What Is an HIV/AIDS Clinical Trial?
HIV/AIDS clinical trials are research studies in which new therapies and prevention strategies for HIV infection and AIDS are tested in humans. These studies are conducted by physicians and other health care professionals and can help determine the usefulness of experimental drugs and vaccines in treating or preventing HIV infection. Carefully conducted clinical trials are the fastest and safest way to help find treatments and prevention strategies that work.
New
therapies are tested in humans only after laboratory and animal studies show
promising results. In Phase I clinical trials, the experimental therapies are
given to small numbers of people to help determine safe doses. Larger groups of
patients may then receive the therapies in Phase II trials to help measure side
effects and preliminary effectiveness. The treatments may then be used in even
larger Phase III studies to compare the new treatment to ones already in use or
to help estimate other effects of the drug.
What is a clinical trial protocol?
A clinical trial protocol is a detailed plan of how the trial will be conducted. Potential clinical trial participants learn details about the clinical trial protocol in a process called informed consent.
Informed consent is the process of learning key facts about a clinical trial before deciding whether or not to participate. To help someone decide whether or not to participate, study staff explain the details of the trial. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are also explained in the document. The participant then decides whether or not to sign the document. Informed consent is an ongoing process and the participant may withdraw from the trial at any time.
Benefits of participating in an HIV/AIDS clinical trial:
- Participants may gain access to new treatments not yet available to the public.
- Participants may receive expert medical care at leading health care facilities.
- Participants have a chance to help others by contributing to medical research.
- Experimental drugs are often provided free of charge.
Risks of participating in an HIV/AIDS clinical trial:
- Experimental drugs may not have any benefits or may even be harmful.
- New drugs may have unanticipated side effects.
- Protocols may require a lot of the participant's time and frequent trips to the study site.
What questions should I ask?
If you are interested in participating in a clinical trial, you may want to ask:
- What is the purpose of the study?
- What are the drug's side effects?
- What other treatment options do I have?
- Will I have to be in the hospital?
- How often will I have study visits?
- How long will the study last?
- Who will provide my medical care after the study is completed?
- What other drugs can I take if I participate in the study?
- What treatments must I avoid while participating in the study?
- Who will pay the costs of the study?
- How will my confidentiality be protected?
The Cost of a Clinical Trial
27th November 2005, 07:17 PM
Excerpt: The 800 Million Dollar Pill by Merrill Goozner (http://www.wnyc.org/books/29397)
By decade's end, with drug costs soaring at double-digit rates, these skewed priorities - which were a major component in the rising cost of drugs - were again drawing fire from the guardians of scientific integrity. "The industry depicts these huge expenditures as serving an educational function," the New England Journal of Medicine editorialized.
It contends that doctors and the public learn about new and useful drugs in this way. Unfortunately, many doctors do indeed rely on drug-company representatives and promotional materials to learn about new drugs, and much of the public learns from direct-to-consumer advertising. But to rely on the drug companies for unbiased evaluations of their products makes about as much sense as relying on beer companies to teach us about alcoholism. The conflict of interest is obvious. The fact is that marketing is meant to sell drugs, and the less important the drug, the more marketing it takes to sell it. Important new drugs do not need much promotion. Me-too drugs do.
A gripping and informative read about the formation of the drug cartel over twentieth century. After reading this excerpt our enlightened skeptic may well want to wait a decade or two before trying any new drug invented in the twenty first century.
The title of the book should have been, "The Billion Dollar Pill."
The $800 million dollar pill?
The research by DiMasi et al. showing that the cost of the average new drug (new chemical entity) is about $802 million dollars is controversial with many people suggesting the results were doctored. A new paper, Estimating the Costs of New Drug Development: Is it really $802m?, by two economists at the Federal Trade Commission, replicates that research using somewhat different data and they indeed find that DiMasi et al. are wrong. The average new drug does not cost $802...it costs between $839 and $868 million.
An interesting aspect of the new study is that the authors break down development costs by drug category finding that AIDS drugs, for example, cost considerably less than average. Why? The authors suggest that AIDS drugs have been regulated less severely than other drugs resulting in lower costs as well as quicker times to market.
Data source: Alliance for Microbicide Development Website
Medical information: Global Humanceuticals, Inc. does not intend to provide specific medical advice or treatment. Global Humanceuticals, Inc. intends to provide the website visitors with documents and information to better understand HIV / AIDS and its prevention and treatment.