Barriers in conducting clinical trials in oncology in the developing world: A cross-sectional survey of oncologists

2016 ◽  
Vol 53 (1) ◽  
pp. 174 ◽  
Author(s):  
AK D'Cruz ◽  
M Dandekar ◽  
R Trivedi ◽  
N Irawati ◽  
K Prabhash ◽  
...  
2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e14004-e14004
Author(s):  
Albert Eusik Kim ◽  
GI-Ming WANG ◽  
Kristin A Waite ◽  
Scott Elder ◽  
Avery Fine ◽  
...  

e14004 Background: Brain metastases (BM) is one of the most feared complications of cancer due to substantial neurologic sequalae, neuro-cognitive morbidity and grim prognosis. In the past decade, targeted therapies and checkpoint inhibitors have resulted in meaningfully improved overall survival for a minority of these patients. Accordingly, there is a growing need to identify issues surrounding patient survivorship and to standardize physician practice patterns for these patients. To date, there has not been a well-conducted formal study to specifically explore these questions of survivorship and practice standardization for BM patients. Methods: Here, we present results from a cross-sectional survey in which we analyzed responses from 237 BM patients, 209 caregivers, and 239 physicians. Surveys contained questions about BM symptoms, discussion of BM diagnosis by the clinician, psychosocial concerns, available treatment options for BM, BM patient advocacy resources, and BM-specific clinical trials. Results: Our survey revealed compelling findings about current care of BM patients. There were discrepancies in the perceived discussion of the implications of the diagnosis of BM, from the patient/caregiver and physician perspective. Important topics, such as prognosis and worrisome symptoms, were felt to have been discussed more frequently by physicians than by patients or caregivers. In our physician survey, private practice physicians, compared to academic physicians, were significantly more likely to recommend whole brain radiotherapy (61.1 vs 39.7%; p = 0.009). Participation in a clinical trial was one of the least recommended treatment options. Many physicians (59.1% private; 71.9% academic) stated that BM patients in their care are denied participation in a clinical trial, specifically due to the presence of BM. The consensus among physicians, patients and caregivers was that the highest yield area for federal assistance is increased treatment and research funding for BM. Conclusions: Our hope is that these findings will serve as a basis for future quality improvement measures to enhance patient-physician communication and patient well-being, continuing medical education activities detailing latest advances in BM for oncologists, and lobbying efforts to the federal government in prioritizing BM research, clinical trials, and patient survivorship.


BMC Cancer ◽  
2017 ◽  
Vol 17 (1) ◽  
Author(s):  
Mariko Carey ◽  
Allison W. Boyes ◽  
Rochelle Smits ◽  
Jamie Bryant ◽  
Amy Waller ◽  
...  

2015 ◽  
Vol 33 (15_suppl) ◽  
pp. e17652-e17652 ◽  
Author(s):  
Vikram Gota ◽  
Manjunath Nookala ◽  
Akanksha Yadav ◽  
Sadhna Kannan ◽  
Raghib Ali

The Lancet ◽  
2001 ◽  
Vol 358 (9295) ◽  
pp. 1772-1777 ◽  
Author(s):  
Steven Joffe ◽  
E Francis Cook ◽  
Paul D Cleary ◽  
Jeffrey W Clark ◽  
Jane C Weeks

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e20631-e20631
Author(s):  
Alejandra Martinez De Pinillos ◽  
Isabel Ricote Lobera ◽  
Cristina Martinez ◽  
Caroline Anger ◽  
Filippo Guglielmetti ◽  
...  

e20631 Background: To date, there are no robust studies in real world practice describing the use of IO (immuno-oncology) treatments in advanced/metastatic (adv/m) NSCLC. The available evidence in Europe is limited to observational studies of small size. This study aims to understand the impact of IO in adv/mNSCLC and study the profile of patients currently receiving these treatments. Methods: 20,157 cases of 1st and 2nd line adv/mNSCLC patients between October 2016 and September 2018 in EU5 (France, Germany, Spain, Italy, UK) were identified within Oncology Dynamics, an IQVIA oncology syndicated cross sectional survey collecting anonymized patient-level data. Patient profile was described, and two groups were created to assess differences in the use of IO treatments (nivolumab, pembrolizumab, atezolizumab, ipilimumab, durvalumab) across 2 time periods: #1 October 2016 - September 2017 (n = 9,310); #2 October 2017 - September 2018 (n = 10,847). Results: IO treatments increased 15% in 1st line adv/mNSCLC (13% in non-squamous and 23% in squamous histology) and 11% in 2nd line across periods; reaching treatment shares of 20.3% and 67.9% in 1st line and 2nd line in Period 2. Within IO-treated patients, 9.5% in 1st line and 13.6% in 2nd line had ECOG ≥2, and 27% were > 71 years old. The use of IO in 1st line patients without mutations (EGFR/ALK/ROS1/BRAF) increased by 24%, while standard chemotherapy decreased by 21%. Conclusions: IO treatments had a rapid adoption in Europe last year, influenced by its approval in 1st line adv/mNSCLC and by clinical guidelines recommendations. Ongoing clinical trials may suggest a growing trend in the future that could potentially impact in healthcare systems. In addition, real world patients treated with IO are older and have a worse performance status than those widely included in clinical trials. An evaluation of these results sheds light into IO treatments in NSCLC and may contribute to the design of real-world studies to generate new evidence and optimize the use of these class of drugs in clinical practice.[Table: see text]


BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e015997 ◽  
Author(s):  
Maram B Hakoum ◽  
Nahla Jouni ◽  
Eliane A Abou-Jaoude ◽  
Divina Justina Hasbani ◽  
Elias A Abou-Jaoude ◽  
...  

ObjectivesTo provide a detailed and current characterisation of funding of a representative sample clinical trials. We also aimed to develop guidance for standardised reporting of funding information.MethodsWe addressed the extent to which clinical trials published in 2015 in any of the 119 Core Clinical Journals included a statement on the funding source (eg, whether a not-for-profit organisation was supported by a private-for-profit organisation), type of funding, amount and role of funder. We used a stepwise approach to develop a guidance and an instrument for standardised reporting of funding information.ResultsOf 200 trials, 178 (89%) included a funding statement, of which 171 (96%) reported being funded. Funding statements in the 171 funded trials indicated the source in 100%, amount in 1% and roles of funders in 50%. The most frequent sources were governmental (58%) and private-for-profit (40%). Of 54 funding statements in which the source was a not-for-profit organisation, we found evidence of undisclosed support of those from private-for-profit organisation(s) in 26 (48%). The most frequently reported roles of funders in the 171 funded trials related to study design (42%) and data analysis, interpretation or management (41%). Of 139 randomised controlled trials (RCTs) addressing pharmacological or surgical interventions, 29 (21%) reported information on the supplier of the medication or device. The proposed guidance addresses both the funding information that RCTs should report and the reporting process. Attached to the guidance is a fillable PDF document for use as an instrument for standardised reporting of funding information.ConclusionAlthough the majority of RCTs report funding, there is considerable variability in the reporting of funding source, amount and roles of funders. A standardised approach to reporting of funding information would address these limitations. Future research should explore the implications of funding by not-for-profit organisations that are supported by for-profit organisations.


2015 ◽  
Vol 42 (6) ◽  
pp. 988-993 ◽  
Author(s):  
Coziana Ciurtin ◽  
Maria Leandro ◽  
Halina Fitz-Clarence ◽  
Hanh Nguyen ◽  
Stephen B. Walsh ◽  
...  

Objective.To investigate the perception and willingness of rheumatology patients to participate in clinical trials. No previous similar studies are available.Methods.We conducted a cross-sectional survey of rheumatology patients using a questionnaire, which comprised 2 demographic questions, two 5-point Likert opinion questions, 19 true/false/unsure knowledge questions, and 1 open question addressing what would help the participant to gain a better understanding about clinical trials.Results.Eighty-five patients returned the questionnaires (response rate 84.1%). The mean number of correct answers to the 19 knowledge questions was 10.5 ± 2.87. Patients with higher versus lower levels of education had significantly higher knowledge scores (mean correct answers 59.4 ± 13.1 vs 39.8 ± 20.4, p = 0.013). They also expressed greater willingness to take part in research (87.5% vs 48.2%, p < 0.001). The patients who agreed to participate in research provided significantly more correct answers (59.4 ± 15.3% vs 47.7 ± 27.2%, p = 0.032). Poor disease control as the main reason to join a clinical trial correlated well with patients’ previous participation in research (r = 0.71; p < 0.05) and the lack of understanding of research principles (defined as less than 50% correct answers to the knowledge questions) correlated with the lack of willingness to participate in clinical trials (r = 0.72; p < 0.05).Conclusion.The results of our study revealed that patients lack information about clinical trials (the correct response rate was only slightly above 50%), and that they had a moderate willingness to take part in clinical trials. The need for educational programs about clinical research was highlighted by the participants to the survey.


2020 ◽  
Author(s):  
Suo Luodan ◽  
Ma Rui ◽  
Wang Zhongzhan ◽  
Tang Tian ◽  
Wang Haihong ◽  
...  

Abstract Background: Covid-19 vaccine research and development is progressing and expected to be put into use in a predictable time, we aimed to learn the awareness and acceptance of the new vaccine by healthcare workers (HCWs) in Beijing, China. Methods: A cross-sectional survey was conducted to investigate HCWs including doctors, nurses and technicians from sixty hospitals in Beijing to obtain the perception of COVID-19 epidemic and the attitudes towards vaccination before before the completion of vaccine phase III clinical trials. Multivariate analysis was applied to evaluate the associated factors with intention to get vaccination.Results: A total of 8040 HCWs was recruited. 67.1% reported they would get vaccination, others said unsure or would not. Half of the HCWs were unsure whether the outbreak in China would come back and the global epidemic would last for a long time. 67.6% agreed the epidemic can be prevented by vaccination. Positive associated factors with willingness to get vaccination were mainly included epidemic situation prognosis, perception of disease severity, self infection risk and disease can be prevented by vaccine, etc. Two positive factors of “wanted the vaccine free of charge” (OR:5.807, 95%CI:5.083-6.635, P<0.001) and “believed vaccine approved for license have been fully evaluated in clinical trials” (OR:4.485, 95%CI:3.849-5.227, P<0.001) were strongly associated with willingness to get vaccination, while two factors of “highest academic degree” (OR:0.840, 95%CI:0.772-0.914, P<0.001) and “professional ranks and titles” (OR:0.930, 95%CI:0.865-1.000, P=0.049) were negative associated .Conclusions: A little above moderate willingness to get COVID-19 vaccination was found among HCWs in Beijing before the vaccine being licensed. Free vaccination strategy should be considered to implement, effective measures should be taken to remove barriers and convey correct information through appropriate ways to enhance the acceptance of COVID-19 vaccination among HCWs in China.


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