The Global Impact of COVID-19 on Clinical Trials and the Way Forward
Restrictions on movements and stay-at-home orders are helping to mitigate the spread of COVID-19. But successful strategies against this global health threat are creating threats of another kind – obstacles to clinical trials essential to finding effective treatments and cures for a myriad of diseases.
While the healthcare community has rallied together in efforts to develop therapeutics and vaccines for COVID-19, we must not forget the other trials underway and those in the R&D pipeline that will also help conquer disease. There is an urgent need to use advanced and innovative approaches to ensure the continuity of existing trials and the start of new studies.
Quantifying the issue
Medidata is conducting repeated analyses of enrollment data from nearly 4,600 current clinical trials and more than 182,000 study sites worldwide. The reports show demonstrable decreases in the number of new patients entering clinical trials for actively recruiting studies.
There was a 65% worldwide average decrease in new patient enrollment year-over-year during March. Among major markets, this ranges from a 43% decrease in Japan to an 84% reduction in India. The U.S. is down an average of 67%. In countries where residents are beginning to return to normalcy, there was a marked improvement from February to March, emphasizing the direct impact of COVID-19. In China, there was a 68% decrease in new patients entering trials year-over-year in March, but March was 240% higher than February in terms of new patients added, which may suggest the beginnings of a recovery.
While it is encouraging to see a turnaround in enrollment here, the dramatic declines during this pandemic indicate that clinical trials are particularly vulnerable to the state of public health. The fragility of our health, our healthcare infrastructure, and of clinical development are all exposed – there are obvious long-term implications across the board.
The impact of COVID-19 is not uniform across therapeutic areas – some are more affected than others. Enrollment in studies for respiratory diseases decreased by 34%, whereas an 80% decline was noted for studies of endocrine diseases. Other categories analyzed also declined and include infectious disease studies (47%), oncology (48%), dermatology (64%), diseases of the central nervous system (68%), and cardiovascular diseases (70%).
The current environment underscores the need to monitor the clinical trials landscape, identify and develop new approaches, and implement solutions. These are crucial steps for trial sponsors, contract research organizations, clinicians and most importantly patients, to have the means to overcome the obstacles that slow down or halt advancements in therapeutics.
Identifying the obstacles
Mobility and travel. Lockdowns and social distancing have significant implications on trials since it affects the mobility of trial participants, both from a patient and clinical staff perspective. Patients cannot travel to retrieve medication and receive regular monitoring. Site staff and monitoring resources are hindered from performing oversight to ensure subject safety and data quality.
Lack of technology. There needs to be a much wider deployment of technology. Simple, intuitive ways for patients to consent to trials must be made more available. And, the ability for patients to capture their own clinical data is a necessity if visits to the clinic or hospital would otherwise be missed.
Supply chain. Where to ship drug, how much to order, and how much to stock to carry are of increasing concern among sponsors. While logistics may not be the first issue that comes to mind during the pandemic, integrating these elements into current and future trials are essential.
Rethinking clinical trials
Real-time data and detailed reporting is the critical first step in gaining a clear understanding of the patient, site, and country-level impact of the pandemic on clinical trials. An accurate, reliable view of the current state of clinical trials allows us to identify leading indicators of recovery and consider solutions quickly.
All of this, of course, must be considered within country-specific regulatory frameworks. Regulations, put in place to help to ensure the safety of patients and the accuracy and validity of data, require adjustment and evolution if investigations are to proceed when in-person trials are challenged. Regulators and other stakeholder groups are emphasizing patient safety, pragmatism and flexibility whenever possible, and have called out the need for use of technologies to support trials.
So, knowing what we now know, the following should be explored:
Shift the mix. There is an unevenness in the distribution of potential patient volunteers and in the conditions under which they live. The challenge of sourcing participants in this current environment can be addressed, at least partially, by shifting the site mix to lower-impacted countries and regions.
Get virtual. The virtualization of trials – using patient-facing technologies to allow clinical research to be conducted remotely – must improve and advance. At Medidata, we have virtualized a number of study aspects–including remote consent, remote randomization, and remote data capture, and reporting – and new generation versions of the web-based application will be released later this year.
Deliver what is needed. We can use technology to closely monitor patient volume and drug supply to minimize disruptions, particularly by centralizing data oversight. This can be used to shift drug delivery if either a patient or a site is incapable of retrieving the drug. It can also allow for instant adjustments in supply plans so that the proper amount of drug is on-hand without expiring.
Be authentic while synthetic. When the participant pool is limited due to mobility issues, it can be even more challenging to designate a control group. However, synthetic control arms can be created from historical trial data combined with AI algorithms to reduce the need for any participants to receive a placebo. Historical trial data can be compared against real-world data from claims or electronic medical records to provide confidence and validation in trial design, better reflecting real-world clinical practice and decreasing sample size requirements.
This unprecedented situation of global proportion and profound consequence has shifted the way business is conducted and how people live their everyday lives. Yet, these significant, dynamic changes are accelerating innovation in technology to support efforts to bring safe and effective therapies to market. It is imperative – for the sake of current and future patients – that clinical trials continue. Working together, medical professionals, regulatory experts, data scientists, software engineers, and so many others can use robust technologies to help ensure the efforts to conquer diseases may continue.
Author Bio: Fareed Melhem is a senior vice president who leads Acorn AI Labs by Medidata, a Dassault Systèmes company.