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Dennis OConnor

Assessing Participation Burden in Clinical Trials: Introducing the Patient Friction Coe... - 0 views

www.clinicaltherapeutics.com/...fulltext

patient-experience design patient-centric protocol-design

shared by Dennis OConnor on 30 Oct 20 - No Cached
  • Dennis OConnor on 30 Oct 20
     
    Abstract: Protocol design complexity, and associated study volunteer burden, negatively impact patient recruitment and retention as well as overall research and development productivity. Complex protocols reduce the willingness of potential clinical trial participants to enroll and reduce retention rates. There have been few systematic assessments of protocol design characteristics to determine the burden placed on study volunteers, although such an assessment would offer a compelling opportunity to optimize trial designs and improve recruitment and retention performance. To be useful, an assessment would need to be patient-centric, and focused on the factors that influence participation throughout the clinical trial. Such an assessment would also need to accommodate the unique cost-value trade-off compared with current treatment patterns that each participant makes when choosing to participate and remain in a clinical trial. This article proposes a new methodology to quantify patient burden: the clinical trial patient friction coefficient (PFC). A case example is provided to illustrate the utility of the PFC. A number of applications for the PFC are envisioned: standardizing patient burden assessment to evaluate clinical trial design feasibility, shedding light on the impact of patient burden on clinical trial economics and performance, and conducting sensitivity analyses to identify factors that most reduce patient burden and improve the performance and efficiency of clinical trials. Key words
Dennis OConnor

What Went Wrong with Coronavirus Testing in the U.S. | The New Yorker - 0 views

www.newyorker.com/...-coronavirus-testing-in-the-us

covid testing research

shared by Dennis OConnor on 18 Mar 20 - No Cached
  • n February 5th, sixteen days after a Seattle resident who had visited relatives in Wuhan, China, was diagnosed as having the first confirmed case of COVID-19 in the United States, the Centers for Disease Control, in Atlanta, began sending diagnostic tests to a network of about a hundred state, city, and county public-health laboratories⁠. Up to that point, all testing for COVID-19 in the U.S. had been done at the C.D.C.; of some five hundred suspected cases⁠ tested at the Centers, twelve had confirmed positive. The new test kits would allow about fifty thousand patients to be tested, and they would also make testing much faster, as patient specimens would no longer have to be sent to Atlanta to be evaluated.
  • Before a state or local lab could use the C.D.C.-developed tests on actual patients
  • verification
  • ...33 more annotations...
  • larger number, about thirty-six of them, received inconclusive⁠ results from one of the reagents.
  • Another five,
  • had problems with two reagents
  • On February 8th
  • e cascading effects that they’ve had on the country’s COVID-19 preparations suggest a much larger problem with the way the United States has structured its pandemic response.
  • the verification problems were “part of the normal procedures⁠.” In the meantime, she said, until new reagents could be manufactured, all COVID-19 testing in the United States would continue to take place exclusively at the C.D.C⁠.
  • The public-health-laboratory network was never intended to provide widespread testing in the event of a pandemic.
  • the three-week delay caused by the C.D.C.’s failure to get working test kits into the hands of the public-health labs came at a crucial time.
  • The void created by the C.D.C.’s faulty tests made it impossible for public-health authorities to get an accurate picture of how far and how fast the disease was spreadin
  • In hotspots like Seattle, and probably elsewhere, COVID-19 spread undetected for several weeks, which in turn only multiplied the need for more tests.
  • The problem was that containment was not done very well.
  • we’re looking at exponential growth, and we need to figure out how to meet an exponential demand.”
  • Yet flexibility was not what Jerome and his lab found when they tried to get an E.U.A. for their COVID-19 test.
  • problem was exacerbated by a President who has simultaneously underplayed the severity of the outbreak and overpromised the means available to fight it
  • problems with COVID-19 testing in the United States have obscured
  • several labs reported their problems to the C.D.C. In a briefing a few days later,
  • Chinese scientists uploaded a copy of the virus’s genome to an online repository⁠, and virologists around the world set to work to develop diagnostic tests for the new disease
  • January 21st, a team in Berlin, led by Christian Drosten, one of the scientists who discovered the original SARS virus, in 2003, submitted the first paper to describe a protocol for testing for SARS-CoV-2.
  • That protocol would form the basis for a test disseminated, early on, by the World Health Organization
  • That same day, Messonnier announced that the C.D.C. had finalized its own test⁠, which it used to confirm the first known case of COVID-19 in the U.S.
  • The U.W. virology lab
  • started, probably in earnest in mid-January, to prepare what we call a laboratory-developed test,⁠
  • It took a team at the lab, working under the direction of Alex Greninger, about two weeks to develop a working version
  • But, as soon as Alex Azar, the Secretary of Health and Human Services, declared a public-health emergency, on February 4th, a new regulatory regime took effect. From that point on, any lab that wanted to conduct its own tests for the new coronavirus would first need to secure something called an Emergency Use Authorization from the F.D.A.
  • This shift in the regulations sounds perverse, since it restricts the use of new tests at precisely the moment they’re most needed.
  • E.U.A. process is supremely flexible.
  • triumph of modern medical science
  • hen there’s a big emergency and we feel like we should really do something, it gets hard. It’s a little frustrating. We’ve got a lot of scientists and doctors and laboratory personnel who are incredibly good at making assays. What we’re not so good at is figuring out all the forms and working with the bureaucracy of the federal government.”
  • At one point, he was very frustrated because he’d e-mailed them what we were doing so they could review it,”
  • Here we are in this SARS-CoV-2 crisis, and you have to send them something through the United States Postal Service. It’s just shocking.
  • Despite these difficulties, Jerome said, the F.D.A. ultimately proved responsive to the lab’s entreaties. “They had good and substantive feedback that made our testing better, and the response time was typically just a couple of days.”
  • believe it was, February 29th,” he said. “And then we got a specimen from one of the people who were the two original cases in Washington
  • The E.U.A. regulations, however, prohibited the lab from reporting the results to the doctors who had ordered the tests for their patients.
  • Dennis OConnor on 18 Mar 20
     
    "Sharfstein, too, thinks that it's fair to criticize the federal government for not recognizing that its pandemic plans had a single point of failure. The C.D.C. quickly developed a working test, and it was understandable, at some level, that people at the Centers thought that fixing the faulty reagents for the public-health labs would be faster than shifting to an entirely different protocol. Nevertheless, Sharfstein said, "Why are we relying only on the C.D.C.? What the F.D.A. could have done, and eventually did do, is say, 'You can use other approaches.' " Even so, he said, "I don't think it's quite fair to totally blame the F.D.A. for this. The F.D.A. can design an approach to support the public-health strategy, but someone has to tell F.D.A. the public-health goal." The delay in clearly establishing those goals, he said, shows why the decision to shut down the N.S.C. directorate was so consequential. "People talk about, like, why does it matter that they closed the White House office on pandemic preparedness? This is one reason.""
Dennis OConnor

Here's Why You Should Care About Holacracy - 1 views

www.fastcompany.com/...ou-should-care-about-holacracy

ecosystem holacracy

shared by Dennis OConnor on 26 May 18 - No Cached
  • For the first time in over a century, we’re beginning to see credible alternatives, and most of them point to this idea of responsiveness–that an organization should be built to learn and respond rapidly by optimizing for the open flow of information; encouraging experimentation and learning in rapid cycles; and organizing a network of employees, customers and partners motivated by a shared purpose.
  • Holacracy is simply the first fully formed alternative to C&C that real companies are using successfully. Is it the only replacement? Should everyone switch to it immediately? Definitely not. There will be many other operating models to choose from in the near future.
  • anies with traditional hierarchy can only change as fast as their leaders can handle it.
  • ...39 more annotations...
  • To avoid chaos, it actually forces you to define roles and accountabilities far more rigorously than the old C&C system
  • Responsive organizations also risk falling prey to the tyranny of consensus and backtracking to old systems of authority. That’s why clear rules and protocols–like those outlined by Holacracy–are so vital and tend to work well.
  • to explain Holacracy, let’s look at what changes it makes
  • Holacracy forces a company to revisit its rules, roles, objectives, and authorities in short cycles. This prevents you from over-planning upfront.
  • you know that companies create products and services that are reflections of themselves. So it makes sense that in order to rapidly iterate your product, you should also rapidly iterate how your organization works.
  • By constantly iterating, Holacratic companies can relieve new tensions caused by changes so they can learn and adapt fast.
  • Working on the right thing is as–if not more important–than how hard you are working.
  • It’s not a waste to build multiple versions if it helps you find the right one.
  • In Holacracy, teams are renamed “circles,” and they can be created or destroyed anytime.
  • Circles only have the authority to change things that are in the domain of their authority.
  • People identify 1-1 with their title, making them imprecise and inflexible.
  • Holacracy fixes this problem by decoupling “role from soul.”
  • You can have more roles than employees, and it’s expected that people will fill multiple roles within several circles.
  • While Holacracy may have a hierarchy of circles, it tries to decouple the humans from that hierarchy as much as possible.
  • The most effective way to solve any problem is to put together all of the people with the skills required to solve it.
  • Holacratic orgs tend to spend more time arguing about who should be able to decide and why that wasn’t clear to begin with
  • work which can be done wholly within a formal team is much easier than work that requires participation from multiple teams.
  • Writ large: Distributing decision-making isn’t easy. It goes against generations of learned behaviors and deep-seated mental models.
  • There is no way to design a permanent org structure where the right people can work together with as few dependencies as possible.
  • Holacracy makes it easy and relatively friction free to create new circles, rearrange people within them, tear it all down and start again.
  • Holacracy deals with this by creating rules around proposals that favor the proposer over objectors.
  • ritualistically squashed.
  • Thus, proposals are deemed “safe to try” as long as everyone agrees that they’ll help gather valuable data. “Safe to try” is a key idea in Holacracy.
  • The only valid objections are A) this circle doesn’t have the authority over the domain you’re changing or B) there is proof the change will cause material harm to the business before it could be mitigated.
  • You can’t simply object because you don’t like an idea or have a better one.
  • Of course, most of the rules are tribal. “Because that’s how we’ve always done it,” is a common phrase at traditional companies.
  • the rules have to be written down so anyone can look them up and quickly figure out who owns what and what the policies really are.
  • Glassfrog is the name of the software you use to help you run a Holacratic company. It’s theoretically possible to run Holacracy without it, but it would be hard.
  • Glassfrog helps you document your organizational structure, circles, roles, accountabilities, policies, etc. It also aids in running meetings. Finally, it provides an ongoing record of changes made to the organization.
  • For a distributed org to function, much more needs to be done in public, where it can be easily discovered by others.
  • . The point isn’t to pre-determine what works for everyone. It’s to give you a basic structure that helps you make the rules transparent, easy to change, and to increase the rate at which you change them.
  • The biggest challenge is dealing with how wrong everything feels at first.
  • ou have to give the new system a real try, which means using it to relieve tensions, reinvent itself and solve the problems it creates.
  • Holacracy “feels” weird to most newcomers.
  • In Holacracy, the power goes to the process itself, making it difficult for individuals to take advantage of their positions.
  • They also agree that Holacracy is not a panacea or definitive replacement for C&C.
  • Each circle has a single role called Lead Link who has authority over assigning people to other roles in the circle.
  • f you choose to follow their lead, remember that distributing authority isn’t binary–it’s a spectrum.
  • not let the problems you know you will encounter get in the way.
Dennis OConnor

Approaches to governance of participant-led research: a qualitative case study | BMJ Open - 0 views

bmjopen.bmj.com/...e025633

Azure-Grant ethics research Gary-Wolfe Camille-Nebeker PLR self-study N-of-One

shared by Dennis OConnor on 22 Nov 19 - No Cached
  • Dennis OConnor on 22 Nov 19
     
    "Prospective consent and governance principles for participant-led research Nine themes emerged from discussions and interviews relating to informed consent in and governance of PLR. As this PLR was driven by people with different backgrounds asking personal questions, we found that ethical reflection needed to be ongoing and tailored to the individual. For this reason, prospective governance principles were drafted rather than codified rules. Many of the themes were expressed over the course of our PLR as an ongoing informed consent. The process, fostered via frequent communication, helped to reinforce trust among participants and organisers.43 44 Transparency: All relevant information about the project should be actively shared among participants and participant-organisers, including the source of research funding, equipment selection, data management protocols, risks and benefits and conflicts of interest. Access to Expertise: Participant-led research (PLR) requires access to experts (eg, in experimental design, data analysis, research ethics) so that participants can rigorously carry out single-subject experiments.45 Data Access & Control: The participant has the right and ability to manage their own data, and has the final say in what they collect about themselves. Right to Withdraw: Participants have a right to reduce or withdraw their participation at any time. Relevance: PLR addresses questions of relevance to the participants. Beneficence: The participant actively reflects on the balance of benefits and risks of participation and freely choose whether to participate. Responsibility: PLR requires that the participant actively consider the potential benefits and harms of the project to both themselves and others. The responsibility to stay informed is an ongoing process, not a one-time decision. Flexibility: Ethical reflection in PLR should be tailored to individual needs and to the specific context, rather than be handled with 'one size fits all
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