March 2020: Coronavirus Impact on Clinical Trials and Drug Development

Nearly one-third of clinical trial sites expect the novel coronavirus will have a “big or extremely big” impact on their ability to recruit patients for new trials or keep patients already enrolled in existing studies compliant with scheduling, according to a new survey conducted by Continuum Clinical, a consulting firm that works with drug makers and trial sites:

  • 56% believe the novel coronavirus has impacted patient willingness to actively participate in trials in which they are enrolled and 73% report that Covid-19 has affected the willingness of new patients to enroll in a trial.
  • 69% of responding EU sites said COVID-19 had reduced the willingness of already-enrolled patients to continue participating in trials, compared with 47% of responding US sites. Continuum Clinical said this was a critical issue for sponsors as any meaningful disruption in patient participation would impact the quality of data.

The survey showed that sites overall do not have a positive outlook on trials moving forward, with 76% of EU sites anticipating a significant negative impact on recruitment and retention moving forward, and 37% of US sites indicating the same. “We are seeing an unprecedented shift in site sentiment over a very short time frame… We need to continue monitoring these trends and building fact-based planning scenarios to help sites and sponsors prepare for a period of very different patient recruitment and retention patterns,” said Continuum Clinical’s Paul Ivsin. “The data show a clear early signal that we’re entering an inflection point in trial site confidence about patient willingness to participate in research as a response to the outbreak,” stated Ivsin. Non-academic hospital sites were more likely to say that recruiting new patients has been challenging. But trial sites located in academic institutions were more likely to report that retaining currently enrolled patients has been “the biggest challenge.”

It’s impossible to know how many clinical trials will be affected adversely by the coronavirus outbreak, but STAT’s search of the BioMedTracker database found 120 Phase 3 clinical trials being conducted by biotech and pharma companies with market values greater than $300 million. All of these clinical trials were expected to announce top-line results before the end of the year.  STAT also queried the same database to look at mid-stage, or Phase 2, clinical trials, some of which could also serve as the basis for FDA submissions. The search found 160 such studies with data readouts planned for this year.

In a March 23rd press release, Eli Lilly said it will delay the start of new clinical trials and suspend enrollment in “most” ongoing studies. Trials in which patient enrollment has already been completed will continue.  Lilly is listed as the sponsor of 86 clinical trials currently enrolling patients, including 30 in Phase 3, according to ClinicalTrials.gov. Another 78 studies are active but no longer recruiting patients.

BIO is still collecting information from member companies, but two significant challenges to conducting clinical trials in the current environment have emerged:

  • Missing or delayed data collection from ongoing clinical trials, particularly at hospital sites overwhelmed by Covid-19 cases; and,
  • Difficulties getting new clinical trials up and running because patients are reluctant to enroll or unable to visit hospitals

In a March 12th blog, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) noted reports of protocol and standard operating procedure deviations due to missed visits by clinical trial patients.

In addition, 39% of 170 clinical trial sites surveyed in the U.S. believe patients will be much less or somewhat less likely to enroll in new clinical research trials. And 25% of the sites expect patients currently enrolled in a trial to be much less or somewhat less willing to continue their participation. “The data show a clear early signal that we’re entering an inflection point in trial site confidence about patient willingness to participate in research as a response to the outbreak,” stated Ivsin.

Further analysis of Continuum’s site survey data shows considerable variation in site concerns driven by differences in specific areas of therapeutic focus.

Within the overall survey average of 39% of sites reporting that COVID-19 is having a “big” or “extremely big” impact on site operations, therapeutic areas ranged from a low of 27% for respiratory trials to a high of 54% for rheumatology trials. Other therapeutic areas with above-average levels of concern for disruption include cardiovascular, endocrinology, neurology, rare disease, and ophthalmology trial sites. We believe these heightened levels are primarily being driven over concerns of incidental exposure to trial patients combined with measures to protect especially vulnerable patient populations.

Compared to just last week, concern jumped the most in four therapeutic areas:

  • Cardiovascular: up 26%
  • Rheumatology: up 32%
  • Endocrinology: up 41%
  • CNS: up 52%

Rare disease sites did not report a significant increase, but those sites were already at very high levels of concern in the initial March 13th survey (46% reporting a big or extremely big impact).

The downstream impact for patients and the drug industry could be substantial, even if regulatory agencies like the FDA, EMA, UK and others providing guidance on conducting trials during the Covid-19 pandemic. Without data from pivotal clinical trials, new drug filings will be delayed, meaning some important new medicines will take longer to reach the market. 

In an effort to continue monitoring the impact Covid-19 has on clinical research, including identifying emerging trends, Continuum Clinical will continue to provide live updates to track how the situation unfolds, providing global data and real-time updates as they become available.

 

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