The hottest Clinical Trials Substack posts right now

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Ensitrelvir (Xocova®): Japanese Company Shionogi & Co., Ltd. Sets a Model for Success in Translational Research for the Coming Future of Ethical Science

Popular Rationalism • 455 implied HN points • 29 Oct 24
🏥 Health Politics Pharmaceuticals Drug Development Clinical Trials Public Health
  1. Ensitrelvir, also known as Xocova, is a new antiviral pill that is 30 times more effective than a placebo. It was developed by a Japanese company called Shionogi & Co., which worked closely with researchers.
  2. This medication targets a key enzyme the virus needs to replicate, making it effective against COVID-19 symptoms, especially those caused by Omicron variants. It has shown a strong safety profile and fewer side effects compared to some other treatments.
  3. Xocova is easier to take than some alternatives because it requires only a once-daily dose and has fewer interactions with other medications. This makes it a more convenient option for many patients.

Anti-depressants: The trials last 8 weeks; People take them for 8+ years

Vinay Prasad's Observations and Thoughts • 85 implied HN points • 04 Mar 25
🏥 Health Politics Mental health Medications Clinical Trials Public Health Psychiatry
  1. People often take anti-depressants for many years, even decades, but they were only studied for about 8 weeks in trials.
  2. There isn't clear evidence that taking these medications long-term is better than not starting them at all, which raises concerns about their effectiveness.
  3. We need longer and better studies to truly understand the benefits and downsides of anti-depressants, including how they impact things like sexual health.

The first RCT for GLP-1 drugs and alcoholism isn't what we hoped

DYNOMIGHT INTERNET NEWSLETTER • 1109 implied HN points • 20 Feb 25
🏥 Health Politics Addiction Medications Clinical Trials Public Health Research
  1. GLP-1 drugs like semaglutide help with diabetes and obesity, but new research shows they might not be effective for alcohol addiction as previously thought. The first clinical trial results were disappointing.
  2. The trial had only 48 participants and mixed results, with no clear evidence that semaglutide reduced alcohol consumption. Some data suggested it might help in a lab setting, but overall findings were weak.
  3. Despite the poor results, there are still many personal stories claiming these drugs help with addiction. More research is needed, as the search for effective treatments for addiction continues.

Exenatide - the drug that failed

Rory’s Always On Newsletter • 595 implied HN points • 18 Oct 24
🏥 Health Politics Clinical Trials Drug Development Patient Care Medical Research
  1. Exenatide, a drug initially hopeful for slowing Parkinson's, failed in its final trial. This has left many in the Parkinson's community feeling uncertain and disappointed.
  2. Researchers are still figuring out why the drug worked in earlier tests but failed later. They need more data to understand if it was because the drug didn't reach the brain or if it just wasn't effective.
  3. The failure of Exenatide could make it harder for other similar drugs to get funding for trials. Meanwhile, experts emphasize that exercise remains a reliable way to manage Parkinson's symptoms.
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A Covid Nasal Vaccine Update

Ground Truths • 10148 implied HN points • 14 Feb 25
🏥 Health Politics Vaccines Public Health Clinical Trials Policy Infectious Diseases
  1. There are now 6 different nasal vaccines in clinical trials in the US aimed at preventing COVID-19 and blocking its transmission. These vaccines are promising because they might work better than traditional shots.
  2. Two major challenges facing these new vaccines are the low current levels of the virus, which make it harder to gather data from trials, and the uncertainty about ongoing government support for these projects.
  3. Successful nasal vaccines could provide a convenient way to protect people from COVID-19, but it will take time to find out if they really work well in humans.

What should the control arm be in a vaccine trial? Is it a placebo if it contains aluminum?

Vinay Prasad's Observations and Thoughts • 106 implied HN points • 19 Feb 25
🏥 Health Politics Vaccines Clinical Trials Public Health Policy Ethics
  1. In vaccine trials, using a control arm that contains something like aluminum may not be truly a placebo, which can make it hard to determine side effects.
  2. If the control group feels side effects from a placebo, like aluminum, they may think they received the vaccine and change their behavior, affecting the trial results.
  3. Sometimes, trials need more than one control group to get a clearer picture of both safety and effectiveness, like comparing a true placebo to a placebo that causes some discomfort.

Defense of Dr. Charles Hoffe Vs. The BC College of Physicians and Surgeons - Part 4

Pierre Kory’s Medical Musings • 4835 implied HN points • 28 Jan 24
🏥 Health & Wellness Health Safety Medical Studies Clinical Trials
  1. Dr. Hoffe advocates for the safety and effectiveness of ivermectin as a Covid treatment.
  2. Extensive data supports the unparalleled safety profile of ivermectin for Covid and parasitic diseases.
  3. Comparisons show that ivermectin is safer than other approved Covid treatments like Remdesivir, Paxlovid, and Molnupiravir.

Lighting up Long Covid

Ground Truths • 15222 implied HN points • 19 Jan 24
🏥 Health & Wellness Long Covid Vaccination Clinical Trials
  1. A new study on Long Covid analyzed 6,600 proteins to identify potential biomarkers like complement activation.
  2. Vaccination offers substantial protection against Long Covid, especially in those not at risk of severe illness.
  3. Recent reports highlight potential neurologic damage from Covid and call for more research on effective treatments.

Forensic analysis of 38 subject deaths shared by Corinne Michels Writer Science Rules by Corinne Michels, found evidence of an over 3.7-fold increase in number of deaths due to cardiovascular events

Alexander News Network -Dr. Paul Elias Alexander's substack • 1572 implied HN points • 25 Jan 24
🏥 Health Politics Vaccine Safety Clinical Trials
  1. Forensic analysis found a 3.7-fold increase in deaths due to cardiovascular events in Pfizer vaccinated individuals compared to placebo.
  2. The adverse event signal was not reported by Pfizer/BioNTech.
  3. Inconsistencies were found in subject data reported in the study and publications by Pfizer/BioNTech trial site administrators.

Karuna Therapeutics, a drug repurposing effort, sold for about $14 billion. This is their story.

Trevor Klee’s Newsletter • 1119 implied HN points • 05 Feb 24
🔬 Science Biotechnology Drug Development Pharmaceuticals Clinical Trials Innovation
  1. Karuna Therapeutics achieved a $14 billion sale through drug repurposing.
  2. Drug repurposing can be a highly lucrative business without requiring excessive brilliance or luck.
  3. VCs often prioritize hype and platform-based drug development over drug repurposing success stories.

Vaccines are like drugs: Some are safe, some are effective, and some have benefits > harms, but not all

Vinay Prasad's Observations and Thoughts • 135 implied HN points • 31 Oct 24
🏥 Health Politics Vaccines Public Health Medical Ethics Drug Safety Clinical Trials
  1. Vaccines, like drugs, can vary in safety and effectiveness. Some work well for certain people but not for others.
  2. It's important to measure how well vaccines work, not just for virus-related issues but for overall health.
  3. We need better monitoring and data sharing after vaccines are given, along with the ability to hold manufacturers accountable if something goes wrong.

LabGenius - the long slow road to faster drug discovery

Rory’s Always On Newsletter • 535 implied HN points • 07 Feb 24
🔬 Science Biotech AI Drug Discovery Machine Learning Clinical Trials
  1. AI and machine learning are revolutionizing drug discovery by speeding up the identification of potential treatments, leading to big rewards for those in the industry.
  2. Building a successful biotech company requires patience, determination, and significant funding, often with a focus on research and development before revenue generation.
  3. Investors in biotech companies must be prepared for a long journey of constant failures and successes, akin to the process of drug discovery, with potential acquisitions being key outcomes.

Sonia Gandhi's mission to change Parkinson's trials

Rory’s Always On Newsletter • 734 implied HN points • 05 Sep 23
🏥 Health & Wellness Clinical Trials Neuroscience
  1. Professor Sonia Gandhi leads a mission to improve Parkinson's trials by implementing ACT PD initiative for more efficient drug testing.
  2. The UK aims to become a hub for clinical trials like the multi-arm system to find disease-modifying therapies for Parkinson's faster.
  3. Funding is crucial for scientists like Professor Gandhi to advance technology and trial designs for breakthroughs in Parkinson's research.

Did the Pfizer Trial Show the Vaccine Increases Heart Disease Deaths?

Harnessing the Power of Nutrients • 2256 implied HN points • 19 Feb 22
🏥 Health Politics Vaccine Safety Clinical Trials
  1. The Pfizer trial did not show a statistically significant increase in all-cause mortality or cardiac mortality among vaccinated individuals
  2. The trial would have needed to be longer for significant differences to show, suggesting the need for longer trials in vaccine studies
  3. It's important to consider all possible risks found in trials seriously, even when statistically insignificant, and to approach vaccine research with caution

URGENT: A young child died of cardiac arrest after being jabbed during Moderna's key Covid vaccine trial

Unreported Truths • 84 implied HN points • 03 Jan 25
🏥 Health Politics Public Health Vaccination Clinical Trials Policy decisions Safety concerns
  1. A young child died from cardiac arrest after receiving a Moderna Covid vaccine during a trial. This incident hasn't been publicly reported in official channels.
  2. Moderna did not mention the child's death in their published results, raising concerns about transparency in their clinical trial process.
  3. The safety results from the trial show that children given the Moderna vaccine had more serious side effects compared to those who received a placebo.

The Placebo Paradox: Why Placebos Are Ineffective In Psychedelic Research

Tripsitter • 79 implied HN points • 20 Mar 24
🏥 Health & Wellness Psychedelics Placebo effect Research Methods Clinical Trials
  1. Researchers struggle with placebo controls in psychedelic trials due to the unmistakable subjective experiences and physiological effects of psychedelics, making blinding participants difficult.
  2. The power of expectations and beliefs influence the effectiveness of psychedelics, leading to challenges in maintaining placebo controls and interpreting trial results.
  3. Alternative approaches in psychedelic research involve creating placebo psychedelic experiences or comparing psychedelics directly to established treatments, offering potential solutions to traditional placebo limitations.

Did FDA know a child had died in Moderna's Covid jab clinical trial? If so, what did the agency do about it?

Unreported Truths • 49 implied HN points • 06 Jan 25
🏥 Health Politics Public Health Regulatory Affairs Pharmaceuticals Vaccination policy Clinical Trials
  1. A child died during Moderna's Covid vaccine trial, and there's confusion about whether the FDA was informed about this death.
  2. The FDA's responses seem deliberately vague, avoiding a clear acknowledgment of the child's death.
  3. Senator Ron Johnson plans to investigate further, which could lead to more transparency from the FDA.

How Moderna hid the death of a child in a Covid vaccine clinical trial - even as it seemed to disclose the trial's results

Unreported Truths • 45 implied HN points • 09 Jan 25
🏥 Health Politics Vaccines Clinical Trials Public Health Health Policy Regulatory issues
  1. A child died during Moderna's Covid vaccine trial, but the company didn't report it properly. This raised concerns about transparency in vaccine testing.
  2. Moderna published trial results that excluded details about the child's death, which created confusion about the safety of their vaccines for children.
  3. The company has not provided further details about the child's health condition or the circumstances of the death, leaving important questions unanswered.

Don't Drink The Electric Kool-Aid: The Acid Ban Explained 🍹🌈

Tripsitter • 159 implied HN points • 31 Aug 23
🏥 Health & Wellness Psychedelics Clinical Trials
  1. LSD was initially used for clinical purposes but got labeled as a Schedule I drug due to potential abuse, hindering its further research and development for treating mental health disorders.
  2. During the counterculture movement in the 1960s, LSD gained popularity for expanding consciousness and creativity, leading to conflicts with traditional values and eventually being banned.
  3. The CIA's Project MK-Ultra involved unethical human experimentation with LSD for mind control, sparking profound consequences and contributing to the stigma and legal issues surrounding LSD today.

Vial: Reimagining Clinical Trials

The Century of Biology • 308 implied HN points • 30 Jul 23
🏥 Health & Wellness Clinical Trials Drug Discovery Medical Technology Healthcare system Biomedical Research
  1. Vial is working to reduce the cost of clinical trials by innovating new technology.
  2. Vial's Act I focuses on structuring, digitizing, and automating the clinical trial process to drive efficiency.
  3. Vial's Act II, Battery Bio, aims to revolutionize drug discovery by integrating software and advanced technologies in a vertically integrated approach.

Pfizer's secret documents reveal that their COVID vaccine actually made you 8.7% more likely to get COVID

Steve Kirsch's newsletter • 14 implied HN points • 08 Jan 25
🏥 Health Politics Vaccination Public Health Policy Analysis Safety concerns Clinical Trials
  1. Pfizer's documents suggest that the COVID vaccine may have actually increased the chance of getting COVID by 8.7%.
  2. The data showed that vaccinated individuals were less likely to develop N-antibodies, which means they might have had more infections than those who weren't vaccinated.
  3. There are serious concerns about the effectiveness of the vaccine, and some people believe it may have contributed to a rise in COVID deaths after it was rolled out.

What the “Casual Cruelty” of Dr. Paul Offit Reveals

Injecting Freedom • 137 implied HN points • 03 Aug 23
🏥 Health & Wellness Vaccines Childhood Clinical Trials Safety Informed consent
  1. Dr. Paul Offit's article raises concerns about vaccine clinical trials and the lack of placebo controls.
  2. There is a debate about the safety and efficacy of childhood vaccines and the importance of proper clinical trials.
  3. The ethical considerations of vaccine trials and the need for valid safety profiles are highlighted.

The CFR from the Pfizer trial show the vaccines make you 5x more likely to die from COVID

Steve Kirsch's newsletter • 14 implied HN points • 25 Dec 24
🏥 Health Politics Vaccines Public Health Clinical Trials COVID-19 Health Risks
  1. Vaccinated individuals may have a higher case fatality rate from COVID, being five times more likely to die if they contract the virus after getting vaccinated.
  2. There is a suggestion that vaccinated people could be 40% more likely to catch COVID compared to unvaccinated individuals.
  3. When combining the increased likelihood of infection with the higher fatality rate, it is estimated that the risk of dying from COVID can be over five times greater for those who received the vaccine.

The One Amino Acid That Could Cure COVID

Harnessing the Power of Nutrients • 219 implied HN points • 19 Feb 22
🏥 Health & Wellness COVID Clinical Trials
  1. An Italian clinical trial published in a respected medical journal provided evidence about the impact of arginine on COVID.
  2. The study's findings were described as incredible, suggesting a potential role for arginine in fighting COVID.
  3. This information was shared by a PhD in Nutritional Sciences and is meant for educational purposes, not medical advice.

Pfizer pregnancy trial showed the COVID shots increased AESIs (like major congenital abnormalities) in newborns by over 4X

Steve Kirsch's newsletter • 12 implied HN points • 26 Nov 24
🏥 Health Politics Vaccine Safety Public Health Medical Ethics Clinical Trials Maternal health
  1. A recent study found that COVID vaccines during pregnancy are linked to a 4.2 times higher rate of serious problems in newborns compared to unvaccinated mothers.
  2. The study showed no benefit in preventing COVID infections among vaccinated and unvaccinated mothers, meaning the vaccine didn't help at all.
  3. Despite these concerning results, there seems to be a lack of awareness or action from health authorities to inform or protect pregnant women from these risks.

Clinical Trial to License RotaTeq, Like Almost All Childhood Vaccines, Did Not Use a Placebo Control

Injecting Freedom • 80 implied HN points • 25 Jun 23
🏥 Health Politics Vaccines Clinical Trials FDA
  1. Most childhood vaccines were licensed without using a placebo control in their clinical trials.
  2. The clinical trial for RotaTeq did not use a true placebo as the control group, but included bioactive ingredients.
  3. Robert F. Kennedy, Jr. advocates for vaccine safety and freedom of choice without restricting access to vaccines.

The Potential of Psychedelics

The Last Bear Standing • 43 implied HN points • 15 Mar 24
🏥 Health & Wellness Psychedelics Mental health Therapeutics Clinical Trials FDA Approval
  1. There has been a resurgence of interest in the medical potential of psychedelics, with ongoing research and clinical trials exploring their efficacy in treating mental health conditions.
  2. Despite the challenges and market fluctuations, there is increasing regulatory support for psychedelic drug trials, potentially leading to FDA approvals and breakthrough therapy designations for conditions like PTSD.
  3. Psychedelic treatments involve controlled drug administration in conjunction with therapy, aiming to address the root causes of mental health disorders by stimulating new perspectives and thought patterns.

Perkins' Tractors: a fashionable remedy put to the test

The Quack Doctor • 19 implied HN points • 01 Dec 23
💾 History Medical Devices Clinical Trials Placebo effect Medical History
  1. Perkins' Metallic Tractors were an 18th-century medical device believed to relieve pain by attracting fluid away from the body using metal prongs, based on the concept of 'Perkinean Electricity'.
  2. Dr. John Haygarth conducted an early clinical trial on Perkins' Tractors, revealing placebo responses that influenced disease perception through imagination, showcasing the importance of evidence in medical treatments.
  3. Haygarth's experiments demonstrated the significance of comparing new treatments against controls, emphasizing the ongoing process of making clinical research as objective as possible.

COVID-19 vaccines’ effectiveness and safety exaggerated in clinical trials & observational studies, academics find

Who is Robert Malone • 15 implied HN points • 06 Mar 24
🏥 Health & Wellness Vaccines Clinical Trials Safety Effectiveness
  1. Claims about COVID-19 vaccines' effectiveness and safety were exaggerated in clinical trials and observational studies, impacting risk-benefit analyses.
  2. Observational studies exhibited biases like case-counting window bias, affecting estimates of vaccine effectiveness.
  3. Studies showed issues with safety estimates, short counting windows, and potential negative effectiveness of COVID-19 vaccines.

An Insider Perspective on the FDA: History and Role

Holodoxa • 39 implied HN points • 14 Oct 22
🏥 Health Politics Clinical Trials Public Trust
  1. Understanding the FDA's approval process for drugs includes stages like drug discovery, preclinical studies, clinical trials, and regulatory approval.
  2. The FDA's accelerated approval program, initiated in the 1990s due to HIV/AIDS, aims to speed up bringing life-saving drugs to market for urgent conditions, but follow-up studies are crucial.
  3. FDA approval decisions hinge on expert clinical judgment, balancing benefits and risks for patient safety and efficacy, a process that involves multiple stakeholders and extensive data evaluation.

The Anatomy of a Clinical Trial

Superfluid • 26 implied HN points • 19 Apr 23
🏥 Health & Wellness Clinical Trials Logistics Data Analytics Future Trends
  1. Clinical trials are expensive and crucial for determining the efficacy and safety of new drugs.
  2. There are multiple stakeholders involved in running a clinical trial, each with important roles to play.
  3. Challenges in clinical trials include patient recruitment, trial logistics, and data analytics, but there are innovative startups working on solutions.

Avoiding Neurotech's Theranos

NEUROTECH FUTURES • 1 HN point • 13 May 24
🕹 Technology Neurotech Startups Clinical Trials Investors Wearable Technology
  1. Elemind, a neurotech startup, raised $12 million but displays red flags such as lack of product-market fit and a potential mismatch between its science and business teams.
  2. The company has made eyebrow-raising claims about its technology, including rapid results in sleep induction and other neurological benefits.
  3. Critical analysis is crucial in the neurotech industry to steer clear of potential scams and inflated promises.

MoonLake Immunotherapeutics

Axial • 7 implied HN points • 17 Feb 24
🏥 Health & Wellness Biotechnology Clinical Trials Drug Development
  1. MoonLake Immunotherapeutics is developing a tri-specific nanobody therapy called Sonelokimab (SLK) that has shown significant efficacy in treating inflammatory diseases like HS, PsA, and PsO.
  2. SLK offers unique benefits like blocking all IL-17 pro-inflammatory dimers, enabling tissue penetration, and maintaining high response rates in patients with moderate-to-severe conditions.
  3. MoonLake's SLK has the potential to become a best-in-class IL-17 inhibitor in a multibillion-dollar market, with its innovative structure, clinical success, and competitive advantages over existing treatments.

Axial Discovery - Clinical trial statistical analysis

Discovery by Axial • 1 implied HN point • 08 Sep 23
🔬 Science Clinical Trials Statistical Analysis Software Development Data Integration Data Visualization
  1. Clinical trial statistical analysis involves collecting and interpreting data to evaluate new treatments.
  2. Startups have opportunities to develop software for automating and streamlining statistical analysis processes due to increasing data complexity.
  3. Software development for data integration, visualization, and communication can improve efficiency in clinical trial statistical analysis.

Five New Vitamin D and COVID-19 Studies

Harnessing the Power of Nutrients • 0 implied HN points • 14 Aug 20
🏥 Health & Wellness Vitamin D COVID-19 Research Studies Clinical Trials
  1. Genetic studies on vitamin D and COVID-19 are inconclusive, showing no clear causal link.
  2. There is potential for a U-shaped curve in the relationship between vitamin D levels and COVID-19 risk, with optimal levels between 30-40 ng/mL.
  3. Maintaining vitamin D levels above 30 ng/mL is associated with lower COVID-19 risk, severity, and mortality, with clinical trials underway to provide more clarity.