scholarly journals Barriers to conducting cancer trials in Canada: an analysis of key informant interviews

2020 ◽  
Vol 27 (3) ◽  
Author(s):  
C. Bentley ◽  
S. Sundquist ◽  
J. Dancey ◽  
S. Peacock
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Health Care Professionals ◽  
Leading Edge ◽  
Spillover Effects ◽  
Comparative Approach ◽  
Software Application ◽  
Canadian Health ◽  
Oncology Clinical Trials ◽  
Cancer Trials

Background In Canada, there is growing evidence that oncology clinical trials units (ctus) and programs face serious financial challenges. Investment in cancer research in Canada has declined almost 20% in the 5 years since its peak in 2011, and the costs of conducting leading-edge trials are rising. Clinical trials units must therefore be strategic about which studies they open. We interviewed Canadian health care professionals responsible for running cancer trials programs to identify the barriers to sustainability that they face. Methods One-on-one telephone interviews were conducted with clinicians and clinical research professionals at oncology ctus in Canada. We asked for their perspectives about the barriers to conducting trials at their institutions, in their provinces, and nationwide. Interviews were digitally recorded, transcribed, anonymized, and coded in the NVivo software application (version 11: QSR International, Melbourne, Australia). The initial coding structure was informed by the interview script, with new concepts drawn out and coded during analysis, using a constant comparative approach. Results Between June 2017 and November 2018, 25 interviews were conducted. Key barriers that participants identified were ■ insufficient stable funding to support trials infrastructure and retain staff; ■ the need to adopt strict cost-recovery policies, leading to fewer academic trials in portfolios; and ■ an overreliance on industry to fund clinical research in Canada. Conclusions Funding uncertainties have led ctus to increasingly rely on industry sponsorship and more stringent feasibility thresholds to remain solvent. Retaining skilled trials staff can create efficiencies in opening and running studies, with spillover effects of more trials being open to patients. More academic studies are needed to curb industry’s influence.  

scholarly journals Implementing a Geriatric Assessment in Cooperative Group Clinical Cancer Trials: CALGB 360401

2011 ◽  
Vol 29 (10) ◽  
pp. 1290-1296 ◽  
Author(s):  
Arti Hurria ◽  
Constance T. Cirrincione ◽  
Hyman B. Muss ◽  
Alice B. Kornblith ◽  
William Barry ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Geriatric Assessment ◽  
Health Care Professionals ◽  
Assessment Tool ◽  
Healthcare Providers ◽  
Psychological State ◽  
Cooperative Group ◽  
Group Setting ◽  
Assessment Measures ◽  
Cancer Trials

Purpose Factors captured in a geriatric assessment can predict morbidity and mortality in older adults, but are not routinely measured in cancer clinical trials. This study evaluated the implementation of a geriatric assessment tool in the cooperative group setting. Patients and Methods Patients age ≥ 65 with cancer, who enrolled on cooperative group cancer trials, were eligible to enroll on Cancer and Leukemia Group B (CALGB) 360401. They completed a geriatric assessment tool before initiation of protocol therapy, consisting of valid and reliable geriatric assessment measures which are primarily self-administered and require minimal resources and time by healthcare providers. The assessment measures functional status, comorbidity, cognitive function, psychological state, social support, and nutritional status. The protocol specified criteria for incorporation of the tool in future cooperative group trials was based on the time to completion and percent of patients who could complete their portion without assistance. Patient satisfaction with the tool was captured. Results Of the 93 patients who enrolled in this study, five (5%) met criteria for cognitive impairment and three did not complete the cognitive screen, leaving 85 assessable patients (median age, 72 years). The median time to complete the geriatric assessment tool was 22 minutes, 87% of patients (n = 74) completed their portion without assistance, 92% (n = 78) were satisfied with the questionnaire length, 95% (n = 81) reported no difficult questions, and 96% (n = 82) reported no upsetting questions. One hundred percent of health care professionals completed their portion. Conclusion This brief, primarily self-administered geriatric assessment tool met the protocol specified criteria for inclusion in future cooperative group clinical trials.

A national survey on patients’ enrollment rate in oncology clinical trials: The French experience.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e17567-e17567
Author(s):  
Iris Pauporte ◽  
Valerie Thibaudeau ◽  
Fabien M. Calvo ◽  
Agnes Buzyn
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Public Investment ◽  
University Hospitals ◽  
Public Intervention ◽  
Therapeutic Trials ◽  
Research Activities ◽  
Number Of Patients ◽  
Oncology Clinical Trials ◽  
The Impact

e17567 Background: The rate of patients enrolled in clinical trials (CT) is one of the main indicators of clinical research and care activity. The successive French Cancer Plans (2003-2007 and 2009-2013) aimed at quantifiable targets of patients to be enrolled in high-quality clinical trials. To help investigators achieving this objective, a substantial financial support for clinical research associates (CRA) recruitment was given to University Hospitals (UH), Comprehensive Cancer Centers (CCC) and public or private community hospitals (CH). In the meantime, significant public investment was allocated to competitively selected academic projects through the Clinical Research National Program. Methods: From 2006 to 2011, we carried out annual national surveys on clinical research activities in oncology in France. A questionnaire was sent to cancer care institutions. Number of CT open for enrolment, number of CT sponsored by the institution, number of patients enrolled and human resources (CRA) were collected. Academic and industry-sponsored trials were analyzed separately. Results: We showed that the number of patients enrolled in CT increased continuously over this period: from 21,500 in 2002 to 35,400 in 2011 (+47%). Based on these figures and assuming that there were 420,000 to 472,000 patients eligible for CT over this period, the enrolment rate for patients in CT is estimated to be 7.5 to 8.5% in 2011 versus 5.8 to 6.7% in 2003. Nearly 80% of all enrolled patients were recruited in academic CT; over 75% of patients in therapeutic trials. UH and CCC equally contributed for 80% of enrolment, CH for the residual 20%. At last, the number of CT increased by more than 35% over the same period, while the number of CRA was multiplied by 3 over the French territory. Conclusions: Our results show that public intervention for improving enrolment to cancer CT seems to be efficient. Other types of intervention are being considered, i.e., targeted on investigators, on patients, or on both. Future work should also consider the impact of CT enrolment on patients’ outcome.

Perspectives on under-representation of minority patients (pts) in clinical trials.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18521-e18521
Author(s):  
Taofeek K. Owonikoko ◽  
Luis E. Raez ◽  
Lee S. Schwartzberg ◽  
Randall F. Holcombe ◽  
Lewis R. Roberts ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Minority Groups ◽  
Community Outreach ◽  
Minority Populations ◽  
Minority Communities ◽  
Native Languages ◽  
Study Materials ◽  
Oncology Clinical Trials ◽  
Study Sites

e18521 Background: About 40% of the US population are from minority groups. Minority pts are under-represented in oncology clinical trials, which limits the applicability of results to the general population and perpetuates poor relationships between healthcare systems and minority communities. This assessment investigated underlying causes of this lack of minority representation in clinical trials and proposes plans to promote diversity. Methods: To better understand the limited inclusion of under-represented pts in oncology clinical trials, 10 specialists in cancer care were selected to provide their perspectives. Specialists were chosen because of their experience enrolling minority pts in clinical trials and met virtually in Dec 2020 via Within3, a secure digital communication platform, to discuss obstacles faced in recruiting minority pts and potential strategies to address these concerns. Specificity and alignment in responses were achieved through software analytics and follow-up queries. Results: The 10 specialists identified as Asian (10%), Black (30%), White (50%), and Hispanic (10%), and began practicing medicine in the 1980s-2010s. All are involved in clinical research and treat a range of minority pts in both urban and suburban settings. Most specialists (8/10) reported treating > 20 minority pts with cancer annually. However, few specialists (2/10) reported that > 20% of their minority pts have enrolled in clinical trials. Specialists agreed that minority pts experience barriers to participation in clinical research, including lack of trust in the healthcare system, materials in their native languages, financial support, minority investigators involved in clinical trials, and accessible study sites. The specialists proposed strategies that could be implemented to increase minority enrollment. These included study sites where minority populations live and industry funded outreach and educational efforts in minority communities. If sites are more accessible, this can reduce time and financial pressures associated with study participation. The specialists recommended that studies be designed to be more supportive of minority populations, specifically regarding inclusion and exclusion criteria and reimbursement of costs. They also advised that increased diversity among clinical researchers and allied personnel may increase the ability of the clinical team to connect with pts and assist in building trust in their communities. Finally, they emphasized the importance of providing informed consent forms and study materials in pts’ native languages. Conclusions: While challenges exist to increasing diversity in oncology clinical studies, a broad consortium of clinical specialists agreed that they can be addressed by community outreach and education, making study sites more accessible, availability of study materials in pts’ native languages, and improving diversity of clinical teams.

Oncology clinical research landscape in Middle East and North Africa (MENA) region: Challenges and proposed solutions.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13567-e13567
Author(s):  
Kareem Sameh ◽  
Natasha Khalife
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Middle East ◽  
Clinical Research ◽  
North Africa ◽  
Research Infrastructure ◽  
Trial Participation ◽  
Mena Region ◽  
Large Patient ◽  
Oncology Clinical Trials

e13567 Background: Similar to other regions of the world, cancer incidence in Middle East and North Africa (MENA) is rising, which has been attributed to increased life expectancy and adoption of western lifestyle habits. Conducting clinical trials in the region is important to assess efficacy and safety of oncology medications in the specific population (response to drugs can be impacted by genetics, demographics and lifestyle factors). Although the MENA comprises around 5% of the global population, the region only participates in approximately 3% of clinical trials worldwide. It is important to understand the challenges in conducting trials in MENA and identify strategies to overcome these in order to facilitate advances in clinical research in the region. Methods: A literature review was conducted (via e.g. PubMed and ClinicalTrials.gov) to understand the current oncology clinical research landscape in MENA (from Jan 2015-Dec 2020), with the aim of identifying key challenges and potential strategies to overcome these. Results: Conduct of oncology clinical trials (phases 1-4) has risen in recent years in MENA, from 47 trials in 2015 to 53 trials in 2020. Despite the presence of various research-favourable factors in MENA (large patient pool, high demand for medication, lower clinical trial operational costs, compliance with ICH-GCP standards), the region still falls behind other countries in clinical research. Key factors identified as challenges in conducting clinical trials in MENA include the research infrastructure and patient awareness/understanding of research. We propose the following strategies to support the advancement of clinical research in the region: (1) Enhance research infrastructure through bolstering national clinical research networks and supporting collaboration between healthcare institutes, academia and the pharma industry; (2) Diversify methods of patient engagement (e.g. patient advisory groups and social media networks) and provide education on pros/cons of participating in research to raise awareness and improve trial participation rates; and (3) Improve availability of comprehensive oncology registries to enhance understanding of disease burden and support clinical research. Conclusions: The conduct of oncology clinical trials in MENA is increasing, yet the region is still under-represented in the global clinical trial market, despite its significant potential. The advancement of clinical research in the region will require a multi-level approach, involving collaboration between multiple stakeholders including the pharma industry, regulators, government, and healthcare professionals.

scholarly journals US Cancer Centers of Excellence Strategies for Increased Inclusion of Racial and Ethnic Minorities in Clinical Trials

2019 ◽  
Vol 15 (4) ◽  
pp. e289-e299 ◽  
Author(s):  
Jeanne M. Regnante ◽  
Nicole A. Richie ◽  
Lola Fashoyin-Aje ◽  
Michelle Vichnin ◽  
Marvella Ford ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Health Care Professionals ◽  
Working Group ◽  
Minority Groups ◽  
Community Outreach ◽  
Cancer Center ◽  
National Minority ◽  
Centers Of Excellence ◽  
Cancer Centers ◽  
Cancer Trials

PURPOSE: Participation of racial and ethnic minority groups (REMGs) in cancer trials is disproportionately low despite a high prevalence of certain cancers in REMG populations. We aimed to identify notable practices used by leading US cancer centers that facilitate REMG participation in cancer trials. METHODS: The National Minority Quality Forum and Sustainable Healthy Communities Diverse Cancer Communities Working Group developed criteria by which to identify eligible US cancer centers—REMGs comprise 10% or more of the catchment area; a 10% to 50% yearly accrual rate of REMGs in cancer trials; and the presence of formal community outreach and diversity enrollment programs. Cancer center leaders were interviewed to ascertain notable practices that facilitate REMG accrual in clinical trials. RESULTS: Eight cancer centers that met the Communities Working Group criteria were invited to participate in in-depth interviews. Notable strategies for increased REMG accrual to cancer trials were reported across five broad themes: commitment and center leadership, investigator training and mentoring, community engagement, patient engagement, and operational practices. Specific notable practices included increased engagement of health care professionals, the presence of formal processes for obtaining REMG patient/caregiver input on research projects, and engagement of community groups to drive REMG participation. Centers also reported an increase in the allocation of resources to improving health disparities and increased dedication of research staff to REMG engagement. CONCLUSION: We have identified notable practices that facilitate increased participation of REMGs in cancer trials. Wide implementation of such strategies across cancer centers is essential to ensure that all populations benefit from advances in an era of increasingly personalized treatment of cancer.

Multiple uses for a clinical research database

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 17037-17037
Author(s):  
A. O. Greco ◽  
C. M. Licavoli ◽  
L. A. White ◽  
J. R. Eckardt ◽  
K. O. Easley ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Data Base ◽  
Metastatic Breast ◽  
Trial Participation ◽  
Research Database ◽  
Cooperative Group ◽  
Oncology Clinical Trials ◽  
Referring Physicians

17037 Background: In Sept 2000, the research staff at The Center for Cancer Care and Research (TCCCR) developed an excel data base to track new consults referred to the practice. It is used to identify pts for participation in Cooperative Group Clinical Trials and to identify gaps in the active protocol list. Several additional uses for the data base have evolved. Methods: Medical records provided by referring physicians for each new consult are evaluated by a Research Coordinator. Information including the pt's name, date of visit, physician, referring physician, diagnosis, protocol for which the pt is evaluated, and eligibility information is entered in the data base. Results: The data base provides a method by which we can follow pts through the protocol selection and informed consent process. Early on, the data base identified a site need for trials in metastatic breast cancer prompting us to search other sources such as the CTSU and industry. Additionally, the percentage of new consults actually enrolled on a clinical trial can be determined as well as tracking eligibility/ineligibility trends. The Pharmaceutical Research Dept can use the information to complete feasibility studies prior to participating in industry trials. The data base can be used to evaluate trends in referral patterns and has helped identify referring physicians who support our research efforts. In 2006, TCCCR had a protocol available for 45% of new consults with a cancer dx. Of those pts, 16% enrolled on a Cooperative Group Clinical Trial. According to published evaluations, 16% is well above the national average of pts who participate in oncology clinical trials. It is our assessment that TCCCR's success is due in part to the data base. Conclusions: It is well known that in order to improve treatment outcomes and diminish treatment toxicity, oncology practices and pts must participate in clinical research. It is also well known that the numbers of pts who participate in oncology clinical trials is dismal. This data base has become a valuable tool providing a method to identify and evaluate some of the reasons why pts do not enroll in clinical trials and given our practice guidance to increase pt participation. Our next goal is to evaluate the differences between the rural and urban population at TCCCR's two sites to identify additional trends in clinical trial participation. No significant financial relationships to disclose.

scholarly journals KNOWLEDGE, ATTITUDE, AND PERCEPTION OF NURSES AND PHYSICIANS REGARDING PHARMACEUTICAL-INITIATED CLINICAL RESEARCH IN UAE, QATAR, OMAN, BAHRAIN, AND JORDAN

2019 ◽  
pp. 44-49
Author(s):  
SHEREEN HAMMAD
Keyword(s):  
Clinical Trials ◽  
Middle East ◽  
Clinical Research ◽  
Health Care Professionals ◽  
Legal Protection ◽  
Willingness To Participate ◽  
Online Questionnaire ◽  
Research Activities ◽  
East Region ◽  
Middle East Region

Objective: The objective of the study was to understand the reasons for the limited number of pharmaceutical-initiated clinical studies in the Middle East region, by assessing the knowledge, attitudes, and perceptions related to pharmaceutical-initiated clinical trials among health-care professionals (HCPs) in UAE, Qatar, Oman, Bahrain, and Jordan. Methods: The study was conducted using an online questionnaire-based survey. The HCP respondents were from UAE, Qatar, Oman, Bahrain, and Jordan and had a good understanding of the English language. Descriptive statistical analysis was used to analyze the responses. Results: The HCPs were not inclined toward participation in clinical trials and research activities. The reasons for their limited participation included a lack of time, resources, and limited awareness about their legal protection associated with such studies, and the lack of necessary training and education related to clinical research. Conclusions: Although there is a willingness to participate in clinical trials conducted by pharmaceutical companies, HCPs face various ethical, administrative, and academic barriers. Addressing these issues would help increase the number of trials conducted in the Middle East region.

scholarly journals SWOT Analysis of Oncology Clinical Trials in Africa: A Town Hall Report From the Global Congress on Oncology Clinical Trials in Blacks

2020 ◽  
pp. 966-972
Author(s):  
Adaora Ezeani ◽  
Folakemi Odedina ◽  
Desiree Rivers ◽  
Omolara Fatiregun ◽  
Titilope Akinremi
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Swot Analysis ◽  
Political Commitment ◽  
African Countries ◽  
Town Hall ◽  
Health Crisis ◽  
Advantages And Disadvantages ◽  
Oncology Clinical Trials ◽  
Black Populations

Cancer is rapidly becoming a public health crisis as a result of the continued growth and ageing of the global population and will greatly affect resource-limited low- to middle-income countries. It is widely acknowledged that research should be conducted within countries that will bear the greatest burden of disease, and Africa has the unparalleled opportunity to lead the way in developing clinical trials to improve the health of its countries. In 2018, the inaugural Global Congress on Oncology Clinical Trials in Blacks was organized to address the global challenges of clinical trials for oncology among black populations. During this event, researchers, scientists, and advocates participated in a town hall meeting where they explored the status of oncology clinical trials in Africa using the SWOT (strengths, weaknesses, opportunities, threats) approach. Participants discussed noteworthy successes, significant barriers, and opportunities to address gaps in developing a sustainable clinical research framework. Many comments centered on the lack of funding and inadequate infrastructure affecting most African countries. Others noted important successes, such as thriving collaborations among institutions and improved political commitment in support of clinical research. The main objectives of the town hall session were to share knowledge on and discuss advantages and disadvantages of conducting clinical research in Africa. These discussions are invaluable in developing interventions and policies that improve clinical research capabilities in Africa.

scholarly journals The role of the clinical research coordinator – data manager – in oncology clinical trials

2004 ◽  
Vol 4 (1) ◽  
Author(s):  
Fernando Rico-Villademoros ◽  
Teresa Hernando ◽  
Juan-Luis Sanz ◽  
Antonio López-Alonso ◽  
Oscar Salamanca ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Clinical Research Coordinator ◽  
Research Coordinator ◽  
Oncology Clinical Trials ◽  
Data Manager

The Use of Digital Clinical Trial Methods in the Evaluation of Digital Therapeutics: A Scoping Review (Preprint)

2019 ◽  
Author(s):  
Allison Hirsch ◽  
Mahip Grewal ◽  
Anthony James Martorell ◽  
Brian Michael Iacoviello
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Scoping Review ◽  
Digital Technologies ◽  
Good Clinical Practice ◽  
The United States ◽  
Clinical Trial Research ◽  
Digital Methods ◽  
Clinical Trial Methods

BACKGROUND Digital Therapeutics (DTx) provide evidence based therapeutic health interventions that have been clinically validated to deliver therapeutic outcomes, such that the software is the treatment. Digital methodologies are increasingly adopted to conduct clinical trials due to advantages they provide including increases in efficiency and decreases in trial costs. Digital therapeutics are digital by design and can leverage the potential of digital and remote clinical trial methods. OBJECTIVE The principal purpose of this scoping review is to review the literature to determine whether digital technologies are being used in DTx clinical research, which type are being used and whether publications are noting any advantages to their use. As DTx development is an emerging field there are likely gaps in the knowledge base regarding DTx and clinical trials, and the purpose of this review is to illuminate those gaps. A secondary purpose is to consider questions which emerged during the review process including whether fully remote digital clinical research is appropriate for all health conditions and whether digital clinical trial methods are inline with the principles of Good Clinical Practice. METHODS 1,326 records were identified by searching research databases and 1,227 reviewed at the full-article level in order to determine if they were appropriate for inclusion. Confirmation of clinical trial status, use of digital clinical research methods and digital therapeutic status as well as inclusion and exclusion criteria were applied in order to determine relevant articles. Digital methods employed in DTx research were extracted from each article and these data were synthesized in order to determine which digital methods are currently used in clinical trial research. RESULTS After applying our criteria for scoping review inclusion, 11 articles were identified. All articles used at least one form of digital clinical research methodology enabling an element of remote research. The most commonly used digital methods are those related to recruitment, enrollment and the assessment of outcomes. A small number of articles reported using other methods such as online compensation (n = 3), or digital reminders for participants (n = 5). The majority of digital therapeutics clinical research using digital methods is conducted in the United States and increasing number of articles using digital methods are published each year. CONCLUSIONS Digital methods are used in clinical trial research evaluating DTx, though not frequently as evidenced by the low proportion of articles included in this review. Fully remote clinical trial research is not yet the standard, more frequently authors are using partially remote methods. Additionally, there is tremendous variability in the level of detail describing digital methods within the literature. As digital technologies continue to advance and the clinical research DTx literature matures, digital methods which facilitate remote research may be used more frequently.

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