Clinical Trials

What is a clinical trial?
A clinical trial is a controlled study of a new drug/treatment

*We have included a glossary page below to help explain some of the language & terms used (trial documents can be a struggle for first timers)

If a clinical trial proves a treatment is effective, further trials are often carried out to find better ways of using  the drug for example using different doses or combining it with other treatments.

Unlike skin melanoma, ocular melanoma is an extremely rare cancer that mostly does not respond well for the majority to  imunotherapies currently available. .  It has not unfortunately gotten the attention it needs to find a treatment to manage it which is why asking your medical oncologist about success rates is imperative!

Because there is no agreed standard of care for Metastatic Ocular Melanoma a clinical trial is often a very real and appropriate option for some people. 

Listed below are links to clinical trial data bases for a number of countries .
There are options to travel within the European Union

Ireland

England

  1. ImcGP100 triall

Germany

Spain
https://reec.aemps.es/reec/public/web.html

France

Romania

Croatia

America

Clinical trials Glossary - Understanding the language of clinical trials

Listed below are some terms/words that are used frequently
(There are many others please see : https://www.centerwatch.com/health-resources/glossary/​)

Adverse reaction
. An unwanted side effect
Control group
.  A group of patients who do NOT get the treatment/drug being studied. This group get the "standard treatment" (treatment already in use and thought to be the best available)
Cohort
.  A group of patients with some characteristics in common
Dosage Regimen
.  How often is the drug/treatment given
.  How much/what quantity of the drug/treatment is given
Efficacy
.  the ability of a drug or treatment to produce positive results.
Eligibility
.  The reasons  a person is allowed to take part in a particular trial
.  Eligibility includes Inclusion and exclusion criteria which may include age, gender, number of other treatments etc.
Enrolling
.  Signing up
Ethics committee
. An independent board set up to ensure participants are safe during the trial
Expanded access
.  Use of a drug/treatment not yet approved
.  Use of drug/treatment outside of a clinical trial
Efficacy
. ability of a drug or treatment to produce positive results
Investigator

Open-label Trial
.  a clinical trial in which both the research staff and the participants know which drug or treatment is being studied.
Phases of clinical trials
.  Generally there are 4 phases sometimes 5
Phase 1
.  Usually a small number of participants
.  The safety of the drug is tested
.  What dose  can be tolerated
.   To see how it works and what the side effects are
Phase 2
.  Tested on a larger group
.  To test further how it is working on the body
Phase 3
. Multi centre studies
. Overall safety
. How effective is it and how can it improve quality of life
Phase 4
. Final stage of process is to get state approval
Recruiting
. The time period when patients are being identified and enrolled in the trial
Randomisation
.  This is a trial method
.  Participants are selected randomly and either get the drug/treatment being studied or the standard treatment
Sponsor
.  The organisation running the trial
Side effect
.  An unwanted effect of the drug/treatment
Standard treatment
.  This is the drug/treatment believed to be the best option and is already available to the patient

*** This draft is as of 22/11/18 - to be updated as reguired ***