While the phrase ‘bench to bedside’ is short, developing a new medicine is a long and complicated process. It typically takes 10 to 15 years, at an average cost of around £1 billion.
About 90 percent of potential drugs fail in clinical trials, usually for 3 main reasons: because they do not work as they are meant to, because of concerns about their safety or because there are other effective drugs already available.
A great deal of the process of developing a new drug is focused on making sure it is effective and safe. There are 4 stages in developing a new medicine: discovery, preclinical studies, clinical development and market approval.
Discovery
Researchers start by finding ‘targets’ in the body that play a key role in causing a specific disease. These could be faulty genes or proteins, which are the body’s building blocks. Proteins are one of the most common targets because they play so many roles.
Scientists then search for substances called compounds (made from 2 or more chemical elements) that interact with the target to limit or stop the disease from progressing. They can screen thousands of compounds to find one which shows signs of working – they call this a ‘candidate’.
Sometimes it’s possible using computers to make or ‘design’ a compound that interacts with the target. This is called ‘rational drug design’ and advances in artificial intelligence (AI) are now making this easier.
Preclinical trials
Researchers carry out rigorous testing of the candidate in the lab, using computer models, human cells and testing in animals.
The aim is to find out if the potential drug works as it is meant to and is safe before it can be studied in humans. These 2 stages together can take up to 6 years.
Clinical development
If a potential drug is successful in the lab, researchers need to find out if it could work in real life. They do this through 3 stages of testing in humans known as clinical trials.
Phase 1
A small number of healthy volunteers try the new medicine to see if the lab findings translate to humans.
The trial aims to make sure the treatment is safe, to understand its side effects and how it works in the body.
Phase 2
A larger group of people with the disease try the drug and the focus is on finding out how well the treatment works.
Phase 3
Typically, several thousand patients volunteer in carefully controlled tests where the new treatment is compared to the current standard treatment, or a dummy pill known as a placebo.
Only 1 in 10 potential medicines will make it through all 3 clinical development phases successfully.
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Market approval
After a treatment is shown to be effective and safe, it can be approved by the regulator for doctors to prescribe for specified diseases and conditions.
In England, Scotland and Wales this is the Medicines and Healthcare products Regulatory Agency and in Northern Ireland, the European Medicines Agency.
Once patients are taking the new medicine, clinical studies called phase 4 trials begin. These collect data on the long-term side effects and adverse reactions to newly-approved treatments.
In England, the National Institute for Health and Care Excellence (NICE) also assesses
any new drug to decide if it should be made available to people being treated on the NHS, and whether there should be any rules on its use.
What is the BHF doing to help heart researchers?
Much of the research the BHF funds aims to create new treatments and tests that transform and save lives.
We provide scientists with funding and support to translate their research into new ways of diagnosing, treating and preventing heart and circulatory diseases.
BHF Translational Awards
Translational Awards aim to develop innovative technologies with the potential to transform the health of people with heart conditions.
Researchers can apply for up to £750,000 over 3 years to bring their research to market.
CardioStars
BHF has joined forces with Panacea Innovation, a life sciences and health platform, to launch CardioStars.
The programme aims to equip researchers with the entrepreneurial and business skills to get their groundbreaking science out of the lab and into the hands of doctors so they can better diagnose, treat and prevent heart diseases.
Scientists doing any kind of research, from behavioural science, to medicines, devices or computer software can apply for the fully funded programme.
NIHR and British Heart Foundation Cardiovascular partnership
BHF is working with the National Institute for Health and Care Research (NIHR), the UK
Government’s major funder of health and social care research, to speed up the benefits of science to people with heart and circulatory conditions.
The partnership connects world-leading researchers funded by BHF and NIHR, based in major universities and NHS trusts across the country.
By working together, they can identify projects that will create the greatest benefit, secure funding, and work with industry to get new treatments to patients.
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