Clinical trials are medical research studies involving people, and aim to look for improved treatments or better ways to prevent, screen or diagnose a disease such as lung cancer. Before any treatment can be approved for widespread use it must first be rigorously tested through clinical trials.
There are four phases of clinical trials and at each stage more and more patients are required for the trial.
- Phase I trials look at whether a trial treatment is safe or has any harmful effects – as well as the best dose to use
- Phase II trials consider how well a treatment works – only those that get through these two phases go into Phase III testing
- Phase III trials test a new treatment against the existing standard treatment – if it gives better results, it may become the new standard treatment
- Phase IV trials are carried out after a drug has been licensed – information on side effects, safety and long-term risks and benefits of a drug is collected.
On average it takes approximately eight years from when a cancer drug enters clinical trials until it is approved for widespread use and only 10% of all drugs started in human clinical trials become an approved drug.
The promise of ‘personalised cancer care’, where patients are treated with therapies toward a specific molecular alteration has the potential to improve outcomes. However, the selection of patients for a specific therapy based on a molecular aberration, while acknowledging the additional complexity of tumour heterogeneity, evolution and treatment resistance, does not fit well with the traditional clinical trial model.
In order to address these challenges, there is need for innovative clinical trial designs and strategies that will incorporate molecular diversity within an individual’s tumour and between patients. Our group is working on getting new therapies to patients faster.
A phase I study of afatinib combined with paclitaxel and bevacizumab in patients with advanced solid tumors (DOI: 10.1007/s00280-016-3189-1)
IDEAL-CRT: A phase 1/2 trial of isotoxic dose-escalated radiation therapy and concurrent chemotherapy in patients with stage II/III non-small cell lung cancer (DOI: http://dx.doi.org/10.1016/j.ijrobp.2016.03.031)
Multicenter, Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Pravastatin Added to First-Line Standard Chemotherapy in Small-Cell Lung Cancer (LUNGSTAR) (DOI: http://dx.doi.org/10.1200/JCO.2016.69.7391)