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.

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.

Dedicated clinical trial tissue tracking database to improve turn-around time at high-volume center.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1543-1543
Author(s):  
Peter Blankenship ◽  
David DeLaRosa ◽  
Marc Burris ◽  
Steven Cusson ◽  
Kayla Hendricks ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Tissue Sample ◽  
High Volume ◽  
Trial Participation ◽  
Fresh Tissue ◽  
Oncology Clinical Trials ◽  
The Status ◽  
Unique Source

1543 Background: Tissue requirements in oncology clinical trials are increasingly complex due to prescreening protocols for patient selection and serial biopsies to understand molecular-level treatment effects. Novel solutions for tissue processing are necessary for timely tissue procurement. Based on these needs, we developed a Tissue Tracker (TT), a comprehensive database for study-related tissue tasks at our high-volume clinical trial center. Methods: In this Microsoft Access database, patients are assigned an ID within the TT that is associated with their name, medical record number, and study that follows their request to external users: pathology departments, clinical trial coordinators and data team members. To complete tasks in the TT, relevant information is required to update the status. Due to the high number of archival tissue requests from unique pathology labs, the TT has a “Follow-Up Dashboard” that organizes information needed to conduct follow-up on all archival samples with the status “Requested”. This results in an autogenerated email and pdf report sent to necessary teams. The TT also includes a kit inventory system and a real-time read only version formatted for interdepartmental communication, metric reporting, and other data-driven efforts. The primary outcome in this study was to evaluate our average turnaround time (ATAT: average time from request to shipment) for archival and fresh tissue samples before and after TT development. Results: Before implementing the TT, between March 2016 and March 2018, we processed 2676 archival requests from 235 unique source labs resulting in 2040 shipments with an ATAT of 19.29 days. We also processed 1099 fresh biopsies resulting in 944 shipments with an ATAT of 7.72 days. After TT implementation, between April 2018 and April 2020, we processed 2664 archival requests from 204 unique source labs resulting in 2506 shipments (+28.0%) with an ATAT of 14.78 days (-23.4%). During that same period, we processed 1795 fresh biopsies (+63.3%) resulting in 2006 shipments (+112.5%) with an ATAT of 6.85 days (-11.3%). Conclusions: Oncology clinical trials continue to evolve toward more extensive tissue requirements for prescreening and scientific exploration of on-treatment molecular profiling. Timely results are required to optimize patient trial participation. During the intervention period, our tissue sample volume and shipments increased, but the development and implementation of an automated tracking system allowed improvement in ATAT of both archival and fresh tissue. This automation not only improves end-user expectations and experiences for patients and trial sponsors but this allows our team to adapt to the increasing interest in tissue exploration.

Transforming Clinical Trial Eligibility Criteria to Reflect Practical Clinical Application

2016 ◽  
pp. 83-90 ◽  
Author(s):  
Edward S. Kim ◽  
Jennifer Atlas ◽  
Gwynn Ison ◽  
Jennifer L. Ersek
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Diagnostic Testing ◽  
Standard Of Care ◽  
Trial Participation ◽  
Eligibility Criteria ◽  
Number Of Patients ◽  
Oncology Clinical Trials ◽  
Clinical Trial Accrual ◽  
Clinical Trial Results

Historically, oncology clinical trials have focused on comparing a new drug’s efficacy to the standard of care. However, as our understanding of molecular pathways in oncology has evolved, so has our ability to predict how patients will respond to a particular drug, and thus comparison with a standard therapy has become less important. Biomarkers and corresponding diagnostic testing are becoming more and more important to drug development but also limit the type of patient who may benefit from the therapy. Newer clinical trial designs have been developed to assess clinically meaningful endpoints in biomarker-enriched populations, and the number of modern, molecularly driven clinical trials are steadily increasing. At the same time, barriers to clinical trial enrollment have also grown. Many barriers contribute to nonenrollment in clinical trials, including patient, physician, institution, protocol, and regulatory barriers. At the protocol level, eligibility criteria have become a large roadblock to clinical trial accrual. Over time, eligibility criteria have become more and more restrictive. To accrue an adequate number of patients to molecularly driven trials, we should consider eligibility criteria carefully and attempt to reduce restrictive criteria. Reducing restrictive eligibility criteria will allow more patients to be eligible for clinical trial participation, will likely increase the speed of drug approvals, and will result in clinical trial results that more accurately reflect treatment of the population in the clinical setting.

Clinical Trial Participation Is Associated With Improved Outcome in Women With Ovarian Cancer

2009 ◽  
Vol 19 (1) ◽  
pp. 124-128 ◽  
Author(s):  
William R. Robinson ◽  
Joyce Ritter ◽  
April S. Rogers ◽  
Sean Tedjarati ◽  
Christy Lieberenz
Keyword(s):  
Ovarian Cancer ◽  
Clinical Trial ◽  
Overall Survival ◽  
Clinical Trials ◽  
Confidence Interval ◽  
Clinical Research ◽  
Trial Participation ◽  
Gynecologic Oncology Group ◽  
Histologic Subtype ◽  
Urban Versus

Objectives:To determine the effect of participation in clinical trials on survival of women with ovarian cancer. Disease-specific factors and demographics were also examined.Methods:A total of 158 women were treated for ovarian cancer at a regional cancer center. All patients were offered treatment with surgery/chemotherapy and were screened at diagnosis for participation in clinical research. Progression-free and overall survival, as well as demographic- and treatment-related data, were recorded.Results:Fifty-three participated in clinical trials and 105 did not. On-study versus off-study subjects were similar in age (64.1 vs 63.5 years), ethnicity (87% vs 85% white), performance status (100% 0-1 Gynecologic Oncology Group scale), and urban versus rural lifestyle (58% vs 55% urban). Stage of disease, histologic subtype, and type/amount of therapy were also similar. Kaplan-Meier analysis showed superior overall survival for on-study subjects (median, 46 vs 25 months, 95% confidence interval, 1.0299-2.1505 months, P = 0.0343). A trend toward improved progression-free survival approached significance for on-study subjects (median, 23 vs 9 months, 95% confidence interval, 0.9545-2.0022 months, P = 0.0866).Conclusions:Women with ovarian cancer who participate in clinical trials at this institution have improved survival compared with those who are treated with standard therapies. No other factors examined were associated with treatment completion or survival. Further, participation in clinical research does not vary by age, ethnicity, urban versus rural lifestyle, or cancer stage or histologic subtype. However, disclosure of this information to potential clinical trial participants may represent an ethical conflict and should be carefully considered in light of existing ethical guidelines for human subject research.

scholarly journals Re-Evaluating Eligibility Criteria for Oncology Clinical Trials: Analysis of Investigational New Drug Applications in 2015

2017 ◽  
Vol 35 (33) ◽  
pp. 3745-3752 ◽  
Author(s):  
Susan Jin ◽  
Richard Pazdur ◽  
Rajeshwari Sridhara
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Patient Population ◽  
Trial Participation ◽  
Cancer Clinical Trials ◽  
Eligibility Criteria ◽  
New Drug ◽  
Drug Clinical Trial ◽  
Oncology Clinical Trials ◽  
Eligibility Requirements

Clinical trial eligibility criteria are necessary to define the patient population under study and improve trial safety. However, there are concerns that eligibility criteria for cancer clinical trials are too restrictive and limit patient enrollment in clinical trials. Recently, there have been initiatives to re-examine and modernize eligibility criteria for oncology clinical trials. To assess current eligibility requirements for cancer clinical trials, we have conducted a comprehensive review of eligibility criteria for commercial investigational new drug clinical trial applications submitted to the US Food and Drug Administration Office of Hematology and Oncology Products in 2015. Our findings suggest that eligibility criteria for current cancer clinical trials tend to narrowly define the study population and limit the study to lower-risk patients, which may not be reflective of the greater patient population outside of the study. We discuss potential areas for expanding eligibility criteria to include more patients in clinical trials and design options for clinical trials incorporating expanded eligibility criteria. The broadening of clinical trial eligibility criteria can be considered to better reflect the real-world patient population, improve clinical trial participation, and increase patient access to new investigational treatments.

scholarly journals Who Needs What? Perceptions of Patients and Caregivers in Oncology Phase 1 Trials

2019 ◽  
Vol 7 (1) ◽  
pp. 27-33 ◽  
Author(s):  
Victoria Rezash ◽  
Janice Reed ◽  
Barbara Gedeon ◽  
Eric Parsons ◽  
Sandra Siedlecki ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Phase 1 ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Oncology Clinical Trial ◽  
Oncology Clinical Trials ◽  
Vulnerable Patient ◽  
Additional Support

Background: The study design and nature of oncology phase 1 clinical trials create a uniquely vulnerable patient population yet little research has been conducted to identify the added burden these trials create for both cancer patients and their caregiver(s). Objective: Examining the perceptions and needs of patients and their caregivers participating in phase 1 oncology clinical trials, the investigators tested the hypothesis that the caregiver will exhibit a higher level of burden and/or distress than the patient. Method: A mixed-methods exploratory process utilizing patient and caregiver interviews and quality-of-life questionnaires was used to assess the psychosocial burdens associated with oncology clinical trial participation. A qualitative and quantitative analysis of the responses were 8 performed. Result: Both patients and caregivers reported similar themes identifying the burdens and benefits related to phase 1 clinical trial participation. However, the caregivers’ expressed burden exceeded that of the patients’ validating the study’s hypothesis. Conclusion: The need for ongoing additional support services for not only the patient but also the caregiver was identified.

Clintrial Refer- a Mobile App To Connect Patients With Local Clinical Trials

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 5600-5600
Author(s):  
Judith Trotman ◽  
Xavier Badoux ◽  
Admir Huseincehajic ◽  
Michele Gambrill ◽  
Anais LeGall ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Data Entry ◽  
Smart Phone ◽  
Mobile App ◽  
Research Network ◽  
Trial Participation ◽  
Time Data ◽  
App Development

Abstract Background Readily accessible, smart-phone applications (Apps) have the potential to revolutionise and improve the delivery of patient care. Significant challenges associated with recruiting patients to haematology clinical trials include the rarity of diseases, complexity of trials, limited site locations, and maintaining knowledge of current trials in the context of rapid therapeutic developments. The Haematology Clinical Research Network, of New South Wales and the Australian Capital Territory (NSW/ACT) aimed to develop an App to facilitate clinician and patient access to current information on local clinical trials and improve trial participation by increasing referrals. Methods Key objectives were to develop an App that was free to download, simple to use and effective. Only publically listed data was to be included. Endpoints were rates of App usage, and cross-site and internal clinical trial referrals. Through liaison between the end-users (clinicians, trial managers and patients), and the contracted software developer, App specifications were refined through successive iterations. With the key search filters of Disease, Location, Sponsor and Study Status, the App has an easy to navigate listing of currently recruiting haematology trials. Useful features include: listing of inclusion and exclusion criteria; direct links to ClinTrials.gov; a lay summary; and direct contacts from the mobile device to participating study sites. Real-time data entry into the database app manager ensures currency of trial information. Results ClinTrial Refer went live in May 2013, on both iOS and Android platforms. As at 10th August, ClinTrial Refer has 654 users, over 4358 sessions and 13924 screen views.91% of current users are repeat users. Despite its local application the App has been accessed in 46 countries. Among the target audience in NSW 290 repeat users returned for an average 11 sessions each indicating a high user acceptance. It is being endorsed on the websites of Australian blood cancer consumer groups. A survey has confirmed that since its launch, through having readily accessible data on their smart-phones, ClinTrial Refer has increased clinician awareness of the NSW trial portfolio. In just twelve weeks it has resulted in the cross-referral of an additional 30+ patients for clinical trials, representing a >300% increase over previous referral patterns. This improvement in trials knowledge management has also increased within-site recruitment; however it is harder to quantify the exact short-term impact of ClinTrial Refer within hospitals. The App has already been duplicated for other Australian state-wide haematology networks and the Adolescent & Young Adult Research Network, NSW. Conclusion ClinTrial Refer is an innovative but simple, readily accessible mobile Application. Its widespread adoption across 18 Haematology Clinical Research sites in NSW Australia is facilitating increased patient recruitment to trials. Only recently available on iTunes and Google Play, it has attracted national and international attention as a template for any clinical trial network portfolio. Disclosures: Trotman: Celgene: Grant for App development Other. Huseincehajic:Celgene: Grant for App development Other.

scholarly journals Provider-reported challenges and barriers to referring patients to neuro-oncology clinical trials: a report from the Society for Neuro-Oncology member survey

2019 ◽  
Vol 7 (1) ◽  
pp. 38-51
Author(s):  
James L Rogers ◽  
Alvina Acquaye ◽  
Elizabeth Vera ◽  
Amanda Bates ◽  
Patrick Y Wen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Standard Of Care ◽  
Geographic Area ◽  
Trial Participation ◽  
Eligibility Criteria ◽  
Electronic Survey ◽  
Oncology Clinical Trials ◽  
Survey Sample

Abstract Background Whereas much information exists in general oncology regarding the barriers to clinical trial referral, those specific to neuro-oncology are not yet well known. Trial barriers lead to lower patient accrual, which can lead to less-efficient clinical trials and slower improvement of the standard of care, which may negatively effect patient outcomes. Thus, the aim of this study was to determine the clinical trial referral barriers that are specific to neuro-oncology to improve trial accrual rates. Methods An electronic survey was completed by 426 Society for Neuro-Oncology members, of whom 372 are included in this report. Descriptive statistics, including frequencies, means, and proportions, were used to characterize our survey sample. Results Only 22% of participants reported that their center tracks referrals to clinical trials inside as well as outside their own institution, with an estimate of less than 30% of patients referred. The most commonly reported provider-referral barrier was finding ongoing trials in the patient’s geographic area. Providers also perceived that while considering participation in a trial their patients may not qualify for any trials, and if they do, may be unable to travel to the study site for follow-up. Additionally, practice location and provider and institution type all influenced referral patterns. Conclusion Efforts should be made to broaden trial availability and eligibility criteria, improve trial referral tracking, and ensure patients and their caregivers understand the goals and importance of clinical trials to reduce barriers and improve trial participation.

Clinical trials in the Middle East and North Africa (MENA) Region: Grandstanding or Grandeur?

2013 ◽  
Vol 36 (2) ◽  
pp. 704-710 ◽  
Author(s):  
Satish Chandrasekhar Nair ◽  
Halah Ibrahim ◽  
David D. Celentano
Keyword(s):  
Clinical Trials ◽  
Middle East ◽  
North Africa ◽  
Mena Region

Representativeness of oncology clinical trials in Alberta.

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 27-27 ◽  
Author(s):  
Safiya Karim ◽  
Yuan Xu ◽  
Shiying Kong ◽  
Winson Y. Cheung
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Real World ◽  
Cox Regression ◽  
Trial Participation ◽  
Tumor Type ◽  
Institute Of Medicine ◽  
Clinical Trial Participation ◽  
Treatment Type ◽  
Oncology Clinical Trials

27 Background: The Institute of Medicine encourages broad participation by patients in clinical trials to “efficiently provide practice-changing evidence”. Enrolment of a representative sample of the general oncology population in clinical trials is essential to ensure that outcomes are generalizable and to ensure equity and social justice. Our aims were to 1) determine the characteristics of all cancer patients compared to those enrolled on a clinical trial and 2) to determine factors and outcomes associated with clinical trial participation. Methods: We assembled a large cohort of patients diagnosed with all solid malignancies between 2004 and 2016 in a large Canadian province. We collected information on age, sex, tumor type, Charlson comorbidity index (CCI), year of diagnosis, treatment type (surgery, chemo, radiation, and immunotherapy). Logistic regression was used to identify factors associated with clinical trial participation. Cox regression models were constructed to determine overall survival (OS). Results: We identified 146,294 patients with a cancer diagnosis, of which 43% were men and the mean age at diagnosis was 61 years (SD 15.6). Approximately 3% (4,364/146,294) of all patients were enrolled in a clinical trial. Baseline characteristics showed that clinical trial patients were younger (mean age 58 years vs 61 years), had fewer comorbidities (CCI 0 = 83% vs. 73%) and more often male (45% vs 43%). Compared to all patients, clinical trial patients were more likely to be younger (OR 0.98, p < 0.001), male (OR 1.21, 95% CI 1.10-1.32 p < 0.001), and to have a diagnosis of brain (OR 3.8, 95% CI 2.86-5.05, p < 0.001), kidney (OR 2.61, 95% CI 1.93-3.52) or breast cancer (OR 2.38, 95% CI 1.84-3.08). Compared to all patients and those not treated on clinical trial, patients on clinical trial had improved OS (HR 0.81, 95% CI 0.77-0.85, p < 0.001). Conclusions: Only a small proportion of real world patients are treated within a clinical trial. Characteristics of clinical trials patients are significantly different from all patients with cancer. More representative clinical trials are needed in order to reflect the real world cancer population.

Sign in / Sign up

Export Citation Format

Share Document