Clinical Trials Involving CRPS/RSD, Chronic Pain, etc.

Introduction

Clinical trials are a standardized, valuable, necessary set of experiments carried out by the owner of a potential new drug, at their expense. This series of tests, developed and enforced by the FDA, has been in use for decades, and provides an excellent picture of the efficacy, side-effects, duration of action, tolerance, addiction liability, and many other variables that affect how a drug will interact with a human body, both healthy and with the illness being investigated.

The series of trials is begun when a company files a New Drug Application (NDA) with FDA, submitting all of their test results to date with cell lines, animals, or any others which support their claim that the results are sufficiently impressive to allow clinical testing to proceed. After a careful, detailed review, the FDA will either give the go-ahead, reject the application, or conditionally accept the application on the condition that certain strictly defined changes are made in the protocol.

The only parameter which is very hard to assess in clinical trials is any long-term effects that may occur after using the drug for years or even decades. The theory used for these situation is that the effects of a lot of drug for a short time are similar to the effects that might be seen after many years of using much less drug each day. The fallacy of this reasoning is obvious, but, so far, it's proved quite good at highlighting long-term effects. Still, it's probably the only real weakness in current drug testing.

There are three parts in the series, called "phases".

Phase I: The new drug is given to a small (30-80) group of healthy volunteers, to determine its safety and identify side-effects. Dose optimization is also begun at this stage.

Phase II: Involving larger (100-300) test groups, where the volunteers are ill with the condition being treated, to gauge the new drug's effectiveness (efficacy) and to further evaluate its side-effect profile. Dosages are optimized here, and the isolation and identification of metabolites takes place.

Phase III: The potential new drug is evaluated in large (1000-3000 or more, usually in multiple locations) groups of volunteers who are ill with the condition being treated. This phase is by far the largest, most important (and expensive) part of a clinical trial, in which drug efficacy is confirmed, side-effects are monitored, the drug is compared to others used to treat the condition, and other data are gathered to provide as much information as possible for the FDA to decide whether to allow the new drug to be sold.


The following links help explain clinical trials in more detail and allow you to find current trials being conducted involving treatments for CRPS/RSD, chronic pain, etc. The banner below is probably the most efficient way to keep track of what trials are going on near you. (It's a wide page, so it will open in a new tab/window.)

Clinical Trials


Learn More about Clinical Trials

The Basics - NIH Clinical Research Trials and You An excellent, thorough article from the NIH, which not only outlines exactly what's involved in trials, but also answers common questions asked by folks who are considering becoming involved in a trial.

CenterWatch The first site to collect trials information for potential volunteers, this is totally dedicated to information about trials, including topics like how to volunteer, informed consent, post clinical trials, etc.

Clinical Research Studies Protocol Database A simple search protocol, enabling a search of all current trials based on diagnosis, symptoms, signs, or other keywords.

Clinical Trial Information for Study Participants & Doctors "a comprehensive resource for trusted information about medical research studies, also called clinical trials. "

Clinical Trials: MedlinePlus Interactive Health Tutorial A wonderful resource about the trials process, via either self-playing or interactive tutorials. A fun, easy way to learn all about the clinical trials process.

Clinical Trials.gov "a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world." This is the granddaddy of all trials sites, upon which many others are based!

Understanding Clinical Trials Part of the ClinicalTrials.gov site, this is probably the most complete and detailed explanation of every facet of trials. It's formatted in a FAQ style, and if your question isn't listed, you probably needn't worry about it. ;-)


Find Clinical Trials of Interest to You

Clinical Trials involving CRPS Currently, there are 43 trials listed, from some which have just completed to those which have not yet begun recruiting volunteers. You can easily remove trials that are complete, and learn much about those which interest you - location, number of volunteers desired, any compensation, etc.

Clinical Trials involving RSD There were 13 trials listed when this page was created. Obviously, there is some overlap with CRPS trials, but there are enough trials specifying one or the other to warrant separate groupings.

Complex Regional Pain Syndrome - Clinical trials Although hosted in the UK, this database is the WHO International Clinical Trials Registry, and the first thing visitors do is select the country in which they wish to locate trials.

    Current Controlled Trials "Current Controlled Trials Ltd is part of Springer Science+Business Media. In response to the growing body of opinion in favour of prospective registration of controlled trials, Current Controlled Trials Ltd launched the Current Controlled Trials website in late 1998, aiming to increase the availability, and promote the exchange, of information about ongoing randomised controlled trials worldwide."

       Neoclinical Trials if you or someone you know lives Down Under, this is the most comprehensive and complete clinical trials locator available there.

Search the Studies - NIH Clinical Research Studies a site run by NIH, which is quick and very easy to use. Just "Enter the diagnosis, sign, symptom, or other key words or phrases", and hit the Search button! Give it a try; it's a great resource.

TrialReach - Medical Treatment Research Trials brand new site! "Our goal is to make clinical trials faster, simpler, and more focused on patient needs. We are working to facilitate the vital connections needed between patients and research teams because it is through this collaboration that progress can be achieved."