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

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.

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Historical Perspectives on Ethical and Regulatory Aspects of Human Participants Research: Implications for Oncology Clinical Trials in Africa

JCO Global Oncology ◽

10.1200/jgo.19.00196 ◽

2020 ◽

pp. 959-965 ◽

Cited By ~ 1

Author(s):

Bodour Salhia ◽

Victoria Olaiya

Keyword(s):

Clinical Trials ◽

Communicable Disease ◽

Ethics Committees ◽

African Countries ◽

Historical Perspectives ◽

Oncology Clinical Trials ◽

Human Participants ◽

National Regulatory Agency ◽

Care Problems ◽

Medical Advances

Clinical trials research involving human participants has led to numerous medical advances. Historically, however, clinical trials research was the source of major concerns for the safety and welfare of the human participants taking part in these studies. The ethical principles of autonomy, beneficence, and justice came about in response to medical atrocities, and regulations were ultimately put in place to protect the rights and welfare of human participants and to maintain the public trust in the research enterprise. Today, clinical trials are one of the most heavily regulated practices in the world, and yet still not all people are provided the same oversights and protections, with improprieties disproportionately affecting poor-resource nations and vulnerable populations. As Africa approaches the post–communicable disease era, cancer is set to take the lead as the most burdensome disease, making the need for oncology clinical trials in Africa greater than ever before. Africa represents a heterogeneous market with 55 countries, most with their own National Regulatory Agency (NRA) and each with varying levels of regulatory maturity. This diversity creates a highly complex regulatory environment and causes challenges when bringing drugs to market. There is a large need for harmonization and increased collaboration between the African nations’ NRAs. In addition, many African countries need to be better equipped to handle research ethics committees and/or learn how to rely on neighboring countries with more established ethics committees. Well-run clinical trials offer solutions to national health care problems, and all people deserve equal access to their benefits.

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

Current Oncology ◽

10.3747/co.27.5707 ◽

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.

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

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.e17567 ◽

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.

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Review of methodology and materials using for building of gum soft tissues

Clinical Practice ◽

10.17816/clinpract10157-62 ◽

2019 ◽

Vol 10 (1) ◽

pp. 57-62

Author(s):

Svetlana V. Tarasenko ◽

S. V. Zagorskij

Keyword(s):

Clinical Trials ◽

Clinical Research ◽

Soft Tissues ◽

Surgical Techniques ◽

Collagen Matrices ◽

Advantages And Disadvantages ◽

Materials Used

In the review we analyze the basic surgical techniques applied to increase the volume of a keratinized gum and materials used for this procedure, such as dermal and collagen matrices. The results of clinical trials are presented on the effectiveness of collagen matrices, including Mucograft. The analysis of the literature highlights the main advantages and disadvantages of these methods and materials, as well as the most significant and promising areas for the further clinical research.

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

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e18521 ◽

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.

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

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e13567 ◽

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.

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2491

Journal of Clinical and Translational Science ◽

10.1017/cts.2017.139 ◽

2017 ◽

Vol 1 (S1) ◽

pp. 38-38

Author(s):

Jennifer Erves ◽

Tilicia Mayo-Gamble ◽

Consuelo Hopkins Wilkins

Keyword(s):

Clinical Trials ◽

Health Status ◽

Clinical Research ◽

Parental Knowledge ◽

Cross Sectional Study ◽

Cross Sectional ◽

Advantages And Disadvantages ◽

Factors Influencing ◽

Adolescent Participation ◽

Parental Willingness

OBJECTIVES/SPECIFIC AIMS: The objective of this study was to identify factors influencing parental willingness of adolescent participation in clinical trials. METHODS/STUDY POPULATION: We applied community engaged research principles to conduct a theory-based, cross-sectional study of parental willingness. Parents (N=307) were given a survey from November 2014 to April 2015. Factors influencing parental willingness were identified using binary logistic regression. SPSS version 22.0 was used to perform analyses, and p<0.05 was considered statistically significant. RESULTS/ANTICIPATED RESULTS: The most impactful factor on willingness was Advantages of Adolescent Clinical Research (p = .001), followed by Disadvantages of Clinical Research (p = .006), Knowledge of Adolescent Clinical Trials (p = 0.029), and Perceived Health Status of Adolescent (p = .036). In further exploring the influence of Perceived Advantages and Perceived Disadvantages, “My child will do something to help others.” (p = .026) and “My child is too young to participate in a clinical trial.” was the only significant Perceived Disadvantage (p = .001) were significantly associated with parental willingness. DISCUSSION/SIGNIFICANCE OF IMPACT: Improving parental knowledge and understanding of adolescent clinical trials, the advantages and disadvantages of adolescent participation, and the health status requirements for child participation are important factors to address when influencing parental willingness to allow adolescents to participate in clinical trials. Recruitment strategies that incorporate this information could improve future adolescent participation in clinical trials, ultimately promoting adolescent health and disease prevention.

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Multiple uses for a clinical research database

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.17037 ◽

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.

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Investigator Experiences Using Mobile Technology in Clinical Research: A Qualitative Descriptive Study (Preprint)

10.2196/preprints.19242 ◽

2020 ◽

Author(s):

Kevin Christopher McKenna ◽

Cindy Geoghegan ◽

Teresa Swezey ◽

Brian Perry ◽

William A. Wood ◽

...

Keyword(s):

Clinical Trials ◽

Clinical Research ◽

Mobile Technology ◽

Descriptive Study ◽

Mobile Technologies ◽

Additional Training ◽

Advantages And Disadvantages ◽

Wide Range ◽

Qualitative Descriptive ◽

Trial Participants

BACKGROUND Successful adoption of mobile technology for use in clinical trials relies on positive reception from key stakeholders, including clinical researchers, yet there is little information about the experiences of investigators using mobile technologies in clinical trials. OBJECTIVE We sought investigator perspectives about the advantages and challenges of mobile clinical trials (MCTs); budgetary, training, and other support needs necessary to adequately prepare for and implement MCTs; and investigator perspectives regarding the advantages and disadvantages of trial participants using mobile technologies in clinical trials. METHODS Using a qualitative descriptive study design, we conducted in-depth interviews with twelve study investigators involved in the conduct of MCTs. RESULTS The investigators represented a wide variety of clinical specialties, and reported using a wide range of mobile technologies. Investigators most commonly cited three advantages of MCTs over traditional clinical trials: 1) more streamlined study operations; 2) remote data capture; and 3) improvement in quality of studies and data collected. Investigators also reported that MCTs can be built around the convenience of trial participants, and individuals may be more willing to participate in MCTs because they can take part from home; although investigators also recognized that MCTs can involve additional burden for participants. Operational challenges, technology adoption barriers, uncertainties about data quality, and time burden made MCTs more challenging than traditional clinical trials. The selection of a particular technology by investigators and/or clinical research sponsors to use in the trial, participant use of the technology, and staff troubleshooting may require additional training and dedicated effort. Moreover, sharing data collected in real-time with investigators and trial participants is an important aspect of MCTs that warrants consideration, and potentially additional training and education. CONCLUSIONS Investigator perspectives can inform use of mobile technologies in future clinical trials by proactively identifying and addressing potential challenges.

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