What's the problem?
Clinical trials are essential to ensure that the medicines that we take are fit for the purpose intended and will improve health with limited side effects. However, it’s not easy to carry out clinical trials, and the process takes a long time. On the data front, healthcare information is scattered and fragmented, and data may be collected and filed in different ways making it nearly impossible to compare. Innovative trial designs may not be well-known or well-accepted by the medical community, and there may be operational difficulties in implementing them. On the practical side, trials are expensive, people may not want to take part, it’s hard to keep participants engaged in the trial, there’s a limited number of well-trained staff who know how to execute high-quality clinical trials, and even if you do get people to take part, they might not be representative of the population that you need to target.
What are we doing about it?
IMI is funding a variety of projects that tackle the different challenges posed by clinical trials, with a view to optimising the clinical trial process from beginning to end.
IHI / IMI research is...
|…digitalising clinical trials including digital endpoints||
IMI Trials@Home is leveraging digital tools to enable clinical trials to be carried out from the comfort of patients’ homes. By using new digital technologies, participants can log information for clinical trials without actually going to the clinic. PharmaLedger is leveraging blockchain technology to optimise the recruitment process for engaging participants in clinical trials. IDEA-FAST is conducting four clinical trials in people’s homes using digital technology like wearable devices to monitor sleep in patients. It’s hoped that utilising digital tools like this this will make clinical trials more attractive to patients, and boost participation. MOBILISE-D is harnessing the power of digital tools like sensors to evaluate mobility in patients, which is an important marker of health.
|…innovating design of clinical trials to improve their efficiency and ultimately bring new treatments to patients faster||EU-PEARL has developed a new methodology to conduct collaborative platform trials through which multiple drug developers can test how well their treatment works against one placebo group, reducing the expense of running many placebo groups across multiple clinical trials. Tuberculosis (TB) is one of the leading causes of death worldwide, and the treatment regimen is long and comes with some unwanted side effects. New drugs are urgently needed. UNITE4TB is developing a new approach to trialling TB drugs in phase 2 clinical trials, leaning on simulation tools to identify the optimal doses for each drug before running a multi-arm adaptive clinical trial, through which many treatment options can be evaluated at the same time.|
|…identifying better tools for assessing a patient's health status (outcomes, endpoints)||Primary Sjögren’s syndrome causes a wide range of symptoms that affect patients in different ways, which makes finding a common treatment difficult. To help design better clinical trials for therapies to tackle Primary Sjögren’s syndrome, NECESSITY developed ‘Sjögren’s Tool for Assessing Response’, a tool that helps evaluate which outcomes are the most relevant for patients. SISAQOL is developing a set of guidelines on how to analyse and use patient reported outcome (PRO) data in cancer clinical trials.|
|…setting up clinical research networks for swift delivery of high quality clinical trials||
|…leveraging real world data to enhance the design of clinical trials||The European Health Data and Evidence Network (EHDEN) is developing a central network of standardised health data, which will make the large-scale analysis of health data a reality and will ensure that better clinical trials can be conducted. Safety concerns mean that very few drugs have been tested on pregnant and breastfeeding women, despite the fact that 90% of women are prescribed medication at some point during their pregnancy. ConcePTION will improve data collection of pregnant and breastfeeding women, and will deliver procedures and tools for that purpose. This will mean that better and safer clinical trials for pregnant and breastfeeding women can be designed, taking into account these data.|