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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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There will soon be one million seats on this popular Amtrak route

“More people are taking the train than ever before,” says Amtrak’s Executive Vice President.

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While the size of the United States makes it hard for it to compete with the inter-city train access available in places like Japan and many European countries, Amtrak trains are a very popular transportation option in certain pockets of the country — so much so that the country’s national railway company is expanding its Northeast Corridor by more than one million seats.

Related: This is what it's like to take a 19-hour train from New York to Chicago

Running from Boston all the way south to Washington, D.C., the route is one of the most popular as it passes through the most densely populated part of the country and serves as a commuter train for those who need to go between East Coast cities such as New York and Philadelphia for business.

Veronika Bondarenko captured this photo of New York’s Moynihan Train Hall. 

Veronika Bondarenko

Amtrak launches new routes, promises travelers ‘additional travel options’

Earlier this month, Amtrak announced that it was adding four additional Northeastern routes to its schedule — two more routes between New York’s Penn Station and Union Station in Washington, D.C. on the weekend, a new early-morning weekday route between New York and Philadelphia’s William H. Gray III 30th Street Station and a weekend route between Philadelphia and Boston’s South Station.

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According to Amtrak, these additions will increase Northeast Corridor’s service by 20% on the weekdays and 10% on the weekends for a total of one million additional seats when counted by how many will ride the corridor over the year.

“More people are taking the train than ever before and we’re proud to offer our customers additional travel options when they ride with us on the Northeast Regional,” Amtrak Executive Vice President and Chief Commercial Officer Eliot Hamlisch said in a statement on the new routes. “The Northeast Regional gets you where you want to go comfortably, conveniently and sustainably as you breeze past traffic on I-95 for a more enjoyable travel experience.”

Here are some of the other Amtrak changes you can expect to see

Amtrak also said that, in the 2023 financial year, the Northeast Corridor had nearly 9.2 million riders — 8% more than it had pre-pandemic and a 29% increase from 2022. The higher demand, particularly during both off-peak hours and the time when many business travelers use to get to work, is pushing Amtrak to invest into this corridor in particular.

To reach more customers, Amtrak has also made several changes to both its routes and pricing system. In the fall of 2023, it introduced a type of new “Night Owl Fare” — if traveling during very late or very early hours, one can go between cities like New York and Philadelphia or Philadelphia and Washington. D.C. for $5 to $15.

As travel on the same routes during peak hours can reach as much as $300, this was a deliberate move to reach those who have the flexibility of time and might have otherwise preferred more affordable methods of transportation such as the bus. After seeing strong uptake, Amtrak added this type of fare to more Boston routes.

The largest distances, such as the ones between Boston and New York or New York and Washington, are available at the lowest rate for $20.

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The next pandemic? It’s already here for Earth’s wildlife

Bird flu is decimating species already threatened by climate change and habitat loss.

I am a conservation biologist who studies emerging infectious diseases. When people ask me what I think the next pandemic will be I often say that we are in the midst of one – it’s just afflicting a great many species more than ours.

I am referring to the highly pathogenic strain of avian influenza H5N1 (HPAI H5N1), otherwise known as bird flu, which has killed millions of birds and unknown numbers of mammals, particularly during the past three years.

This is the strain that emerged in domestic geese in China in 1997 and quickly jumped to humans in south-east Asia with a mortality rate of around 40-50%. My research group encountered the virus when it killed a mammal, an endangered Owston’s palm civet, in a captive breeding programme in Cuc Phuong National Park Vietnam in 2005.

How these animals caught bird flu was never confirmed. Their diet is mainly earthworms, so they had not been infected by eating diseased poultry like many captive tigers in the region.

This discovery prompted us to collate all confirmed reports of fatal infection with bird flu to assess just how broad a threat to wildlife this virus might pose.

This is how a newly discovered virus in Chinese poultry came to threaten so much of the world’s biodiversity.

H5N1 originated on a Chinese poultry farm in 1997. ChameleonsEye/Shutterstock

The first signs

Until December 2005, most confirmed infections had been found in a few zoos and rescue centres in Thailand and Cambodia. Our analysis in 2006 showed that nearly half (48%) of all the different groups of birds (known to taxonomists as “orders”) contained a species in which a fatal infection of bird flu had been reported. These 13 orders comprised 84% of all bird species.

We reasoned 20 years ago that the strains of H5N1 circulating were probably highly pathogenic to all bird orders. We also showed that the list of confirmed infected species included those that were globally threatened and that important habitats, such as Vietnam’s Mekong delta, lay close to reported poultry outbreaks.

Mammals known to be susceptible to bird flu during the early 2000s included primates, rodents, pigs and rabbits. Large carnivores such as Bengal tigers and clouded leopards were reported to have been killed, as well as domestic cats.

Our 2006 paper showed the ease with which this virus crossed species barriers and suggested it might one day produce a pandemic-scale threat to global biodiversity.

Unfortunately, our warnings were correct.

A roving sickness

Two decades on, bird flu is killing species from the high Arctic to mainland Antarctica.

In the past couple of years, bird flu has spread rapidly across Europe and infiltrated North and South America, killing millions of poultry and a variety of bird and mammal species. A recent paper found that 26 countries have reported at least 48 mammal species that have died from the virus since 2020, when the latest increase in reported infections started.

Not even the ocean is safe. Since 2020, 13 species of aquatic mammal have succumbed, including American sea lions, porpoises and dolphins, often dying in their thousands in South America. A wide range of scavenging and predatory mammals that live on land are now also confirmed to be susceptible, including mountain lions, lynx, brown, black and polar bears.

The UK alone has lost over 75% of its great skuas and seen a 25% decline in northern gannets. Recent declines in sandwich terns (35%) and common terns (42%) were also largely driven by the virus.

Scientists haven’t managed to completely sequence the virus in all affected species. Research and continuous surveillance could tell us how adaptable it ultimately becomes, and whether it can jump to even more species. We know it can already infect humans – one or more genetic mutations may make it more infectious.

At the crossroads

Between January 1 2003 and December 21 2023, 882 cases of human infection with the H5N1 virus were reported from 23 countries, of which 461 (52%) were fatal.

Of these fatal cases, more than half were in Vietnam, China, Cambodia and Laos. Poultry-to-human infections were first recorded in Cambodia in December 2003. Intermittent cases were reported until 2014, followed by a gap until 2023, yielding 41 deaths from 64 cases. The subtype of H5N1 virus responsible has been detected in poultry in Cambodia since 2014. In the early 2000s, the H5N1 virus circulating had a high human mortality rate, so it is worrying that we are now starting to see people dying after contact with poultry again.

It’s not just H5 subtypes of bird flu that concern humans. The H10N1 virus was originally isolated from wild birds in South Korea, but has also been reported in samples from China and Mongolia.

Recent research found that these particular virus subtypes may be able to jump to humans after they were found to be pathogenic in laboratory mice and ferrets. The first person who was confirmed to be infected with H10N5 died in China on January 27 2024, but this patient was also suffering from seasonal flu (H3N2). They had been exposed to live poultry which also tested positive for H10N5.

Species already threatened with extinction are among those which have died due to bird flu in the past three years. The first deaths from the virus in mainland Antarctica have just been confirmed in skuas, highlighting a looming threat to penguin colonies whose eggs and chicks skuas prey on. Humboldt penguins have already been killed by the virus in Chile.

A colony of king penguins.
Remote penguin colonies are already threatened by climate change. AndreAnita/Shutterstock

How can we stem this tsunami of H5N1 and other avian influenzas? Completely overhaul poultry production on a global scale. Make farms self-sufficient in rearing eggs and chicks instead of exporting them internationally. The trend towards megafarms containing over a million birds must be stopped in its tracks.

To prevent the worst outcomes for this virus, we must revisit its primary source: the incubator of intensive poultry farms.

Diana Bell does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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This is the biggest money mistake you’re making during travel

A retail expert talks of some common money mistakes travelers make on their trips.

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Travel is expensive. Despite the explosion of travel demand in the two years since the world opened up from the pandemic, survey after survey shows that financial reasons are the biggest factor keeping some from taking their desired trips.

Airfare, accommodation as well as food and entertainment during the trip have all outpaced inflation over the last four years.

Related: This is why we're still spending an insane amount of money on travel

But while there are multiple tricks and “travel hacks” for finding cheaper plane tickets and accommodation, the biggest financial mistake that leads to blown travel budgets is much smaller and more insidious.

A traveler watches a plane takeoff at an airport gate.

Jeshoots on Unsplash

This is what you should (and shouldn’t) spend your money on while abroad

“When it comes to traveling, it's hard to resist buying items so you can have a piece of that memory at home,” Kristen Gall, a retail expert who heads the financial planning section at points-back platform Rakuten, told Travel + Leisure in an interview. “However, it's important to remember that you don't need every souvenir that catches your eye.”

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According to Gall, souvenirs not only have a tendency to add up in price but also weight which can in turn require one to pay for extra weight or even another suitcase at the airport — over the last two months, airlines like Delta  (DAL) , American Airlines  (AAL)  and JetBlue Airways  (JBLU)  have all followed each other in increasing baggage prices to in some cases as much as $60 for a first bag and $100 for a second one.

While such extras may not seem like a lot compared to the thousands one might have spent on the hotel and ticket, they all have what is sometimes known as a “coffee” or “takeout effect” in which small expenses can lead one to overspend by a large amount.

‘Save up for one special thing rather than a bunch of trinkets…’

“When traveling abroad, I recommend only purchasing items that you can't get back at home, or that are small enough to not impact your luggage weight,” Gall said. “If you’re set on bringing home a souvenir, save up for one special thing, rather than wasting your money on a bunch of trinkets you may not think twice about once you return home.”

Along with the immediate costs, there is also the risk of purchasing things that go to waste when returning home from an international vacation. Alcohol is subject to airlines’ liquid rules while certain types of foods, particularly meat and other animal products, can be confiscated by customs. 

While one incident of losing an expensive bottle of liquor or cheese brought back from a country like France will often make travelers forever careful, those who travel internationally less frequently will often be unaware of specific rules and be forced to part with something they spent money on at the airport.

“It's important to keep in mind that you're going to have to travel back with everything you purchased,” Gall continued. “[…] Be careful when buying food or wine, as it may not make it through customs. Foods like chocolate are typically fine, but items like meat and produce are likely prohibited to come back into the country.

Related: Veteran fund manager picks favorite stocks for 2024

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