What Makes a Successful Trial? MorenikeUkpong Nigeria HIV Vaccine and Microbicide Advocacy Group

Outline Understanding Clinical Trials The Design of Clinical Trials Understanding Clinical Trial Results What is a Successful Clinical Trial?

Understanding Clinical Trials Clinical trials give the most reliable form of evidence in science. Clinical trials are conducted in humans Microbicide clinical trials entail the randomisation of trial participants to study products. Microbicide trials are conducted as double blind studies

Design of a Clinical Trial 1. Prior to a clinical trial, there are preclinical studies -Laboratory studies -Animal studies 2. Clinical studies are in phases -Phase I -Phase II -Phase III 3. Post clinical studies also exists -Phase IV

Designing a Clinical Trial Development of the concept note Concept note shared with sponsors before approval for funding Various drafts of protocol developed Protocol presented for PSRC review Revised versions developed Final draft sent to local IRBs for input and approval Activation of site, protocol implementation, data collection

Understanding Clinical Trial Results –A clinical trial could end in any of the phases –A phase III trial could be end because: -Proof of efficacy (e.g. male circumcision) -Proof of non-efficacy (e.g. carraguard) -Evidence of harm (e.g. N9) -Unclear results (e.g. SAVVY)

What Makes a Clinical Trial Successful? The research plan is conducted as stated in the study protocol. The methodology is sound The trial provides further information to the HIV prevention field Participants are informed and educated about HIV, the purpose and outcome of the study. The health of participants is protected

What Makes a Clinical Trial Successful? (cont.) Trial is continuously monitored at defined intervals Participants and the community are engaged with the research process in an ethical, respectful and efficient manner. The trial achieved a high retention rate The study results are communicated to participants, their communities and other stakeholders. A plan for access to study products is developed in the case of a positive result.

Clinical Trial Results Are Valuable They can tell us which products are not worth pursuing They can point to the kinds of modifications that could be made to improve trial design They may yield beneficial information about behavioral and cultural practices that influence HIV transmission and clinical trial outcomes; and They provide valuable information about how prevention trials can be better managed.