Virtual Clinical Trials – The Next Generation of Clinical Trials
Since the first modern randomized controlled clinical trial in the year 1948, the pharmaceutical industry has undergone an astounding evolution. Today’s industry status quo is continuously disrupted by seismic shifts. The new paradigm of the industry is defined
- by the swing from treatment to prevention, diagnostics and cure;
- by the move from blockbusters to “niche-busters”;
- by new products and service offerings “beyond the pill”;
- by Advanced Therapy Medicinal Products (ATMP) for personalized treatments;
- and by the emergence of new technologies.
With the help of emerging technologies, the industry’s focus is shifting to patient-centric treatments and to the improvement of the overall patient experience. Technology is at the heart of the future of the pharmaceutical industry. It can enable fundamentally different end-to-end capabilities and support a patient-centric value chain -from the design/molecule to the patient, or vein-to-vein. One key element of the patient-centric value chain is clinical trial and the next step change is virtual clinical trial.
In this article we focus on the key elements to build a holistic strategy for virtual clinical trials.
The evolution of clinical trials
Clinical trials are an integral part of the pharmaceutical value chain. With the introduction of personalized treatments and an increase in new product launches, number of global clinical trials are growing significantly. The ability to run efficient and effective clinical trials is a clear competitive advantage and has huge impact on how Pharma innovations reach patients and how the industry communicates with their patients.
Advancement in technology creates opportunities and increases the capabilities to innovate in the area of clinical trials, specifically patient-facing technologies like wearables, smartphone and tablet apps, or smart blisters.
In the current situation where the world is battling with the coronavirus (COVID-19) pandemic, there is an urgent need of innovation in the clinical trials process. Most Pharma companies are facing the impact due to increased risk of patients being infected, lockdowns and implemented travel bans. For some sponsors, the urge to find a test, treatment or vaccine for COVID-19 is driving recruitment and competition for patients. There are more than 50 new covid-19 related clinical trials happening which need to recruit new patients and each patient usually can only participate in one, so there is a large amount of competition. In other cases, the industry has decided to put trials on hold to ease the burden on the local Healthcare systems. Add to this the challenges due to different national regulatory frameworks and ethical requirements. On March 18, 2020, the FDA released a new guidance, supporting virtual activities during the execution of clinical trials, specifically virtual visits. This gives the required boost to take clinical trials to the next level of virtual clinical trials.
What is a virtual clinical trial?
In this article, we will use the term “virtual clinical trial” as a collective term for various types of trials that are supported by patient-facing technologies, such as decentralized trials, remote trials, digital trials, hybrid trials or direct-to-patient (DTP) trials. This excludes in-silico trials, since these do not involve human’s, but are run as a “virtual” simulation in computer systems.
Though virtual trial is a widely used term, but we are yet to see a “true” virtual clinical trial, conducted without any face-to-face interactions with patients. While we expect this scenario to be a reality in near future, we see most companies focusing on introduction of patient-facing technologies, remote data collection & advanced data analytics; to make the trials “near” virtual. For us, a clinical trial starts to become virtual with the introduction of patient-facing technologies, that reduces the need for patient visits in the traditional setting. Most visits are virtual and performed via telemedicine, supported by patient-facing technologies for remote monitoring and data collection.
Opportunity for the industry and benefits for the patients
Most of the technologies and solutions that are needed for virtual clinical trials are already available; the use of the right technology provides unparalleled opportunities to the pharmaceutical industry. The ability to remotely monitor a patient’s activities; collect, aggregate and evaluate patient data; and to merge that data with other internal (Research & Development) and external (Real-World Evidence) data provides access to an immeasurable trial, patient, product and market intelligence. Additional benefits are much smarter resource utilization and improved cost/benefit ratios.
In addition, the industry will also benefit from the increased patient availability, improved patient recruitment, and better patient engagement, while at the same time improving the overall patient experience:
The ability to execute virtual trials maximizes patient availability and enrollment in the study. It increases the flexibility in time and location.
Patient recruitment & enrollment is one of the longest stages of a clinical trial with 80% of trials failing to meet initial targets.
Unlike site-based clinical trials, which require frequent visits to a designated research facility, virtual clinical trials are home based for the patients. Even patients with mobility issues are able to participate in the trial.
While virtual trials require the study site to house support staff and invest in data collection & analysis platforms; they can be more cost-effective as they don't require the traditional set-up of multiple study sites and other cost-driving factors.
As virtual trials have more patient engagement through more frequent interactions, it is expected that the drop-out rate would be lower for them as compared to traditional trials.
Remote Access & Travel
Many patients would like to participate in clinical trials, but their location or other restrictions do not allow them to participate. In a virtual clinical trial, travel is significantly reduced.
Risks and challenges to keep in mind
Moving to virtual clinical trials is not just a simple technological effort but requires a well thought and holistic strategy. It should have involvement of right stakeholders both internal and external and should take into account all identified risks and concerns.
Some of the areas that should be considered and planned for are patient safety, data privacy, unclear regulatory acceptance and missing industry standards & terminology.
In addition, while patient-facing technology will be a key enabler for the set-up and execution of virtual clinical trials, the industry needs to find the right balance between technology and traditional human-to-human interaction. In some cases, and depending on the therapeutic area, the traditional approach to clinical trials will continue to be the preferred option.
Key enablers for virtual clinical trials
Moving to virtual clinical trials requires a robust business transformation strategy, supported by a strong business case and complemented by a realistic implementation plan. Most pharma companies know how to run such transformation programs, but the complexity of the journey towards virtual clinical trials should not be underestimated.
This changes the way pharmaceutical companies operate today and run technology-based projects; it demands introduction of new technology; changes in processes, data, and organizations. Further, it requires the acquisition and retention of new technology skills, and a significant re-skilling effort of the existing workforce. The resulting projects are not an ordinary internal IT project. The patient is the end-user of the patient-facing technology and needs to be involved during the entire project lifecycle.
The enablers are categorized into 3 buckets - operational processes, solutions and technologies.
Operational processes enable how we interact with the patients and exercise the virtual clinical trials. They have a large impact on the organization of the clinical trials.
The Direct-to-Patient model allows for drug therapies to be delivered and administered in the patient's home. Biological samples can be taken and uplifted from the patient's home.
A subforum of virtual clinical trials. Digital trials can be run without any medicine but focus on utilizing wearables and other information to gain insights. They can be run completely digital without the patient having to see a medical professional.
Solutions are enablers, which allow the organization to enable certain factors which are usually done at the site. They have the biggest impact on the execution of the clinical trial remotely at patient’s home.
New methodologies, like wearables or smart blisters, allow to control and monitor remotely the adherence to taking the medication.
It can be an enabler for Patient Engagement and to consent remotely to the clinical trial.
Digital and electronic clinical trial diary allows an immediate understanding and analysis of patients' daily log from a central point of view. Results can be reflected in the trial over time.
The current supply chain for clinical trials allows only limited changes to the labels and booklets. eLabels bring the relevant information to the patients and an ability to connect to the website for more information if needed. This will allow faster changes to the trials and make them more adaptive. Please follow to our article on eLabels.
Telemedicine and remote visits allow seeing patients without the restriction of time and distance. Adaptive systems will also allow older or previously not applicable patients to participate in clinical trials from home.
The introduction of telemedicine, wearables and other devices requires that patients have constant availability of these devices. Predictive Maintenance will allow to send repairs and replacements ahead of time.
The use of new technologies further supports all the other enablers. These are key for virtual clinical trials in the organization.
The analysis of the data generated by virtual clinical trials is a key factor. The target should be to go paperless to be able to get immediate access to the data for analytics.
Data is the driver for clinical trials. Faster access to data allows us to react to results faster. IoT data from wearables and smart blisters provides deep insights into the patient results without bringing the burden to the patient of providing the data.
Other factors that influence the virtual clinical trials strategy
The virtual clinical trial is very much here, and the right strategy will outline the path and guide the choice of right enablers for different types of clinical trials. For a robust clinical trial strategy along with the enablers listed in the previous section a good understanding of additional factors such as organization, wider system landscape and processes is needed. This analysis is relevant for all type of clinical trials in an organization and are not limited to virtual or digital clinical trials.
Next generation eco-systems
Virtual clinical trials require a holistic approach to systems, a new way of looking at the existing systems and adding the right components to build a next generation eco-system. It is important to understand the existing landscape and closely look at the vendor strategy for supporting systems like ERP or clinical trial supply management. These providers will impact the overall system integration and influence the outcome for sponsors and patients.
Trials should be flexible for virtual clinical trials to be able to react to situations faster. Adaptable trials will provide a flexible structure for better execution & management and allow iterations. Relevant enablers will support improvement of output at each phase.
Continuous patient data
An important aspect of clinical trials is the patient data. With patient consent, patient data could be shared within different parts of the organization and in some cases with other sponsors too. Standards will enable different trials to use the available patient data. The digital transmission of this data will give early insights. Further, it will allow higher data quality and decrease the associated risks.
Virtual clinical trials will be a major asset and a significant game changer for the Pharmaceutical industry. They are already very much here and with the current situation and new FDA guidelines they present a perfect opportunity for organizations to leap-frog into the new evolution.
Tenthpin has number of years of experience in building system oriented clinical strategies. We understand the opportunity that Pharma companies have and also the associated challenges to ensure a successful move to virtual clinical trials. We can help you define and implement your virtual clinical trials strategy and take it to successful implementation.
Contact our industry experts at Tenthpin Management Consultants if you would like to learn more.
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