Delays in clinical trials present opportunities for pharma companies to evolve

COVID-19 has upended clinical trial timelines – putting billions of forecasted sales at risk and delaying getting life-saving treatments to patients. This analysis from Garima Kaul, Senior Director, Research and Insights, Decision Resources Group, part of Clarivate, and Jamie Munro, Executive Director, CIRS explores the opportunities that delays in clinical trials present for pharma companies. Which areas have been hit the hardest, and how are pharma companies and regulatory agencies adapting to new ways of working?

The pandemic is significantly impacting clinical trials, with 1,356 trials (both industry and non-industry sponsored)1 reporting delays* due to COVID-19. With the cumulative cost of bringing a new molecule from bench to bedside standing at more than $2 billion, on average, these COVID-19-related trial delays are a potential threat to future pharma R&D budgets and launch timelines. Moreover, they mean that patients may have to wait longer for new therapeutics now in development and pharma companies will have to adapt to new ways of working.


Nearly $60Bn at stake due to clinical trial delays during the pandemic


Figure 1. Clinical phase of trials impacted by COVID-19

Sources: Cortellis Trial IntelligenceTM; DRG Company and Drug Insights; DRG Disease Landscape and Forecasts


Several of the top 30 companies have reported evidence of at least some delays in their end of Q2 reporting. Pfizer, Novartis, Roche, Takeda, Novo Nordisk, BMS, Gilead and Ipsen indicated evidence of earlier delays. Boehringer Ingelheim, Astellas and Lundbeck explicitly reported delays in their clinical programs.


Figure 2. Companies with >10 trials impacted due to COVID-19

Sources: Cortellis Clinical Trials IntelligenceTM; DRG Company and Drug Insights; DRG Disease Landscape and Forecasts


Despite regulatory agency support, trials still face numerous challenges

Numerous pandemic-related factors are believed to be disrupting trials, including lockdowns and quarantines, travel restrictions, interruptions to supply chains, reallocation of principal investigators, a shift in focus to COVID-19 treatments and vaccines, and patient anxiety.

Keeping in mind the safety of trial participants during this time, regulatory agencies have been very flexible and pragmatic in providing support and flexibility to work around pandemic-related challenges.4-10

Along with prioritizing participant safety, agencies need to safeguard compliance with good clinical practices, maintain trial integrity, ensure that only participants meeting inclusion/exclusion criteria are enrolled and evaluate risk-benefit risk-mitigation plans.


Ways regulatory agencies have provided clinical trial support and flexibility during COVID-19:

  • Remote consultation and trial monitoring
  • Flexibility to use technology, including adoption of digital sensors and telehealth
  • Recognition of protocol deviations and modifications
  • Diverse approaches to delivery, including secure drop-shipping
  • Decentralized data collection offsite
  • Changes to the number and type of participant monitoring visits


Figure 3.Pandemic-related challenges after adoption of newer ways of working.

Sources: Cortellis Clinical Trials IntelligenceTM; DRG Company and Drug Insights; DRG Disease Landscape and Forecasts


Trials across all therapy areas have been affected

All major therapy areas saw clinical trial delays due to the pandemic. Oncology trials (27%) were most impacted, consistent with the fact that they are most prevalent among ongoing trials.


Figure 4. Top 10 therapy areas of trials impacted by COVID-19

Sources: Cortellis Clinical Trials Intelligence; DRG Disease Landscape and Forecasts


Patient recruitment issues are a key factor behind trial delays


Figure 5. Reasons cited for COVID-19 driven trial delay among top 30 pharma companies

Sources: Cortellis Clinical Trials Intelligence


Delays were seen in a majority of clinical trials for injectables (around 60%) and in two out of five clinical trials for treatments that could be administered remotely (for example, orally, ophthalmic or via inhaler).



79% of impacted trials were conducted in fewer than 50 sites, with more than half conducted in fewer than 10 sites.


Figure 6. Number of impacted trials by trials sites they are being conducted.

Sources: Cortellis Clinical Trials Intelligence; DRG Disease Landscape and Forecasts


Pharmas should embrace this opportunity to evolve how they conduct trials

Companies are now trying to bring trials back on track after early disruptions. The severity of the impact will also depend on the duration of the pandemic. Before trials resume, companies should use this time to prioritize critical studies, and document and analyze the available data. When trials restart, it is expected that enrolled participants might not return, necessitating recruitment of new subjects. The IMPs may expire or lack stability data to validate their shelf-life under various storage conditions during the pandemic, requiring developers to manufacture them again.

As the biopharmaceutical industry adapts to this ‘new normal,’ it seems unlikely that traditional models of drug development will resume. To be successful, pharma companies may need to embrace work closely not only with each other, but also with technology companies. They may also need to explore innovative tools and upskill their workforce to adapt to new operations.

It will not be easy to integrate new technologies and mindset, but with the support and engagement and of regulatory agencies, companies can resume their momentum. Digitalization, new trial designs, use of real-world evidence data and artificial intelligence could help in evolving this process and finding innovative ways to better meet patient unmet needs and improve outcomes.


Download our Trends in clinical trial planning report to access insights from more than 250,000 global trials.


(*Delay manually created from trial registry information that indicates a trial has been delayed)


  1. Cortellis Clinical Trials Intelligence as of July 27, 2020
  2. DRG Company and Drug Insights
  3. DRG Disease Landscape and Forecasts
  4. FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. Available at
  5. Managing clinical trials during Coronavirus (COVID-19). Available at
  6. Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic. Available at
  7. How COVID is reshaping global policy and what it means for market access, Executive Briefing, July 8,2020. Available at
  9. The International Coalition of Medicines Regulatory Authorities (ICMRA) statement on Covid-19. Available at
  10. Centre for Innovation in Regulatory Science (CIRS) R&D Briefing 75. Available at