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Rethinking trial engagement and recruitment starts with patient perspectives: patient survey insights

With countless media stories regarding COVID-19 published over a period of several years, it was obvious that people
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With countless media stories regarding COVID-19 published over a period of several years, it was obvious that people around the globe were tuned in to every step of the fight against the pandemic, eagerly learning about everything from symptoms to vaccine development. It was the most engaged a global audience has ever been with a public health issue, media playing a key role.

It’s through that sharp lens that the pharma industry also saw an all-time high in consumer interest in clinical research during the pandemic. Recruitment for much-needed COVID-19 vaccine and treatment trials accelerated. But post-pandemic, the industry needed to figure out how to sustain the heightened interest in research for many therapeutic foci, especially considering the decrease in diagnoses during the pandemic that is only now being identified.

Step one was to better understand what would make possible participants’ desire to enrol and stay in trials. As will be discussed at the 2022 DPharm annual conference in Boston, IQVIA, a global clinical research organization, surveyed more than 6,400 participants across the U.S. and the EU in order to examine the perception of clinical research one year into the pandemic and attitudes toward trial participation, including the reasons patients enrol in clinical trials.

By learning more about participation concerns and motivators, trial sponsors can understand the differing needs among populations and how to best integrate their feedback into trial design and recruitment strategies for stronger outcomes.

Leveraging patient perspectives

By soliciting feedback from individuals from various regions and differing racial and ethnic backgrounds and experiences, the industry got a closer look at key patient insights that could help identify the right mix of solutions to ensure sustainable interest in clinical trial participation.

Interest by demographics

Higher awareness of research during the pandemic drove interest across all demographics. Participants in the U.S. (about 70%) and EU (80%) said they were “somewhat interested” in trial participation, with 40% across all age groups and demographics saying they were “extremely” or “very interested.” And, of those “very/extremely interested,” nearly half of U.S. respondents and a third of EU respondents reported that their trust in clinical research and the pharma industry had increased since the start of the pandemic. African-American respondents showed the most significant positive shift in thinking (33%).

While all groups reported increased willingness to participate in clinical trials, different populations cited unique influencing factors:

  • Among U.S. African-Americans and Hispanics, COVID-19 had a more significant impact on desire to participate in trials, with approximately 25% saying they were “much more” interested, compared to 15% of white respondents.
  • African-Americans were twice as likely as the overall population to cite religious organizations as top influencers.
  • U.S. men aged 35 to 54 were more likely than other groups to cite family and friends’ opinions as influencers.
  • Regarding new-found interest in research, 63% cited a combination of wanting to help others and advance science, and 53% cited interest in earning more money

Sufficient representation matters

The expectation to improve diversity and inclusion in clinical trials comes not only from a regulatory perspective. Among survey respondents with high participation interest, 40% cited wanting “people like me” to be represented in trials, with African-American respondents more likely to choose this reason (33% compared to 21% of white U.S. counterparts).

As an initial step in planning future trials, sponsors can consider leveraging the breadth of data insights (e.g., existing literature, public health, electronic medical records, demographics, etc.) available to them to better understand prevalence of the condition being studied among these communities. An evidence-based approach can help sponsors tackle a long-standing issue with better informed diversity goals.

Reasons for “no” to trials

Because we can’t rely on the impact of the pandemic to hold patient interest, sponsors must find ways in their recruitment efforts to target patients who remain highly interested in trials. A key step is quantifying barriers to participation and finding innovative ways to resolve these concerns.

Notable participation barriers included:

  • Fears about health and safety (62%), which outweighed concerns about time (37%) and logistical burdens (18%).
  • African-Americans were more likely to cite trust of the study team as a barrier than other groups. Also, those 55 and older were more distrustful than individuals aged 35 to 54.

Conversely, less than 10% said they would participate in a trial for access to care and novel treatments, despite this being a key incentive for participation.

Traditionally, recruitment has been heavily dependent on medical care providers. However, to optimize recruitment, it is essential to find multiple ways to reach potential participants and connect them to trials appropriate for them. For example, if the majority of potential participants are unaware of the benefit of access to care and novel treatments with participation, it may be because providers are not regularly discussing research as a care option. Sponsors need to take on the role of educating patients as to the value of clinical research to the trial participant.

Opportunities for change

During the pandemic, the media was key to broadening awareness of research, but sponsors and CRO partners also increased targeted engagement through multi-pronged, direct-to-patient outreach. By leveraging real-world data insights from deidentified and anonymized EMR data, claims data, and more, sponsors identified target patient profiles. From there, through fine-tuned DTP advertising, marketing materials, recruiting campaigns and community outreach, sponsors helped build trust among patient populations and better informed them as to the real value of clinical trials specifically for their health.

Data analytics tools also helped with monitoring recruitment success across demographics. Sponsors adapted strategies in real-time to update messaging (e.g., in social media, news, community organizations, pharmacies, etc.) and shifted outreach resources to better reach target patients, including traditionally underserved populations, and ensure their interests and concerns were addressed.

DTP recruitment also entailed providing interested participants with click-of-the-mouse sign-up opportunities via user-friendly platforms. If participants met trial criteria, they instantly matched to an active site, the initial visit time was confirmed, and research site staff were alerted.

Decentralized trial solutions

While participants can be identified and enrolled into trials without burdening them, the survey showed that participants actually expect minimal disruptions to their lives and flexibility in options for trial participation. Nearly 70% of respondents wanted access to decentralized trial options (i.e., telehealth and in-home care), and the use of their providers and local labs when possible.

By using telehealth, wearables, online patient portals, and more during the pandemic, we saw how tech-enabled DCT models could be effectively integrated into trials, allowing patient engagement with minimal on-site visits and less burden. It is encouraging to see hybrid trials weaving in DCT solutions since and becoming the norm.

However, a notable survey finding showed nearly 75% of respondents as being unaware of DCT options. So, it is critical that sponsors better promote DCT models and communicate the ease of the trial experience at every touchpoint when recruiting.

Long-term partners

Though patients are more proactive about their health and well-being than ever before, interest in trials alone won’t keep participation going. Sponsors need to prioritize listening and integrating patients’ varying needs and perspectives into trial planning in order to enhance trial participants’ individual experiences. In turn, sponsors have an opportunity to build and execute more accurate recruiting strategies from the ground up and reduce timelines and trial costs. And, as importantly, they have a chance to build trust with patients, a trust which can grow along with their trial programs.

About the author

Mark Brown, Vice President, Global Patient and Site Solutions, IQVIA

With more than three decades at IQVIA, Mark Brown, vice president, Global Patient and Site Solutions, has touched on several areas of expertise in clinical research, including clinical documentation, data management, system compliance and validation, site selection and management, protocol and patient feasibility, and more. In his current role with Global Patient and Site Solutions, Mark helps oversee the Patient Recruitment Operations team and Avacare, IQVIA’s U.S.-based site management organization. In 2020, Mark led the creation and launch of a service to support clinical research sites by addressing flexible staffing needs, due to dynamic workloads related to large COVID-19 vaccine research trials and related staffing shortages. This led to placement of more than 600 research staff in less than six months.

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Spread & Containment

Decrease in Japanese children’s ability to balance during movement related to COVID-19 activity restrictions

A team of researchers from Nagoya University in central Japan investigated how restrictions on children’s activities during the COVID-19 pandemic affected…

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A team of researchers from Nagoya University in central Japan investigated how restrictions on children’s activities during the COVID-19 pandemic affected their life habits and their abilities to perform physical activities. By comparing medical examination data before and after the onset of the pandemic, they found that physical functions among adolescents deteriorated, including their dynamic balance. They also found that the children had higher body fat levels and worse life habits. Rather than a lack of exercise time, this may have been because of a lack of quality exercise due to activity restrictions.  

Credit: Credit must be given when image is used

A team of researchers from Nagoya University in central Japan investigated how restrictions on children’s activities during the COVID-19 pandemic affected their life habits and their abilities to perform physical activities. By comparing medical examination data before and after the onset of the pandemic, they found that physical functions among adolescents deteriorated, including their dynamic balance. They also found that the children had higher body fat levels and worse life habits. Rather than a lack of exercise time, this may have been because of a lack of quality exercise due to activity restrictions.  

During the COVID-19 pandemic, in Japan, as in other countries, schools and sports clubs tried to prevent the spread of infection by reducing physical education and restricting outdoor physical activities, club activities, and sports. However, children who are denied opportunities for physical activity with social elements may develop bad habits. During the pandemic, children, like adults, increased the time they spent looking at television, smartphone, and computer screens, exercised less, and slept less. Such changes in lifestyle can harm adolescent bodies, leading to weight gain and health problems. 

Visiting Researcher Tadashi Ito and Professor Hideshi Sugiura from the Department of Biological Functional Science at the Nagoya University Graduate School of Medicine, together with Dr. Yuji Ito from the Department of Pediatrics at Nagoya University Hospital, and  Dr. Nobuhiko Ochi and Dr. Koji Noritake from Aichi Prefectural Mikawa Aoitori Medical and Rehabilitation Center for Developmental Disabilities, conducted a study of Japanese children and students in elementary and junior high schools, aged 9-15, by analyzing data from physical examinations before and during the COVID-19 pandemic. They evaluated the children’s muscle strength, dynamic balance functions, walking speed, body fat percentage, screen time, sleep time, quality of life, and physical activity time.  

The researchers found that after the onset of the pandemic, children were more likely to have decreased balance ability when moving, larger body fat percentage, report spending more time looking at TV, computers or smartphones, and sleep less. Since there were no changes in the time spent on physical activity or the number of meals eaten, Sugiura and his colleagues suggest that the worsening of physical functions was related to the quality of exercise of the children. The researchers reported their findings in the International Journal of Environmental Research and Public Health.  

“Since the outbreak of the novel coronavirus in Japan after April 2020, children have not been able to engage in sufficient physical education, sports activities, and outdoor play at school. It became clear that balance ability during movement was easily affected, lifestyle habits were disrupted, and the percentage of body fat was likely to increase,” explained Ito. “This may have been because of shorter outdoor playtime and club activities, which impeded children’s ability to learn the motor skills necessary to balance during movement.” 

“Limitations on children’s opportunities for physical activity because of the outbreak of the novel coronavirus have had a significant impact on the development of physical function and lifestyle and may cause physical deterioration and health problems in the future,” warned Ito. “Especially, the risk of injury to children may increase because of a reduced dynamic balance function.” 

The results suggest that even after the novel coronavirus becomes endemic, it is important to consider the effects of social restrictions on the body composition of adolescents. Since physical activities with a social element may be important for health, authorities should prioritize preventing the reduction of children’s physical inactivity and actively encourage them to play outdoors and exercise. The group has some recommendations for families worried about the effects of school closings and other coronavirus measures on their children. “It is important for children to practice dynamic balance ability, maintaining balance to avoid falling over while performing movements,” Ito advised. “To improve balance function in children, it is important to incorporate enhanced content, such as short-term exercise programs specifically designed to improve balance functions.” 


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Government

Contradictions, Lies, And “I Don’t Recalls”: The Fauci Deposition

Contradictions, Lies, And "I Don’t Recalls": The Fauci Deposition

Authored by Techno Fog via The Reactionary,

Today, Missouri Attoney General…

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Contradictions, Lies, And "I Don't Recalls": The Fauci Deposition

Authored by Techno Fog via The Reactionary,

Today, Missouri Attoney General Eric Schmitt released the transcript of the testimony of Dr. Anthony Fauci. As you might recall, Fauci was deposed as part of an ongoing federal lawsuit challenging the Biden Administration’s violations of the First Amendment in targeting and suppressing the speech of Americans who challenged the government’s narrative on COVID-19.

Here is the Fauci deposition transcript.

And here are the highlights…

EcoHealth Alliance - the Peter Daszak group - is knee-deep in the Wuhan controversy, having been funded by the Fauci’s NIH for coronavirus and gain of function research in China (and having worked with the Chinese team in Wuhan). What does Fauci say about EcoHealth Alliance? Over two years after the COVID-19 pandemic began, and after millions dead worldwide, he’s “vaguely familiar” with their work.

In early 2020, Fauci was put on notice that his group - NIAID - had funded EcoHealth alliance on bat coronavirus research for the past five years.

This coincided with early reports - directly to Fauci, from Jeremy Ferrar and Christian Anderson - “of the possibility of there being a manipulation of the virus” based on the fact that “it was an unusual virus.”

Fauci conceded that he was specifically made aware by Anderson that “the unusual features of the virus” make it look “potentially engineered.”

Fauci couldn’t recall why he sent an article discussing gain of function research in China to his deputy, Hugh Auchincloss, telling him it was essential that they speak on the phone. He couldn’t recall speaking with Auchincloss via phone that day. But remarkably, Fauci did remember assigning research tasks to Auchincloss

Fauci was evasive on conversations with Francis Collins about whether NIAID may have funded coronavirus-related research in China, eventually stating “I don’t recall.”

The phrase “I don’t recall” was prominent in Fauci’s deposition. He said it a total of 174 times:

For example, Fauci couldn’t remember what anyone said on a call discussing whether the virus originated in a lab:

During that same call, Fauci couldn’t recall whether anyone expressed concern that the lab leak “might discredit scientific funding projects.” He also couldn’t recall whether there was a discussion about a lab leak distracting from the virus response. Fauci did remember, however, that they agreed there needed to be more time to investigate the virus origins - including the lab leak theory.

What else couldn’t Fauci remember? Whether, early into the pandemic, his confidants raised concerns about social media posts about the origins of COVID-19.

Yet Fauci did admit he was concerned about social media posts blaming China for the pandemic. He even admitted the accidental lab leak “certainly is a possibility,” contradicting his prior claims to National Geographic where he said the virus “could not have been artificially or deliberately manipulated.”

Fauci also couldn’t recall whether he had any conversations with Daszak about the origins of COVID-19 in February 2020, but admitted those conversations might have happened: “I told you before that I did not remember any direct conversations with him about the origin, and I said I very well might have had conversations but I don't specifically remember conversations.” And he couldn’t recall telling the media early on during the pandemic that the virus was consistent with a jump “from an animal to a human.”

Fauci said he was in the dark on social media actions to curb speech and suspend accounts that posted COVID-19 information that didn’t fit the mainstream narrative: “I’m not aware of suppression of speech on social media.” Yet it was Fauci’s proclamations of the truth, whether about the origins of COVID-19 to the effectiveness of hydroxychloroquine, that led to social media companies banning discussions of contrary information.

Regarding those removals of content, Fauci had no personal knowledge of a US Government/Social Media effort to curb “misinformation.” But he conceded the possibility numerous times.

Then there’s the issue of masks. In February 2020, Fauci informed an acquaintance that was traveling: “I do not recommend that you wear a mask.” Fauci would later become a vocal proponent of masks only two months later.

I’m near my Substack length limit - posting the excerpts does that - but you can see from Fauci’s testimony that his public statements about COVID-19 origins and the necessity to wear a mask didn’t match his private conversations. This has been known for some time, but it’s finally nice to get him on record.

Again, read it all and subscribe here.

Tyler Durden Mon, 12/05/2022 - 21:40

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International

Global Wages Take A Hit As Inflation Eats Into Paychecks

Global Wages Take A Hit As Inflation Eats Into Paychecks

The global inflation crisis paired with lackluster economic growth and an outlook…

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Global Wages Take A Hit As Inflation Eats Into Paychecks

The global inflation crisis paired with lackluster economic growth and an outlook clouded by uncertainties have led to a decline in real wages around the world, a new report published by the International Labour Organization (ILO) has found.

As Statista's Felix Richter reports, according to the 2022-23 Global Wage Report, global real monthly wages fell 0.9 percent this year on average, marking the first decline in real earnings at a global scale in the 21st century.

You will find more infographics at Statista

The multiple global crises we are facing have led to a decline in real wages.

"It has placed tens of millions of workers in a dire situation as they face increasing uncertainties,” ILO Director-General Gilbert F. Houngbo said in a statement, adding that “income inequality and poverty will rise if the purchasing power of the lowest paid is not maintained.”

While inflation rose faster in high-income countries, leading to above-average real wage declines in North America (minus 3.2 percent) and the European Union (minus 2.4 percent), the ILO finds that low-income earners are disproportionately affected by rising inflation. As lower-wage earners spend a larger share of their disposable income on essential goods and services, which generally see greater price increases than non-essential items, those who can least afford it suffer the biggest cost-of-living impact of rising prices.

“We must place particular attention to workers at the middle and lower end of the pay scale,” Rosalia Vazquez-Alvarez, one of the report’s authors said.

“Fighting against the deterioration of real wages can help maintain economic growth, which in turn can help to recover the employment levels observed before the pandemic. This can be an effective way to lessen the probability or depth of recessions in all countries and regions,” she said.

Tyler Durden Mon, 12/05/2022 - 20:00

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