From Your Point of View Dr. Agar?

[B]Nephrologist Point of View

What’s your thoughts on this for Lupus Patients with ESRD and On Dialysis?

Clinical Trials
Clinical trials are research studies that involve patients to answer specific questions about new treatments or new ways of using known treatments. Carefully conducted clinical trials are the fastest and safest way to determine whether new drugs or other treatments work in people.

In clinical trials, one group of participants receives the experimental drug while another group, the control group, gets standard treatment or an inactive treatment known as a placebo. Studies that include control groups are known as controlled trials.

Four Phases
There are four phases of clinical trials:

Phase I tests a new drug or treatment in a small group to see how the drug works in the human body, if there are side effects with increasing doses, and to gain early evidence the drug is effective.
Phase II tests the new drug or treatment in a controlled trial, with one group of patients getting the experimental drug and another group getting standard treatment, or a placebo.
Phase III tests the new drug or treatment in expanded controlled and uncontrolled trials to get additional information to evaluate the treatment’s overall benefits and risks and to use for the medication label.
Phase IV continues to test the drug after it has been licensed and marketed to get more information on its risks, benefits and best ways to use it.
In addition to investigating new treatments for lupus, clinical trials may also look for better ways to prevent lupus, better tests or procedures for detecting and diagnosing lupus, and ways to improve the quality of life for people who have lupus.

By participating in a clinical trial, you can gain access to new research treatments before they are widely available and help others by contributing to medical research. All clinical trials have guidelines and eligibility criteria designed to make sure the participants will be safe and the study will be valid and answer the research questions

Any comment’s or concerns appreciated, as always,

Dear Karen

Trial conditions are well and truly set and established.

The description you give above is ‘standard’. I have really nothing else to say on this other than if you (or others) are asked to be part of a trial, the conditions of that trial will be … no, must be - by law … clearly explained before you agree to take part.

Phase I, II, III and IV trials are common - all agents/devices pass through them. If you have questions, you muct discuss these with the trial coordinators or investigators.

I can make (need make) no further comment on this issue.

John Agar