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Clinical Trials

Myths and Misconceptions
About Clinical Trials

Myth: Clinical trials are not safe.

Reality: The investigational drugs and procedures that are given to trial participants go through a rigorous testing process to make sure that the drug is safe for use in humans and likely to be effective for treating the condition which it is being tested. All clinical trials are reviewed by an institutional review board (IRB), a committee made up of doctors, scientists and researchers who are there to ensure patient safety.

Myth: I’ve tried all recommendations by doctors, a clinical trial will probably not help either.

Reality: Participants of clinical trials are given the latest medicines and procedures. They are also overseen and taken care of by specialized medical professionals, researchers, and doctors that are there to ensure participant’s safety and the medication or treatment’s efficacy. Numerous studies show that patients who participate in clinical trials have outcomes that are as good, or better than the general patient population.

Myth: Being in a clinical trial is expensive.

Reality: It is very rare that volunteers for clinical trials have to pay any costs related to participating in a clinical trial. There are two types of costs associated with clinical trials: research costs and patient care costs. The research costs are associated with conducting the actual clinical trial and these costs are almost always covered by the sponsoring organization, such as a pharmaceutical company. Patient costs in most if not all cases are covered, and you may also receive compensation for your time and travel expenses.

Myth: If you sign up for a clinical trial, you lose control of your personal and health information.

Reality: If you agree to participate in a clinical trial, you will have to share your personal and some medical history with the team. As part of the informed consent process, you will receive information about the personal and health details that will be collected. There are very strict laws in place that prevent the sharing of personal and health information to anyone beyond the study team and personnel directly involved with the study. Protecting the privacy of participating individuals is most important to the team and the sponsor.

If you are interested in participating in a clinical trial, see our clinical trial page for trial currently recruiting

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Clinical Trials

Women and Clinical Trials

Traditionally, women are underrepresented in clinical trials. Larger gender gaps limit how much we know about the differences between men and women, including their reactions to certain treatments and medication. According to the Institute of Medicine, every cell in our body has a sex, which means that treating different conditions and diseases may have different effects depending on the gender of the patient.

Historically, women have been excluded from clinical trials since minorities and women were not included in government-funded health research until 1993; this is when the National Institutes of Health created a new mandate for the inclusion of women and minorities. In a recent effort to combat the ongoing gender gap issue, the NIH further provided $10 million to include more women in studies and in 2016 decreed that all studies had to include sex as part of the equation.

A perfect example of why involving women in clinical trials is so important is illustrated when one looks at the depression statistics. There are major endocrine changes that a woman goes through during the course of her life, including puberty, pregnancy, and menopause; all of which have been directly linked to depression. Twice as many women will be diagnosed with depression in their life when compared to men. When women are excluded from clinical trials, researchers are missing out on important information that could be learned about the metabolism rate of women, especially during the various changes that females go through.

Another example is shown with Alzheimer’s disease. Over two-thirds of the 5.1 million people in the USA suffering from Alzheimer’s are women. Research shows that not only is this the case because women live longer, but it also shows that the impact of hormonal changes at menopause and sex differences in gene expression may be involved as well.

Governing bodies, like the NIH, are now mandating the inclusion of women in clinical trials and studies. These changes have also led to the formation of many women’s health programs at government agencies which also advocate for change and inclusion. Continuing the dialogue, creating marketing campaigns that are female-targeted, encouraging the inclusion of females, and advocating for women’s health are all steps towards a fair and scientifically accurate medical and drug research system.

References
[1] https://www.theguardian.com/lifeandstyle/2015/apr/30/fda-clinical-trials-gender-gap-epa-nih-institute-of-medicine-cardiovascular-disease
[2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4478054/
[3] https://www.alzheimers.net/8-12-15-why-is-alzheimers-more-likely-in-women/
[4] https://www.nytimes.com/2014/09/23/health/23gender.html

Categories
Clinical Trials

What is Placebo?

In clinical trials or research studies, the research team needs to be certain that the results of their trial are accurate; that the drug or treatment safe and effective. The “gold standard” for testing different treatments for different conditions is the “randomized, placebo-controlled clinical trial”. This means that participants taking part in the study are randomly assigned to either receive the treatment or the placebo.

By comparing the results of these two different groups, researchers are able to effectively determine whether the effects experienced by taking the treatment are in fact true, or just occurred by chance. In a double-blind, placebo-controlled clinical trial, the participant, their family members, and their dedicated study care team are all “blind” to the treatment (either placebo or study treatment), while the trial is happening.

But what is a placebo?

Placebo, in Latin means “to please”. The first use of the word in English was not related to medicine at all, in fact, it was used as a part of prayer in the early 13th Century. It did not make its medical debut until about 100 years later when doctors would prescribe placebos to their patients for their psychological benefit. There was no medical or biochemical benefit, but it did provide their patients with peace of mind that their ailment was being “treated”. Fast forward another few hundred years to the mid-20th Century placebos were no longer given to patients to please them or provide peace of mind. Now, due to the demand for new treatments, leading to clinical trials and research studies, placebos are an important part of control and accuracy.

Ultimately, placebo-controlled trials have a high interval of validity and accuracy when compared with the opposite. Before deciding whether or not to take part in a clinical trial or research study, make sure you are fully informed of the rationale for the use of placebo, along with the associated risks.

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Clinical Trials

Digital Marketing Is Critical For To Engage And Retain Patients For Clinical Trials.

“If I were diagnosed with something tomorrow, one of the first things I would do is go online.”Digital marketing, the use of internet based media activities like content marketing, e-commerce, social media, e-mail direct, digital display advertising, search engine advertising and the use of video imagery across digital media like mobile phones, smart devices and laptops has become the preferred method to connect product and service providers with customers. The era of television, radio and traditional print mass media’s dominance is being upended, as digital savvy consumers are demanding more information from providers in a more individualized relationship. Digital marketing is causing a shift from a marketer empowered mass distributed connection to a consumer empowered, individualized personal relationship connection.

As with many industries, the delivery of healthcare has been dramatically disrupted by the digital technology revolution, both in the way services are provided and how the health care industry markets to their consumers. Accustomed to traditional institutional forms of marketing, the Pharmaceutical and Healthcare sectors tasked with transitioning to the new digital communication environment are finding it challenging but critical in order to remain competitive especially in clinical trial patient recruitment.

Bethany Bray, Founder & CEO, AutoCruitment says, “In order for Pharmaceutical Companies or healthcare providers to actively engage and reach potential patients, it’s critical to develop a marketing strategy that accounts for digital marketing. We often see clients engage our firm in rescue mode, after most of the marketing budget has been spent, resulting in an anemic digital marketing effort. With more than 80 percent of consumers utilizing the internet to look up health related information it is imperative to invest in a marketing strategy that promises the most lucrative return on investment.” Many health-care marketing professionals say digital’s measurability helps them defend their budgets. “Return on investment is on the top of everybody’s agenda,” said Paul Matsen, CMO of Cleveland Clinic.

Pharmaceutical Companies, CROs and healthcare providers conducting clinical trials are facing a brand new world of transparency and competition brought on by technology. Just as other industries have been compelled to abandon well established methods of attracting customers and promoting their services, Pharmaceutical Companies, CROs and healthcare providers must embrace the digital marketing experience to engage an ever more informed patient. “The patient journey is largely a digital journey at their moment of need,” said John Weston, CMO at Mayo Clinic. “If I were diagnosed with something tomorrow, one of the first things I would do is go online.”

AutoCruitment provides a path to effective digital marketing presence through a proprietary and targeted, direct-to-patient, online marketing platform that targets, recruits screens and automatically refers new patients for clinical trials or specialty medical procedures. By streamlining the patient recruitment process, AutoCruitment helps accelerate the commercialization of safe, effective new treatments for devastating diseases and conditions and directs patients to new and suitable providers.

For more information contact AutoCruitment at info@autocruitment.com

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AutoCruitment

AutoCruitment Announces Canada Expansion

AutoCruitment LLC, a leading Clinical Trial Online Patient Recruitment company with a direct-to-patient, web-based technology platform, announces their expansion into Canada with the incorporation of AutoCruitment Canada Ltd.

November 20th, 2018 – AutoCruitment LLC, a leading Clinical Trial Online Patient Recruitment company with a direct-to-patient, web-based technology platform, announces their expansion into Canada with the incorporation of AutoCruitment Canada Ltd.  AutoCruitment Canada will operate under AutoCruitment to strengthen corporate growth, technology operations and client relations.

The opening of the AutoCruitment Toronto office will mark the third office location for AutoCruitment with other locations including New York, NY and Atlanta, GA.

“We are excited at the opportunity to expand into Canada and the opening of a third office location,” said Bethany Bray, Chief Executive Officer of AutoCruitment, “this additional growth will allow us to expand our Technology, Operations, Leadership, Digital Marketing, Site Engagement, Patient Engagement and Project Management teams to support our growing patient network and increased client base as we continue to develop and enhance the AutoCruitment Platform.

AutoCruitment is committed to supporting their global clients by continuing to optimize and accelerate clinical trial patient recruitment, reducing the time it takes to get therapies to market. With the addition of the Toronto, ON location AutoCruitment remains focused on this mission.

For more information email info@autocruitment.com or visit www.autocruitment.com.

About AutoCruitment

AutoCruitment is an industry leader in clinical trial patient recruitment, offering online recruitment services and use of the web-based AutoCruitment Platform globally.

AutoCruitment was founded in 2014 by Bethany Bray, MBA MRes (Imperial College London), Ben Cooper and Chris Klaus (founder of Internet Security Systems; now part of the IBM Group). The leading, web-based recruitment company is headquartered in Technology Square, Atlanta GA with Project Management and Operations located in New York, NY and Toronto, ON.

AutoCruitment has assisted in the recruitment and automated screening of patients for all therapeutic areas and is currently working with 4 of the top 10 pharmaceutical companies, 9 of the largest CROs worldwide, numerous hospitals and research sites to reduce the time it takes to get lifesaving therapies to market; through the use of their platform which recruits and matches qualified patients to the correct trials and clinical programs, automatically.

AutoCruitment’s targeted, metrics-driven approach and web-based technology closes the enrollment gap and accelerates patient recruitment by an average of 72%.

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AutoCruitment

Patient Recruitment A Focus Of DIA

ATLANTA, GA – July 20, 2016:

Bethany Bray, Chief Executive Officer and Co-Founder of AutoCruitment recently presented at the DIA Annual Meeting in Philadelphia, PA.

Drug Information Association (DIA) is the only global forum for knowledge exchange that fosters innovation to raise the level of health and well-being worldwide and has become an essential resource that provides opportunities to extend debate and discussion to advance scientific and medical innovation.

The session entitled “Patient Recruitment in Rare Diseases: Ideas and Framework for out-of-the-Box Exploration”, explored the challenges of recruiting patient participants in clinical studies involving rare diseases where populations are small and geographically dispersed. The aim of the session was to “catalyze unconventional thinking and to provide a framework to organize innovative recruitment ideas.” The discussion focused on patient recruitment, retention, engagement and clinical trial designs.

Bethany’s presentation, “Direct-to-Patient Digital Recruitment: A Targeted Approach to Recruitment Enrollment and Retention”, addressed how targeted digital marketing techniques can be used to target, engage and recruit the right patients in the external patient population; improving recruitment, enrollment and retention problems in clinical trials. An Oncology and Neuroscience Researcher, Entrepreneur and Technologist, Bethany founded AutoCruitment to fulfill a vision of utilizing the power of the internet to address patient recruitment, enrollment and retention problems in clinical trials.

“It was an honor to be asked to speak at DIA. As a company we were impressed with the number of sessions that discussed how Sponsors and CROs approach patient recruitment, highlighting that typically Sponsors and CROs will rely solely on research sites or key opinion leaders (KOLs) to recruit patients from existing databases, which creates a bottleneck. We couldn’t agree more.” comments Bray. “There is a need to devise strategies to reach out to patients in the external community directly. A targeted digital recruitment strategy allows us to attract the right patients in the external community, screen them online and automatically and immediately refer them to the KOLs or contracted research sites; removing the bottleneck and ultimately accelerating the trial timeline.”

AutoCruitment is able to provide a path to effective digital marketing presence through a proprietary and targeted, direct-to-patient, online marketing platform that targets, recruits, screens and automatically refers new patients for clinical trials or specialty medical procedures. By streamlining the recruitment process, AutoCruitment helps accelerate the commercialization of safe, effective new treatments for devastating diseases and conditions and directs patients to new and suitable providers.

“DIA was an excellent opportunity for AutoCruitment to highlight the innovative strategies that we are employing to accelerate patient recruitment. Getting the buy-in from CROs and Sponsors is incredibly important in adopting new digital technologies to improve not just patient recruitment but the overall outcome of the clinical trial or specialty study.”

To learn more about how AutoCruitment can develop unique strategies to support your clinical trials, contact AutoCruitment at info@autocruitment.com or visit www.autocruitment.com

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AutoCruitment

AutoCruitment Co-Founder & CEO Bethany Bray To Present And Participate In A Panel At DIA Annual Meeting

ATLANTA, GA – June 23, 2016: Bethany Bray, Chief Executive Officer and Co-Founder of AutoCruitment will be a featured presenter and panelist at the DIA Annual Meeting in Philadelphia, PA. Drug Information Association (DIA) is the only global forum for knowledge exchange that fosters innovation to raise the level of health and well-being worldwide and has become an essential resource that provides opportunities to extend debate and discussion to advance scientific and medical innovation.

The session entitled “Patient Recruitment in Rare Diseases: Ideas and Framework for out-of-the-Box Exploration”, will explore the challenges of recruiting patient participants in clinical studies involving rare diseases where populations are small and geographically dispersed. The aim of the session is to “catalyze unconventional thinking, judge industry leaders various recruitment strategies and to provide a framework to organize innovative recruitment ideas.” The discussion will focus on patient recruitment, retention, engagement and clinical trial designs.

Bethany’s initial presentation, “Direct-to-Patient Digital Recruitment: A Targeted Approach to Recruitment Enrollment and Retention”, addresses how digital marketing techniques can be used to recruit, control and retain enrolled participants in clinical trials. An Oncology and Neuroscience Researcher, Entrepreneur and Technologist, Bethany founded AutoCruitment to fulfill a vision of utilizing the power of the internet to address recruitment, enrollment and retention problems in clinical trials.

AutoCruitment is able to provide a path to effective digital marketing presence through a proprietary and targeted, direct-to-patient, online marketing platform that targets, recruits, screens and automatically refers new patients for clinical trials or specialty medical procedures. By streamlining the recruitment process, AutoCruitment helps accelerate the commercialization of safe, effective new treatments for devastating diseases and conditions and directs patients to new and suitable providers.

Bray has 10 years of experience in Pharmaceutical Research, Operations and Business Development and holds a BSc in Pharmacology, a Masters in Translational Medicine & Neuroscience from Imperial College London and an MBA from the Georgia Institute of Technology.

For more information on the DIA 2016 Annual Meeting and Conference and how you can participate click on http://www.diaglobal.org

About AutoCruitment

AutoCruitment is an industry leader in clinical trial patient recruitment, offering online recruitment services and use of the web-based AutoCruitment Platform globally.

AutoCruitment was founded in 2014 by Bethany Bray, MBA MRes (Imperial College London), Ben Cooper and Chris Klaus (founder of Internet Security Systems; now part of the IBM Group). The leading, web-based recruitment company is headquartered in Technology Square, Atlanta GA with Project Management and Operations located in New York, NY and Toronto, ON.

AutoCruitment has assisted in the recruitment and automated screening of patients for all therapeutic areas and is currently working with 4 of the top 10 pharmaceutical companies, 9 of the largest CROs worldwide, numerous hospitals and research sites to reduce the time it takes to get lifesaving therapies to market; through the use of their platform which recruits and matches qualified patients to the correct trials and clinical programs, automatically.

AutoCruitment’s targeted, metrics-driven approach and web-based technology closes the enrollment gap and accelerates patient recruitment by an average of 72%.