Questions tagged [clinical-study]

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Good Resoures for Learning/Studying GCP

Are there any widely accepted resources out there for studying/learning good clinical practices in the U.S. outside of the actual FDA webpage for the matter? Something an entry-level clinical ...
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How are two-dose vaccine schedules developed?

How are vaccination schedules determined for multi-dose vaccines? That is, are several different schedules tested in an early-phase trial? Or do the developers of a vaccine choose a schedule (based on ...
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What does “pause” mean in Covid19 Vaccine Clinical Trials?

Johnson and Johnson as well as Astra Zeneca recently announced that they were going to "pause" in their respective clinical trials for a Covid19 vaccine. What exactly are they "pausing&...
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Have any regulatory agencies announced they would allow live Covid-19 human challenges (for vaccine testing purposes)?

It's been mentioned to me in the discussion on another question that the following proposal has been advanced (in a medical journal): Controlled human challenge trials of SARS-CoV-2 vaccine ...
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How can I set up alerts to notify me of COVID-19 clinical trial participation opportunities for healthy US volunteers outside of infection “hotspots”?

I live in a mid-size US city not hit too hard by the coronavirus. Is there a good way to set up email alerts (or similar) to alert me to COVID-19 clinical trials in my area that I can volunteer for? I ...
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1answer
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What happens when a candidate drug becomes an ATMP? What's the list of ATMPs?

According to The Alliance for Regenerative Medicine, the following six Tissue-Engineered Products are available in Europe. Spherox Novocart 3D ReNovaCell ReGenerCel Vergenix FG Vergenix-STR I ...
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In contraceptive effectiveness ratings, are “typical use,” and “perfect use” self-reported?

The effectiveness of contraception methods is typically reported as two percentages: typical use and perfect use. Typical use is the measure of how the average couple is likely to use the method, and ...
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Meaning of “central registration system” in Japanese clinical trials

Quote from a Japanese clinical trial report: METHOD: An observational study was conducted on patients who relapsed after primary systemic therapy with TZM using the central registration system. The ...
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How are participants in a clinical study of a new medication selected and monitored?

I don't have any background in medicine, but I'm interested. How are participants in a clinical study of a new medication selected and monitored? Do they make an announcement calling for volunteers? ...
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35 views

Do side effects spoil blind studies?

One group is given a newly developed medication X, and the other group placebo. If X has noticeable side effects, like extra sleepiness, change in appetite, tremors, etc, wouldn't the participates in ...
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Why do phase I [vaccine] trials [normally] last several months if [on average] they can't find any serious adverse effects?

Let me ask a "devils' advocate" question that hopefully clarifies a point on another popular (for some reason) question here: We can read for example (in a meta-analysis that's not even ...
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Long-term side effects of anti-covid vaccines

I am interested in statistical procedures and study designs used to determine the absence/acceptability of long-term side effects of the anti-covid vaccines. Given that these vaccines were created and ...
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Is there solid data whether abandoning information technology in healthcare increases adverse events or errors made?

Hello fellow scientists, I work in a hospital where a lot of processes are digitalized (e.g., electronic health records, QR-code assisted workflow for prescribing medication etc.). I am looking for ...
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Is the MSC-based regenerative medicine promising for Ischemic stroke stroke patients? ; two points difference in the 47-point test

Many papers says, regenerative medicine using MSCs are promising for Ischemic stroke stroke patients. But in my layman's sense, various data don't seem promising. So, I want to hear the opinions of ...
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Among COVID-19 patients who have died - what is the estimated distrubution of the time from symptom onset to death?

In the https://www.who.int/docs/default-source/coronaviruse/who-china-joint-mission-on-covid-19-final-report.pdf I found: Among patients who have died, the time from symptom onset to outcome ...
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Meaning of “platinum sensitivity and primary PFI being repowered as prognostic factors”

Quote from a clinical trial report: Recurrence eventually affects 70–80% of patients with advanced epithelial ovar-ian cancer [2, 22], with platinum sensitivity and primary PFI being repowered as ...
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What is the difference between “clinician” and “therapist”?

I am reading the book Mindfulness and Psychotherapy, and at first I thought clinician and therapist are used interchangeably, but it seems not. So is there any difference between the two? If yes, is ...
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Do drugs that increase (or don't decrease) mortality during clinical studies still get approved and if so - why?

From reading about clinical studies on various chronic diseases, I get a sense that increasing lifespan is rarely the primary objective of these studies, and instead they focus on surrogate markers, ...
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Are there any examples of successful multi-decade prevention interventions with pharmaceuticals?

With many tests able to detect various physical abnormalities, even before symptoms develop (if ever), modern treatments may require individuals to take medications for decades. Are there any examples ...
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What are the pitfalls using the standard vaccine effectiveness calculation process if applied to reinfectivity observations?

Phase 3 clinical trials for Covid-19 vaccines have been completed, and the "effectiveness" values have been made available. The trials involved a placebo arm, such that if the vaccine were ...
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34 views

What study design is used in this research?

https://www.sciencedirect.com/science/article/abs/pii/S1939865415001113 I've learned about many types of study design including experimental (randomised control trials etc.) and observational study ...
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Studies On The Affect Of Immunotherapy On Larynx Surgeries

I've been searching online for a study regarding the affect of immunotherapy on the necessity for an affected individual diagnosed with laryngeal cancer to require larynx surgery, to no avail. Could ...
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Meaning of “patients were self-selected to undergo treatment or remain untreated”

From Treatment of Folate Metabolism Abnormalities in Autism Spectrum Disorder: In an open-label therapeutic trial of patients with nonsyndromic infantile ASD, patients were self-selected to undergo a ...
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Effects of placebo on viral load in tests for effectiveness of a drug combination for COVID-19

I have very little background in Medicine, pardon me for that. I came across this reference recently. Loosely speaking, this study aims at testing the effect of azithromycin and hydroxychloroquin for ...
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A question about clinical trials for different formulations

Suppose a new antibiotic in an iv formulation exists and has been approved When you want to test the oral formulation and phase 3 comes you should test it against what? A placebo or the iv formulation ...