8 Clinical trials and research

8.1-8.2 Introduction and aims

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8.1 Introduction

Section 8 provides information about clinical trials and research.

• It provide a key grounding for advocates interested in this subject.
• It also includes information about how research is presented and how to analyse and interpret trial results.

Community involvement in HIV research is important. Advocates have always argued for active patient and community representation and involvement at all stages of our health care, including research.

This includes being involved on the type of research and the design of trials. It helps make sure that:

• Trials are run properly
• All patients receive at least current standard-of-care treatment
• We are able to follow both enrolment and how the trial is run
• We are able to monitor and follow early results

As patients and advocates we have a good idea on how latest treatment advances may affect the standard of care in the future. This will help plan trials that will still be relevant when they come to enrol.

Even after a study is finalised, it will often take a year or longer before any patients are enrolled, and then several years for the study to run. Trials need to therefore be designed based on what we expect the standard of care to be for the duration of the study.

For community advocates to be actively involved, and not just included to show good clinical practice, or for researchers to get grant approved, most advocates will need training and support.

8.2 Aims for this section

After reading section 8, advocates will have an understanding of:

• How trials are designed to produce reliable and accurate information
• Why research is needed to inform treatment choices
• The basic concepts used in trials
• The main types of trials and quality of different types of studies
• Advantages and disadvantages of different studies
• Common features of all studies
• Informed consent and patient care
• Interpreting study results
• The different roles advocates can take