By Tyler Reynolds and Nadeem Fazal, PA Consulting
The time for bold change within clinical trials is now. COVID-19 has proven to be a universal disruptor to the traditional clinical trial model globally and the pharmaceutical industry has been forced to adopt new ways of working to ensure the continued safety of patients. Physical interaction limitations have accelerated the implementation of innovative approaches to new and existing trial designs. As a result, virtual clinical trial models have arrived as meaningful alternatives to traditional clinical trial conduct.
Traditional clinical trial processes are run in a top-down fashion and in a closely monitored setting, making them expensive and oftentimes inefficient. The process is heavily reliant on in-person collection of data at sites using a mix of paper-based and electronic methods. The need for patients to physically go to sites can make trials inconvenient and inaccessible to those who need them most. In comparison, virtual clinical trials allow for remote participation by patients and can be designed to have an efficient and seamless flow of data directly from a patient’s home to electronic health records and/or electronic data capture systems.
The move toward virtual clinical trials necessitates the use and adoption of digital technologies such as telehealth platforms, electronic informed consent, and digital data collection tools like wearable devices. Automated data collection, collaboration tools, and use of artificial intelligence and machine learning are also components that should be further explored in this new model. Despite the existence of innovative technologies, they are only one piece of a complicated puzzle needed to successfully implement virtual clinical trial models. It’s critical that sponsors also consider three key steps for achieving sustainable change in the bold, patient-centric move to virtual clinical trials.
1. Understand the impact to stakeholder experience.
A shift to virtual clinical trials will affect each stakeholder (e.g., principle investigator, clinical staff, sponsor, patients) differently and to a varied magnitude. Because of this, it’s necessary that sponsors dedicate time to understand how changes in process may impact changes in experience. Consider that a small change for site staff could result in a large impact on the patient experience. For example, shifting study support from in-person visits to virtual visits may not be too big of a change for site staff. However, for a patient who isn’t as comfortable using technology, this change may feel monumental. To truly understand how virtual clinical trials will impact stakeholders’ experiences, the status quo needs to be challenged, which can be done by conducting journey mapping exercises, testing underlying assumptions, and identifying the areas of greatest change.
One opportunity for virtual clinical trials to transform the stakeholder experience is patient recruitment and enrollment. Virtual clinical trials can help to remove geographic barriers to participation for patients, resulting in increased accessibility and a reduction in recruitment delays for sponsors. For this to be successful, sponsors will need to modify recruitment strategies and utilize additional mediums of communication to reach greater geographies. On the other hand, patients may need to reevaluate what’s most important to them while participating in a clinical trial and whether a virtual trial will meet their needs. For example, does a reduced need for on-site visits outweigh an associated reduction in in-person treatment? To assist patients in their decision-making, pharmaceutical companies must clearly explain the differences associated with participating in a virtual clinical trial versus a traditional clinical trial. When seeking out virtual clinical trials, patients and primary care physicians may need to expand their search criteria to include key terms such as virtual, decentralized, and remote, for example.
While a shift to virtual clinical trials will help address certain pain points in the trial environment, there will be some conditions that are better suited to this model based on the way treatment is delivered and the outcomes measured. For example, oncology trials may be difficult to run in a fully virtual model. This is true of many therapies that require trained professionals to administer treatments and complex diagnostic equipment to measure outcomes. These trials are likely to be better suited to a “hybrid” approach to limit the number of clinic visits except when absolutely necessary for ensuring patient safety and data integrity. Other therapeutic areas, such as inflammation and immunology, may provide a much easier transition to a fully virtual trial model. This is especially true in instances where trials are utilizing small molecules from well-studied classes of drugs. In this situation there is a higher likelihood that patients can safely and effectively administer their own medication with a very low adverse event risk.
2. Identify the global regulatory implications.
Precedents have been set for successfully conducting virtual clinical trials thanks to studies like the TOPAZ and ADAPTABLE trials. Claims to the contrary are perpetuating a myth. Many major health authorities have already begun to pave the way forward for conducting digitally enabled clinical trials. For example, the regulations governing clinical trials for drugs in the U.S. and EU already allow for electronic submission of the clinical trial application and the clinical trial report, although exceptions may exist in the EU at local levels.
There are no immediate regulatory implications on study execution activities; however, many activities (e.g., informed consent and trial master file) need to move from paper to electronic systems. Different countries may have different rules surrounding collection, protection, and submission of data. It’s imperative that sponsors understand this and build into plans for virtual clinical trials conversations with health authorities. Prepare to engage health authorities early and often for the greatest likelihood of success.
Understanding regulatory implications is only one part of successfully conducting virtual clinical trials. Sponsors will need to prepare in other ways, including setting up electronic document management systems, training staff and patients in online document usage, and moving to electronic document storage. Companies must also ensure that the electronic systems used are compliant with relevant good practice guidelines and that patient privacy is protected.
3. Assess your organization’s readiness for virtual clinical trials.
Though COVID-19 disrupted over a thousand trials involving tens of thousands of patients, many trials were sustained by remote patient monitoring, the use of electronic clinical outcomes assessments, and other tools used in virtual clinical trials. Johnson & Johnson, for example, launched two fully virtual clinical trials since the start of 2020, Heartline and CHIEF-HF. CHIEF-HF, an indication-seeking study assessing the effectiveness of INVOKANA, is the first trial of its kind to be fully decentralized, in which all contact with study participants will be done virtually and clinical data will be captured via smart technology and wearable devices. This shows that the ultimate hurdle preventing the pharmaceutical industry from executing virtual clinical trials is not as much the technology but the maturity of an organization’s R&D operational capabilities to be able to run virtual clinical trials at scale. By dissecting clinical trial operations across the entirety of the clinical trial process – from study design to study close-out – organizations can fully understand their outstanding development and capability needs and their readiness to transition to virtual clinical trial conduct.
Clinical trials have followed the gold standard of randomized control trial methodologies for the last 50+ years and, frankly, until the emergence of COVID-19, the pharmaceutical industry has had little incentive to diversify from that standard. That said, simply recognizing opportunities for growth and innovation is not enough. Companies must also conduct multi-stage, in-depth analyses of R&D operations and technology capabilities to uncover and capitalize on the right opportunities:
Step 1: Document existing processes and workflows – Prior to analyzing your operational maturity, it is important to clearly understand each of the processes supporting the clinical trials in your pipeline and how these processes may vary between study teams.
Step 2: Define the vision for your future world – Despite the use of similar research methods across the industry, each company maintains both a different set of R&D capabilities as well as a different set of R&D goals to improve such capabilities. That said, defining “best-in-class” for each operational capability is essential, along with the critical success factors needed to achieve that best-in-class maturity.
Step 3: Determine your stage of readiness and associated next steps for growth – After understanding what the target is, you can then assess where your R&D maturity stands today versus where it needs to go. Comparing the future state against the current state will organically bring to light the areas in R&D operations preventing innovation and that require additional investment for transformation.
During a time of difficulty and ambiguity, clinical trial conduct experienced a spark of ingenuity demonstrating real feasibility of virtual clinical trials. Therefore, having successfully pushed the bounds of innovation and demonstrated a path for transformation, a return to traditional ways of conducting clinical trials would be a disservice to patients. Now, virtual clinical trials have demonstrated their ability to improve access, reduce participation burdens, and enable the collection of robust data, among other benefits. To stay at the forefront of innovation, it’s imperative that organizations understand whether they have the capabilities and plans necessary to deliver virtual clinical trials to patients.
About The Authors:
Tyler Reynolds is a health and life sciences expert at PA Consulting with a focus on digital health. His expertise is in the areas of strategic thinking, operating model design, process improvement and project management. He has worked with organizations of varying size and complexity, ranging from Fortune 15 companies to boutique biopharmaceutical labs. Most recently, he led a nonprofit initiative managing a team of 40 digital health professionals toward a goal of further enabling and accelerating the global use of digital health technologies in clinical research.
Nadeem Fazal is a health and life sciences expert at PA Consulting. He brings strong expertise and a multidisciplinary skillset of quality and performance improvement, health policy, and public health for his clients across the healthcare value chain. With experience from healthcare service design to process optimization, he is equipped with the versatility to deliver value-based solutions in an ever-changing healthcare environment.