Connecting for Clinical Trials
Australian clinical trials app
Whenever we carry out research with patient groups, involvement in clinical trials is often near the top of each wishlist. At the same time, the industry is embracing technology to recruit and retain for clinical trials.
ClinTrial Refer app
Since its launch in 2013, the Australian ClinTrial Refer app has listed more than 1000 trials across a range of therapy areas including oncology, haematology and gastroenterology. The not for profit team behind the app say it aims to bridge “a critical gap in clinical research, facilitating better knowledge management, and allowing more equitable access to clinical trials.”
The core functionality enables people to search for apps by therapy area, location, and inclusion and exclusion criteria. It includes overview information on each trial to enable an informed choice. The same function is available in a suite of related apps focusing on specific therapy areas.
The app is run by South Eastern Sydney Local Health District, and Sydney Local Health District, and covers more than 850 trial sites primarily in Australia, New Zealand, with some in France and Belgium and a few in the rest of the world.
Australian patient groups supporting the app include Lymphoma Australia and the Leukaemia Foundation. Patient groups play an increasingly important role in signposting upcoming trials to their members, and sometimes taking a more active role in recruitment. However, groups also share with us some of their challenges and frustrations with clinical trials.
Challenge 1: Exclusion criteria
There’s always a difficulty in perception where the inclusion/exclusion criteria in a clinical trial protocol by definition has to exclude most patients with the target condition. Patient groups share their concerns about this with us, and some patients suspect the industry of setting inclusion criteria with more of an eye to commercial advantage and future marketing.
Although scientifically, clinical trial cohorts need to be very tightly-defined to remove confounding variables, groups sometimes feel that the industry does not explain why it is focused on a specific cohort. However, with the growing capability to gather and analyse Real World Evidence, there is the potential for an improving balance between the narrow population specified in protocols and the messy complexity of the wider target population for a treatment.
Challenge 2: Location
When we hear from patient groups worldwide, they consistently complain that in their therapy area clinical trials are not run in their country. Digital would appear to be helping a little to level the economic side of this on trials where remote reporting or wearables can make a wider mix of countries possible. However, the focus on science and clinical safety will continue in some cases to require recruits to be close to specific testing centres.
Challenge 3: Lack of patient-centric design
Having worked on patient/subject/participant support in clinical trials, it’s not always obvious to clinical teams what to take into account about the impact of the patient’s condition when designing trials. Although designing trials around the needs of specific patient types is fundamental to retaining participants, many practical, regulatory and commercial reasons have made it hard to design protocols in a patient-centric way. Patient groups tell us they want trials to be more patient-centric, and to be actively involved in trial design, and there are signs industry is taking some steps to improve in this area.
As the ClinTrial Refer team say, the ideal aim is for “more equitable access to clinical trials.”