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Clinical trials of drugs, procedures, and devices. We typically talk about clinical trials in four phases. In the FDA's language:

  1. phase I clinical trial — safety screening. "Researchers test an experimental drug or treatment in a small group of people for the first time. The researchers evaluate the treatment’s safety, determine a safe dosage range, and identify side effects."
  2. phase II clinical trial — efficacy and dosing, often placebo controlled. "The experimental drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety."
  3. phase III clinical trial — large-scale, randomized, placebo controlled test of safety and efficacy, typically involving thousands of test subjects. "The experimental study drug or treatment is given to large groups of people. Researchers confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely."
  4. phase IV clinical trial — post-marketing evaluation of risk, benefit, and optimal use. "Post-marketing studies, which are conducted after a treatment is approved for use by the FDA, provide additional information including the treatment or drug’s risks, benefits, and best use."

Since about 2006 the FDA has issued guidelines for the "phase 0 trial," using very small numbers of volunteers (<15) to evaluate pharmacodynamic and pharmacokinetic properties.

See https://www.fda.gov/patients/clinical-trials-what-patients-need-know/what-are-different-types-clinical-research (accessed Jan 2021).

Found 42 search result(s) for "clinical trial" OR phase.

Page: 3.2 Samuel Broder: The First Clinical Trials of Antiretroviral Drugs (HIV/AIDS Research: Its History & Future Meeting)
... GlaxoSmithKline) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=15532443  cell culture, tissue culture, immortalized cell line https://libwiki.cshl.edu/confluence/display/AT/cellculture%2Ctissueculture%2Cimmortalizedcellline  clinical trials (phases of clinical research) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12944889  Concanavalin A (ConA) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=15532840  control — experimental control, control group ... strong belief that there was some rationale for thinking other products would be available.  This was the first ...
Apr 27, 2021
Page: clinical endpoint, clinical outcome (HIV/AIDS Research: Its History & Future Meeting)
... clinical trials (phases of clinical research) the "clinical endpoint" is the desired outcome of the treatment being tested. Contrast with surrogate marker (surrogate ...
Dec 31, 2020
Page: iPrEx (Iniciativa Profilaxis Pre-Exposición) study, 2007–2011 (HIV/AIDS Research: Its History & Future Meeting)
... iPrEx study (2007–2011) was the first phase III clinical trial to study the effectiveness of preexposure prophylaxis (PrEP). See  Grant, Robert M., Javier ...
Feb 04, 2021
Page: CAPRISA 004 study (2007–2010) (HIV/AIDS Research: Its History & Future Meeting)
... CAPRISA 004 was a phase II trial of topically applied tenofovir gel for HIV prevention in women, conducted from 2007 ...
Feb 18, 2021
Page: Fem-PrEP study (2009–2011) (HIV/AIDS Research: Its History & Future Meeting)
... FEMPrEP was a Phase III clinical trial designed to assess the safety and effectiveness of a daily Truvada (FTCtenofovir) for HIV prevention among ...
Feb 04, 2021
Page: VOICE study (2009–2011) (HIV/AIDS Research: Its History & Future Meeting)
... VOICE study ("Vaginal and Oral Interventions to Control the Epidemic") study was a phase II clinical trial that examined the use of tenofovir vaginal gel. It began in 2009 and was stopped in 2011 because ...
Mar 07, 2021
Page: STEP study (2004–2011) (HIV/AIDS Research: Its History & Future Meeting)
... STEP study was a phase 2 clinical trial (double blinded, randomized, placebo controlled) of the Merck MRKAd5 HIV1 Gag/Pol ... Nef trivalent vaccine, conducted from 2004 to 2007, and with results published in 20112012. The trial ...
Feb 17, 2021
Page: 3.3 Douglas Richman: Antiviral Drug Resistance and Combination ART (HIV/AIDS Research: Its History & Future Meeting)
... 00:10:00 for the same mutation. Once we were able to initiate phase I and phase II studies through the ACTG (AIDS Clinical Trials Group) with nevirapine, we made a couple of observations regarding drug resistance in vivo ...
Apr 27, 2021
Page: 3.1 Marty St. Clair: Discovery of AZT as the First Anti-HIV Drug (HIV/AIDS Research: Its History & Future Meeting)
... step. 00:24:30 In this journey, our one step was AZT. applause #clinical trials (phases of clinical research) #placebo #control — experimental control, control group, blinded experiment     #bioethics ... ...
Apr 27, 2021
Page: 8.5 Sharon Lewin — Research to a Cure: A Possible Goal? (HIV/AIDS Research: Its History & Future Meeting)
... chemokines https://libwiki.cshl.edu/confluence/display/AT/chemokines Chen, Zhiwei (陳志偉) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=15535016 China https://libwiki.cshl.edu/confluence/display/AT/China clinical trials (phases of clinical research) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12944889 cohort study https://libwiki.cshl.edu/confluence/display/AT/cohortstudy Cold Spring Harbor Laboratory (CSHL ... Histone Deacetylase Inhibitor, for LatentVirus Reactivation in HIVInfected Patients on Suppressive Antiretroviral Therapy: A ...
Apr 27, 2021
Page: Session 7: Prospects for an HIV Vaccine (HIV/AIDS Research: Its History & Future Meeting)
... culture, tissue culture, immortalized cell line https://libwiki.cshl.edu/confluence/display/AT/cellculture%2Ctissueculture%2Cimmortalizedcellline  chemistry, chemists https://libwiki.cshl.edu/confluence/display/AT/chemistry%2Cchemists  clinical trials (phases of clinical research) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12944889  demographic cohort Ebola https://libwiki.cshl.edu/confluence/display/AT/Ebola  education and early career https://libwiki.cshl.edu/confluence/display/AT/educationandearlycareer ... FLSC will display the CD4 00:35:30 induced form of gp120. And in our ...
Apr 27, 2021
Page: 8.2 David Ho — Unraveling of HIV Dynamics In Vivo (HIV/AIDS Research: Its History & Future Meeting)
... cell line https://libwiki.cshl.edu/confluence/display/AT/cellculture%2Ctissueculture%2Cimmortalizedcellline chemistry, chemists https://libwiki.cshl.edu/confluence/display/AT/chemistry%2Cchemists Chiron (1981–2006) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=15534828 clinical trials (phases of clinical research) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12944889 Clinton, Bill (b. 1946) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=15532228 diagram https://libwiki.cshl.edu/confluence/display/AT/diagram drug ... ...
Apr 27, 2021
Page: 6.1 Sharon Hillier — Development and Application of Pre-exposure Prophylaxis (PrEP) (HIV/AIDS Research: Its History & Future Meeting)
... L. https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=15534369 chlamydia https://libwiki.cshl.edu/confluence/display/AT/chlamydia circumcision https://libwiki.cshl.edu/confluence/display/AT/circumcision Clemetson, David B. A. https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=15534292 clinical trials (phases of clinical research) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12944889 Cold Spring Harbor Laboratory (CSHL) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12943828 Conference on Retroviruses ... ...
Apr 27, 2021
Page: 6.4 Barton Haynes — Development of HIV Vaccine: Steps and Missteps (HIV/AIDS Research: Its History & Future Meeting)
... https://libwiki.cshl.edu/confluence/display/AT/cellculture%2Ctissueculture%2Cimmortalizedcellline centrifuge https://libwiki.cshl.edu/confluence/display/AT/centrifuge Chen, Bing https://libwiki.cshl.edu/confluence/display/AT/Chen%2CBing chimpanzee (Pan troglodytes) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=15532569 clinical trials (phases of clinical research) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12944889 Cohen, Myron S. "Mike" (b. 1950) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12944725 cohort ... ...
Apr 27, 2021
Page: ACTG trial 076 (1991–1994) (HIV/AIDS Research: Its History & Future Meeting)
... AIDS Clinical Trials Group (ACTG) trial 076, 1991–1994. Test of prophylactic use of AZT (azidothymidine) for pregnant HIVpositive ...
Aug 28, 2020
Page: ACTG protocol 019 (1989–1994) (HIV/AIDS Research: Its History & Future Meeting)
... AIDS Clinical Trials Group protocol 019, 1989–1994, "Safety and Efficacy of Zidovudine for Asymptomatic HIV ...
Sep 01, 2020
Page: surrogate marker (surrogate endpoint) (HIV/AIDS Research: Its History & Future Meeting)
... During a clinical trial, a surrogate marker or surrogate endpoint is an effect measured during the trial that is a substitute for the intended clinical outcome or clinical endpoint. This is an alternative to measuring the actual clinical outcome during the trial
Dec 31, 2020
Page: parallel track policy (HIV/AIDS Research: Its History & Future Meeting)
... HIV related diseases under a separate "expanded access" protocol that "parallels" the controlled clinical trials that are essential to establish the safety and effectiveness of new drugs. It provides an administrative system that expands ...
Dec 31, 2020
Page: 3.6 John C. Martin — Making it Simpler: A Single Pill to Treat HIV (HIV/AIDS Research: Its History & Future Meeting)
... https://libwiki.cshl.edu/confluence/display/AT/cellculture%2Ctissueculture%2Cimmortalizedcellline  chemistry, chemists https://libwiki.cshl.edu/confluence/display/AT/chemistry%2Cchemists  Children's Hospital Oakland https://libwiki.cshl.edu/confluence/display/AT/Children%27sHospitalOakland  cidofovir https://libwiki.cshl.edu/confluence/display/AT/cidofovir  clinical trials (phases of clinical research) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12944889  cobicistat (Tybost) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=15533312  cohort study compassionate use (Emergency ... TAF for hepatitis B is under review and 00:21:59 we have in  ...
Apr 27, 2021
Page: 5.1 Flossie Wong-Staal — Discovery of Human Retroviral Transactivators (HIV/AIDS Research: Its History & Future Meeting)
... clones, cDNA library https://libwiki.cshl.edu/confluence/display/AT/cDNAclones%2CcDNAlibrary Cell (journal) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=15533831 Chun, TaeWook https://libwiki.cshl.edu/confluence/display/AT/Chun%2CTaeWook clinical trials (phases of clinical research) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12944889 cohort study Cold Spring Harbor Laboratory (CSHL) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12943828 ... ...
Apr 27, 2021
Page: 8.1 John Mellors — MACS and Beyond: Epidemiology, Viremia and Pathogenesis (HIV/AIDS Research: Its History & Future Meeting)
... step as a prognostic biomarker. (8, 9) As important is to validate as a surrogate endpoint for treatment trials, meaning that a change in the marker is a surrogate for a clinical outcome 00:08:30 AIDS or death. This was nicely shown by two studies ...
Apr 27, 2021
Page: 6.7 Salim Abdool Karim — Stopping the Spread of HIV in Developing Countries (HIV/AIDS Research: Its History & Future Meeting)
... CAPRISA (Centre for the AIDS Programme of Research in South Africa) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=15534734 circumcision https://libwiki.cshl.edu/confluence/display/AT/circumcision clinical trials (phases of clinical research) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12944889 Columbia University https://libwiki.cshl.edu/confluence/display/AT/ColumbiaUniversity condom https://libwiki.cshl.edu/confluence/display/AT/condom Department of Health and Human ... ...
Apr 27, 2021
Page: 4.2 Martine Peeters — On the Road to HIV: Primate Lentiviruses (HIV/AIDS Research: Its History & Future Meeting)
... Gabon https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=15533522 Cercopithecus monkeys (guenons) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=15533527 chimpanzee (Pan troglodytes) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=15532569 clinical trials (phases of clinical research) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12944889 coevolution https://libwiki.cshl.edu/confluence/display/AT/coevolution colobus monkeys, blackandwhite colobus https://libwiki.cshl.edu/confluence/display/AT/colobusmonkeys%2Cblackandwhitecolobus De ... ...
Apr 27, 2021
Page: 8.6 David Baltimore — Bringing it to an End (And Where Are We Going?) (HIV/AIDS Research: Its History & Future Meeting)
... clotting factors (factor VIII), PBMCs https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12944097 chimpanzee (Pan troglodytes) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=15532569 clinical trials (phases of clinical research) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12944889 Congress, US https://libwiki.cshl.edu/confluence/display/AT/Congress%2CUS disease surveillance https://libwiki.cshl.edu/confluence/display/AT/diseasesurveillance drug safety ... ...
Apr 27, 2021
Page: 2.3 Mark Harrington — The Importance of Activism to the US Response (HIV/AIDS Research: Its History & Future Meeting)
... gamble on all our parts. It turned out to be a gamble that was worth it because when the clinical trials finally came through in '92, it was shown that ddI had a clinical benefit over longterm AZT and people who'd already been on the AZT for a while ...
Apr 27, 2021
Page: 6.5 Emilio Emini — Issues in HIV Vaccine Development: Will the Future be any Easier than the Past? (HIV/AIDS Research: Its History & Future Meeting)
... tissue culture, immortalized cell line https://libwiki.cshl.edu/confluence/display/AT/cellculture%2Ctissueculture%2Cimmortalizedcellline chimpanzee (Pan troglodytes) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=15532569 clinical trials (phases of clinical research) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12944889 control — experimental control, control group, blinded experiment https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12944973 ... ...
Apr 27, 2021
Page: Session 10: What Have We Learned? (HIV/AIDS Research: Its History & Future Meeting)
... bully pulpit https://libwiki.cshl.edu/confluence/display/AT/bullypulpit CDC (Centers for Disease Control and Prevention, US) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12944044 clinical trials (phases of clinical research) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12944889 Clinton, Hillary (b. 1947) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=15532230 Cold Spring Harbor ... ...
Apr 27, 2021
Page: 2.2 James Curran — Deciphering the Epidemiology of AIDS (HIV/AIDS Research: Its History & Future Meeting)
... https://libwiki.cshl.edu/confluence/display/AT/casecontrolstudy CDC (Centers for Disease Control and Prevention, US) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12944044 chlamydia https://libwiki.cshl.edu/confluence/display/AT/chlamydia clinical trials (phases of clinical research) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12944889 Cohen, Myron S. "Mike" (b. 1950) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12944725 cohort ... ...
Apr 27, 2021
Page: 9.1 Jon Cohen — Responding to AIDS: A Journalist's View (HIV/AIDS Research: Its History & Future Meeting)
... https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12944763 chimpanzee (Pan troglodytes) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=15532569 Chirac, Jacques (1932–2019) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=15535134 clinical trials (phases of clinical research) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12944889 Congress, US https://libwiki.cshl.edu/confluence/display/AT/Congress%2CUS credit, priority https://libwiki.cshl.edu/confluence/display/AT/credit%2Cpriority dengue virus ... ...
Apr 27, 2021
Page: 5.3 Michael Malim — Discovery of APOBEC Restriction (HIV/AIDS Research: Its History & Future Meeting)
... Tolerability, and Mechanisms of Antiretroviral Activity of Pegylated Interferon Alfa2a in HIV1 Monoinfected Participants: A Phase II Clinical Trial.” The Journal of Infectious Diseases 201, no. 11 (June 1, 2010): 1686–96 ...
Apr 27, 2021
Page: 3.4 Raymond Schinazi — Discovery and Development of Novel NRTIs (HIV/AIDS Research: Its History & Future Meeting)
... enzyme, if you remember work done by several 00:09:30 people in clinical trials. It failed in the lab and it also failed in the clinic. The real revolution really took place ... ...
Apr 27, 2021
Page: HPTN Study 069/ACTG A5305 (2012–2016) (HIV/AIDS Research: Its History & Future Meeting)
... HPTN Study 069 (ACTG A5305) was a Phase II trial of maraviroc (Selzentry, Celsentri) to prevent HIV infection in men who have sex ... K. Rivet Amico, Alicia M. Young, Paul Richardson, et al. “ ...
Feb 04, 2021
Page: 2.1 Paul Volberding — The First Patients (HIV/AIDS Research: Its History & Future Meeting)
... board and we were guessing.  Just to end with a couple of thoughts, this is now AIDS Clinical Trials Group (ACTG) protocol 019, Doug Richman will remember, was a ACTG (AIDS Clinical ... ...
Apr 27, 2021
Page: 2.6 Tony Fauci — 35 Years of HIV/AIDS: Science and Policy (HIV/AIDS Research: Its History & Future Meeting)
... very unpopular in academia because I believe I'm one of the ACTG (AIDS Clinical Trials Group) researchers just called it the DUMB study because everyone believed that everyone ... Vaccine and Drug Discovery Groups (NCVDGs) to the various networks HVTN HIV Vaccine ...
May 25, 2021
Page: 2.5 Françoise Barré-Sinoussi — Discovery of HIV (HIV/AIDS Research: Its History & Future Meeting)
... Disease as Causative Agents & Preparation for the Future https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12943622 3.2 Samuel Broder: The First Clinical Trials of Antiretroviral Drugs https://libwiki.cshl.edu/confluence/display/AT/3.2SamuelBroder%3ATheFirstClinicalTrialsofAntiretroviralDrugs 4.0.1 Jeffrey Lifson — Session 4, Introduction 1 ... ...
Apr 27, 2021
Page: Dictyostelium discoideum (HIV/AIDS Research: Its History & Future Meeting)
... Dictyostelium discoideum is a soildwelling amoeboid protist with both unicellular and multicellular phases in its lifecycle
Jan 28, 2021
Page: 2.4 Robert Gallo — Discoveries of Human Retrovirus, Their Linkage to Disease as Causative Agents & Preparation for the Future (HIV/AIDS Research: Its History & Future Meeting)
... 2.5 Françoise BarréSinoussi — Discovery of HIV https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12943624  3.2 Samuel Broder: The First Clinical Trials of Antiretroviral Drugs https://libwiki.cshl.edu/confluence/display/AT/3.2SamuelBroder%3ATheFirstClinicalTrialsofAntiretroviralDrugs  3.4 Raymond Schinazi — Discovery and Development of Novel NRTIs ... like a retrovirus. Again, Robin referred to this last night, I'll be very brief. A  ...
Apr 27, 2021
Page: 8.3 George Shaw — Transmitted/Founder HIV Genomes: What They Teach Us (HIV/AIDS Research: Its History & Future Meeting)
... responses. George: Yes, this is Louis Picker's thing. We actually have a preclinical trial underway right now. Which instead of looking at five animals were looking ...
Apr 27, 2021
Page: 8.4 Robert Siliciano — The Challenge of the HIV Reservoir (HIV/AIDS Research: Its History & Future Meeting)
... die by pyroptosis. But if they are activated before that, they can complete the virus life cycle. This represents a phase of preintegration latency. We hypothesized that a more stable form of latency might arise ...
Apr 27, 2021
Page: 6.2 Dennis Burton — How Does HIV Evade the Antibody Response? (HIV/AIDS Research: Its History & Future Meeting)
... from Michel Nussenzweig, and from ourselves. A number of these have already hit the human phase one and a number are about to do so, so it'd be quite interesting to see ...
Apr 27, 2021

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