iiinova — where your digital self keeps evolving

1Day Sooner @1daysooner.bsky.social · 09/10/2026

This publication emerged out of a March 2025 international, multidisciplinary stakeholder meeting, which was held in Oxford, UK. You can read the article here: academic.oup.com/jid/advance-... You can also find our full list of research publications here: www.1daysooner.org/publications/

academic.oup.com

Expert Consensus on Controlled Human Infection Studies for Gonorrhoea

Gonorrhoea CHIS are an underutilised but valuable research tool with potential to accelerate progress against gonorrhoea and AMR. With robust ethical overs

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1Day Sooner @1daysooner.bsky.social · 09/10/2026

In it, they argue that controlled human infection studies (CHIS) offer a powerful approach to accelerate gonorrhoea vaccine and antimicrobial development and improve understanding of host–pathogen interactions.

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1Day Sooner @1daysooner.bsky.social · 09/10/2026

Paul Zimmer-Harwood, @1daysooner.bsky.social's research lead for clinical trials worked with colleagues from leading universities across several continents, including @ox.ac.uk, @unimelb.edu.au, @utoronto.ca, @imperialcollegeldn.bsky.social to develop our latest research publication.

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1Day Sooner @1daysooner.bsky.social · 06/10/2026

Critics raise serious concerns, noting that early-phase studies do not establish a drug’s safety for patient use and arguing that profiting from unproven products without FDA oversight creates a risk of both physical harm and exploitation.

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1Day Sooner @1daysooner.bsky.social · 06/10/2026

Supporters see a responsible route for people who wish to exercise medical freedom and who have been unable to access unapproved products through clinical trials or the federal right-to-try or expanded-access pathways.

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1Day Sooner @1daysooner.bsky.social · 06/10/2026

Join 1Day Sooner on Oct 20 at 10:00 AM ET for a moderated conversation on Montana's new right-to-try laws. Montana has built a pathway that lets biotech companies sell experimental drugs that have completed testing equivalent to a phase-1 trial directly to consumers

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1Day Sooner @1daysooner.bsky.social · 02/10/2026

3️⃣ Policy: At a recent lobby day, 1Day Sooner pushed for clinicaltrials.gov fields specific to pregnancy/lactation and for bipartisan H.R. 8651, which would make it easier for pregnant and lactating women to participate in clinical trials.

clinicaltrials.gov

ClinicalTrials.gov

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1Day Sooner @1daysooner.bsky.social · 02/10/2026

2️⃣ Better data: A recent STAT op-ed by @ambilinski.bsky.social, Sullivan & Lee calls on clinicaltrials.gov to flag whether trials enroll pregnant and lactating people. Today, fewer than 1% of drug trials explicitly allow pregnant participants. Read more here: statnews.com/2026/09/21/c...

clinicaltrials.gov

ClinicalTrials.gov

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1Day Sooner @1daysooner.bsky.social · 02/10/2026

@dndi.org's Craig Tipple showed that designing for inclusion works: a recent DNDi Phase I study reached a 50:50 split. You can read the full report, see slides, and watch the recording here: volrethics.org/index.php/ne...

volrethics.org

NEWS – The VOLRETHICS Association: Protecting and Empowering Healthy Volunteers

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1Day Sooner @1daysooner.bsky.social · 02/10/2026

1️⃣ Phase I trials: At the VOLRETHICS "Meet the Authors" webinar, Jill Fisher showed that women were only 22–31% of US Phase I participants for decades. Her conclusion was that the barriers are largely cultural, not scientific.

volrethics.org

NEWS – The VOLRETHICS Association: Protecting and Empowering Healthy Volunteers

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1Day Sooner @1daysooner.bsky.social · 02/10/2026

Closing the Pregnancy & Lactation Evidence Gap: More than 90% of pregnant people take at least one medication, yet fewer than 10% of drugs approved since 1980 have evidence on pregnancy safety. Three recent conversations show where the gap starts and how to close it.

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1Day Sooner @1daysooner.bsky.social · 25/09/2026

Learn more: The trial is recruiting now, so see the eligibility details and site locations at the link: www.msdclinicaltrials.com/trial/nct070... At 1Day Sooner, we believe volunteers are essential to medical progress!

msdclinicaltrials.com

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 - MSD

Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection. The goals of this study are to learn: * If taking MK-8527 once a month works

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1Day Sooner @1daysooner.bsky.social · 25/09/2026

The impact: If it works, a cheap, easy-to-distribute monthly pill, with generic makers already lined up, could reach millions of young women without needing a clinic visit for every dose.

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1Day Sooner @1daysooner.bsky.social · 25/09/2026

Why we love it: Swapping 30 pills a month for one could close the adherence gap that keeps current PrEP from protecting the people who need it most.

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1Day Sooner @1daysooner.bsky.social · 25/09/2026

Trials We Love! What's happening? Merck's Phase 3 trial is enrolling young women in Kenya, South Africa, and Uganda to test whether a pill taken just once a month can prevent HIV as well as, or better than, today's daily PrEP.

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1Day Sooner @1daysooner.bsky.social · 18/09/2026

You can read both at the link below. Grateful to everyone who put their name on this. www.regulations.gov/comment/HHSI...

regulations.gov

Regulations.gov

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1Day Sooner @1daysooner.bsky.social · 18/09/2026

Alongside it, we filed our own comment asking OIG to build a safe harbor around IRB review and anti-steering conditions rather than dollar ceilings, and to cover compensation for time, burden, and risk rather than documented expenses alone.

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1Day Sooner @1daysooner.bsky.social · 18/09/2026

Their letter opens: "We write to you not as lawyers, ethicists, or industry representatives, but as people who have done the thing your rules are written about."

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1Day Sooner @1daysooner.bsky.social · 18/09/2026

What they asked for is not complicated. Cover the real costs of participating. Pay for time, burden, and discomfort. Let IRBs do the job they already do. Skip the one-size-fits-all caps. And stop treating fair payment as evidence that someone was too poor to choose freely.

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1Day Sooner @1daysooner.bsky.social · 18/09/2026

Twenty-four agreed. Between them they've enrolled in roughly a hundred studies over the past decade, including challenge studies where volunteers are deliberately infected so researchers can learn how to prevent and treat disease.

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1Day Sooner @1daysooner.bsky.social · 18/09/2026

1Day Sooner reached out to our network and asked current and former participants whether they wanted to share perspectives on fair compensation with OIG directly.

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1Day Sooner @1daysooner.bsky.social · 18/09/2026

HHS's Office of Inspector General asked whether federal fraud and abuse law is making it harder than it should be to pay clinical trial participants fairly.

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1Day Sooner @1daysooner.bsky.social · 16/09/2026

They are accepting requests to present public comments until Oct. 15 on the following questions: What is the value of global data harmonization? What are the primary barriers and potential solutions? If those questions are important to you, then make your voice heard!

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1Day Sooner @1daysooner.bsky.social · 16/09/2026

The event takes place on Nov. 5, 1-4pm EST in Washington. Its major goal is to bring together regulators, industry, technologists, clinicians, and policy experts to discuss the current landscape and potential solutions for global data harmonization

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1Day Sooner @1daysooner.bsky.social · 16/09/2026

Registration is live (both for in-person and virtual attendance) for Global Harmonization for Data Access & Exchange. @1daysooner.bsky.social supported the planning of this event, which is being hosted by the Reagan-Udall Foundation for the FDA: reaganudall.org/news-and-eve...

reaganudall.org

Global Harmonization for Data Access & Exchange

Reagan-Udall Foundation for the FDA, independent 501(c)(3) organization created by Congress to advance the mission of the Food and Drug Administration.

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1Day Sooner @1daysooner.bsky.social · 16/09/2026

"The drug company files that 1Day Sooner is seeking... typically contain the back-and-forth between companies and regulators... and essentially provide everything that is known about a drug." Learn more about the project at @technologyreview.com www.technologyreview.com/2026/09/15/1...

technologyreview.com

AI models need more data about biology, and OpenAI is paying to create it

The OpenAI Foundation is funding a new effort called Data for Public Health.

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1Day Sooner @1daysooner.bsky.social · 16/09/2026

"The $500,000 grant to 1Day Sooner will help the group prove it can obtain the data troves of bankrupt companies, says the organization’s president and cofounder, Josh Morrison. He thinks nonexclusive copies of company datasets could be acquired for only “a few tens of thousands of dollars” each."

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1Day Sooner @1daysooner.bsky.social · 15/09/2026

See all of this and more in our newsletter: mailchi.mp/1daysooner.o... Sign up to stay in touch here: www.1daysooner.org/volunteer/

mailchi.mp

1Day Sooner September Newsletter

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1Day Sooner @1daysooner.bsky.social · 15/09/2026

➡️ 1Day Sooner is hiring for a range of roles related to our Clinical Trial Abundance program and the Cooperative Participant Organization. Learn more about our open roles here: www.1daysooner.org/jobs/

1daysooner.org

Careers - 1Day Sooner

We are Hiring Director, Science Policy and Advocacy The development of lifesaving vaccines and treatments for infectious diseases is increasingly […]

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1Day Sooner @1daysooner.bsky.social · 15/09/2026

➡️ Clinical trial volunteers, research teams, and public officials gathered in Blantyre, Malawi, on August 14 to celebrate healthy volunteers and recognize their contributions to clinical research. This event was co-organized by the Malawi-Liverpool Wellcome Research Programme and 1Day Sooner.

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1Day Sooner @1daysooner.bsky.social · 15/09/2026

Highlights from our September newsletter: ➡️ 1Day Sooner was one of 128 advocacy groups who signed in support of the @americancancersoc.bsky.social Action Network letter urging for the adoption of the Clinical Trial Modernization Act. Read the letter here: www.fightcancer.org/releases/pub...

fightcancer.org

Public Health Organizations Urge HHS to Remove Financial Barriers in Clinical Trial Participation

Today, the American Cancer Society Cancer Action Network (ACS CAN), joined by 128 other patient advocacy groups, public health organizations and professional societies, submitted a letter responding t...

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1Day Sooner @1daysooner.bsky.social · 10/09/2026

Her fixes cost very little: internet during waits, someone to talk to, transport reimbursed. That's the perspective she brings to 1Day Sooner's Participant Council. Full story: 1daysooner.org/meet-tabitha... Learn more about the Participant Council: 1daysooner.org/council/

1daysooner.org

Meet Tabitha Kisakye: Passionate about participant-centered trial design - 1Day Sooner

When Tabitha Kisakye explains her willingness to volunteer for medical research, she emphasizes that she made her choice “to benefit […]

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1Day Sooner @1daysooner.bsky.social · 10/09/2026

The hardest parts weren't medical. Long waits with no data left on your phone. Unscheduled visits. A regimen that wears on you until what you want most is someone to talk to.

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1Day Sooner @1daysooner.bsky.social · 10/09/2026

"People look at healthy volunteers as lab rats," she says. Her own experience ran the other way: connections, friendships, a sense of being part of something.

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1Day Sooner @1daysooner.bsky.social · 10/09/2026

The disease affects more than 240 million people worldwide, and roughly 30% of Ugandans are infected. In a controlled human infection study, volunteers are exposed under close supervision to parasites that can't reproduce. It's a step toward a vaccine.

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1Day Sooner @1daysooner.bsky.social · 10/09/2026

Tabitha Kisakye was a public health student in Uganda when she learned researchers needed healthy volunteers for a schistosomiasis study — people willing to be deliberately infected. She weighed the risks, then enrolled.

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1Day Sooner @1daysooner.bsky.social · 01/09/2026

1Day's involvement was via our Cooperative Participant Organization, which helps to integrate participant voices into clinical trial processes & provide flexible support for study teams. Learn more here: www.1daysooner.org/cpo-investig...

1daysooner.org

Cooperative Participant Organization (CPO) Study Support for Trials Involving Healthy Participants - 1Day Sooner

Our Cooperative Participant Organization (CPO) embeds 1Day Sooner staff scientists directly into study teams worldwide, especially in controlled human infection […]

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1Day Sooner @1daysooner.bsky.social · 01/09/2026

Sessions focused on healthy volunteers’ experiences, the importance of community engagement, and how to continue strengthening participant-centered research in Malawi.

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1Day Sooner @1daysooner.bsky.social · 01/09/2026

On August 14, 1Day Sooner and The Malawi Liverpool Wellcome Research Programme (www.mlw.mw) welcomed 50 clinical trial volunteers, research teams, and public officials to Blantyre, Malawi to celebrate healthy volunteers and recognize their contributions to clinical research.

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1Day Sooner @1daysooner.bsky.social · 10/08/2026

You can also learn more about the set of reforms that fit into the Clinical Trial Abundance agenda on our website: 1daysooner.org/clinical-tri... If you're passionate about any of these ideas and want to connect, you can reach us at cta@1daysooner.org

1daysooner.org

Clinical Trial Abundance - 1Day Sooner

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1Day Sooner @1daysooner.bsky.social · 10/08/2026

Attendees are not named to protect the candor of the exchange. The views summarized are participants’ own—not 1Day Sooner’s—and do not represent the full human research ecosystem. Read the report: www.1daysooner.org/wp-content/u...

1daysooner.org

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1Day Sooner @1daysooner.bsky.social · 10/08/2026

The conversation covered IRB reform, clinical trial workforce gaps, innovative trial design, real-world data, and the use of AI in clinical research. Our new report highlights the key ideas, critiques, and opportunities participants raised.

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1Day Sooner @1daysooner.bsky.social · 10/08/2026

Clinical trials are changing—and implementation will matter. On July 2, 1Day Sooner convened a closed-door roundtable with experts from academia, industry, and advocacy to discuss HHS’s Operation TrialBlazer, draft guidance, and pilot initiatives.

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1Day Sooner @1daysooner.bsky.social · 10/08/2026

At 1Day Sooner, we believe volunteers are essential to medical progress. #TrialsWeLove #ClinicalResearch #ResearchImpact #1DaySooner

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1Day Sooner @1daysooner.bsky.social · 10/08/2026

The impact: This trial will map the clinical, viral, and immune responses to dengue over time, supporting the development of future dengue vaccines. Learn more: clinicaltrials.gov/study/NCT07412483

clinicaltrials.gov

ClinicalTrials.gov

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1Day Sooner @1daysooner.bsky.social · 10/08/2026

Why we love it: Healthy volunteers are making it possible to observe dengue infection from its earliest moments — something no natural infection study can capture.

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1Day Sooner @1daysooner.bsky.social · 10/08/2026

Trials We Love! What's happening? Researchers are using a carefully controlled dengue human challenge model in healthy adult volunteers to study how the virus interacts with the human immune system.

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