There is a very long and expensive development and approval process before a drug makes it to market. Most oncology drugs follow a similar overarching drug development path. This traditional pathway can take up to 15 years, but efforts have been made by industry to reduce this timeline.
All drugs start in the lab – the lab may be private, or in a university, hospital or specialist cancer center – but generally this early research is no longer done by pharmaceutical companies. This starting point is called basic or pre-clinical research. There are usually 3 stages before a drug can be approved:
1. Pre-clinical, or basic research
Researchers or doctors have an idea of something they would like to test, a question they would like answered. This could come from laboratory work, other trial results or experience with patients. After initial testing, any promising compounds undergo further study in the laboratory on animals such as mice, or on biopsied tissue. This pre-clinical stage can take several years. For example, the University of Edinburgh project that we are funding will take up to 3 years to complete its lab work. If results from basic research studies are positive, the new drug or approach will then begin to be tested on people in a clinical trial .
2. Approvals and funding process
All trials and studies go through an approval and funding process. This includes:
3. Clinical trials
Clinical trials aim to provide reliable evidence about how effective treatments are and whether they should be made available to patients. For patients who have often run out of other options, they offer access to experimental treatments.
Traditional Randomised Control Trials, considered by many to be ‘gold standard’, compare a new drug with standard care or a placebo. In most cancer drug trials, some patients will receive a new or repurposed drug, while others will have a standard treatment, such as chemotherapy for comparison purposes as cancer patients can’t afford to have no treatment at all. In other types of trials, especially for advanced or less common cancers which have few or no approved treatments, only the experimental drug is given.
Patients on trials are closely checked, meaning that any side effects are noticed and dealt with quickly.
Clinical trial results are used to help governing bodies decide whether the treatment should be available for use on the NHS. The more trials that can recruit patients quickly and be completed, the more new drugs will become available faster.