06Jun

Amidst all the uncertainty about a COVID vaccine, at least this one thing is certain: it is changing how clinical trials are conducted.

Instead of taking years to move apotential vaccine from laboratory to trial, the US’s Operation Warp Speed has moved two of six prospective COVID vaccines into Phase 3 recruitment in under six months. Two more are expected to begin Phase 3 recruitment this month.

In the United Kingdom, a different type of clinical trial showed it is possible to enroll 12,000 patients, test several different existing treatment candidates and have the first significant results in fewer than 100 days.

Even given the substantial differences between the government-run health care system of the UK and the private, decentralized US system, there are lessons – “ideas,” Nicole Mather calls them in an article for the journal Nature – researchers here can apply to accelerate trials.

Describing how the UK’s RECOVERY trial went from concept to first, actionable results in such a short time, Mather identifies five differences with traditional trials:

  1. The trial protocol took only 20 pages to detail the design, and data and regulatory requirements. It was flexible enough to allow trial arms to be stopped or added.
  2. It got approvals in 9 days, versus the typical 30-60.
  3. Recruitment paperwork was simplified.
  4. Data collection and processing was accelerated through the UK’s DigiTrials hub, which provides centralized support for clinical trials.
  5. Results were quickly made public.

Though the RECOVERY program has its critics – objections center on releasing results without first being peer-reviewed and structural issues – Mather says it shows how a centralized health data system and a streamlined design and approval process can accelerate the timeline.

“We’ve gone so far towards managing risk that we’ve created layers of bureaucracy that absorb time and money, and, paradoxically, increase the risk that beneficial treatments are not tested,” she writes.

That view is echoed by Martin Landray, deputy chief investigator of RECOVERY, who said the way the National Institute for Health Research cut red tape was “fabulous.” “Many academic and commercial trials have accumulated so much extra baggage over the years, such as long case report forms and 10 page patient consent forms,” he said in an interview with The BMJ.

Digital entry for the RECOVERY trial made consent and subsequent data collection quick and simple, The BMJ article reports.

Leveraging data systems is an important lesson, says Mather, who is life-sciences lead at IBM Services in London, which was a partner in the DigiTrials project. Because of the UK’s National Health System, much information was already available for trial study patients, simplifying the participation process.

That would be a much greater challenge in the US because of its private medical system, although the strong push over the last decade to digitize medical records is making the portability of patient data easier.

The UK RECOVERY program has given momentum to accelerating clinical trial processes. To build on it, says Landray, “We now need to apply the lessons from this approach to other major health challenges such as heart disease, cancer, arthritis, and mental health.”

Photo by JC Gellidon on Unsplash

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Green Key
Jun 6, 2023

Drug Industry Invests $1 Billion For Antibiotic Development

Before the discovery of antibiotics, tuberculosis was the second most common cause of death in the US. Today, thanks to antibiotics, the few who contract the disease rarely die.

But as TB and other once-easily cured diseases grow increasingly antibiotic resistant, the very real fear is that medicine may run out of treatment options, leading to epidemics dwarfing COVID-19.

To head-off that kind of future, two dozen pharmaceutical firms have invested nearly $1 billion creating the AMR Action Fund with the goal of developing 2-4 new antibiotics by 2030.

AMR – antimicrobial resistance – arises when infectious disease pathogens become resistant to existing medicines. Tuberculosis is one of them, as are several others including the much publicized MRSA.

“AMR has the potential to render diseases that are relatively easy to treat today virtually incurable,” said Dr. Paul Stoffels, vice chairman of the executive committee and chief scientific officer, Johnson & Johnson.

“Left unchecked, AMR could significantly eclipse the global health challenge that the world is facing currently with COVID-19,” he said in a statement announcing the launch of the AMR Action Fund.

The initial funding pledges from the bioscience and drug firms – including $100 million pledged each by Johnson & Johnson and Pfizer – will be supplemented by non-industry partners, the Fund says on its website.

Explaining that “drug resistant bacteria are developing faster than new antibiotics can reach the market,” the Fund says there are few antibiotics in clinical development to meet current and anticipated needs. The reason is that the market for antibiotics “doesn’t support the level of investment needed to maintain a robust antibiotic pipeline.”

The website goes on to explain that smaller biotech firms have trouble financing trials of the antibiotics they do develop. Some that have developed new antibiotics “have declared bankruptcy or exited this space,” cautions the Fund, “Due to the lack of commercial sustainability, resulting in the loss of valuable expertise and resources.”

To achieve its goal of bringing to market the new antibiotics in a decade, the Fund said it “will invest in smaller biotech companies focused on developing new antibiotics that address the highest priority public health needs.”

Specifically, the AMR Action Fund will:

  1. “Invest based on the WHO/CDC priority lists of pathogens, with the goal to address major unmet needs and maximize public health impact.
  2. “Prioritize novel antibacterial treatments, as recognized by leading public health agencies, with significant and differentiated clinical utility and that reduces patient mortality.
  3. “Invest across all stages of clinical development.”

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Jun 6, 2023

Nation Starts Recruiting 100,000 Contact Tracers to ‘Box-in’ COVID-19

An army of workers is being recruited across the US to help “box-in” the coronavirus to prevent its spread and reduce the chance of new outbreaks.

Tens of thousands – 100,000 at least — of these special workers will be deployed to track down and counsel individuals who may have come into contact with an infected person. When they do, they’ll ask them about their health, informing them they were potentially exposed to the virus and advising them about what steps to take.

These contact tracers may also ask them who they’ve been in contact with and then reach out to those individuals as well.

Contact tracing is a key part of how public health officials will contain the spread of COVID-19.

Described in a document prepared by the Association of State and Territorial Health Officials, boxing-in the virus involves four tactics: “(1) testing, (2) isolation of all infected people, (3) finding everyone who has been in contact with infected people, (4) quarantine all contacts for 14 days, and (1) re-testing of those people.”

Each piece is essential to containing the pandemic, but success depends first on identifying the infected and who they may have infected, which is why so many cities and states have begun beefing up the ranks of their public health investigators.

“Contact tracing, monitoring, and provision of social supports to infected individuals and their contacts is an urgent priority of local, state, territorial, and tribal health departments,” says the association, “And will require rapid and massive scaling up of existing contact investigation resources in every community in the United States and its territories.”

As recruiting for these positions gets underway, agencies are making a determined effort to recruit from the ethnic and minority communities most impacted by COVID-19, reports Kaiser Health News.

“There are some communities that aren’t going to respond to a phone call, a text message or a letter,” explains Dr. Kara Odom Walker, secretary of the Delaware Department of Health and Social Services. “That could be due to health literacy issues, which could be due to fear, or documentation status.”

In Long Beach, California, which has a substantial Cambodian, Vietnamese, Samoan, Pilipino and Spanish-speaking population, the city weeks ago assembled a team of 60 contact tracers and interpreters from among its bilingual municipal workers.

Virginia, which plans to hire 1,300 tracers and support staff, is recruiting speakers of Mandarin, Haitian Creole, Spanish and Bengali, according to the Kaiser report.

Having a tracer who understands the culture as well as speaks the language can make a big difference in how much cooperation – and success – public health agencies will have.

Says Walker, “You need someone to be a cultural broker to say, not only are these policies in place to protect you, but I’m telling you to trust me that this will be OK.”

Photo by Martin Sanchez on Unsplash

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