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Treialon Clinigol

Ar y dudalen hon byddwch yn gallu gweld beth yw treialon clinigol, beth maent yn ceisio ei gyflawni, a sut i gymryd rhan ynddynt.

There are probably thousands of studies and trials taking place throughout the world into ALK-positive lung cancer. Many will be in the laboratory. All add to scientific knowledge.

A relatively small number of studies and trials will involve a drug being taken by a patient. Every clinical trial will have strict inclusion and exclusion criteria which means that they may not be available to some patients. Some clinical trials will be ALK+ specific while others will be open to non-ALK+ patients.

Because of inclusion and exclusion criteria, the results of clinical trials may not be replicated in the real world.

Phase I studies primarily assess the safety of a drug. They can be the very first time the drug has been administered to humans or it can be an approved drug that is being tested in a different type of cancer. A relatively small number of patients may be included at this stage. This initial phase of testing can last for several years because the trial design slowly increases the drug dose to identify the side effects before they are severe. The study will also determine how the drug(s) are absorbed, metabolized, and excreted.

Phase II studies primarily assess the efficacy of a drug. This second phase of testing can last several years. Some phase II studies are randomized trials where one group of patients receives the experimental drug while a second “control” group receives a standard treatment. This allows investigators to provide comparative information about the relative safety and effectiveness of the new drug.

Phase III studies are typically randomized studies with many hundreds of patients that can last many years. In the end, the information provides a more thorough understanding of the effectiveness of the drug, the benefits, and the range of possible adverse reactions.

Before a drug can be used in the UK, it must receive a marketing authorisation (product licence) from The Medicines and Healthcare products Regulatory Agency confirming that it meets standards of quality, safety, and efficacy.

Before a drug can be prescribed in the NHS, it must be approved by the National Institute for Health and Care Excellence (NICE) as being cost-effective. Scotland has a similar regulator.

Because targeted therapies can be very efective for ALK+ patients, newly diagnosed patients would not usually seek clinical trials until they had exhausted standard treatments. An exception might be the Neladalkib/Alectinib trial referred to below.

Treialon Clinigol yn y DU

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