Focus on research: clinical trials

Dr Molyneaux standing in the lab
July 2022

Dr Molyneaux talks to us about taking part in clinical trials and the impact they have on the treatment of pulmonary fibrosis.

As the Clinical Research Facility Director at Royal Brompton, Dr Molyneaux is responsible for overseeing the delivery of all respiratory research at the centre. He leads a team of nurses and research coordinators who set up and run clinical trials across pulmonary fibrosis, pulmonary hypertension, asthma, cystic fibrosis, COPD and infection.

What is a clinical trial?

Essentially it’s a study to evaluate a treatment, device or procedure in a group of patients. This can mean simply observing what happens (an observational study) when treatment is given to everyone or comparing it to a placebo, where we compare how the new drug works compared to a sham/sugar pill.

In terms of advances in research, these really are exciting times for patients with pulmonary fibrosis. There are numerous studies in IPF, PF-ILD, Sarcoid and more rare ILD (e.g. PAP) which are targeting a number of different pathways and vary from inhaled therapy, to tablets and intravenous injections through a drip. Importantly, the majority of these trials allow patients to continue on their existing antifibrotic therapy for pulmonary fibrosis. The even better news is that the majority of them are added into existing therapy for PF (Nintedanib and Pirfenidone) meaning that more people are eligible to take part.

How many trials are you currently leading?

At present we’re running 14 trials in pulmonary fibrosis, some are studies run by Imperial College London and others are run and organised by commercial companies where we are one of many sites across the world.

What impacts have you seen as a result of clinical trials in the treatment of people with pulmonary fibrosis?

When I started my training there were no proven or approved therapies for pulmonary fibrosis.  In the past decade we have seen positive studies in IPF, Scleroderma and PF-ILD which have all resulted in NICE approval and access to life extending therapies for patients. None of this would have been possible without the generosity of the thousands of pulmonary fibrosis patients who participated in these clinical trials.

Are clinical trials safe?

Clinical trials are very tightly controlled in the UK.  For example, clinical trials in England are stringently reviewed and monitored by the Health Research Authority (HRA) to ensure they are safe for participants. Any trials including a drug also undergo review by the Medicines and Healthcare products Regulatory Agency (MHRA). Often studies are running simultaneously across a number of countries and continents and therefore undergo similar reviews in each country.

All trials come with risks and the information you are provided with and the team you speak to about studies should be able to explain and discuss these with you. These risks will depend on a number of factors including the stage of development (phase) of the potential treatment. In earlier phases, less patients will have received the drug and the focus of the study is normally to assess the safety of the drug in patients, while also investigating how it works.

What are the disadvantages of taking part in a clinical trial?

Normally the main sacrifice for patients is their time, as they generally involve multiple visits to hospital. However, we find that the majority of our patients ultimately find this to be of benefit as they receive regular face to face review and lung function from a specialist team of doctors and nurses experiences  in pulmonary fibrosis and clinical trials.

Ultimately what motivates people to get involved?

I feel altruism is one of the leading motivators. Many patients I see hope to help those diagnosed in the future. They recognise how devastating the disease is and how powerless they feel when they are unable to get answers as to why they developed the disease and how it may progress.

How can patients access trials and get involved?

Ask your local clinician or specialist nurse. You can email us direct at to ask about studies here (and you don’t have to move your clinical care). Your local pulmonary fibrosis support group and APF will also often provide details of upcoming studies.

“My dad has taken part in a number of clinical trials in the past year. Primarily, he participated so he could help progress treatments. Overall, with no trials there can be no progress – but it’s provided so much more than this. Not only has he been given the best care and monitoring from detailed lung function tests, he’s also been able to spend time discovering more about his condition and discussing his own PF journey. I know my dad’s felt less alone having had these conversations and is able to understand what’s happening to him. It’s extremely comforting for his family to know this.”
Sam, daughter of Tony

This article was sourced from our APF Insider magazine, packed with free information to help you live well, stories from others living with pulmonary fibrosis, research news and updates from our community. Sign up to receive your own copy.