10 steps of medicine development
Clinical Trial Approval in Europe
Types of study in early clinical development
The Journey of Roger and Ellen to FindMeCure
Community Involvement in Clinical Research
Patient advocates involved in clinical development
Inclusion of women in HIV clinical research
Women Living with HIV and Research: Mind the Gap
Advancing HIV research with pregnant women: navigating challenges and opportunities
Lessons from GRACE: A US Study Focused on Women Living with HIV
Women under-represented in HIV clinical trials.
Representation of Women and Pregnant Women in HIV Research: A Limited Systematic Review.
Review of the Literature: Primary Barriers and Facilitators to Participation in Clinical Research.
Webinar: It’s Time to Deliver – Including Pregnant and Lactating Women in Clinical Research, Pt
Bioavailability and bioequivalence
Mechanisms of disease: Basic concepts
AIDS 2018 Conference, Amsterdam
Christina Antoniadi, EATG, Greece
Lisa Hamzah, King’s College Hospital
Angelina Namiba, Salamander Trust, UK
Soren Holm, University of Manchester
Understanding clinical trials
10 steps of medicine development
Author: EUPATI
EUPATI articles to be found under “Basics of medicine development” describing the ten steps of medicine development.
step 1: Pre-discovery;
step 2: Target selection;
step 3 and 4: Choosing a molecule or lead;
step 5: Non-clinical safety testing;
step 6: Phase 1 – Proof of mechanism;
step 7: Phase 2: Proof of concept;
step 8: Confirmatory studies;
step 9: Regulatory submission;
step 10: Life-Cycle management
Enrolling in clinical trials
Author: EUPATI
EUPATI article describing how patients are informed about clinical trials, the screening process, and the structure and requirements of informed consent.
Clinical Trial Approval in Europe
Author: EUPATI
EUPATI article covering clinical trials and how and by whom they are conducted, as well as the clinical research legislation in Europe.
Clinical Trial Designs
Author: EUPATI
EUPATI article briefly explaining the various types of clinical trial designs
Types of study in early clinical development
Author: EUPATI
EUPATI article describing the types of studies that are usually conducted in phases I and II of clinical research
Clinical trials and research
Author: i-Base
Chapter 8 on Clinical trials and research of the i-Base Treatment Training Manual
URL: https://i-base.info/ttfa/8-clinical-trials-and-research/
Understanding Clinical Trials
Author : The Wellproject
Website article on Clinical Trials from the Wellproject.
Topics covered: “What are Clinical Trials”, “The Basic Components of Clinical Trials”, “The Stages of Treatment Trials”, “Why is it important to participate in a Clinical Trial?”, “Should I participate in a Clinical Trial?”, “Important Lessons from Clinical Trials”, “Clinical Trials and Women living with HIV”
URL: https://www.thewellproject.org/hiv-information/understanding-clinical-trials#
The Journey of Roger and Ellen to FindMeCure
Author : FindMeCure
Roger is a nice guy, he has a caring family and a promising job. But lately, Roger’s quality of life has worsened. He has a medical condition that can’t be effectively treated by the current drugs on the market. At the same time, Ellen, who is a medical researcher, is developing a new drug to help people having the same medical condition as Roger. If only Roger and Ellen had a place where they could meet and help each other? FindMeCure is this place. Visit www.findmecure.com to learn how!
FindMeCure BETA Demo
Author : FindMeCure
The BETA version of FindMeCure, the Google for clinical trials, is live! Watch our demo and try it yourself on www.findmecure.com! FindMeCure helps you search and compare through thousands of studies and smartly decide according to your own criteria whether to join a clinical trial or not.
Community Involvement in Clinical Research
Patient advocates involved in clinical development
Author: EUPATI
Short EUPATI article listing the possibilities for community involvement in clinical development
Enrolling in clinical trials
Author: EUPATI
EUPATI article describing how patients are informed about clinical trials, the screening process, and the structure and requirements of informed consent.
Inclusion of women in HIV clinical research
Women Living with HIV and Research: Mind the Gap
Author: Silvia Petretti
Presentation by Silvia Petretti on the gender gap in research presented on Sunday 8th of November 2015 at a meeting with Eucoord researchers organized by the European Treatment Action Group (EATG)
URL: https://hivpolicyspeakup.wordpress.com/2015/11/08/women-living-with-hiv-and-research-mind-the-gap/
Advancing HIV research with pregnant women: navigating challenges and opportunities
Author: Krubiner C, Raden R, Cadigan J et al. (2016)
This article provides a summary of interviews held with 62 HIV investigators and clinicians on the perceived barriers to HIV research with pregnant women.
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Recruitment and Retention of Diverse Populations in Antiretroviral Clinical Trials: Practical Applications from the Gender, Race And Clinical Experience Study
Author: Falcon R, Dawn AB, Currier J et al. (2011)
The Gender, Race, and Clinical Experience Study (GRACE) study is considered as a successful example for the enrollment of a representative population of women. This article decribes the recruitment and retention strategy used in the study
URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3130514/
Lessons from GRACE: A US Study Focused on Women Living with HIV
Author : The Wellproject (2016)
This website article provides a short description of the GRACE study and of the tailored recruitment strategies aimed at ensuring high participation of women
A Systematic Review of the Inclusion (or Exclusion) of Women in HIV Research: From Clinical Studies of Antiretrovirals and Vaccines to Cure Strategies
Author: Curno M, Rossi S, Hodges-Mameletzis I et al. (2016)
A literature review that characterizes women’s participation in HIV clinical studies of antiretroviral drugs (ARV), prophylactic vaccines (VAX), and curative strategies (CURE). This article confirms that women continue to be under-represented in HIV clinical trials.
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Women under-represented in HIV clinical trials
Author: Pebody Roger (2016)
Short article on aidsmap.com summarizing the main messages of the article “Systematic Review of the Inclusion (or Exclusion) of Women in HIV Research”
URL: https://www.aidsmap.com/news/feb-2016/women-under-represented-hiv-clinical-trials
Follow YOUR Heart: development of an evidence-based campaign empowering older women with HIV to participate in a large-scale cardiovascular disease prevention trial
Author: Zanni M, Fitch K, Rivard C et al. (2017)
This article provides the results of surveys of 40 women with or at risk for HIV about factors that might facilitate or impede engagement in HIV and cardiovascular disease research. Insights derived from these surveys were used for the development of the Follow YOUR Heart campaign, educating women about HIV-associated cardiovascular diseases
URL: https://www.tandfonline.com/doi/full/10.1080/15284336.2017.1297551
Representation of Women and Pregnant Women in HIV Research: A Limited Systematic Review
Author : Westreich D, Rosenberg M, Schwartz S, Swamy G (2013)
The article contains the results of a review of HIV-related articles published in fifteen journals from January to March of 2011 aimed at characterizing the representation of women in HIV-related research
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Review of the Literature: Primary Barriers and Facilitators to Participation in Clinical Research
Author: National Institute of Health (NIH)
Literature review and description of barriers and facilitators for participation in clinical research
Webinar: It’s Time to Deliver – Including Pregnant and Lactating Women in Clinical Research, Pt 1
Author: Treatment Action Group (2018)
The first part of a webinar organized by the Treatment Action Group (TAG) on the inclusion of pregnant and lactating women in Clinical Research
Other Relevant Materials
Bioavailability and bioequivalence
Author: EUPATI
EUPATI article describing the concepts of bioavailability and bioequivalence
Mechanisms of disease: Basic concepts
Author: EUPATI
EUPATI article briefly describing the concepts of “symptom”, “diagnosis”, “mechanisms” and “targets”
Biomarkers
Author: EUPATI
EUPATI article explaining what a biomarker is, how biomarkers are used, and the role of biomarkers in medicine development
HIV pipeline 2017
Author: HIV i-base
Report on the HIV drug pipeline in 2017
URL: https://i-base.info/htb/wp-content/uploads/2017/07/HIV-Pipeline-2017-full-version.pdf
Presentations
AIDS 2018 Conference, Amsterdam
Addressing research gaps identified by women living with HIV in Europe and Central Asia
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Lisa Hamzah
Pharmacokinetics and Pharmacology in women
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Lisa Hamzah
Different kinds of clinical trials and their uses.
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Christina Antoniadi, EATG, Greece
Opening and introduction to Metrodora
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Lisa Hamzah, King’s College Hospital
HIV R&D – Setting the scene
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Angelina Namiba, Salamander Trust, UK
Priorities for women in R&D
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Mark Rapa, EATG, UK/Malta
Gaps & barriers: findings of METRODORA research project
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Soren Holm, University of Manchester
Ethical Issues
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Mark Rapa, EATG, UK/Malta
Regulatory barriers
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Lisa Hamzah, King’s College Hospital
Reaching out and retainment: challenges & good practices
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Jackie Morton, EATG, UK
Participation and Education: Increasing community awareness
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