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

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.

2021 ◽  
pp. 572-576
Author(s):  
Delva Shamley ◽  
Adaora Ezeani ◽  
Ifeoma Okoye

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.


2020 ◽  
Vol 15 (5) ◽  
pp. 415-424
Author(s):  
Heeyoung Lee ◽  
Cholong Park ◽  
Jinwon Choi ◽  
Seongeun Jeong ◽  
Hyunin Cho ◽  
...  

Safety surveillance, using appropriately consistent review criteria, could improve human participants’ well-being in clinical trials. To establish a globally consistent framework, the quality of the current content for review by institutional review boards (IRBs), as mandatory oversight entities, requires evaluation. This study collected and analyzed forms reporting serious adverse events (SAEs) to IRBs/ Research Ethics Committees(RECs) to compare them with the well-structured form presented in the literature using completeness and accuracy scores. We found sub-optimal completeness and accuracy scores when compared with perfect scores ( p < .05). Less than half of the retrieved forms had queries on causality assessment (≤43.1%). Thus, contents of SAE forms require improvement for IRB oversight and, further, there is a need to develop a well-structured form that could improve international consistency.


2020 ◽  
pp. 966-972
Author(s):  
Adaora Ezeani ◽  
Folakemi Odedina ◽  
Desiree Rivers ◽  
Omolara Fatiregun ◽  
Titilope Akinremi

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.


2020 ◽  
Author(s):  
Lida Feyz ◽  
Yale Wang ◽  
Atul Pathak ◽  
Manish Saxena ◽  
Felix Mahfoud ◽  
...  

BACKGROUND Great and costly efforts are required to recruit potential participants into clinical trials. Using social media may make the recruitment process more efficient. Merely 20% of clinical trials are completed on time, a finding mostly linked to challenges in patient recruitment [1]. Recruitment through social media is increasingly being recognized as a tool to efficiently identify eligible subjects at lower costs [2, 3]. One of the key reasons for its success is the strong adherence of users to specific social media platforms. Facebook for instance has over 2.38 billion active monthly users of which about 75% access the network on a daily basis [4]. As such, the platform and other like it offer great potential to quickly and affordably enroll patients into clinical trials and surveys [3, 5-7]. At present, little evidence is available on the efficacy of using social media to recruit patients into cardiovascular and hypertension trials [8]. The aim of the present study was to evaluate the efficacy of social media as an approach to recruit hypertensive patients into the RADIANCE-HTN SOLO trial. OBJECTIVE The aim of the present study was to evaluate the efficacy of social media as an approach to recruit hypertensive patients into the RADIANCE-HTN SOLO trial. METHODS The RADIANCE-HTN SOLO (NCT02649426) is a multicenter, randomised study that was designed to demonstrate the efficacy and safety of endovascular ultrasound renal denervation (RDN) to reduce ambulatory blood pressure at 2 months in patients with combined systolic–diastolic hypertension in the absence of medications. Between March 28, 2016, and Dec 28, 2017, 803 patients were screened for eligibility and 146 were randomised to undergo RDN (n=74) or a sham procedure (n=72) [9]. Key entry criteria included: age 18-75 years with essential hypertension using 0-2 antihypertensive drugs. Patients were recruited from 21 hospitals in the USA and 18 hospitals in Europe. The study was approved by local ethics committees or institutional review boards and was performed in accordance with the declaration of Helsinki. All participants provided written informed consent. All recruitment materials including social media campaigns was approved by local ethics committees of the involved sites. Recruitment strategies included social media (Facebook), conventional advertisements (ads) (magazine, brochure/poster, radio, newspaper), web search (the clinical website, craigslist and web-browsing), and physician referral. Both newspaper ads and posters contained brief information about study entry criteria. Newspapers were distributed at public transport places and posters were displayed in outpatient cardiology and hypertension clinics. Radio ads were run for 30 or 60 seconds providing a short summary of the study, entry criteria and contact information. Ads were run in major metropolitan areas on radio stations with large adult listener bases during popular days and times. Facebook ads were targeted towards subjects >45 years old within a certain distance from a recruitment site (range 20-50 miles). Criteria were modified over time in order to increase response rates [i.e. distance was increased or decreased, age was increased to >55 year]. Facebook ads referred to a dedicated study website translated into country specific languages. If interested, subjects could complete an anonymous online screening questionnaire which provided direct automatic feedback on study eligibility. Eligible subjects were asked to provide contact details (name and telephone number) to receive additional information, a process coordinated via a secure online portal (Galen Gateway Patient Recruitment Portal, Galen Patient Recruitment, Inc., Cumberland, RI). Study site were only able to contact potential candidates within their area. The study sponsor was not able to access any personal data. Trained local site personnel or contracted secondary screeners contacted candidates by phone to verify eligibility and answer potential questions. A subsequent outpatient clinic visit was scheduled during which the study was explained in greater detail and the informed consent form could be signed. Statistical analysis Categorical variables were expressed as percentages and counts. Continuous variables were described as mean  standard deviation (SD) when normally distributed, data was compared using an Independent-Samples or Paired-Samples T test to analyze the difference between recruitment methods. In case of non-normal distribution, median data was presented with the interquartile range [IQR]. All statistical tests are 2-tailed. A P-value <0.05 was considered statistically significant. Statistical analysis was performed using SPSS statistical analysis (version 24.0).   RESULTS Results Facebook ads were active during a 115-day recruitment period between August and November 2017. A total of 285 potential candidates were recruited by different recruitment strategies in this specific time period, of which 184 (65%) were consented through Facebook (Table 1). The average age of the subjects consented through Facebook was 59 ± 8 years and 51% were male (Table 2). Facebook reached 5.3 million people in 168 separate campaigns run in proximity to 19 sites in the US and 14 sites in Europe. The number of candidates per site was variable with a median of 23 [17 – 26] candidates per site that passed the questionnaire (Figure 1). A total of 27/184 subjects were eventually randomised. Total cost for the Facebook ads was $152,412; costing $907/campaign and $0.83/click. This resulted in a total cost of $828/consent. During the same recruitment period, 7-day radio spots were launched with a total cost of $2,870; resulting in 9 inquiries with eventually 5 potential candidates and 2 consents ($1,435/consent).   CONCLUSIONS Conclusion Targeted social media was a successful and efficient strategy to find potential candidates for a multicenter blood pressure clinical trial. Whether this approach can be replicated across other disease states or demographics remains to be studied.


2020 ◽  
Vol 47 (1) ◽  
pp. 7-11
Author(s):  
Maud O. Jansen ◽  
Peter Angelos ◽  
Stephen J. Schrantz ◽  
Jessica S. Donington ◽  
Maria Lucia L. Madariaga ◽  
...  

Clinical trials emerged in rapid succession as the COVID-19 pandemic created an unprecedented need for life-saving therapies. Fair and equitable subject selection in clinical trials offering investigational therapies ought to be an urgent moral concern. Subject selection determines the distribution of risks and benefits, and impacts the applicability of the study results for the larger population. While Research Ethics Committees monitor fair subject selection within each trial, no standard oversight exists for subject selection across multiple trials for the same disease. Drawing on the experience of multiple clinical trials at a single academic medical centre in the USA, we posit that concurrent COVID-19 trials are liable to unfair and inequitable subject selection on account of scientific uncertainty, lack of transparency, scarcity and, lastly, structural barriers to equity compounded by implicit bias. To address the critical gap in the current literature and international regulation, we propose new ethical guidelines for research design and conduct that bolsters fair and equitable subject selection. Although the proposed guidelines are tailored to the research design and protocol of concurrent trials in the COVID-19 pandemic, they may have broader relevance to single COVID-19 trials.


2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Daria Kim ◽  
Joerg Hasford

Abstract The problem of wasteful clinical trials has been debated relentlessly in the medical community. To a significant extent, it is attributed to redundant trials – studies that are carried out to address questions, which can be answered satisfactorily on the basis of existing knowledge and accessible evidence from prior research. This article presents the first evaluation of the potential of the EU Clinical Trials Regulation 536/2014, which entered into force in 2014 but is expected to become applicable at the end of 2021, to prevent such trials. Having reviewed provisions related to the trial authorisation, we propose how certain regulatory requirements for the assessment of trial applications can and should be interpreted and applied by national research ethics committees and other relevant authorities in order to avoid redundant trials and, most importantly, preclude the unnecessary recruitment of trial participants and their unjustified exposure to health risks.


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