I was honoured to be invited to speak at the Cystic Fibrosis (CF) clinical trials conference in Manchester, UK last week.
About Cystic Fibrosis
Cystic Fibrosis is a critical and debilitating illness that has historically shortened the lives of many individuals around the world. Fortunately, treatments have continued to improve outcomes, taking the median life expectancy of 5 years in the mid 1950s to 47 today. Despite this positive progression, the condition does impose life challenges and these are reflected in how clinical trials are planned and run. We can do better.
CF Clinical Trials
One of the enlightening presentations during the day was from a CF patient parent who described their daughter’s history of participating in clinical research from her early years. Her daughter is now in her mid-teens.
1). Mobility – attending a clinical trial that has many visits is not great at the best of times. For a patient with a more severe form of the condition, the act of attending a site can be detrimental in itself. It was also pointed out during the conference that young people prefer to live as normal a life as possible. Frequent trips to the hospital to participate in a clinical trial goes against this.
2). Meet-ups – People with cystic fibrosis should not meet one another as they have different bacteria or ‘bugs’ that grow in their lungs. These ‘bugs’ are rarely harmful to those who do not have cystic fibrosis, but may be harmful to other people with the condition. This means that interaction outside a clinical trial should be ‘remote’ where possible. This lends itself to forums such as the Cystic Fibrosis Trust Forum.
3). Match trials – Underdeveloped trial matching is bad. What I mean by this is that when systems are used to notify patients of clinical trials, if the trial’s inclusion/exclusion criteria do not match the patient receiving the notification, this can often lead to frustration. A better solution is to store the typically relevant information on the patient’s record and then to match this against proper electronic representations of the inclusion/exclusion criteria. This requires better trial definitions (metadata) than are currently defined on ClinicalTrials.gov. Only trials that actually meet a patient’s known condition state and demographics would be sent out.
Taking action
At the conference, I spoke about how we and other enablement organisations are making it possible to run increasingly virtual clinical trials where trial participation and activities are carried out remotely in the patient’s own home – or even at a local doctor’s surgery/office. It just makes so much sense.
- Patients are less negatively impacted by the clinical trial process.
- Patients can take part even if their condition would make it otherwise difficult.
- Patients can more easily lead a normal life without the need for interruptions for hospital visits.
- Data – in the form of timely electronic patient diaries or remote patient monitoring – can more accurately reflect the patient’s condition and responses.
Lets do it together!