In the Research Lab for your Doctor’s Office This Is What Occur in Phase 1, 2, 3 Drug Trials

 

Explaining Clinical Trials for Bladder Cancer

Video taken from the channel: Bladder Cancer Advocacy Network


 

Phase I clinical trials: Access to hope

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5.5 Clinical Trials and Informed Consent

Video taken from the channel: Ohio State University Comprehensive Cancer Center-James Cancer Hospital & Solove Research Institute


 

PART 2 | Dr. Alejandra Guerchicoff Clinical Trials and Adverse Events Reporting

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Phases of Clinical Trial

Video taken from the channel: CLINICAL GYAN


 

Understanding Clinical Trials

Video taken from the channel: LymphomaTV


 

The Clinical Trial Journey

Video taken from the channel: Mayo Clinic


Drugs that pass phase 1 trials can be considered likely safe, but whether they work or not still remains to be seen. Phase 2 trials. In phase 2 trials.

If there is evidence in either phase 1 or phase 2 that the drug or vaccine is unsafe or ineffective, the teams will stop the trial. Phase 3 trials. Phase 3 trials are where researchers look to.

From the research lab to your doctor’s office – here’s what happens in phase 1, 2, 3 drug trials June 2, 2020 8.13am EDT For COVID-19, like all illnesses, the drugs and vaccines to treat or prevent. Your Health From the Research Lab to Your Doctor’s Office – Here’s What Happens in Phase 1, 2, 3 Drug Trials Drugs and vaccines to fight the coronavirus are already in clinical trials. It is important to understand the difference between each step in this process as efforts to fight COVID-19 continue.

From the research lab to your doctor’s office – here’s what happens in phase 1, 2, 3 drug trials. Jun 02, 2020. Recommended for you. New drug could stop deadly superbug, save tens of thousands.

Here’s what happens in phase 1, 2, 3 clinical drug trials. Phase 1 trials are focused on safety.Researchers monitor kidney, liver, hormone and cardiac functions to look for adverse affects in. Read more: From the research lab to your doctor’s office – here’s what happens in phase 1, 2, 3 drug trials Ginseng in 11th-century. Alzheimer’s Clinical Trials Consortium Down Syndrome. From the research lab to your doctor’s office – here’s what happens in phase 1, 2, 3 drug trials.

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Footer. Phase III of a clinical trial usually involves up to 3,000 participants who have the condition that the new medication is meant to treat. Trials in this phase can last for several years.

Phase 3 trials: Final confirmation of safety and effectiveness If phase 2 has confirmed the effectiveness of a drug, the FDA and sponsors will discuss how to conduct large-scale studies in phase 3.

List of related literature:

The reasons to conduct these trials are diverse, and the number of patients studied over the lifetime of the drug can ultimately exceed the original development programme, as theoretically there is no point at which Phase IV stops.

“Seminars in Clinical Psychopharmacology” by Peter M. Haddad, David J. Nutt
from Seminars in Clinical Psychopharmacology
by Peter M. Haddad, David J. Nutt
Cambridge University Press, 2020

The last is phase III which is randomized controlled trial done on a large number of patients with different case histories.

“Biostatistics for Medical, Nursing and Pharmacy Students” by A. Indrayan, L. Satyanarayana
from Biostatistics for Medical, Nursing and Pharmacy Students
by A. Indrayan, L. Satyanarayana
Prentice-Hall of India, 2006

Phase IV trials continue once the drug has approval for clinical use in order to monitor, report and collate adverse and other reactions not reported in earlier phases.

“Alexander's Nursing Practice E-Book: Hospital and Home” by Ian Peate
from Alexander’s Nursing Practice E-Book: Hospital and Home
by Ian Peate
Elsevier Health Sciences, 2019

A phase II trial determines the safety and efficacy of the drug, device or procedure by testing it on a small number of patients who have the disease being studied.

“Mastering Medical Terminology EPUB: Australia and New Zealand” by Sue Walker, Maryann Wood, Jenny Nicol
from Mastering Medical Terminology EPUB: Australia and New Zealand
by Sue Walker, Maryann Wood, Jenny Nicol
Elsevier Health Sciences, 2020

Finally, phase III trials involve testing the drug on a larger group of patients who take it under supervision for a longer period of time.

“Medical Law: Text, Cases, and Materials” by Emily Jackson
from Medical Law: Text, Cases, and Materials
by Emily Jackson
Oxford University Press, 2019

Phase 4 clinical trials: These are postmarketing trials that may be requested by regulatory agencies upon their review of the New Drug Application (NDA) or in response to effects that become evident as more patients become exposed to the drug.

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from Hayes’ Principles and Methods of Toxicology
by A. Wallace Hayes, Claire L. Kruger
CRC Press, 2014

In a phase III trial, patients are randomized to a new regimen or to a control group.

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from Predictive Biomarkers in Oncology: Applications in Precision Medicine
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Springer International Publishing, 2018

These trials serve to assess the potential role of the new drug in routine clinical practice; the phase III results will largely dictate whether or not the prospective drug subsequently gains approval for general medical use.

“Pharmaceutical Biotechnology: Concepts and Applications” by Gary Walsh
from Pharmaceutical Biotechnology: Concepts and Applications
by Gary Walsh
Wiley, 2007

If a drug shows promise in the first phase, it moves into phase-two trials, which are conducted on patients.

“Social Issues in America: An Encyclopedia” by James Ciment
from Social Issues in America: An Encyclopedia
by James Ciment
Taylor & Francis, 2015

Phase I (Assess Drug Safety): The Phase I clinical trial is the first experiment in which a drug is tested on the human body.

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from SAS Clinical Programming: In 18 Easy steps
by Y. LAKSHMI PRASAD
Notion Press, 2014

Oktay Kutluk

Kutluk Oktay, MD, FACOG is one of the world's foremost experts in fertility preservation as well as ovarian stimulation and in vitro fertilization for infertility treatments. He developed and performed the world's first ovarian transplantation procedures as well as pioneered new ovarian stimulation protocols for embryo and oocyte freezing for breast and endometrial cancer patients.

Mail: kutluk.ok[email protected]
Telephone: +1 (877) 492-3666

Biography: https://medicine.yale.edu/profile/kutluk_oktay/
Bibliography: oktay_bibliography

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7 comments

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  • according to updated informations approx. 2 % of all drugs can cure something and 98 % only can supress symptoms…. at its best…. but so many victims have been killed from terrible side effects because of hidden information about how ddangerous many of these drugs really are… it is just very SAD… so thank GOD for the younger and much wiser generation of scientists around the world devoted to go a totally different pathway to heal sick people and save them from the evil and dangerous pharma (drug) industry:-(

  • Imagine if it will take how many years to reach that vaccine to the human.. millions or thousands of people die every day or month year.. Genocide

  • Thank you very much for this informative video. Grateful to you for the effort. I think the background music is a bit distracting so it might be good to have the video without it.

  • Indian medicine 100% can be recover Corona virus3 drop basil liquid +1 drop neem liquid solution (3:1) -1spoon boil water used……. Continue 10 times a day that’s recover totally Corona virus….. Please do every country those who affected……

  • Why do you need to vaccinate the whole World for, so Gates & Fauci get richer? What tests have been done on the new vaccine, what are the side effects? (Takes at least 5 years to test) Look at the page full of information below. What do they put in Vaccines (Look at CDC document below and you will be shocked!) BILL GATES, FAUCI, THE POLITICIANS AND MEDIA SHOULD GO TO JAIL!

    https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf

    ​Look at the DAMAGE CAUSED BY wearing of Masks (Not what our corrupt Media & Government are saying!)
    https://www.bitchute.com/video/msAZ6UhtvI4C/

    THIS VIDEO WITH ONE OF THE TOP 50 DOCTORS, AND OVER 100 OTHER UNCENSORED DOCTORS BELOW?
    http://www.londonreal.tv/roundtable

    ​I’m NOT ANTI VAX, i’M ANTI UNTESTED VAX BEING PUMPED OUT! I THINK YOU SHOULD ASK THE PEOPLE IN AFRICA AND INDIA ABOUT GATES!
    https://davidicke.com/2020/05/01/bill-gates-wants-indemnity/
    https://questioningcovid.com/

    ​​ https://csglobe.com/agenda-21-depopulation-95-world-2030/

    ​​ https://www.youtube.com/watch?v=O0p5YTVgJyg

    ​​ https://www.youtube.com/watch?v=StrBjHK7qeg

    ​​ https://twitter.com/Jordan_Sather_/status/1290135792027750403

    ​WATCH A FILM CALLED VAXXED BEFORE TAKING ANY VACCINE
    Join https://twitter.com/StopNewNormal​ OR https://www.standupx.info/​

  • I am so happy for the people devoting their careers to demand full openness about all clinical trials so all the hidden bad side effects and deaths no more can be hidden for public and health care providers in general… in Europe we have come far….. so far…..

  • Very good explained. But there is a lot of very precialsy equipment like ecg machines, holter or blood pressure devices behind to collect, measure and interprate all this important datas which come in. I work in a Core Lab and we make a lot of Phase I/II studies.