Drugs showing unintended value in unexpected areas isn’t new in pharma and biotech. Sildenafil (Viagra) remains one of the most notable and memorable near-history examples, having been aimed at treating cardiovascular problems originally and now being known almost solely as an erectile dysfunction drug. Dealing with anxiety issues in my family, I recently learned that hydroxyzine (Vistaril), which is a pretty effective anxiety-reliever, was mostly intended as an antihistamine.
There are many other examples, but my point is that sometimes in this industry, good things result by accident. Or, sometimes, as a result of unpleasantness—in this case the COVID-19 pandemic.
Because, for all the horrific and problematic aspects of the pandemic, good things have come out of it, not the least of which being coordination, focus, and approval of vaccines at unprecedented rates. Given regulatory and risk-aversion issues, I don’t expect light-speed R&D and approvals to become the norm, though. One thing that might become normalized out of all this, though, is the shift to digital tools and decentralization in clinical trials.
We’ve been talking about that a lot around here recently. Last issue, we had an entire Special Report titled “Delving into decentralization: Pandemic perils accelerate digital adoption in clinical trials.” We’ve also had various news stories about the same or similar topics, including one in the Clinical Trials & Studies section of this issue, titled “Clinical trial transformation: Decentralization accelerates during pandemic, with positive results.”
As data and analytics company GlobalData noted in March, “Even though the pharmaceutical sector used to display a more conservative stance toward the adoption of new technologies, the COVID-19 pandemic acted as a trigger that forced the pharmaceutical sector to accelerate the digital transformation timeline.”
According to a GlobalData survey, 35 percent of pharmaceutical industry professionals believe that the COVID-19 pandemic sped up digital transformation in the pharmaceutical industry by more than five years. The respondents in Europe and North America seemed to be particularly affected by digitalization efforts, with 40 percent of them highlighting that the digital transformation was accelerated by more than five years.
Unlike the “blip” on the radar that has been speedier R&D and regulatory approvals, this sounds like something that is going to stick.
“In a short space of time, the pharmaceutical industry has witnessed years-long digital transformation roadmaps squeezed into weeks in order to adapt to reduced in-person interactions, mobility restrictions and shift towards remote work,” said GlobalData’s senior director of market research, Urte Jakimaviciute. “Lockdowns, movement restrictions, and social distancing norms have rapidly pushed healthcare services and patient monitoring toward remote options, paving the way for increased usage of telemedicine, digital therapeutics, as well as decentralized clinical trials. The pandemic has also changed traditional sales and marketing models, leading to increased demand for online marketing and communication tools.”
I have little doubt that once the pandemic is over, we will see a significant shift back to traditional clinical trial operations. But I don’t see a full return. If anything, I see the trend toward decentralization—even if it retracts a bit post-pandemic—continuing to gain traction and grow over the long run.
I suspect that except in cases where the trial simply cannot be conducted remotely because of the logistics of the treatment and monitoring, remote trials will eventually become the norm. Symptom and progress monitoring will increasingly be achieved through digital tools and sometimes wearable devices.
Before I let you go, another bit of pandemic trial-related news from GlobalData: After more than a year of the pandemic, clinical trial disruptions continue to be notable, though many of the figures in March coming from the analytics company were improved compared to February.
Gastrointestinal studies currently have the highest proportion of disrupted clinical trials due to COVID-19, with 2.04 percent of such trials disrupted, followed by hematological disorders at 2 percent. Infectious disease trials have the lowest proportion of disrupted trials, with just 0.91 percent of trials disrupted, and oncology falls right in between at 1.18 percent.
And bringing it right back to decentralization issues, GlobalData clinical trials analyst Mohamed Abukar notes of these numbers: “Gastrointestinal studies and hematological disorders trials generally require more frequent sample collection to assess the efficacy of a therapy through biomarker concentration analysis. The increased use of decentralized and virtual trials may be less suitable for therapy areas that require frequent non-point-of-care data collection and analysis.”
Welcome to the new world of clinical trials. Perhaps the situation is less akin to unintended side effects and unexpected benefits and a lot more like environmental pressures forcing evolutionary adaptation.