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Challenges and Solutions for the Latinx Population to Effectively Participate in Clinical Trials

Guidelines by the National Institutes of Health in 1994 mandated the inclusion of minority participants in clinical research. Despite these efforts, there is still inadequate representation of Latinx groups in U.S. clinical trials, which results in inequitable distribution of the risks and benefits of research participation and reduces the generalizability of trial results. 

Insightful solutions to fill the gap are suggested in this article

By Karen Mancera Cuevas MS, MPH, CHES

Associate Director, Research Projects at Northwestern University, Feinberg School of Medicine, Chicago USA

Challenges and Solutions for the Latinx Population to Effectively Participate in Clinical Trials

 

In the past decades, as the first-generation Latinx population has become more acclimated to the U.S. medical system, there has been ongoing interest in how to effectively engage the multi-faceted population comprised of a variety of nationalities, cultures, traditions, and dialects into clinical trials. Inclusion in clinical trials is important as Latinx are largely underrepresented in ongoing recruitment and retention efforts 1 in both academic and pharmaceutical studies. Guidelines published by the National Institutes of Health in 1994 mandated the inclusion of minority participants in clinical research 2. Despite these efforts, there is still inadequate representation of racial/ethnic groups in clinical trials, which results in inequitable distribution of the risks and benefits of research participation and reduces the generalizability of trial results 3. This is because the purpose of clinical trial research is to examine new ways to treat, prevent, and diagnose diseases or conditions 4.

Providers in many traditional clinical settings have limited time, resources, or personnel to effectively engage interested Latinx patients into studies 5. Although these factors exist, the role of trust with providers is critical for Latinx patients to participate in clinical trial research 6 that must be leveraged with added organizational infrastructure to facilitate participation. Patients who are less educated may not feel comfortable or even feel empowered to advocate for their interest in clinical research 7, understand the topic 8, or may even express fear of participation9.  Latinx participants need to find meaning in the relationship and proper accommodations such as scheduling mutually convenient times around work schedules and providing meaningful incentives are critical 10 in addressing cultural salient participant behavior. Increasing Latinx providers and advocates 1 are also integral to recruitment efforts and include having providers devote more time with study patients which may ultimately impact feelings of altruism as a motivator for participation 1.  Moreover, integration of clinical research within the clinic, as part of a patients overall health care plan, is usually absent or a final alternative therapy.  Earlier consideration of applicable clinical trials could provide the under resourced Latinx community with access to diagnostic procedures and therapies, which are usually cost prohibitive.

Solutions include addressing low literacy efforts and developing educational materials that effectively engage the intended Latinx audiences in the language of origin. As voiced in a study of Latino clinical trial participants, “If the message is going to be translated from English to Spanish, you have to be sure to choose the right words.” 1 Examples include language-congruent care, that influences behaviors, attitudes, and policies in clinical trial recruitment and is a key element in dissemination of awareness with Latinx patients 11. The educational method most applicable are audiovisual materials that offer advantages to Latinx populations in that they have been shown to have high rates of acceptability 12 over group or individual education sessions 13. Additionally, clinical trial studies indicate that health education materials, particularly those with a focus on promoting behavior change, are more successful when “transcreated” and available to the target population in their native language 14 where the text is not merely translated into another language; but it is reconstructed to meet the health literacy and informational needs of the target audience in a manner that is culturally appropriate 15.

Patient-centered trial designs16 incorporating Latinx centered solutions to address participant burden are necessary to promote increased trial participation. Measures include reduction of extra procedures, explanation of cost, and education to resolve negative perceptions of clinical trials and medical expertise5. Assurance from clinical trial recruitment staff should include the message that immigration status will not be documented1. The role of patient navigators has also been welcomed by Latinx participants as a way to overcome barriers although, findings have yielded greater application through clinical trial retention measures rather than recruitment efforts although navigated participants have demonstrated higher overall retention rates 17. Additionally, partnership with selected faith-based community-based organizations may increase participation rates with selected Latinx population groups (i.e. older adults) 8. Although recommendations are provided, health disparities outcomes among Latinx clinical trial patients will continue as long as therapies are not tested equally in targeted communities. This inequity needs to be properly addressed for future measures to be adapted in Latinx communities that will benefit from participation.

 

References

  1. Ford, M., Siminoff, L., Pickelsimer, E., Mainous, A., Smith, D., Diaz, VA, Soderstrom, L., Jefferson, M., Tilley, B., 2013 Unequal Burden of Disease, Unequal Participation in Clinical Trials: Solutions from African American and Latino Community Members. Health Social Work, 38 (10), 29-38.
  2. National Institutes of Health. NIH guidelines on the inclusion of women and minorities as subjects in clinical research. Available at: https://grants.nih.gov/grants/funding/women_min/guidelines.htm. Published 1994. Accessed May 19, 2018.
  3. Pinsky, P., Ford, M., Gamito, E., Higgins, D., Jenkins, V., Lamerato L., Tenorio, S., Marcus, P., Gohagan, J.,.2008 Enrollment of racial and ethnic minorities in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. Journal of the National Medical Association, 100(3), 291–298.
  4. Toledo, L., McLellan-Lemal, E., Arreola, S., Campbell, C., Sutton, M., 2014, African-American and Hispanic perceptions of HIV vaccine clinical research: a qualitative study. American Journal of Health Promotion, 29 (2), e82-90.
  5. Grunfeld , E., Zitzelsberger, L., Coristine, M., Aspelund, F., 2009 Barriers and facilitators to enrollment in cancer clinical trials: Qualitative study of the perspectives of clinical research associates. Cancer, 95:1577–1583.
  6. Ford, M., Alford, S., Britton, D., McClary, B., Gordon H., 2007 Factors influencing perceptions of breast cancer genetic counseling among women in an urban health care system. Journal of Genetic Counseling, 16:735–753.
  7. Ford, M., Wahlquist, A., Ridgeway, C., Streets, J., Mitchum, K., Harper, R. Jr., 2011, Evaluating an intervention to increase cancer knowledge in racially diverse communities in South Carolina. Patient Education and Counseling, 83:256–280.
  8. Moreno, G., Mangione, C., Meza, C., Kwon, I., Seeman, T., Trejo, L., Moore, M., Sarkisian, C, 2015, Perceptions from Latino and African American Older Adults about Biological Markers in Research, 25 (3), 355-362.
  9. Giuliano, A., Mokuau, N., Hughes, C., Tortolero-Luna, G., Risendal, B., Ho, R.,2000 Participation of minorities in cancer research: the influence of structural, cultural, and linguistic factors. Annals of Epidemiology, 10(Suppl. 8):S22.
  10. Gonzalez, E., Gardner, E., Murasko, D., 2007 Recruitment and retention of older adults in influenza immunization study. Journal of Cultural Diversity, 14:81–87.
  11. O’Brien, R., Kosoko-Lasaki, O., Cook, C., Kissell, J., Peak, F., Williams, E., 2006 Self-assessment of cultural attitudes and competence of clinical investigators to enhance recruitment and participation of minority populations in research. Journal of the National Medical Association, 98:674–682.
  12. Albrecht, T., Ruckdeschel, J., Riddle, D., Blanchard, C., Penner, L., Coovert, M., 2003. Communication and consumer decision making about cancer clinical trials. Patient Education and Counseling. 50(1):39–42.
  13. Hutchison, C., Cowan, C., McMahon, T., Paul, J., 2007 A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials. British Journal of Cancer, 97:705–711.
  14. Solomon, F., Eberl-Lefko, A., Michaels, M., Macario, E., Tesauro, G., Rowland, J, 2005 Development of a linguistically and culturally appropriate booklet for Latino cancer survivors: lessons learned. Health Promotion Practice. 6:405.
  15. Quinn, G., Hauser, K., Bell-Ellison, B., Rodriguez, N., Frias J., 2006. Promoting pre-conceptual use of folic acid to Hispanic women: A social marketing approach. Maternal Child Health Journal. 10:403–412.
  16. Mullins, C., Vandigo, J., Zheng, Z., Wicks, P., 2014 Patient-Centeredness in the Design of Clinical Trials. Value in Health. 17(4):471-475.
  17. Guadagnolo, B., Petereit, D., Helbig, P., Koop, D., Kussman, P., Dunn, E., Patnaik A., 2009 Involving American Indians and medically underserved rural populations in cancer clinical trials. Clinical Trials. 6:610–617.

 

 

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HPV Awareness Day

Despite the existence of prevention and screening tools, not everybody is aware of HPV (Human Papilloma Viruses), that it is associated with multiple types of cancer, and of the fact that HPV-related cancers can potentially be prevented. To help address the lack of knowledge and awareness, the International Papillomavirus Society (IPVS) coordinated the first International HPV Awareness Day on March 4, 2018

By Corie Leifer

Give Love Not HPV Campaign Coordinator

International Papillomavirus Society*

International HPV Awareness Day

 

HPV Affects Everyone

HPV Affects Everyone. Regardless of age, gender, race, or sexual orientation, the Human Papilloma Viruses (HPV) affects you, either directly or indirectly.

The most widespread and common sexually transmitted infections (STIs) in the world, there are many different types of HPV.

Studies show that more than 80% of sexually active men and women will acquire at least one HPV infection by the age of 45 years. As an infection with HPV may have no symptoms, it can go unnoticed.  Most HPV infections clear on their own, but some can lead to genital warts, and others can even lead to cancer.

HPV- Related Cancers

Cervical, anal, oral, penile, and other deadly cancers can all be related to HPV infection.  HPV is associated with 1 in every 20 cancer cases worldwide including almost all cervical and anal cancers, over a third of throat cancers and a quarter of mouth cancers. This accounts for approximately 640,000 new cancer diagnoses around the world every year. 80% of these diagnoses will be cervical cancer, but head and neck cancers continue to grow in number of cases at an alarming rate.

In 2006, HPV vaccines began to be introduced worldwide. These vaccines are both effective and safe for both boys and girls. Along with screening, vaccines provide the possibility to significantly reduce the number of newly diagnosed HPV-related cancers.

International HPV Awareness Day

Despite these alarming facts and the existence of prevention and screening tools, not everybody is aware of HPV, that it is associated with multiple types of cancer, and of the fact that HPV-related cancers can potentially be prevented.

To help address the lack of knowledge and awareness, the International Papillomavirus Society (IPVS) coordinated the first International HPV Awareness Day on March 4, 2018. Rather than a focus on a disease, this campaign focuses on HPV, which causes many diseases. This initiative was implemented in partnership with more than 80 organisations around world and will take place every March 4.

Campaign activities included press releases, workshops, conferences, races, rallies, interviews, print ads and conversations on a wide variety of social media.

On social media the #GiveLoveNotHPV  increased in the online conversation about HPV by over 5000% on March 2nd – March 5th and the campaign hashtag reached 2 million unique users on social media.

 

The International Papillomavirus Society (IPVS) is the leading global authority on human papillomaviruses (HPV). Our work facilitates the worldwide exchange of ideas, knowledge, and research about HPV and related diseases. IPVS actively promotes the translation of research results into new clinical applications and public health policies. IPVS inaugurated International HPV Awareness Day on March 4th 2018 as part of the organization’s commitment to raising awareness of HPV. Through this annual campaign IPVS aims to promote progress on HPV prevention, screening and management of HPV related diseases.

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Waste in Medical Research Threatens SDG Health Targets

The negative effects of incomplete registration and reporting of clinical trials go far beyond the wasteful duplication of research efforts. Opacity in clinical trials also slows down the discovery of new treatments and cures. In addition, selective reporting of trial results tends to make new and more expensive drugs look more effective than cheaper generic alternatives, leading to the misallocation of scarce public health funds, including in developing countries

By Till Bruckner

Founder of TranspariMED

Governments’ Failure to Curb Rampant Waste in Medical Research Threatens SDG Health Targets

 

Most major medical research funders are still failing to curb research waste, slowing down medical progress and threatening the attainment of several of the Sustainable Development Goalshealth targets, a new study shows.

Published in JAMA in April 2018, the study led by Nicholas DeVito of the University of Oxford shows that many of the world’s largest public and philanthropic funders have failed to put into place basic safeguards to ensure that the results of the clinical trials they fund contribute to scientific progress and global health, with public funders in China, France, Italy, and Spain performing particularly poorly.

Around half of all clinical trials conducted worldwide do not report their results, and hence make no contribution whatsoever to the global search for new treatments and cures. As a result, an estimated $85 billion invested into medical research go to waste every year. For example, a recent search of the U.S. government run registry Clinicaltrials.gov conducted by TranspariMED identified 494 completed clinical trials of potential vaccines for HIV, tuberculosis and malaria. Out of those, 82% had not posted summary results onto the registry, contrary to best practices set out by the World Health Organization. The proportion of these trials that have additionally failed to publish results in the academic literature is unknown.

For the new study, the team in Oxford selected the top 20 non-commercial funders of health research globally and examined their policies on clinical trial transparency and research waste. (Between them, these funders spent $41 billion on health care research in 2013 alone.)

Only four of the twenty top funders, Britain’s National Institute for Health Research (NIHR), Germany’s Deutsche Forschungsgemeinschaft (DFG), the European Union’s Horizon 2020 programme, and the United States’ National Institutes of Health (NIH), earned full marks for demanding that all trials they fund are registered and their results reported, and for ensuring grantees’ compliance with these rules through audits.

In contrast, public research funders in China, France (CNRS and Inserm), Italy (Ministry of Health), and Spain (ISCIII) had not even put related policies onto paper, let alone taken steps to ensure that they were followed in practice.

Which Funders Ensure that Clinical Trials are Registered and Reported?

Note: A funder is counted as ensuring that trials are registered and/or reported only if it has a relevant policy and audits grantees’ compliance. Table adapted from DeVito et al (2018). Countries highlighted in yellow have a mixed performance.

The performance of major philanthropic funders was also disappointing. At the time they were assessed, in spring 2017, neither the Gates Foundation nor the Wellcome Trust required their grantees to share the results of their research. Both organizations have since pledged to strengthen their policies and conduct regular audits of their grantees’ performance.

Clinical trials are the cornerstone of modern medicine. The negative effects of incomplete registration and reporting of clinical trials go far beyond the wasteful duplication of research efforts. For example, it can leave potential harms undetected; over 100,000 patient deaths in the United States alone have been directly linked to weak clinical trial transparency.
Opacity in clinical trials also slows down the discovery of new treatments and cures. In West Africa, efforts to contain the Ebola epidemic foundered because the results of many Ebola trials remained unknown. Unless research funders fix the system and speed up results sharing, the Sustainable Development Goals’ targets of supporting the development of new vaccines and medicines, and of ending the epidemics of AIDS, tuberculosis, malaria and neglected tropical diseases by 2030, are unlikely to be achieved.

In addition, selective reporting of trial results tends to make new and more expensive drugs look more effective than cheaper generic alternatives, leading to the misallocation of scarce public health funds, including in developing countries. For example, governments worldwide spent billions on the drug Tamiflu based on partial trial data, only to discover later that the drug was largely ineffective. Clearly, the Sustainable Development Goals’ target of “access to safe, effective, quality and affordable essential medicines and vaccines for all” cannot be achieved as long as health officials cannot even determine whether a given drug is safe or effective, let alone whether it is cost-effective compared to other treatments.

For this reason, a coalition of health integrity groups led by Transparency International recently called on governments worldwide to take decisive action to make clinical trials transparent. “In future, to help ensure that public funding for medical research actually benefits the public, government funders should only give taxpayers’ money to institutions and individuals that verifiably comply with best practices in clinical research,” the global anti-corruption group recommended. “Taking this simple first step would deliver significant transparency gains at minimal cost.”

As the transparency pioneers in Britain, Germany and the United States demonstrate, this is entirely feasible. The next step will be for global health advocates, scientists and taxpayers in Australia, China, France, Italy, and Spain to ask their politicians why they are still allowing public funds to be wasted on clinical trials that fail to adhere to global transparency norms.

 

AUTHOR BIO

Till Bruckner (tillbruckner@gmail.com) is the founder of TranspariMED, a campaign that works to end evidence distortion in medicine. He previously worked for the AllTrials campaign and the anti-corruption group Transparency International. He remains active with Transparify, an initiative to promote transparency and integrity in policy research and advocacy. In his previous life, he worked in international development, occupying both field and research roles. Till holds a PhD in political science from the University of Bristol, U.K.  

 

 

 

 

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Fair Research Partnerships in European Commission Funded Research

The EU is clearly not the only research funder that struggles with ‘partnerships’ – in fact, we are not aware of any widely accepted framework related to effectiveness, efficiency, impact or ‘fairness’ of research partnerships anywhere. There is also no systematic learning happening – we are not sharing best practices – we are not learning what happens in other parts of the world.

In response, COHRED has developed the Research Fairness Initiative (RFI)  aimed at creating a due diligence instrument and compliance tool for exactly this : ensuring that partnerships work and are ‘fair’

By Carel IJsselmuiden, Executive Director

and Kirsty Klipp, Research Fairness Initiative – RFI Implementation Manager

Council on Health Research for Development – COHRED

Fair Research Partnerships in European Commission Funded Research – Do We Know What is Actually Happening with Public Funds?

 

The EU Directorate-General for Research and Innovation (DG-RTD) is responsible for EU policy and action on research and innovation aiming at making the EU globally competitive, creating jobs and economic growth, building EU-wide research infrastructure, tackling the big societal challenges, and supporting general EC’s mission to promote justice and human rights and become a global actor.

That is quite a portfolio. Commensurate to the task, the resources available for achieving the mission and strategies of the DG-RTD are substantial. The Horizon 20/20 programme alone already has more than €70 billion allocated to it. With all types of added special funds and special interests of member states, the total is certainly much higher.

In the context of pursuit of justice and of Europe as a global actor, special programmes such as the EDCTP (European and Developing Country Clinical Trials Programme)  add substantially to the total funds available to low and middle income countries to help build their research and innovation systems and resilience. Similar aims within Europe are pursued with programmes like WIDESPREAD that aim to bring ‘underperforming’ EU and Associated countries to a higher level of research performance.

Irrespective of the specific focus of programme – almost all EU funded research programmes and research calls aim for two specific outcomes. Firstly, improvement in knowledge and understanding – advancing specific scientific fields that have been prioritized by the DG-RTD.

The second focus, although implied and hardly visible but nevertheless a cornerstone of any EU funding, is to bring EU institutions together in research partnerships: within the EU to improve the research and innovation infrastructure within the EU, and with external countries to either access expertise needed to make EU more globally competitive (in case of collaboration with high-income countries) or to support low and middle income countries to build up their own research and innovation systems and become more economically resilient.

In brief – EU funded research focuses on specific scientific advancement and on supporting institutional research partnerships.

The first – specific scientific advancement – is well measured.  DG-RTD holds EU wide consultations, involves citizens, pays consultants, holds meeting – and, above all, has an extensive metric with which to assess cutting edge research, researchers and research institutions. This metric is based on globally acceptable standards and on EU developed criteria that are well worked out, public and made obligatory for reviewers in judging proposals for funding submitted in response to research calls by the DG-RTD. So far, no problem.

It is the second one where problems appear – supporting institutional research partnerships. A short view on the H2020 call page today (25 April 2018) shows long lists of calls – almost everyone has ‘collaboration’, ‘partners’, ‘joint’, ‘regional’, and more expressions showing the centrality of partnership to achieving research and innovation goals.

Yet, there is hardly any criteria by which to measure impact nor with which to equip reviewers of calls to make informed and transparent selection of applications successful in this second core aspect of EU calls.

The best summary is informal. We have ‘discovered’ 3 criteria – one of which is ‘hard’ but largely meaningless, and the other 2 cannot really be objectively interpreted, and seem to run against reality.

Criteria 1 – if the call specifies a certain number of partners, then the check is simple. Meets or does not meet. Very objective and very accurate, but hardly of any relevance to the goal.

Criteria 2 and 3 – focus on ‘approximate similar budgets’ and ‘approximately similar responsibilities’ to safeguard against calls serving only one or a few institutions where the others are added pro-forma. This may be especially important in joint research with low and middle income institutions and reduces the massive resource imbalance between partners. However, it is not clear how this rewards partnerships where some partners really have higher expertise, equipment, facilities whereas others are just starting. There is no ‘right figure’ for ‘approximately similar budget’ or ‘approximately similar responsibility’ – and, in fact, this is not a criteria which reviewers can reasonably use transparently. The EU can also not really measure impact of the partnership component – for example in achieving competitiveness, or in achieving research system building in low and middle income countries.

The EU is clearly not the only research funder that struggles with ‘partnerships’ – in fact, we are not aware of any widely accepted framework related to effectiveness, efficiency, impact or ‘fairness’ of research partnerships anywhere. There is also no systematic learning happening – we are not sharing best practices – we are not learning what happens in other parts of the world. It seems that science has deserted its own core – there is no systematic study and learning of the second pillar of successful and competitive science infrastructure: partnerships.

In response, the Council on Health Research for Development – COHRED has developed the Research Fairness Initiative (RFI) aimed at creating a due diligence instrument and compliance tool for exactly this: ensuring that partnerships work and are ‘fair’.

Essentially, the RFI proposes a global reporting system for academic and research institutions, government agencies, research funders and business engaged in research – in fact, it is applicable to all key stakeholders in global (health) research. The RFI Report is written around pragmatic and universally applicable indicators of the quality and fairness of research collaborations. Originally aimed at research collaborations that involved low and middle income countries, it is now clear that it applies across sciences and across socio-economic strata of countries.

The concept is simple: every institution prepares their own RFI Report once every two years. The report consists of the answers to a series of questions focusing on the quality, fairness and equitability of research collaborations. The questions are simple – the answers are usually simple – but action to improve may be intensive : i) what is your institution’s current policy or practice related to … ; ii) if you have examples of good policies and practices, please share this, and iii) what improvements are envisaged in the short term. This is repeated for 15 key topics – each assessed by 3 indicators.

This will achieve transparency in how research partnerships are set up and managed, create a pool of shared practices and systematic learning from which new standards and benchmarks can be developed.

There is no doubt that institutions at the beginning of the research excellence curve need international partnerships to develop their science base further – and there is also no doubt that many of the current partnerships are far from optimal these institutions – for example, in terms of sharing intellectual property, authorship, data ownership, decision making, and access to funding – all issues that the RFI requests answers to.

A first RFI Report has been published now by the Tropical Disease Research and Training Programme of the WHO (WHO/TDR). This enables you to see how the RFI works, what an RFI Report can look like. The RFI Reports of three Senegalese institutions and of the Institute of Tropical Medicine and Hygiene of the New University of Lisbon are nearing completion. Others are in the pipeline.

It is time that one of the world’s biggest research funders begins to focus seriously on improving metrics, transparency and impact of the thousands of partnerships it promotes and supports through its funding by adopting the RFI as a key due diligence tool – that is readily available, increasingly used and creates the first systematic learning platform for improved research and innovation partnerships.

Why not insist that a lead organization in any EU funded partnership submits their own institutional Research Fairness Initiative Report as evidence that it has thought seriously about 15 of the most frequently mentioned aspects that make or break partnerships?

Surely – €70+ billion in partnership funding requires such a tool.