Effect of Pandemic on Clinical Trial Organizations
By Space Coast Daily // June 28, 2021
COVID-19 isn’t the only health emergency we are dealing with right now. We still have people with respiratory disorders, cardiovascular disorders, and autoimmune diseases that make for a large chunk of the global population. And we need to continue conducting clinical trials to develop treatment options.
But as the pandemic has affected all kinds of operations in other industries, it has also caused clinical trials to come to a halt. From enrollment issues to delayed data analysis and reporting, it has had a substantial effect on the global public healthcare system.
Here is how the COVID-19 pandemic has impacted clinical trial organizations.
Decentralized clinical trials
The biggest conundrum posed by the COVID-19 pandemic is that we need to carry out clinical trials to find a solution to prevent, diagnose, and treat this disease.
A clinical trial requires months (even years) of preparation and planning to ensure high-quality data, which can be used to inform policy decisions and provide treatment options for patients. But since social distancing is a must-follow guideline, researchers are unable to meet with patients to develop solutions faster.
That’s what decentralized clinical trials aim to solve! In the past, patients were required to travel long distances numerous times to the research institution to get their progress recorded. But decentralized or remote clinical trials significantly eliminate the need for contact.
By definition, decentralized clinical trials are trials that are “executed through telemedicine and mobile/local healthcare providers (HCPs), using procedures that vary from the traditional clinical trial model.”
Decentralized clinical trials allow researchers to conduct studies using remote monitoring technology. Researchers can track patients and measure the efficiency of the treatment without meeting with the patients in person. And although they are less expensive, their reports are quite reliable as they make use of wearable technology such as smartwatches, mobile ECG monitors, and fitness trackers.
A decline in participation
Researchers across the world recorded a 30% decline in new subject enrollment in many ongoing clinical trials immediately after COVID-19 hit the globe. They believe this is a direct result of the growing effect of the pandemic on clinical trials at both regional and international levels given the “continued regulations for social distancing and guidelines recommending movement restriction outside of the home.”
The problem is that this could lead to a delay in the approval of new drugs and vaccines as well as in conducting clinical trials. And the 184 vaccine candidates still in the pre-clinical phase are proof of this.
That’s not all. A delay of even a day in clinical trials costs sponsors between $600,000 to $8 million. And even though our current economic state doesn’t allow us to drain our funds, we still have to bear hefty losses as we can’t overrun the guidelines come what may.
Interruption in the supply chains
The pandemic has completely crippled the clinical trial process. Researchers have confirmed that interruptions of supply chains have posed an additional hindrance during the pandemic. We can’t procure the resources needed to accelerate the vaccine development process.
Since much of traditional clinical trial procedures rely on systems and processes found in centralized operations, transportation and communication disruptions have introduced significant delays in continuing or even starting clinical trials. Safe to say, these interruptions have set us back by at least a few months.
Huge disruptions in therapy areas
GlobalData found that oncology phase II clinical trials have been the most affected therapy area by COVID-19 disruptions, followed by central nervous system clinical trials.
There isn’t a cut-and-dried answer to this question because it is a combination of various reasons. But GlobalData’s report provides us with some insights. The data observes the disruptions from April 2020 to April 2021 and the results are divided into three reasons: slow enrollment (58.2%), enrollment suspension (28.6%), and delayed initiation (13.2%).
The reason for the slow enrollment could mostly be because cancer patients are at a high risk of transmission, making it extremely difficult for researchers to find participants for oncology trials. Furthermore, clinical trials also require the patients to travel to the research centers, which isn’t the safest option for cancer patients given their vulnerability to the COVID-19 virus.
Finally, some randomized trials don’t provide the participants with an immediate or clear benefit, which is further preventing them from volunteering for the research.
Trial recruitment issues
With the current pandemic, some trials have been abandoned and others have been delayed. The trial recruitment difficulties are due to mobility restrictions, government policy, and ethics approval issues to name a few.
This has introduced trial recruitment issues, which has reduced the sample sizes for conducting the research. Patients with complex conditions can’t volunteer for the studies as the pandemic has increased the risk of patient loss.
Since the trial sizes have been reduced, the results obtained from the study may not be reliable enough or sufficiently conclusive. For example, any research conducted on a rare disease won’t be able to conclude anything as it won’t have enough participants, to begin with.
Besides, as clinical trial sizes become smaller, so do the budgets. This can further make it more difficult to meet the costs associated with conducting a definitive study or even carry out newer studies.
The severe and prolonged nature of the pandemic has affected enrollment, subject retention rates, data collection and analysis, and study completion. The delays and disruptions affect everyone, not just the stakeholders of the clinical trial organizations.
Although it seems likely that these effects will compromise the quality as well as the integrity of the trials, they have also offered opportunities for innovative approaches to mitigate such effects and enhance the clinical research procedures. Every clinical trial organization will have to come up with unique strategies to combat their issues rather than relying on a one-size-fits-all approach.
Who knows, perhaps with a comprehensive understanding of the effects of the current pandemic on clinical research, researchers might be able to design and implement effective strategies for improving the efficiency of clinical trials in the immediate future.