Happy New Year — ClinTex perspectives on what to look out for in 2021
In our current environment, we need more resourceful, transformative ways to accomplish clinical research, and many pharma companies are beginning to look at blockchain as a potential solution to enable this paradigm shift. Now is the time for looking at new, creative ways to conduct clinical trials versus doing things the way they have always been done. For example, are there better ways to access information and data? The industry will reevaluate the whole infrastructure of clinical trials to become more operationally nimble by taking advantage of new opportunities afforded by technology like CTi.
What themes are set to dominate clinical research over the next 12 months? Here are a few data driven initiatives that ClinTex see as important and will highlight the need for better data quality, data analytics and data collaboration offered by the CTi platform.
Vaccines and the pandemic
2020 saw the roll-out of the first vaccines authorized for use against COVID-19. The effectiveness of several new vaccines will become clearer in early 2021. Of particular interest will be the results of phase III clinical trials of immunizations developed by the US pharmaceutical companies Novavax and Johnson & Johnson. These jabs are likely to be easier to distribute than the RNA-based vaccines made by Pfizer–BioNTech and Moderna, which have already returned phase III results but must be stored at very low temperatures. The Pfizer vaccine already has emergency authorization for use in some countries. Late last year, Novavax launched two large trials of its viral-spike-protein vaccine in the United Kingdom and the United States, which will report in early 2021. The company could produce as many as two billion vaccine doses per year. Johnson & Johnson is testing a single-shot version of its vaccine; by contrast, those from Pfizer and Moderna require two.
Digitising Clinical Research
Another healthcare sector that is projected to experience growth in 2021 is digital platforms like the ClinTex CTi platform, as unsurprisingly the pandemic has reinforced and propelled the digital transformation of healthcare. The speakers at a recent Frost & Sullivan webinar attended by ClinTex predicted that 35% of patients interactions would go virtual globally in 2021; and a physician will no longer be the automatic first touchpoint, as care moves outside the four walls of the hospital and into the home. This digitisation and sharing of data to support medicines development is central to the CTi development roadmap.
More Remote Clinical Trials
To say this has been a transformative year for clinical trials would be an understatement. The pandemic has forced investigator sites to shut down and collaboration between sponsors, CROs, and study teams to go remote, among other complications. Critical steps in the clinical trial journey that have traditionally been in-person processes — from site monitoring to investigator meetings and regulatory inspections — are going virtual.
One of the biggest challenges in conducting clinical trials remotely is that investigators and patients are physically unable to go to the sites. If patients can’t get to sites, clinical trial planning and execution needs to account for remote or hybrid capabilities. Helping sites equip with the technology and processes needed to facilitate a remote trial is key. Sponsors also need a clear understanding of how to execute remote trials and virtual visits going into 2021, and should ensure they have the expertise available to do so.
Another major challenge is the lack of predictability tied to study start-up times. In 2020, sites stopped initiating studies for six months in some places. This new consideration has made it hard to set a reliable timetable and delays new medicines development, the very problem CTi will address.
Hope for Alzheimer’s Disease
US regulators are to decide whether the first drug reported to slow down the progression of Alzheimer’s disease can be used as a treatment. The drug, aducanumab, made by pharmaceutical company Biogen, is an antibody that binds to a sticky brain protein called amyloid, which most scientists think could be the main trigger for the disease. Evidence that the drug works is mixed. Two phase III clinical trials have offered conflicting results, and an independent advisory panel convened by the US Food and Drug Administration to assess the drug’s effectiveness says that the data do not support its use. The only Alzheimer’s drugs approved so far treat cognitive symptoms such as memory loss, rather than the progression of the disease.
The 2021 Galleri NHS trial
An interesting developing diagnostic and monitoring tool is that of liquid biopsies, where a sample of blood is taken to look for cancer cells or DNA from a tumour. This technique has the potential to identify cancer at an early stage or ‘stage zero’ and to plan treatments pertaining to whether the patients cancer has returned.
One such test is the Galleri multi-cancer early detection produced by healthcare company GRAIL, which announced in November a partnership program with the NHS for a trial of their product to be rolled out in 2021. Their blood test has so far proven to be promising; clinical trials in the US of an earlier version of Galleri detected over 50 types of cancer with a low false-positive rate of less than 1%. And according to GRAIL, adding the blood test to existing care procedures could cut the number of late-stage diagnoses by nearly half and could potentially reduce cancer mortality in the UK by 20%.
Overall, the UK 2021 trial will involve 165,000 people split into two groups. The first group of 140,000 people over the age of 50 without any suspicion of cancer and the second will include 25,000 people aged 40 and above with suspicious signs or symptoms of cancer. If the program is deemed a success, the program has been earmarked for a further expansion to approximately one million people across 2024 to 2025 and then onto a larger population afterwards.
Multigene panels, NGS tests, and digital technology
Multigene panel testing is a type of genetic testing that examines gene mutations in multiple genes at once, which can help healthcare providers determine what cancer screenings a person may need, therefore providing a personalised treatment plan for those who already have been identified as being genetically at risk from certain cancers. While NGS tests are a rapid and cheap sequencing of genomes, that could be invaluable in cancer treatment as it will enable a more precise diagnostics and will facilitate personalised therapies.
CTi Predictive Analytics: Clinical Data from Digital Biomarkers Will Expose Symptoms Before They Turn Serious
ClinTex are aware of tech-minded epidemiologists working to crack the code of digital biomarkers as they could signal early and important changes in the trajectory of a disease. Researchers are now able to capture quality data, on a longitudinal scale, and harness the data across groups of patients to establish accurate markers. The fallout of COVID-19 has accelerated this effort as more companies take a decentralized approach to clinical trials as offered by Clintex CTi, and leverage remote data capture
While the ability to capture digital biomarkers remotely is often constrained by cost and logistics, there are rich data that can be collected reliably with modern technology. For instance, a daily video that shows progressive changes to a Parkinson’s patient’s shuffle, a wearable device that measures hand tremors continuously, and a digital sleep monitor that tracks REM sleep cycles all inject new factors into the research equation to help determine accurate digital signatures. Just as critical, DCT platforms enable researchers to collect higher quality data from patients in their natural environment when they are most relaxed, eliminating the “white coat effect.”
As DCT adoption increases, tools like the CTi platform will be able to identify the early symptoms that could turn into adverse events later in the trial. Since the development of symptoms has the potential to jeopardize patient safety and instill fear and panic, patients could drop out of a trial prematurely. Identify these early, however, and the care team may be able to mitigate symptoms, prevent psychological harm, and avoid losing patient participation — especially if the incident was not caused by the investigative drug but by external factors, such as dehydration or lack of sleep.
In 2021, the momentum of DCTs and the CTi technology will allow clinicians and researchers to better utilise digital biomarkers to help improve care and maintain the integrity of vital clinical trials. It will be the beginning of truly proactive, CTi blockchain powered patient care.
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