scholarly journals Oncology Clinical Trials in Africa: Partnering for Quality

2021 ◽  
pp. 572-576
Author(s):  
Delva Shamley ◽  
Adaora Ezeani ◽  
Ifeoma Okoye
Keyword(s):  
Clinical Trials ◽  
Treatment Options ◽  
Improve Patient Care ◽  
Ethics Committees ◽  
Good Clinical Practice ◽  
Research Capacity ◽  
Strategic Partnerships ◽  
Local Evidence ◽  
Human Research Ethics ◽  
Oncology Clinical Trials

Oncology clinical trials are requisite for testing the safety and effectiveness of promising treatments and deciphering new knowledge into concrete benefits for patients. They present opportunities to innovate promising, novel cancer remedies. A dearth of local evidence to guide cancer treatment in Africans is creating an increased interest in oncology clinical trials to improve patient care. This is primarily because of limitations in pathology, surgery, medical oncology, radiation, and palliation that are leading to worse cancer outcomes on the continent. Investment in oversight of Human Research Ethics committees and Medicines Regulatory Authorities in Africa has improved the potential for many countries to host clinical trials. However, the distribution of cancer trials remains poor across the continent, resulting in inadequate treatment options for patients with cancer. There are some initiatives aimed at developing research capacity to host trials in Africa. However, there is now a need to establish strategic partnerships whose aim should be to achieve harmonized, accredited Clinical Trials Units capable of running trials to meet Good Clinical Practice standards. This article discusses what has been achieved and proposes a model for quality oversight of Clinical Trials Units in Africa.

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

2020 ◽  
pp. 959-965 ◽  
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.

Integrating Genomics Into Neuro-Oncology Clinical Trials and Practice

2018 ◽  
pp. 148-157
Author(s):  
Evanthia Galanis ◽  
Farhad Nassiri ◽  
Shannon Coy ◽  
Romina Nejad ◽  
Gelareh Zadeh ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Treatment Options ◽  
Rapid Evolution ◽  
Cns Tumors ◽  
World Health ◽  
World Health Organization Classification ◽  
Improved Outcomes ◽  
Oncology Clinical Trials ◽  
Health Organization

Important advances in our understanding of the molecular biology of brain tumors have resulted in a rapid evolution in the taxonomy of central nervous system (CNS) tumors, which culminated in the revised 2016 World Health Organization classification of CNS tumors that incorporates an integrated molecular/histologic diagnostic approach. Our expanding understanding of brain tumor genomics and molecular evolution during the disease course has started to impact clinical management. Furthermore, incorporation of genomic information in ongoing and planned neuro-oncology clinical trials is expected to lead to improved outcomes and result in personalized treatment options for patients with CNS malignancies.

Overall Assessment of Human Research and Ethics Committees in the United Arab Emirates

2017 ◽  
Vol 12 (2) ◽  
pp. 71-78 ◽  
Author(s):  
Mahera Abdulrahman ◽  
Satish Chandrasekhar Nair
Keyword(s):  
Research Ethics ◽  
United Arab Emirates ◽  
Research Output ◽  
Ethics Committees ◽  
Good Clinical Practice ◽  
Adverse Event Reporting ◽  
Mentoring Program ◽  
Continuous Training ◽  
Human Research ◽  
Human Research Ethics

Growing demand for human health research in the United Arab Emirates (UAE) has prompted the need to develop a robust research ethics oversight. Examination of the structure, function, and practices of the human research ethics committees (HRECs), followed by evaluation of standards for measuring research output, was conducted. Results indicate that among the HRECs, 90% followed International Council for Harmonization–Good Clinical Practice guidelines, 66.6% have been in operation for more than 5 years, 95% reviewed proposals within 8 weeks, and 56% reviewed for scientific merit apart from ethics. However, systems to recognize accomplishments of researchers, funding transparency, and adverse event reporting were deployed in less than 30% of all HRECs. Research was incorporated into the vision and mission statements of many (65%) organizations. Research publications, collaborations, and recognitions were used to measure research output and report key performance indicators. In spite, resources to generate research output such as dedicated budget (20%), support staff (20%), and continuous training and mentoring program for medical residents (15%) and HREC members (25%) were somehow lacking. HREC structure and operations in the UAE are similar to other regions of the world. Systems to conduct research and report outcomes are defined in the UAE. Regulatory legislation and allocation of resources to support the clinical research enterprise will not only help to meet growing demand for clinical trials but also transform the quality of patient care in the UAE. It is anticipated that the results of this study will benefit investigators, regulators, pharmaceutical sponsors, and the policy makers in the region.

scholarly journals Clinical trials with cannabis medicines—guidance for ethics committees, governance officers and researchers to streamline ethics applications and ensuring patient safety: considerations from the Australian experience

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Jennifer H. Martin ◽  
Courtney Hill ◽  
Anna Walsh ◽  
Daryl Efron ◽  
Kaitlyn Taylor ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Legal Status ◽  
Therapeutic Option ◽  
Ethics Committees ◽  
Evidence Base ◽  
Pharmaceutical Products ◽  
Medical Professional ◽  
Institutional Review Boards ◽  
Safety Issues ◽  
Human Research Ethics

AbstractWith cannabis medicines now obtaining legal status in many international jurisdictions (generally on the authorisation of a medical professional), a rapid increase in consumer demand for access to cannabis as a therapeutic option in the treatment and management of a range of indications is being noted. Despite this accessibility, knowledge on optimal use is lacking. Further drug development and clinical trials at regulatory standards are necessary both if a better understanding of the efficacy of cannabis medicines, optimal product formulation and indication-specific dosing is needed and to ensure the broader quality and safety of cannabis medicines in the clinical setting.To enable this, clinical, academic and public calls for the undertaking of rigorous clinical trials to establish an evidence base for the therapeutic use of cannabis medicines have been made internationally. While this commitment to undertake human studies with cannabis medicines is welcomed, it has highlighted unique challenges, notably in the review stages of ethics and governance. This often results in lengthy delays to approval by Human Research Ethics Committees (herein ‘HREC’, Australia’s nomenclature for Institutional Review Boards) and trial commencement. A principal concern in these cases is that in contrast to clinical trials using other more conventional pharmaceutical products, trials of cannabis medicines in humans often involve the use of an investigational product prior to some (or any) of the preclinical and pharmaceutical safety issues being established. This paucity of data around product safety, potential drug interactions, continuity of supply, shelf life and product storage results in apprehension by HRECs and governance bodies to endorse trials using cannabis medicines.This manuscript draws from the experiences of Australian researchers and staff involved in clinical trials of cannabis medicines to describe some of the common difficulties that may be faced in the HREC approval process. It also presents practical advice aimed to assist researchers, HRECs and governance officers navigate this complex terrain. While the authors’ experiences are situated within the Australian setting, many of the barriers described are applicable within the international context and thus, the solutions that have been proposed are typically adaptive for use within other jurisdictions.

scholarly journals Non-alcoholic steatohepatitis: diagnosis, management and challenges in clinical trials: an Indian perspective

2021 ◽  
Vol 8 (1) ◽  
pp. 92
Author(s):  
Ena Lyn R. Ang ◽  
Ma Cecilia M. Sison ◽  
Saket M. Ghaisas ◽  
Rashna C. Cama
Keyword(s):  
Clinical Trials ◽  
Liver Disease ◽  
Treatment Options ◽  
Unmet Need ◽  
Placebo Response ◽  
Improve Patient Care ◽  
Alcoholic Fatty Liver ◽  
Alcoholic Steatohepatitis ◽  
Risk Of Progression ◽  
End Stage

<p class="abstract">Non-alcoholic fatty liver disease (NAFLD) is the most prevalent chronic liver disease worldwide and non-alcoholic steatohepatitis (NASH), its progressive form, is rapidly becoming the leading cause of end-stage liver disease and liver transplantation. There is a huge unmet need in the management of NAFLD and NASH. The key challenge is that NAFLD/NASH remains to be an under recognized disease despite its increasing prevalence, and early diagnosis is crucial to reduce the risk of progression and its consequent complications. In India, cases of NAFLD/NASH may go undetected due to lack of awareness and absence of a structured patient referral pathway. Efforts to increase patient and physician awareness along with standardization of local management guidelines for NAFLD and NASH can help improve patient care in India. Another major concern is the lack of approved NASH therapy; in order to address this issue, there has been a global surge in clinical trials. However, many countries, including India, have encountered challenges in the conduct of these trials related to patient recruitment and retention, lack of validated less invasive diagnostic tests, and the effect of placebo response on trial outcomes. Measures to improve the NAFLD and NASH clinical trial environment can help accelerate the approval and availability of better treatment options for NASH.</p><p class="abstract"> </p>

Initiative to streamline clinical trials (ISCT): Guidance for academic investigators/sponsors.

2016 ◽  
Vol 34 (7_suppl) ◽  
pp. 219-219
Author(s):  
Jasmine Grant ◽  
Katherine Brodeur-Robb ◽  
Alison May Urton ◽  
Jacqueline Bosch ◽  
Lesley Seymour ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Good Clinical Practice ◽  
Primary Objective ◽  
Conference Calls ◽  
Fda Guidance ◽  
Future Goals ◽  
Oncology Clinical Trials ◽  
Drug Regulations ◽  
Areas Of Concern ◽  
Health Canada

219 Background: The 2011 Canadian Cancer Research Alliance (CCRA) report on the State of Cancer Clinical Trials in Canada outlined in detail the threats to the conduct of academic oncology clinical trials caused by increasing complexity and workload resulting from a perceived onerous regulatory environment. The report recommended engaging Health Canada and key stakeholders to foster agreement in appropriate interpretations of the Canadian Food and Drug Regulations Part C Division 5 and ICH Good Clinical Practice (GCP) guidelines. Methods: The ISCT Working Group (ISCT WG) was formed in 2012 to address the CCRA recommendations for academic clinical trials and include experts from multiple therapeutic areas. The primary objective of the ISCT is to develop specific, practical interpretations of current regulations, laws and guidelines to facilitate Canadian clinical trials. Feedback was obtained from interested parties and ISCT members by means of surveys, face-to-face meetings and conference calls. Results: The major areas of concern identified include Health Canada Clinical Trial Applications, Investigational Product supply, monitoring, oversight of equipment and facilities, delegation of duties, validation of electronic systems, source documents and records retention, trial costs, the consistency of interpretation by different divisions of Health Canada, and access to related resources. A subcommittee was established for each area identified above and a series of recommendations to streamline processes with a focus to reduce regulatory burden for academic clinical trials. The ISCT WG used other relevant documents including the OECD framework and FDA Guidance on Risk Based Monitoring to inform its work. Conclusions: The final recommendations of the ISCT have been provided to all stakeholders, presented at international conferences and published on the N2 website. Canadian academic sites have used guidelines during Health Canada inspections with success. Future goals include an ISCT Workshop for academic site leaders to facilitate implementation of the ISCT guidelines, continue to address areas of concern, and track the success of the recommendations in ameliorating the conduct of academic trials.

scholarly journals On-site monitoring of clinical trials by an Ethics Committee in India: a road less travelled

2020 ◽  
pp. 174701612093392
Author(s):  
Nusrat Shafiq ◽  
Savita Kumari ◽  
Vivek Kumar ◽  
Vinita Suri ◽  
Muralidharan Jayashree ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Tertiary Care ◽  
Ethics Committees ◽  
Good Clinical Practice ◽  
Ethics Committee ◽  
Research Centre ◽  
Regulatory Changes ◽  
Site Monitoring ◽  
Document Review ◽  
Important Activity

Monitoring of clinical trials is important to ensure adherence to protocol, to safeguard the rights of research participants and to achieve compliance with principles of good clinical practice. Recent regulatory changes in India require Ethics Committees to keep an oversight of ongoing clinical trials including on-site monitoring. In this article, we share the experience of on-site monitoring of clinical trials by the Ethics Committee of a tertiary care, academic and research centre in India. We found a large number of shortcomings in the areas of informed consent, adverse events, insurance and reimbursement, which would not have been detected by off-site document review. Interestingly, many shortcomings were also not detected by on-site monitoring arranged by clinical trial sponsors. We therefore conclude that on-site monitoring of ongoing clinical trials is a highly important activity for Indian Ethics Committees.

Improving start-up times in oncology clinical trials: An ASCO quality improvement project.

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 297-297 ◽  
Author(s):  
Leslie Byatt ◽  
Kaylee Deutsch ◽  
Zoneddy R. Dayao
Keyword(s):  
Clinical Trials ◽  
Positive Impact ◽  
Improve Patient Care ◽  
Novel Therapies ◽  
Patient Access ◽  
Activation Time ◽  
Improvement Project ◽  
Start Up ◽  
Oncology Clinical Trials ◽  
Improve Patient

297 Background: With the increasing complexity of clinical trials, the UNMCCC and NMCCA are seeing increased delays in study activation. Currently, the average time from protocol receipt to trial activation is 33 weeks. Creating strategies to shorten the timeline where the longest delays occur will expedite patient access to novel therapies and improve patient care. Aims: Define the average activation timelines; Identify the timeline where an intervention will make the most impact in shortening start-up time; Implement an intervention, beginning February 2018; Identify strategies to decrease the longest timeline by 50% by December 2018. Methods: Timelines of 81 clinical trials opened in 2017 were analyzed. Data showed that the longest timeline is IRB approval to activation (12 weeks) and identified this as the focus of intervention to decrease our overall activation time by 50% (6 weeks). Two focus group meetings with involved staff were organized and completed. Interventions were identified. The time to complete activation tasks cannot be shortened due to staffing resources. However, shifting these tasks forward in our timeline could decrease the time to activation by at least 6 weeks. A sponsor survey was created to identify logistical concerns earlier. Regulatory coordinators were provided an email template to request systems access early. Site initiation visits are scheduled earlier. Results: Our data shows that our interventions have had a strong positive impact on our timelines. Conclusions: Since implementation, we have seen an improvement in our study timeline. We will continue to track and analyze our timeline data to determine if these strategies are effective across trials with varying startup complexities.[Table: see text]

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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