Insight

The clinical trial conundrum

Failing to resume clinical trials could present as many risks to certain patients as COVID-19

Kristin C. Pothier

Kristin C. Pothier

Global and National Healthcare and Life Sciences Strategy Leader, and Global Deal Advisory Leader, Healthcare and Life Science, KPMG US

+1 617 549 2779

Jeff Stoll

Jeff Stoll

Principal, National Strategy Life Sciences Leader, KPMG US

+1 617-988-1000

Roger van den Heuvel

Roger van den Heuvel

Principal, Corporate Strategy, Life Sciences Lead, KPMG US

+1 212-997-0500

Right now, the search for a COVID-19 vaccine and viable treatments are top priorities for pharmaceutical companies. At the same time, many clinical trials have been put on hold due to enrollment issues driven by stay-at-home orders, travel restrictions and patient anxiety; delayed initiation due to staff furloughs, illness, or risk profiles; and a shift in resources toward COVID-19-related trials.1

While there is already concern about chronic disease patients missing critical appointments with their providers, abandoning clinical trials could have an equally detrimental effect on certain patients. There can be significant risks to patient health if clinical trials are suspended mid-course or never started – particularly when it comes to rare disease drugs and experimental treatments for cancer.   

The numbers tell an interesting story when taken in the aggregate:

  • Of the clinical trials that were halted after December 19, 19 percent were halted due to COVID-19.2
  • There was a 74 percent decrease in the average number of new patients entering clinical trials, globally, between the first two weeks of May in 2019 and the same time period in 2020.3
  • Year-over-year impact (May 2019 to May 2020) varies by therapeutic area with the suspension of 308 oncology studies (28 percent), 125 cardiovascular studies (11 percent), and 93 neurologic studies (8.5 percent).4

Some trials have proven to be more vulnerable to suspension during COVID-19 than others. For example, clinical trials focused more on “life style therapies” or trials that require in-person diagnostics and/or monitoring in hospitals or tertiary academic centers with high incidences of COVID-19. Some trials that enroll a large number of elderly or immunocompromised patients have been deemed too risky. 

In general, we do expect volumes of clinical trials to return to near-normal over time. Taking China as an example, the country’s clinical recovery cycle was six to eight weeks. China was able to facilitate this recovery by minimizing on-site visits and shifting to new testing modes mid-course, acquiring protective equipment and procedures for clinical research coordinators, utilizing virtual and other digital technologies, and mailing oral medications to patients’ homes with detailed instructions. 

Many industry analysts believe that the U.S. could follow a similar trajectory, if drug companies follow certain protocols.5 For example, organizations could consider:

  • Deploying alternative monitoring methods in patients’ homes
  • Adopting direct-to-patient (DTP) and direct-from-patient (DFP) services to ensure safety along with real-time updates to patients
  • Shifting the site mix to lower-impacted countries & regions
  • Eliminating patient touchpoints when possible

In the longer term, although there will still be a focus on rolling out COVID-19 vaccines and preparing for potential virus mutations, the pharmaceutical industry should seize the opportunity to modernize its historical approach to clinical trials. To this end, organizations could consider:

  • Partnering with technology companies to accelerate adoption of virtual trials and facilitate remote consent, data capture, and reporting
  • Expanding their own telemedicine and remote monitoring capabilities
  • Leveraging CROs with advanced technology capabilities
  • Shifting to a greater reliance on real-world data and evidence collected from patients
  • Using data analytics to ensure that the clinical site environments for each therapeutic area has the highest chance of success

As the industry continues to work toward developing a COVID-19 vaccine and pinpointing effective treatments, steps should be taken to bring clinical trials back online. Failing to do so could present as much of a risk to vulnerable patients as the virus does.



Contact us

Kristin C. Pothier

Kristin C. Pothier

Global and National Healthcare and Life Sciences Strategy Leader, and Global Deal Advisory Leader, Healthcare and Life Science, KPMG US

+1 617 549 2779
Jeff Stoll

Jeff Stoll

Principal, National Strategy Life Sciences Leader, KPMG US

+1 617-988-1000
Roger van den Heuvel

Roger van den Heuvel

Principal, Corporate Strategy, Life Sciences Lead, KPMG US

+1 212-997-0500

Footnotes

  1. Clinical trial disruption due to COVID-19 has begun to decline, Clinical Trials Arena, July 9, 2020.
  2. Source: ClinicalTrials.gov, Citeline 2020, KPMG research and analysis.
  3. COVID-19 and clinical trials: The Medidata perspective, May 18, 2020.
  4. Daniel Levine, Calculating the pandemic’s toll on clinical trials, Global Genes, May 12, 2020.
  5. Clinical study conduct during the COVID-19 pandemic:  Challenges & solutions, Clinical Leader, April 2020