Questions tagged [clinical-study]

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Meaning of “episode-based analysis” in a description of a medical records-based study of suicide incidence after therapy

From "ECT Reduces Suicide Risk in Severe Depression: New Data" (MedScape) Quote: In the matched sample, ECT was associated with a significantly decreased risk for suicide within 12 months ...
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Do experimenters in clinical trials refuse to give a placebo to a patient depending on his condition?

In clinical trials to test a new drug, typically there is a group who takes the new drug and another group which gets another already existing drug which is supposed to be effective or a placebo. Each ...
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Meaning of “There was no assessment of the types or effectiveness of risk factor controls over time in reducing stroke odds”

From a news article titled Having OCD May Triple a Person's Odds for a Stroke: Dr. Larry Goldstein, chairman of the University of Kentucky department of neurology in Lexington, reviewed the study ...
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Were thrombocyte counts or bleeding events monitored at all during ChAdOx1 (AZD1222) clinical trials?

Maybe I'm just missing something, but on a quick look, I find it a bit strange that since issues with thrombocyte (platelet) counts in adenovirus-vectored therapeutics have (1) been known for about ...
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What is missing for the Pfizer-BioNTech vaccine to get “regular” FDA approval?

Last year, the US FDA issued an "Emergency Use Authorization" for Pfizer-BioNTech vaccine for Covid-19. I read the wikipedia page on what that means, and it seems as though this can be ...
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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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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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How do I read this graph about pneumonia death rates in the elderly?

I want to decipher this graph, but it confuses me: Source The color indicates the age bracket of the patient, but the age bracket is already in the x axis. For example, what does the gray bar in the ...
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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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BNT162b2 mRNA Covid-19 Vaccine efficacy after 1st dose - explain the statistics

Pfizer's paper (Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine) published recently states the following in the Efficacy subsection of the Results section: Between the first dose and the ...
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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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How to find FDA's and EMA's review reports and related minutes

Lately, I've been thinking about how we can't make various decisions without going back to what data and the logic behind the drug's approval. I'd like to ask a question about how to search such ...
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Relationship between FDA Agencies and the Advisory Committee

This article has the following descriptions; "Perhaps what is most surprising is that in mid-August, the FDA's Oncologic Drugs Advisory Committee (ODAC) voted 9 to 1 to recommend the drug for ...
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The process of drug approval; The flow from R&D, planning a clinical trial to drug approval, or other additional process

I'd like to know the process of drug approval; the flow from R&D, planning a clinical trial to drug approval, or other additional process. As far as I am aware, some documents provide too much detail ...
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Would neurons regenerate even in adults? [closed]

I want to know whether or not the nerves regenerate in human adults. My Question Please give me evidences for this issue. What experiments and logic do they use to prove that the nerves are/are not ...
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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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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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Is the efficacy of N95 respirators or surgical masks reduced when wet (COVID-19)?

If my face mask gets wet, is its efficacy in preventing the spread of coronavirus diminished? If so, how much? It's monsoon season here in India, and my method of transportation (safer than crowded ...
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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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If placebo controls work even when the patient is aware that the treatment is a placebo. Why are deceptive placebo controls used?

Placebos are “fake” treatments prescribed for the psychological benefit to the patient rather than for any physiological effect. Placebos are used for conditions defined by “self-observation” symptoms ...
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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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The placebo effect [closed]

Is it possible to eliminate the groups of placebos in all those clinical trials that have a precision medicine nature? Since if it is precision medicine, it is supposed to cure 100% of those affected ...
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Progress of the FDA's review of RMAT products

The U.S. FDA appears to have five shortcut regulatory approval ways, as follows; (1) Accelerated Approval (2) Priority Review (3) Fast Track (4) Breakthrough Therapy (5) RMAT:Regenerative Medicine ...
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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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When would a placebo/control group *not* be used in medical research?

Related: Why use a placebo in some potential COVID-19 vaccine trials? What is the point of a placebo in studies where the subject can determine their group? The answers to the questions above give ...
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Meaning of “I” in a table in a study poster

From a poster to a study: I don't understand the meaning of "I" used in several fields of this table. What could it mean? I've read the abstract of the study but still cannot get it. The ...
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Meaning of “(ref)” in a table describing the characteristics of patients taking part in a cancer study

From a poster describing a study in cancer patients. This is from a table in the poster, which describes the characteristics of the patients (Age groups, Sex ect.) You can see what percentage of the ...
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Meaning of “D1 q3w” in a poster to a clinical trial

From a poster to a clinical trial: I can understand that q3w means "once every 3 weeks", but what is the meaning of D1? I think the first DI must be a typo and it stands for D1 too.
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Efficiency of favipiravir to treat covid 19

I have seen in news that Russia approved the drug Avifavir (favipiravir) for covid treatment.As this drug has significantly reduced the duration of infection.Some scientists Claimed that it is a good ...
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Meaning of “correlates” in “.. clinical therapeutic studies of LAC in depression and TRD and its correlates .. ”

From "Myriad of implications of acetyl-l-carnitine deficits in depression": Nasca et al. (1) were appropriately conservative in interpreting their findings and pointing out multiple directions for ...
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what is the difference between clinical trial study and clinical study?

Can every study that is focused on evaluating the effect of a drug in humans be regarded as a clinical trial study? For example: A study is conducted to find the effect of "Azadirachta indica" on ...
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What would it be like to participate in a (coronavirus) challenge trial, in the US?

I am strongly considering volunteering for any COVID human challenge trial that becomes available near me (midwestern United States). I am willing to undergo long-term isolation. However, I am not ...
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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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Can COVID-19 be damaging lung without showing fever? [closed]

Given that a man of 39 years without underlying health condition, is having chest discomfort and tightness, which is more discomfort during evening and night before fall asleep. He don't have cold and ...
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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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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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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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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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What is the meaning of “group-by-region interaction effects” (PET scan study of brains affected by schizophrenia)?

I was reading a recent study on schizophrenia and came across this sentence: We found significant group and group-by-region interaction effects on volume of distribution (VT). What is the ...
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How to evaluate the results of diagnostic studies: how to prove that new method is better than gold standard?

I understand how to evaluate therapeutic studies: basically you compare the results of two groups that were chosen randomly. One group gets the new drug, the other group gets the placebo (or the drug ...
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What is Spanish equivalent of webpage clinicaltrials.gov?

Can you recommend any Spanish database of medical studies/clinical records, equivalent to English clinicaltrials.gov ? Medical texts should be in Spanish, not webpage necessarily.
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How has the research of the effects/benefits of yoga progressed since 2015?

Four years ago, in 2015, Vox published this piece: I read more than 50 scientific studies about yoga. Here's what I learned. I'm assuming (correct me if I'm wrong) that it's a reasonable survey 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 ...
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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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Are there websites with clinical trial reports freely available for download?

I'm a translator, and I'm currently translating clinical trial reports, Russian to English. I wonder if there are depositories of freely available clinical trial reports, with all appendixes and all ...
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Are there any studies that prove the effectiveness of saw palmetto for restoring hair in the bald places and stop hair fall?

I'm looking for studies apart from the ones in the third link in my question, that prove the efficacy of saw palmetto in 1) stop hair fall, and 2) growing back hair in the places of the scalp where ...
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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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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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Are “data cut off” and “data lock” the same thing in a clinical trial?

Quotes from a clinical trial report (JGOG3022 trial): Follow-up was terminated in February 2017 and data were locked in October 2017. Of the 346 patients enrolled, ineligible patients and patients ...
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What is the purpose of the “observation cohort” in a clinical trial?

Quote from a clinical trial report (JGOG3022 trial): Patients who were scheduled to receive bevacizumab concomitantly with platinum-based combination chemotherapy after PDS or IDS were included in ...