The Development of Priority Cervical Cancer Trials: A Gynecologic Cancer InterGroup Report

2010 ◽  
Vol 20 (6) ◽  
pp. 1092-1100 ◽  
Author(s):  
Henry Charles Kitchener ◽  
William Hoskins ◽  
William Small ◽  
Gillian M. Thomas ◽  
Edward Lloyd Trimble
Keyword(s):  
Cervical Cancer ◽  
Clinical Trials ◽  
Early Stage ◽  
Gynecologic Cancer ◽  
Good Clinical Practice ◽  
Middle Income ◽  
Middle Income Countries ◽  
Current State ◽  
International Participation ◽  
Cancer Trials

Since the late 1990s, when a spate of US studies reported the benefit of chemoradiation for cervical cancer, there has been a dearth of clinical trials in cervical cancer. This requires to be addressed with urgency because this disease is responsible for a quarter of a million deaths globally each year, mostly in developing countries, but therapeutic advances are required in all health care settings.The Gynecologic Cancer InterGroup (GCIG) is a worldwide collaborative of leading national groups that develops and promotes multinational trials in gynecologic cancer. In recognition of the pressing need for action, the GCIG convened an international meeting with expert representations from most of the GCIG groups and selected large centers in low- and middle-income countries. The focus was to identify consensus on several concepts for clinical trials, which would be developed and promoted by the GCIG and launched with major international participation.The first half of the meeting was devoted to a resume of the current state of the knowledge and identifying the gaps most needing new evidence. The second half of the meeting was concerned with achieving consensus on the way forward. There were 2 principal outcomes. The first was a proposal to establish, under the umbrella of GCIG, a cervical cancer trials network of centers from countries currently outside GCIG (Eastern Europe, India, Thailand, Southern Africa, and South and Central America), which could increase international participation in trials, conducted within the principles of good clinical practice. The second was to identify the priorities for clinical trials. These included additional systemic therapy before or after chemoradiation; less radical surgery for small, early-stage tumors; the use of fewer fractions to improve cost-effectiveness of treatment in centers with limited resources; and chemotherapy to improve resectability of bulky tumors.

Human papillomavirus (HPV) vaccination: from clinical studies to immunization programs

2019 ◽  
Vol 29 (8) ◽  
pp. 1317-1326 ◽  
Author(s):  
Raúl Murillo ◽  
Camila Ordóñez- Reyes
Keyword(s):  
Cervical Cancer ◽  
Clinical Trials ◽  
Human Papillomavirus ◽  
Hpv Vaccine ◽  
Hpv Vaccination ◽  
Population Based ◽  
Immunization Programs ◽  
Hpv Vaccines ◽  
Middle Income ◽  
Middle Income Countries

Cervical cancer incidence and mortality have decreased in high-income countries, but low- and middle-income countries continue to bear a significant burden from the disease. Human papillomavirus (HPV) vaccines are a promising alternative for disease control; however, their introduction is slow in settings with greater need. We conducted a review of HPV vaccine efficacy and effectiveness reported in clinical trials and population-based studies. Efficacy of HPV vaccines is close to 100% when using a three-dose schedule in HPV-negative young women (<25 years old) for protection against persistent infection and HPV vaccine-type associated pre-cancerous lesions. Furthermore, sustained protection for up to 12 years of follow-up has been demonstrated; cross-protection against non-vaccine types is particularly observed for the bivalent vaccine, and preliminary data regarding impact on invasive cancer have emerged. Given its lower efficacy, catch-up vaccination beyond 19 years of age and proposals for vaccinating adult women deserve careful evaluation in accurately designed studies and economic analyses. Despite positive results regarding immunogenicity and post-hoc analysis for cervical intra-epithelial neoplasia in clinical trials, population-based data for prime and booster two-dose schedules are not available. Evaluation of vaccine safety from surveillance systems in immunization programs that have already distributed more than 270 million doses found no association of HPV vaccination with serious side effects. The introduction of HPV vaccination in national immunization programs remains the main challenge in tackling the burden of cervical cancer (up to 2018, only 89 countries have introduced vaccination worldwide, and most of these are high-income countries). Access models and technical capacity require further development to help low- and middle-income countries to increase the pace of vaccine delivery. Alternative approaches such as one-dose schedules and vaccination at younger ages may help reduce the programmatic and economic challenges to adolescent vaccination.

scholarly journals Disparities in Breast, Lung, and Cervical Cancer Trials Worldwide

2018 ◽  
pp. 1-11 ◽  
Author(s):  
Ramya Ramaswami ◽  
Eduardo Paulino ◽  
Adriana Barrichello ◽  
Angelica Nogueira-Rodrigues ◽  
Alexandra Bukowski ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Phase Iii ◽  
Clinical Trial Registry ◽  
Cancer Trial ◽  
Middle Income ◽  
Middle Income Countries ◽  
Registration Data ◽  
The World Bank ◽  
Phase Iii Trials ◽  
Cancer Trials

Purpose As cancer burden has risen worldwide, physicians, patients, and their advocates have become aware that the clinical cancer trial research paradigm is not ubiquitous. Furthermore, the number and characteristics of trials that are registered in low- and middle-income countries (LMICs) compared with that in high-income countries (HICs) are unknown. Methods We collected retrospective data on trials for breast, lung, and cervical cancer registered in ClinicalTrials.gov or with the WHO International Clinical Trial Registry Platform between 2010 and 2017. The data were then classified as trials within LMICs or HICs using definitions from the World Bank. Results Included in these analyses were 6,710 trials, of which 3,164 (47%) were breast cancer trials, 3,283 (49%) were lung cancer trials, and 263 (4%) were cervical cancer trials. There were 1,951 (29%) trials from LMICs and 4,759 (71%) trials from HICs ( P < .001). Although the proportion of phase III trials in HICs versus LMICs was similar (18% v 17%; P = .66), the number of phase I trials in LMICs was significantly lower than that of HICs (20% v 2%; P < .001). For several LMICs with the highest mortality-to-incidence ratios for breast, lung, or cervical cancer, there were no cancer trials registered in the registration data bases searched for this work. Conclusion There are differences in access to cancer clinical trials in LMICs compared with HICs. Several factors, such as excessive cost and a lack of infrastructure and expertise, may explain these differences.

scholarly journals Evaluation of an enhanced training package to support clinical trials training in low and middle income countries (LMICs): experiences from the Born Too Soon Optimising Nutrition study

2021 ◽  
Author(s):  
Eleanor Jane Mitchell ◽  
Jalemba Aluvaala ◽  
Lucy Bradshaw ◽  
Jane P Daniels ◽  
Ashok Kumar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Informed Consent ◽  
Global Health ◽  
Good Clinical Practice ◽  
Research Experience ◽  
Middle Income ◽  
Middle Income Countries ◽  
Training Package

Abstract Background Training is essential before working on a clinical trial, yet there is limited evidence on effective training methods. In low and middle income countries (LMICs), training of research staff was considered the second highest priority in a global health methodological research priority setting exercise. Methods We explored whether an enhanced training package in a neonatal feasibility study in Kenya and India, utilising elements of the train-the-trainer approach, altered clinicians and researchers’ clinical trials knowledge. A lead “trainer” was identified at each site who attended a UK-based introductory course on clinical trials. A two-day in-country training session was conducted at each hospital. Sessions included the study protocol, governance, data collection and ICH-Good Clinical Practice (GCP). To assess effectiveness of the training package, participants completed questionnaires at the start and end of the study period, including demographics, prior research experience, protocol-specific questions, informed consent and ICH-GCP. Results Thirty participants attended in-country training sessions and completed baseline questionnaires. Around three quarters had previously worked on a research study, yet only half had previously received training. Nineteen participants completed questionnaires at the end of the study period. Questionnaire scores were higher at the end of the study period, though not significantly so. Few participants ‘passed’ the informed consent and ICH-Good Clinical Practice (GCP) modules, using the Global Health Network Training Centre pass mark of ≥ 80%. Participants who reported having prior research experience scored higher in questionnaires before the start of the study period. Conclusions An enhanced training package can improve knowledge of research methods and governance though only small improvements in mean scores between questionnaires completed before and at the end of the study period were seen and were not statistically significant. This is the first report evaluating a clinical trial training package in a neonatal trial in LMICs. Due to the Covid-19 pandemic, research activity was paused and there was a significant time lapse between training and start of the study, which likely impacted upon the scores reported here. Given the burden of disease in LMICs, developing high-quality training materials which utilise a variety of approaches and build research capacity, is critical.

scholarly journals Cervical Precancer Treatment in Low- and Middle-Income Countries: A Technology Overview

2017 ◽  
Vol 3 (4) ◽  
pp. 400-408 ◽  
Author(s):  
Mauricio Maza ◽  
Celina M. Schocken ◽  
Katherine L. Bergman ◽  
Thomas C. Randall ◽  
Miriam L. Cremer
Keyword(s):  
Cervical Cancer ◽  
Early Stage ◽  
Precancerous Lesions ◽  
Low Cost ◽  
Treatment Modalities ◽  
Middle Income ◽  
Novel Technologies ◽  
Middle Income Countries ◽  
Cervical Precancer ◽  
Low And Middle Income

Cervical cancer is the fourth leading cause of cancer-related death in women worldwide, with 90% of cases occurring in low- and middle-income countries (LMICs). There has been a global effort to increase access to affordable screening in these settings; however, a corresponding increase in availability of effective and inexpensive treatment modalities for ablating or excising precancerous lesions is also needed to decrease mortality. This article reviews the current landscape of available and developing technologies for treatment of cervical precancer in LMICs. At present, the standard treatment of most precancerous lesions in LMICs is gas-based cryotherapy. This low-cost, effective technology is an expedient treatment in many areas; however, obtaining and transporting gas is often difficult, and unwieldy gas tanks are not conducive to mobile health campaigns. There are several promising ablative technologies in development that are gasless or require less gas than conventional cryotherapy. Although further evaluation of the efficacy and cost-effectiveness is needed, several of these technologies are safe and can now be implemented in LMICs. Nonsurgical therapies, such as therapeutic vaccines, antivirals, and topical applications, are also promising, but most remain in early-stage trials. The establishment of evidence-based standardized protocols for available treatments and the development and introduction of novel technologies are necessary steps in overcoming barriers to treatment in LMICs and decreasing the global burden of cervical cancer. Guidance from WHO on emerging treatment technologies is also needed.

scholarly journals The Role of Girl Adolescents' Immunization in Eradicating Cervical Cancer in Rwanda by 2020

2018 ◽  
Vol 4 (Supplement 2) ◽  
pp. 25s-25s
Author(s):  
O. Nimbabazi
Keyword(s):  
Cervical Cancer ◽  
Adolescent Girls ◽  
Early Stage ◽  
Early Screening ◽  
Ministry Of Health ◽  
Middle Income ◽  
Middle Income Countries ◽  
The Government ◽  
Low And Middle Income

Background: Cervical cancer is one of the cancers that highly affect women today, and human papilloma virus is the virus that causes this cancer. By WHO 1 million of women is estimated to have this cancer and more than 80% of them live in low and middle income countries where Rwanda belongs. Even though this cancer is preventable at early age by immunization and can be treated at early stage. With this the government of Rwanda aimed at eradicating cervical cancer by 2020 by immunizing all adolescent girls with age between 11 and 15. Aim: The aim of this study was to assess the role of Rwanda initiative of adolescent girls' immunization will have toward cervical cancer eradication by 2020 in Rwanda and prevention for future generations. Methods: Scientific literature review has been used with the WHO report, Ministry of Health and recent publications on cervical cancer. Results: HPV vaccination for girls reduces the possibility of developing cervical cancer later in life, in the initiative of adolescent girls' immunization aged between 11 and 15 started in 2011 by the Ministry of Health and in 2013 about 97% of girls were immunized. The program is eased by distributing vaccines through schools to minimize time going to hospitals. By the ministry statistics indicates that in 2011 and 2012 eligible girls vaccinated with three doses were 93.2 and 96.6% respectively and 2013 were 99.3% and are always recommended to be vaccinated and older ladies are recommended for early screening. With this showed that in 2020 Rwanda will be able to achieve the goal of cervical cancer eradication. Conclusion: Cervical cancer is preventable and treatable by early vaccination to young adolescents and screening to others, with the statistics indicates that Rwanda is achieving the eradication by 2020 and this will be by recommending young girls to be immunized and others screened early and this is an important initiative that can be used globally in low and middle income countries that is mostly affected.

scholarly journals National Cancer Grid of India Consensus Guidelines on the Management of Cervical Cancer

2018 ◽  
pp. 1-15 ◽  
Author(s):  
Supriya J. Chopra ◽  
Ashwathy Mathew ◽  
Amita Maheshwari ◽  
Neerja Bhatla ◽  
Shalini Singh ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Clinical Care ◽  
Gynecologic Cancer ◽  
Locally Advanced ◽  
Standard Of Care ◽  
Middle Income ◽  
Middle Income Countries ◽  
Care Treatment ◽  
Standard Of Care Treatment ◽  
Care Practices

Standard guidelines for the management of early and locally advanced cervical cancer are available from various academic consortiums nationally and internationally. However, implementing standard-of-care treatment poses unique challenges within low- and middle-income countries, such as India, where diverse clinical care practices may exist. The National Cancer Grid, a consortium of 108 institutions in India, aims to homogenize care for patients with cervical cancer by achieving consensus on not only imaging and management, but also in addressing potential solutions to prevalent challenges that affect the homogenous implementation of standard-of-care treatment. These guidelines therefore represent a consensus statement of the National Cancer Grid gynecologic cancer expert group and will assist in homogenization of the therapeutic management of patients with cervical cancer in India.

scholarly journals The Cervical Cancer Research Network (Gynecologic Cancer InterGroup) roadmap to expand research in low- and middle-income countries

2021 ◽  
Vol 31 (5) ◽  
pp. 775-778
Author(s):  
Mary McCormack ◽  
David Gaffney ◽  
David Tan ◽  
Kathy Bennet ◽  
Adriana Chavez-Blanco ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Research ◽  
New Technologies ◽  
Gynecologic Cancer ◽  
Research Network ◽  
World Health ◽  
Middle Income ◽  
Cancer Research Network ◽  
Middle Income Countries ◽  
Low And Middle Income

Cervical cancer is a global health problem which disproportionally affects women in low- and middle- income countries. The World Health Organization recently launched its global strategy to eliminate this disease in the next two decades. For those women diagnosed today with cervical cancer better strategies are needed to improve outcome and reduce treatment-related morbidity. Clinical trials are critical to shaping future treatment, and much has been achieved already. However, such opportunities are limited in low resource settings, and the Cervical Cancer Research Network is dedicated to expanding access to new technologies in surgery, radiation, and medical oncology. In this article we review the status of the trials portfolio and outline future objectives, including the launch of a number of research grants for aspiring or established researchers in low- and middle-income settings

'Have a Pap smear!' – doctors, their clients, and opportunistic cervical cancer screening

2005 ◽  
Vol 16 (3) ◽  
pp. 233-236 ◽  
Author(s):  
L C Chingang ◽  
U Bischof ◽  
G Andall-Brereton ◽  
O Razum
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Pap Smear ◽  
Cervical Screening ◽  
Pap Test ◽  
Community Members ◽  
Middle Income ◽  
Middle Income Countries ◽  
High Incidence

In many middle-income countries with a high incidence of cervical cancer, organized screening programmes with the Pap test are being planned. We assessed the knowledge of, and attitudes towards, cervical screening among 63 doctors and 102 randomly selected community members in Trinidad where screening is still opportunistic. Doctors were well informed about cervical cancer, but not all knew the approximate specificity of the Pap test. Many did not routinely discuss the benefits and disadvantages of screening with their clients. Most women had heard of the Pap test, but only 56% knew its purpose; 25% would not participate in screening, stating reasons such as being in menopause or not having symptoms. More information about the aim of screening and the purpose of the Pap test must be communicated. Doctors need to keep their knowledge on screening up-to-date, and offer counselling that helps women to make an informed decision whether or not to participate in screening.

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