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An overwhelming majority of Americans (86%) agree that health care professionals should discuss clinical trials with patients diagnosed with a disease as part of their standard of care, according to a new national public opinion survey commissioned by Research!America. And three-quarters of respondents (75%) agree that taking part in clinical trials is as valuable to our health care system as giving blood. But Americans are split on whether it’s important for everyone to take part in a clinical trial if they are asked – 44% agree while 45% disagree and 12% are not sure. A higher percentage (74%) said they would participate if they are asked by someone they trust.
Eighty-percent of respondents say they have heard of a clinical trial, but only 18% say they or someone in their family has ever participated in one. More than half (55%) say individuals do not participate because of lack of awareness and information, followed by “too risky” (43%), lack of information about the process (41%), and lack of trust (38%). Nearly two-thirds (64%) say a doctor or health care provider is a reliable source for clinical trial information. Americans say doctors and other health care providers (44%), followed by the government (23%) have the greatest responsibility in educating the public about clinical trials, but a strong majority (74%) say neither their doctor nor other health care professional has ever talked to them about medical research.
A plurality of Americans (44%) agree that clinical trial participation should be a routine health behavior, whether healthy or ill, similar to getting an annual checkup with a health care provider. Men are significantly more likely to say participation should be routine (48%) than do women (39%). A larger percentage of 18 – 29 year olds (53%) and 30 — 49 year olds (48%) agree compared to those 50 – 64 (38%) and 65 and above (34%).
The findings reveal a positive shift in public attitudes about clinical trials since a similar comprehensive survey was commissioned in 2013 by Research!America and partners. In the current survey, 37% of Americans say they would ‘very likely’ participate in a clinical trial if their doctor recommended, an 11% increase from 2013. Eighty-four percent are willing to share personal health information, assuming that appropriate privacy protections are in place, so researchers can better understand diseases and develop new ways to prevent, treat and cure them, a 10% increase, and 82% say they would share information to advance medical research, a 9% increase. When asked how much you admire people who volunteer for clinical trials, 46% said ‘a great deal,’ a 9% boost.
“More and more Americans appear to recognize the value of clinical trials – a very positive sign, but stubborn barriers to participation remain in place” said Mary Woolley, president and CEO of Research!America. “Development of incentives to drive more discussions between patients and health care professionals about the importance of participating in trials could encourage both ill and healthy individuals to view this as a routine health behavior.” The results also indicate a willingness to tap into digital platforms for data sharing. A majority (72%) say they are likely to use technology such as apps, phones and monitoring devices to share their personal health data for clinical research. And nearly half (47%) say they like having clinical trial information/data/results delivered through their phone. A strong majority (88%) agree that participants should have access to results of clinical trials.
“We are pleased to have joined with Research!America in commissioning this important survey,” said Doug Peddicord, executive director of the Association of Clinical Research Organizations (ACRO), “and gratified that the public’s knowledge of and attitudes toward clinical trials have moved in positive directions since 2013. The option to participate in a clinical trial, when appropriate, should be a routine part of the health care encounter and ACRO will continue to work with Research!America and others to spread that message to doctors and patients alike.”
The survey contains significant insights on factors important to clinical trial participation including competence and reputation of people or the institution conducting the research (91%); closely followed by opportunity to improve your own health and understanding potential risks and benefits (90%); whether you would have medical bills covered if you had an injury from the study (89%); the opportunity to improve the health of others (87%); having an expert guide you through the clinical trials process and the location of the clinical trial is easily accessible (86%).
Among other findings:
Ninety-percent agree that clinical trials are important to advancing science; and 87% agree clinical trials are important to improving our nation’s health.
More than half (53%) say the federal government should provide tax incentives to companies to encourage them to conduct clinical trials in the U.S. rather than in other countries.
Nearly half (46%) say they are concerned that most medications approved by FDA for use in America are tested in other countries as well as in the U.S. – 38% say they are not concerned and 16% say they are not sure.
The nationwide survey of 1,000 U.S. adults was conducted by Zogby Analytics for Research!America and the Association of Clinical Research Organizations in July 2017. The margin of error is +/- 3.1 percentage points. To view the survey, click here.
About Research!America surveys
Research!America began commissioning surveys in 1992 in an effort to understand public support for medical, health and scientific research. The results of Research!America’s surveys have proven invaluable to our alliance of member organizations and, in turn, to the fulfillment of our mission to make research to improve health a higher national priority. In response to growing usage and demand, Research!America has expanded its portfolio, which includes state, national and issue-specific polling.
About Research!America
Research!America is the nation’s largest nonprofit public education and advocacy alliance working to make research to improve health a higher national priority. Founded in 1989, Research!America is supported by member organizations representing 125 million Americans.
Sandoz today announces the expansion of a pilot project with leading charity World Child Cancer, aimed at improving access to treatment and optimizing survival outcomes for children suffering from cancer in four developing countries. The agreement builds on an existing partnership with World Child Cancer in the Philippines, where Sandoz is funding staff training needs and helping children to access diagnosis and subsequent treatment. It expands the partnership to cover three additional countries across three continents: Ghana, Mexico and Myanmar.
These particular projects were chosen because of the gravity of the situation in the four regions concerned: across all four, an estimated 6000 children develop cancer each year, but only approximately 20% even receive a diagnosis, let alone effective treatment.
Jon Rosser, Chief Executive of World Child Cancer, said: “It is just unacceptable that children’s odds of surviving cancer depend so much on geography. In developed countries, 80% now survive, but in developing countries it’s still only about 10%. World Child Cancer is changing this – in our programs we can raise that survival rate to around 60%.”
He added: “We are very excited at this growing partnership with Sandoz, which will enable us to prevent so many children dying without even a diagnosis and without effective pain relief. We believe that all children, regardless of where they live, deserve better.”
Peter Stenico, Sandoz Head of Oncology, said: “These projects will take simple, pragmatic measures to attack cancer where it is most vulnerable: among children suffering from forms of cancer that are often absolutely treatable. Together with World Child Cancer, we believe we can make a real difference by enhancing the standard of care for children in these countries and, ultimately, improving childhood cancer survival rates.”
The expanded partnership highlights Sandoz’s commitment to work together with key stakeholders worldwide to expand access to healthcare. As a targeted philanthropy project, our work with World Child Cancer complements our broader Novartis Corporate Responsibility efforts across a number of lower income countries.
About Sandoz
Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2016 sales of USD 10.1 billion. In 2016, our products reached well over 500 million patients and we aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.
About World Child Cancer
World Child Cancer helps children with cancer access diagnosis, treatment and support in developing countries where the chances of survival can be as low as 10% compared with 80% in the developed world.
World Child Cancer does this by building partnerships between doctors and nurses at hospitals in the developed world who provide training and mentoring for doctors in developing countries. It also helps with transport, food and accommodation costs to meet the wider needs of families who have a child with cancer.
World Child Cancer programs run in some of the poorest places in the world. Last year it helped over 5,500 children but, with an estimated 200,000 unnecessary deaths each year, there is so much more that needs to be done.
Johnson & Johnson
Johnson & Johnson announces encouraging first-in-human clinical data for investigational HIV preventive vaccine
Johnson & Johnson
Johnson & Johnson has announced encouraging first-in-human clinical data for an investigational HIV-1 vaccine regimen in development at its Janssen Pharmaceutical Companies. In an oral presentation of the early stage Phase 1/2a APPROACH study at the 9th IAS Conference on HIV Science (IAS 2017), the “mosaic”-based vaccine regimen from Janssen Vaccines & Prevention B.V. (Janssen) appeared to be well-tolerated and elicited HIV-1 antibody responses in 100% of healthy volunteers (n=393).”Finding a preventive vaccine has proven to be one of the biggest scientific challenges in the 35-year quest to end the HIV pandemic. A successful preventive vaccine for HIV will need to provide broad protection against a wide range of viral strains,” said Professor Dan Barouch, Harvard Medical School, Director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and a key collaborator for APPROACH. “These promising, early-stage results suggest that these vaccines utilizing mosaic immunogens should be evaluated further for their potential ability to achieve this historic goal.”
Significant progress has been made in the global battle against HIV/AIDS, including the development of critical antiretroviral treatments and HIV prevention tools, yet the disease remains one of the greatest global health threats of our time. An estimated 37 million people are currently living with HIV-1 globally, and nearly 2 million people become newly infected each year. An effective HIV vaccine is elusive due to the unique properties of the virus – including its genetic diversity and ability to mutate rapidly.
Mosaic-based vaccines contain immunogens created using genes from different HIV subtypes responsible for HIV-1 infections worldwide. These immunogens are delivered through viral vectors, including Janssen’s AdVac® technology based on adenovirus serotype 26 (Ad26). The viral vectors are combined with other components such as soluble proteins to form mosaic-based prime-boost vaccine regimens that first prime and then boost the immune system, with the aim of producing stronger and longer-lasting immunity to HIV.
Paul Stoffels, M.D., Chief Scientific Officer, Johnson & Johnson said, “In recent years, a new optimism has emerged that we will find an effective HIV vaccine in our lifetime. The results from today’s study add to that belief and we look forward to advancing to the next stage of clinical development as quickly as possible.”
In pre-clinical studies, regimens incorporating mosaic vaccines demonstrated protection against infection with an HIV-like virus. The most effective prime-boost regimen in these studies reduced the per-exposure risk of infection by 94 percent and resulted in 66 percent complete protection after six exposures.
Based on immunologic responses observed in APPROACH, as well as protection observed in pre-clinical studies, a lead HIV-1 vaccine regimen comprising Janssen’s Ad26 mosaic candidate and the Clade C gp140 soluble protein has been selected as the basis for further evaluation in a potential Phase 2b proof-of-concept efficacy study. Should this study move forward, Janssen and its global partners anticipate initiating this investigation in southern African countries in late 2017 or early 2018.
About the APPROACH Study
APPROACH (HIV-V-A004/NCT02315703) is a multi-center, randomized, parallel-group, placebo-controlled, double-blind Phase 1/2a study in 393 healthy HIV-uninfected adults in the US, Rwanda, Uganda, South Africa and Thailand. It is evaluating the safety, tolerability and immunogenicity of various mosaic-based, prime-boost vaccine regimens for HIV-1. These vaccine regimens contain two prime doses of the mosaic viral vector Ad26.Mos.HIV and two boosts of either Ad26.Mos.HIV, MVA-Mosaic and/or different doses of the soluble protein Clade C gp140 adjuvanted with aluminum phosphate. Vaccination schedules have been completed for all study participants and 12-month follow-up after the 4th dose is underway.
Results presented at IAS 2017 suggest that all vaccine regimens appeared to be well-tolerated. Injection site pain, headache and fatigue were the most common reported adverse events. The primary analysis post 3rd vaccination showed that most active vaccine regimens elicited antibody responses in 100% of study participants. Antibody titers against autologous Clade C and heterologous cross-clade Env antigens increased in groups boosted with gp140 protein, irrespective of vector. After the 4th vaccination, humoral and cellular responses further increased.
The APPROACH study was sponsored by Janssen with support from partner organizations including Beth Israel Deaconess Medical Center (BIDMC); the United States Military HIV Research Program (MHRP) at the Walter Reed Army Institute of Research (WRAIR), with the Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF); the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH); the Ragon Institute; the International AIDS Vaccine Initiative (IAVI); and the HIV Vaccine Trials Network (HVTN).
About Janssen’s HIV Preventive Vaccine
Janssen’s HIV-1 AdVac®-based vaccine regimen, along with the company’s investigational Ebola and inactivated polio vaccine candidates, utilize Janssen’s PER.C6® production cell line technology, which has the potential to reduce costs by increasing vaccine production at lower reactor volume.
Since 2005, Janssen Vaccines & Prevention B.V. has been participating in the NIH-supported Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) program under grants AI066305, AI078526 and AI096040. Janssen’s HIV vaccine program has also received funding from the United States Military HIV Research Program and the Ragon Institute.
About Johnson & Johnson
Caring for the world one person at a time inspires and unites the people of Johnson & Johnson. We embrace research and science – bringing innovative ideas, products and services to advance the health and well-being of people. Our approximately 126,400 employees at more than 230 Johnson & Johnson operating companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
About the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it.