Reinink ◽  
Bridget Colam ◽  
Iris Alpers ◽  
Alfonso Ciccone ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Regulatory Authority ◽  
Recruitment Rate ◽  
Phase Iii ◽  
Randomised Clinical Trials ◽  
Patient Recruitment ◽  
Trial Site ◽  
Number Of Patients ◽  
Clinical Stroke Trial

Introduction The initiation and conduct of randomised clinical trials are complicated by multiple barriers, including delays in obtaining regulatory approvals. Quantitative data on the extent of the delays due to national or local review in randomised clinical trials is scarce. Materials and methods We assessed the times needed to obtain regulatory approval and to initiate a trial site for an academic, EU-funded, phase III, randomised clinical trial of pharmacological prevention of complications in patients with acute stroke in over 80 sites in nine European countries. The primary outcome was the time from the first submission to a regulatory authority to initiation of a trial site. Secondary outcomes included time needed to complete each individual preparatory requirement and the number of patients recruited by each site in the first 6 and 12 months. Results The median time from the first submission to a regulatory authority to initiation of a trial site was 784 days (IQR: 586–1102). The single most time-consuming step was the conclusion of a clinical trial agreement between the national coordinator and the trial site, which took a median of 194 days (IQR: 93–293). A longer time to site initiation was associated with a lower patient recruitment rate in the first six months after initiation (B = –0.002; p = 0.02). Discussion Conclusion In this EU-funded clinical trial, approximately 26 months were needed to initiate a trial site for patient recruitment. The conclusion of a contract with a trial site was the most time-consuming activity. To simplify and speed up the process, we suggest that the level of detail of contracts for academic trials should be proportional to the risks and commercial interests of these trials.

scholarly journals Role of cooperative groups and funding source in clinical trials supporting guidelines for systemic therapy of breast cancer

Oncotarget ◽  
2018 ◽  
Vol 9 (19) ◽  
pp. 15061-15067
Author(s):  
Ariadna Tibau ◽  
Geòrgia Anguera ◽  
Fernando Andrés-Pretel ◽  
Arnoud J. Templeton ◽  
Bostjan Seruga ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Systemic Therapy ◽  
Funding Source ◽  
Cooperative Groups

scholarly journals Recommendations for Collection and Handling of Specimens From Group Breast Cancer Clinical Trials

2008 ◽  
Vol 26 (34) ◽  
pp. 5638-5644 ◽  
Author(s):  
Brian R. Leyland-Jones ◽  
Christine B. Ambrosone ◽  
John Bartlett ◽  
Matthew J.C. Ellis ◽  
Rebecca A. Enos ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
North American ◽  
Ffpe Tissue ◽  
Cancer Clinical Trials ◽  
Cooperative Groups ◽  
Specimen Collection ◽  
Frozen Tissue ◽  
Fresh Frozen ◽  
Working Groups

Recommendations for specimen collection and handling have been developed for adoption across breast cancer clinical trials conducted by the Breast International Group (BIG)-sponsored Groups and the National Cancer Institute (NCI)-sponsored North American Cooperative Groups. These recommendations are meant to promote identifiable standards for specimen collection and handling within and across breast cancer trials, such that the variability in collection/handling practices that currently exists is minimized and specimen condition and quality are enhanced, thereby maximizing results from specimen-based diagnostic testing and research. Three working groups were formed from the Cooperative Group Banking Committee, BIG groups, and North American breast cancer cooperative groups to identify standards for collection and handling of (1) formalin-fixed, paraffin-embedded (FFPE) tissue; (2) blood and its components; and (3) fresh/frozen tissue from breast cancer trials. The working groups collected standard operating procedures from multiple group specimen banks, administered a survey on banking practices to those banks, and engaged in a series of discussions from 2005 to 2007. Their contributions were synthesized into this document, which focuses primarily on collection and handling of specimens to the point of shipment to the central bank, although also offers some guidance to central banks. Major recommendations include submission of an FFPE block, whole blood, and serial serum or plasma from breast cancer clinical trials, and use of one fixative and buffer type (10% neutral phosphate-buffered formalin, pH 7) for FFPE tissue across trials. Recommendations for proper handling and shipping were developed for blood, serum, plasma, FFPE, and fresh/frozen tissue.

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