Understanding clinical trials

10 steps of medicine development

Enrolling in clinical trials

Clinical Trial Approval in Europe

Clinical Trial Designs

Types of study in early clinical development

Clinical trials and research

 Understanding Clinical Trials

The Journey of Roger and Ellen to FindMeCure

FindMeCure BETA Demo

Community Involvement in Clinical Research

Patient advocates involved in clinical development

Enrolling in clinical trials.

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

Recruitment and Retention of Diverse Populations in Antiretroviral Clinical Trials: Practical Applications from the Gender, Race And Clinical Experience Study

Lessons from GRACE: A US Study Focused on Women Living with HIV

A Systematic Review of the Inclusion (or Exclusion) of Women in HIV Research: From Clinical Studies of Antiretrovirals and Vaccines to Cure Strategies.

Women under-represented in 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.

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

Other Relevant Materials

Bioavailability and bioequivalence

Mechanisms of disease: Basic concepts

Biomarkers

HIV pipeline 2017

Presentations

AIDS 2018 Conference, Amsterdam

Lisa Hamzah

Lisa Hamzah

Christina Antoniadi, EATG, Greece

Lisa Hamzah, King’s College Hospital

Angelina Namiba, Salamander Trust, UK

Mark Rapa, EATG, UK/Malta

Soren Holm, University of Manchester

Mark Rapa, EATG, UK/Malta

Lisa Hamzah, King’s College Hospital

Jackie Morton, EATG, UK

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.

Loader Loading...
EAD Logo Taking too long?

Reload Reload document
| Open Open in new tab

 

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

URL: https://www.thewellproject.org/hiv-information/lessons-grace-us-study-focused-women-living-hiv#Successful%20recruitment

 

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.

Loader Loading...
EAD Logo Taking too long?

Reload Reload document
| Open Open in new tab

 

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

Loader Loading...
EAD Logo Taking too long?

Reload Reload document
| Open Open in new tab

 

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

URL: https://www.treatmentactiongroup.org/webinar/its-time-to-deliver-including-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

Loader Loading...
EAD Logo Taking too long?

Reload Reload document
| Open Open in new tab

 

Lisa Hamzah

Pharmacokinetics and Pharmacology in women

Loader Loading...
EAD Logo Taking too long?

Reload Reload document
| Open Open in new tab

 

Lisa Hamzah

Different kinds of clinical trials and their uses.

Loader Loading...
EAD Logo Taking too long?

Reload Reload document
| Open Open in new tab

 

Christina Antoniadi, EATG, Greece

Opening and introduction to Metrodora

Loader Loading...
EAD Logo Taking too long?

Reload Reload document
| Open Open in new tab

 

Lisa Hamzah, King’s College Hospital

HIV R&D – Setting the scene

Loader Loading...
EAD Logo Taking too long?

Reload Reload document
| Open Open in new tab

 

Angelina Namiba, Salamander Trust, UK

Priorities for women in R&D

Loader Loading...
EAD Logo Taking too long?

Reload Reload document
| Open Open in new tab

 

Mark Rapa, EATG, UK/Malta

Gaps & barriers: findings of METRODORA research project

Loader Loading...
EAD Logo Taking too long?

Reload Reload document
| Open Open in new tab

 

Soren Holm, University of Manchester

Ethical Issues

Loader Loading...
EAD Logo Taking too long?

Reload Reload document
| Open Open in new tab

 

Mark Rapa, EATG, UK/Malta

Regulatory barriers

Loader Loading...
EAD Logo Taking too long?

Reload Reload document
| Open Open in new tab

 

Lisa Hamzah, King’s College Hospital

Reaching out and retainment: challenges & good practices

Loader Loading...
EAD Logo Taking too long?

Reload Reload document
| Open Open in new tab

 

Jackie Morton, EATG, UK

Participation and Education: Increasing community awareness

Loader Loading...
EAD Logo Taking too long?

Reload Reload document
| Open Open in new tab

Get involved

Are you living with HIV/AIDS? Are you part of a community affected by HIV/AIDS and co-infections? Do you work or volunteer in the field? Are you motivated by our cause and interested to support our work?

Subscribe

Stay in the loop and get all the important EATG updates in your inbox with the EATG newsletter. The HIV & co-infections bulletin is your source of handpicked news from the field arriving regularly to your inbox.