The following is an excerpt from our ebook “Clinical Trials in the Digital Age: Leaner, Smarter and More Connected”. Click here to download the ebook in its entirety.
The exponential pace of innovations has generated some truly exciting developments in the drug development arena. Gains in computing power are spurring new paradigms in clinical trials such as in silico clinical trials (ISCTs), blockchain-based trials, AI for patient recruitment, and digital pills.
Some organizations are running trials without actual patients and drugs, instead using ISCTs to help them analyze diverse datasets and explore alternative study designs.
Deﬁnition of ISCT: “an individualized computer simulation used in the development or regulatory evaluation of a medicinal product, device, or intervention”
ISCTs would be particularly valuable in paediatric or rare diseases, populations that are extra challenging in terms of recruitment, or for investigational medicines that are costly to make or can only be made in small amounts. Ultimately, ISCTs can help ensure that precious resources are not wasted due to a poorly designed protocol. Recently, the US FDA’s Center for Drug Evaluation and Research (CDER) announced that it is using ISCTs to inform trial designs, optimize dosing, predict outcomes and safety, and support evidence of effectiveness. Such an announcement provides a clear signal that regulatory agencies are also embracing tech to look at ways to rationalize drug development through the different stages of clinical trials.
For Bristol-Myers Squibb, outsourcing computer-intensive ISCTs also provided patent pay-offs. Two thousand simulations that used to take 60 hours in-house were completed in only 1.2 hours on the Amazon Web Services Cloud. The output optimized a pediatric trial to achieve signiﬁcant projected reductions in patient numbers from 60 to 40, trial length from 2.5 to 1.7 years, and study costs from $700,000 to $250,000. Patients also beneﬁted, with the number of blood samples needed per person reduced from 12 to 5 and length of stay shrunk to 26 hours from the original 72 hours.
Although blockchain technology has been around for a decade, how it actually works is probably only understood by a minor proportion of the population (~20% according to one survey).
Deﬁnition of blockchain: “a decentralized, distributed and public digital ledger that is used to record transactions across many computers, so that the record cannot be altered retroactively without the alteration of all subsequent blocks and the collusion of the network”
Intimately connected to cryptocurrencies such as Bitcoin, blockchain is a nascent concept in pharma, being explored primarily as a way to provide absolute source data veriﬁcation across the clinical trial process. It will take time to distinguish hype from reality, but its promise for revolutionizing trials is worth further scrutiny, particularly its potential to enhance transparency and collaboration among organizations while preserving patient privacy.
A collaboration between IBM Watson Health and the Mayo Clinic saw on average an 80% increase in enrollment into breast cancer trials after 11 months of implementing the cognitive computing system. Speciﬁcally, the natural language processing technique identiﬁed eligible patients in an unbiased manner, upping the average number of patients enrolled in a trial per
month from 3.5 to 6.3.
Meanwhile, Novartis also note that use of AI can provide valuable learning lessons in protocol designs and free up site study staff to focus on other activities. In a pilot study, it took a clinical trial coordinator 1 hour and 50 minutes to process 90 patients against 3 breast cancer protocols, while Watson completed the task in just 24 minutes.
Intelligent use of tech to increase patient compliance in particular would lead to massive beneﬁts. The greater the number of patients that sees a trial through, the fewer numbers of patients that need to be enrolled in the ﬁrst place. Moreover, the study team will have fewer disruptions to manage caused by dropouts. Such gains in compliance will trickle down to overall
cost savings too.
In November 2017, the US FDA approved the world’s ﬁrst ‘digital pill’ Abilify MyCite (aripiprazole tablets with a sensor embedded in the pill) for the treatment of schizophrenia, bipolar I disorder, and depression in adults. The system also includes a wearable patch sensor, a smartphone app, and web-based portals.
Once ingested, the stomach’s acid activates the sensor in the pill, and this activation is detected and recorded by the wearable patch. The patch then transmits info to the app, and selected members of the patient’s healthcare team or family can view this information via a secure web-based dashboard.
Whether this system actually improves adherence has not been demonstrated. However, the aim is “to help enhance collaboration with healthcare providers who treat patients with certain serious mental illnesses”. Because of its novelty, Abilify MyCite will only be available to a limited number of carefully selected patients.
It will be intriguing to follow Abilify MyCite’s progress in the real world to see whether this type of tech — a medical example of the Internet of Things— will truly beneﬁt patients.
This blog post is an excerpt from our ebook “Clinical Trials in the Digital Age: Leaner, Smarter and More Connected”. Click here to download the ebook in its entirety.