A clinical trial is a research study in volunteer human subjects to determine the safety and efficacy of new treatments, screening methods, preventive techniques, or diagnostic methods for a disease. New devices, drugs, procedures, and medical innovations must be thoroughly tested to ensure that they are safe and effective for human patients. Human trials are only conducted after both laboratory and animal studies show promising results.
The ultimate goal of HIV/AIDS clinical trials is to find more effective and safer ways to diagnose, treat, and prevent HIV/AIDS.
Researchers develop ideas for clinical trials when they have a hypothesis about something. For instance, if there have been reports of pregnant HIV patients who received HIV treatment and did not pass the virus on to their babies, researchers may choose to investigate the safety and effectiveness of anti-HIV drugs (antiretrovirals) during pregnancy.
Before a clinical trial is conducted, a specific set of rules, called protocol, is developed.
A protocol includes information on types of patients who can participate in the trial, the schedule of tests, procedures, medications/dosages, and length of the study.
During a clinical trial, the researchers monitor the participants' health to determine the safety and effectiveness of treatment.
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clinical trial phases
Phase I: In phase I clinical trials, researchers test a new drug or treatment in a small group of 20-80 patients for the first time. The goal is to evaluate the drug or treatment's safety, determine a safe dosage range, and identify side effects.
Phase II: Phase II clinical trials study the effects of a drug or treatment in a larger group of 100-300 patients. During this phase, researchers aim to determine the drug or treatment's efficacy and further assess its safety.
Phase III: During phase III trials, researchers study the effect of a drug or treatment in large groups of 1,000-3,000 patients. This type of trial is used to confirm the drug or treatment's effectiveness and monitor side effects. The drug or treatment is also compared to commonly used treatments and researchers collect information that will help ensure that the drug or treatment is used safely.
Phase IV: Phase IV clinical trials are performed after the drug or treatment has been marketed to the general public. These studies are conducted to collect information on the drug or treatment's long-term effects and side effects in various patient populations.
reporting trial results
Medical Journals: After a clinical trial is performed, the gold standard for presenting the results is publication in a peer-reviewed professional journal. These journal articles are reviewed by experts in the same field as the authors of the studies. Journal articles contain five major sections: abstract, introduction/background, design and methods, results, and discussion.
The abstract is a short summary of the research article. It includes the researchers' objective and goals of the study. It also briefly summarizes each section of the paper and includes the authors' conclusions.
The introduction/background section usually provides a statement that explains the issue that was investigated. It also explains why the study was performed and what the researchers hypothesized (expected to prove).
In the design and methods sections, which may be combined, the researchers explain how the study was carried out. This section includes detailed information about the study participants, the treatments used, the tests that were performed, and how the data was assessed.
The results section provides detailed information of all the data that was collected. This section typically includes graphs, charts, tables, and/or pictures, as well as a statistical analysis of the results.
In the discussion section, the authors explain their interpretations of the results. Here, researchers explain what the results mean and how they might affect clinical practice. Authors also explain whether their initial hypothesis was confirmed, as well as potential limitations of the study and suggestions for additional research.
Scientific conferences: In addition to medical journals, researchers may also present their findings at conferences related to their fields of study. Some of the most significant HIV/AIDS conferences include the annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), the annual Conference on Retroviruses and Opportunistic Infections, and the biannual International AIDS Conference.
Researchers submit their study abstracts before the conference. Lead authors of the most interesting or groundbreaking studies are presented. Additional studies are typically presented on posters. Depending on the size of the conference, abstracts from oral and poster presentations may be published and/or available online.