Christian Hebenstreit, of Medidata Solutions, talks how becoming patient-centric in clinical trials means being open to new ways of working.
Clinical trials have historically been organised to gain medical knowledge above the personal experience of the patients involved. They often use highly technical language and procedures, with data passing straight from investigators to drug companies, affording little understanding to patients. This has resulted in patients unintentionally being treated as subjects, not people. Thankfully, this is changing and there is a growing understanding that when a patient enrols in a clinical trial, they are offering something of great value, which is why we are starting to see a shift towards organising and conducting trials at their convenience. They are becoming patient-centric.
Patient centricity is largely being facilitated by new and advancing technologies, in two ways. Firstly, it’s enabling patients to take part in trials remotely, in a way which is most convenient to them and often in the comfort of their own home. Secondly, technology has a huge role to play in the ethics of clinical trials; providing access to existing data which, in some cases, replaces the need for patients with serious illnesses to be given placebos.
Smart devices: Enabling more virtual patient trials
If a patient is going through an extreme form of illness, reducing the number of visits to a hospital or other trial site can help lessen the burden of the trial, both on the individual and their families. Virtual trials, utilising smart devices, such as phones, tablets and watches, can provide patients with trial information, and allow them to input data in the comfort of their own homes.
Additionally, smart devices can empower those who have been underserved in healthcare due to their demographic or geographical background. Elderly patients, or those who live far away from a hospital or clinic, may find that a virtual trial gives them access to treatment that they would otherwise not have been able to receive.
Smartphones have emerged as the champions in this space, due to their ability to run medical apps, and use in-built biometric and location tracking systems to record and transmit data remotely and in real time, in a way which has been shown to be reliable and clinically meaningful. For example, GlaxoSmithKline has developed an iPhone app to measure the severity and progression of arthritis. A simple test, which enables the tension and flexion in the wrist to be measured by holding the device, is allowing patients to provide data from home. The app records data about whether they are flexing their wrist correctly, and researchers are able to distinguish between good and bad data from these tests.
Artificial Intelligence: Using existing trial data
To date, clinical trials have used randomised control groups as the basis for proving that new drugs are safe and effective. This involves a random selection of patients being given a placebo, rather than a real drug, which poses an ethical dilemma and has understandably made some patients reluctant to take part in a trial.
With artificial intelligence (AI) and machine learning (ML), the pharmaceutical industry is now able to start moving away from the use of placebos and instead take advantage of the wealth of existing clinical trial data to create synthetic control arms. The huge backlog of digitally collected data can be accessed and narrowed down to create a control arm from the extract type of trial, patient or illness that is being studied. This provides a reliable point of comparison for the randomised control arm, allowing data points and findings to be matched to, and contrasted against, relevant existing data.
When the right data is available, a placebo group is not needed to act as a control or point of comparison, removing the burden to patients with disappointment or false hope of receiving a potentially lifesaving treatment. Furthermore, this means that overall patient outcome can be improved, as more patients who take part in clinical trials are guaranteed to receive a potentially life altering or lifesaving drug.
Big data: Making the most of what we collect
Did you know that 90 percent of the data in the world has been generated over the last two years alone? For clinicians and healthcare professionals this poses as many challenges as it does opportunities. After all, a large amount of data by itself is not useful; it must be crunched, analysed and understood in order to aid the advancement of medicine.
To achieve this, it is essential that the correct infrastructure is in place, allowing for one single, unified view of all data. The information silos that traditional pharmaceutical companies have maintained for so long must disappear and be replaced by cross-domain roles, aimed at closing the loop between the lab and the real world. For example, the data collected from wearable smart devices must be able to integrate and be compared to the data collected during hospital visits in order to provide a complete picture of how a patient responds to a drug.
It is also important to have clean, uniform data, and homogenisation between organisations. This too requires an understanding of how to curate big data, for example using advanced software to determine and remove outliers and anomalies much more efficiently than humans can.
Recent trends suggest that organisations are starting to open their eyes to the transformation that is required to capitalise on big data. In a short space of time there has been a transcendence of bold and brave pharmaceutical companies such as Pharm Olam, Novartis and Erytech that have embarked on digital transformation journeys to accelerate the hope they bring to patients.
A new future for patients undergoing clinical trials
The technologies explored here all have the capacity to help reduce the burden on patients and put their well being at the heart of all clinical trials. If we continue to use smart devices, remote trials and data collected by AI, and put in place the infrastructure to garner meaningful insights from it, then trials will run more smoothly, less invasively and become truly patient-centric.
While clinical trials are, of course, designed with the intent of gaining medical knowledge and advancing the treatment of illness and disease, this must no longer be done at the expense of patient well being.
Senior vice president EMEA