Novel clinical trial designs for the development of new antiretroviral agents
AIDS, ISSN: 0269-9370, Vol: 26, Issue: 8, Page: 899-907
2012
- 18Citations
- 37Captures
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Example: if you select the 1-year option for an article published in 2019 and a metric category shows 90%, that means that the article or review is performing better than 90% of the other articles/reviews published in that journal in 2019. If you select the 3-year option for the same article published in 2019 and the metric category shows 90%, that means that the article or review is performing better than 90% of the other articles/reviews published in that journal in 2019, 2018 and 2017.
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Metrics Details
- Citations18
- Citation Indexes18
- 18
- CrossRef11
- Captures37
- Readers37
- 37
Review Description
The resounding success of combination antiretroviral efficacy for both treatment-naïve and treatment-experienced patients - with 70-90% viral suppression rates in recent studies - has made registration trials for new agents challenging. With the inevitable specter of drug resistance, new agents must have a pathway to approval. The Forum for Collaborative HIV Research obtained input from concerned stakeholders including industry, clinical sciences, community advocacy, and regulatory sciences (Food and Drug Administration and European Medicines Agency) to discuss how safety and efficacy of new agents could be demonstrated. Recognizing the shortfalls of superiority or noninferiority trials in this environment, a new trial design for treatment-experienced patients, minimizing the risk for drug resistance but allowing full assessment of safety, was proposed. The antiviral efficacy of an active investigational drug would be assessed by comparison to placebo as an add-on to a failing regimen in a short, 10-14-day study followed by institution of an optimized background regimen (OBR) in both arms with investigational drug given to all patients. The follow-on stage would assess dose response, safety, durability of initial response, and development of resistance. Additionally, a second safety trial could be conducted comparing patients randomized to the investigational agent with a new OBR to those on a new OBR and placebo. Finally, approval decisions could consider other long-term safety endpoints. Exposing treatment-naïve patients to investigational agents remains a controversial issue; stakeholders have different interpretations of risk-benefit for trials in this population that necessitate careful consideration before initiating trials in them. © 2012 Wolters Kluwer Health | Lippincott Williams and Wilkins.
Bibliographic Details
http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=84861094901&origin=inward; http://dx.doi.org/10.1097/qad.0b013e3283519371; http://www.ncbi.nlm.nih.gov/pubmed/22301412; http://content.wkhealth.com/linkback/openurl?sid=WKPTLP:landingpage&an=00002030-201205150-00001; https://journals.lww.com/00002030-201205150-00001; https://dx.doi.org/10.1097/qad.0b013e3283519371; https://journals.lww.com/aidsonline/Fulltext/2012/05150/Novel_clinical_trial_designs_for_the_development.1.aspx
Ovid Technologies (Wolters Kluwer Health)
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