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Impact of the COVID-19 pandemic on clinical trial conduct

February 14, 2022
 - Tim Hardman

Early in 2020, COVID-19 was spreading rapidly across the globe. The World Health Organisation declared the COVID-19 outbreak to be a pandemic on 11 March 2020 [1], having a marked effect on every aspect of our lives. Clinical trials were also impacted, with the consequence of the pandemic on clinical research believed to peak between March and May, 2020. While stakeholders assessed the impact of the pandemic, ongoing clinical trials were suspended, some never to re-start [1–6].

Despite players within the clinical trial space having established procedures within their quality systems to deal with service disruption in the form of ‘disaster plans’, it was apparent that many contract research organisations (CROs) were not prepared adequately for the restrictions that affected patients/subjects, sites and investigators and monitoring activities. Information sourced from databases such as Global Data suggested that by March 2020, more than sponsor 500 companies and 1,000 CROs were publicly admitting to disruptions to their planned and ongoing clinical trials [7]. The number of studies affected reportedly increased steadily during the last quarter of 2020 [8]. The clinical trial community needed to innovate to address service interruptions. Industry players introduced new, pragmatic changes to operational procedures to allow businesses and clinical studies to continue running during the COVID-19 outbreak. The current survey was conducted during the second half of 2020 to get a better understanding of both the successes and failures in dealing with the pandemic.

The European CRO Federation (EUCROF) consists of Members from 12 EU countries and has also 14 associate members  as well as three partner members. At the start of the pandemic EUCROF represented 387 member organisations across 25 countries, employing approximately over 25.000 clinical and administrative staff running hundreds of studies. All members were invited by email to take part in the survey, performed between 1 to the 31 October, 2020. The findings indicated that the COVID-19 pandemic significantly disrupted the conduct of clinical trials in Contract Research Organizations (CROs), but it also led to innovative approaches and valuable lessons that could reshape the future of clinical research. The findings of the survey were summarised [9]. The understanding from the investigation provided some insight into the impact that the COVID-19 pandemic had on clinical trial conduct and what lessons can we might learn for the future?

A. Key Impacts of COVID-19 on Clinical Trial Conduct in CROs

Trial Disruptions and Delays:

  • •Pauses and terminations: The pandemic led to delays, suspensions, or even cancellations of many clinical trials as site access restrictions, travel limitations, and patient recruitment challenges emerged. Over 80% of non-COVID-19 clinical trials were affected during the pandemic’s peak, resulting in data gaps and extended timelines .
  • •Shift to virtual trials: CROs had to rapidly pivot to decentralised and virtual trials, where remote monitoring, telemedicine, and electronic data capture became critical to continue research under social distancing restrictions.

Supply Chain and Logistic Challenges:

  • Delays in drug supply: Global supply chain disruptions meant that trial materials, such as investigational drugs and equipment, faced significant delays. This led to problems with maintaining drug accountability and adherence to investigational protocols.
  • Limited access to trial sites: CROs encountered difficulties in gaining physical access to trial sites due to lockdowns, which slowed down both trial monitoring and patient visits.

Data Collection and Monitoring Hurdles:

  • Patient recruitment and retention: With travel restrictions and fears of contracting the virus, many patients were unwilling or unable to participate in clinical trials. This had a direct impact on recruitment and retention, leading to smaller sample sizes or missing data points.
  • Remote monitoring: Clinical monitors could no longer visit sites in person, leading to the rapid adoption of remote monitoring technologies. Electronic data capture and eCRFs (electronic case report forms) became essential for keeping trials on track.

Regulatory Flexibility:

  • Adapted regulations: Regulatory authorities, such as the FDA, EMA, and MHRA, issued emergency guidance allowing for flexibility in trial conduct. For instance, they permitted remote consent, virtual monitoring, and telemedicine visits, which helped trials continue despite disruptions .
  • Expedited approvals: Agencies fast-tracked approval processes, particularly for COVID-19 therapies and vaccines, showcasing the importance of streamlining clinical trial procedures for urgent public health needs.

 

Lessons Learned for the Future of Clinical Trials

Embrace Decentralised and Hybrid Trial Models:

  • Decentralised trials: The pandemic accelerated the shift toward decentralised clinical trials, where technologies such as telemedicine, home health visits, and remote data capture became integral. Moving forward, CROs and sponsors are expected to incorporate hybrid trial designs more broadly, combining in-person and virtual elements to improve trial efficiency and patient accessibility.
  • Patient-centric approaches: Decentralised models increase patient engagement by making participation more convenient, reducing the need for travel, and improving retention. Future trials will likely continue to employ tools like wearables, mobile apps, and home-based data collection to streamline the patient experience.

Technology Integration and Innovation:

  • AI and machine learning: CROs will increasingly turn to artificial intelligence (AI) and machine learning to optimise trial design, patient recruitment, and data analysis. AI-powered tools can identify suitable trial participants, predict outcomes, and automate monitoring processes.
  • Telemedicine: Remote patient interactions via telemedicine have proven essential, allowing patients to consult with trial investigators without physically visiting trial sites. Post-pandemic, this technology will remain a critical tool for enhancing the patient experience, reducing site burden, and ensuring continuity of care.

Enhanced Regulatory Agility:

  • Flexible regulatory frameworks: The pandemic demonstrated the need for more flexible regulatory oversight. Regulators learned to adapt quickly, allowing trials to continue under modified protocols. Going forward, regulatory bodies are likely to maintain some of these flexible approaches, speeding up approval processes and enabling more adaptive trial designs in urgent situations.
  • Transparency and collaboration: Increased collaboration between regulatory agencies, CROs, and pharmaceutical companies fostered faster data sharing and decision-making. Such transparency will be crucial in the future for dealing with global health crises.

Improved Risk Management and Contingency Planning:

  • Robust risk management plans: The pandemic underscored the importance of having robust contingency plans in place for disruptions like pandemics, natural disasters, or political instability. CROs and sponsors are now more focused on developing comprehensive risk management strategies, including backup plans for patient recruitment, monitoring, and drug supply.
  • Crisis preparedness: Organizations have learned to expect the unexpected, and trials now incorporate greater flexibility to adapt to sudden challenges, whether that be through virtual trial components, alternative site locations, or risk-based monitoring.

Patient Recruitment and Diversity:

  • Broader patient access: The ability to recruit patients remotely during the pandemic opened trials to a more diverse and geographically dispersed patient population. This lesson in accessibility will push CROs to continue leveraging technology to include underrepresented populations in clinical research, addressing long-standing disparities in trial participation.

The COVID-19 pandemic reshaped the clinical trial landscape, forcing CROs to adopt new technologies, flexible trial designs, and innovative patient-centric methods. While the pandemic posed numerous challenges, it also led to lasting improvements in trial conduct, particularly in terms of decentralisation, technological integration, and regulatory agility. Future trials will likely build upon these lessons, making clinical research more resilient, efficient, and accessible.

References

  1. WHO Director-General's opening remarks at the media briefing on COVID-19 [Internet]. WHO.2020. https://www.who.int/director-general/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020 [Accessed 05 June 2021]
  2. Asaad M, Habibullah NK, Butler CE. The Impact of COVID-19 on Clinical Trials. Ann Surg 2020;272:e222–e223.
  3. Hasford J. Impact of the COVID-19 pandemic on clinical trials with drugs, Expert Opinion on Drug Safety, 2020:19:11; 1373-1375, DOI: 10.1080/14740338.2020.1828861
  4. Early Impact of COVID-19 on the Conduct of Oncology Clinical Trials and Long-Term Opportunities for Transformation: Findings From an American Society of Clinical Oncology Survey.
  5. Waterhouse, DM, Harvey RD, Hurley P, et al. Challenges in Assessing the Impact of the COVID-19 Pandemic on the Integrity and Interpretability of Clinical Trials. Stat Biopharm Res, 2020:12:4, 419-426, DOI: 10.1080/19466315.2020.1788984
  6. Kunz CU, Jörgens S, Bretz F, et al. Clinical Trials Impacted by the COVID-19 Pandemic: Adaptive Designs to the Rescue?, Stat Biopharm Res, 2020: 12:4, 461-477, DOI: 10.1080/19466315.2020.1799857
  7. Global Data Coronavirus Disease COVID19 PharmaExecutive Briefing [Internet] GlobalData. 2021. www.globaldata.com [Accessed 01 June 2021]
  8. QPS. How COVID-19 Has Impacted Clinical Trials [Internet] 2021. https://www.qps.com/2021/02/17/how-covid-19-has-impacted-clinical-trials/ [Accessed 05 June 21]
  9. Francisco Harrison, Rino Coladangelo, Maël Heutte et al. Impact of the COVID-19 Pandemic on Clinical Trial Conduct: Lessons for the Future, 14 February 2022, PREPRINT (Version 1) available at Research Square [https://doi.org/10.21203/rs.3.rs-1118410/v1]

About the author

Tim Hardman
Managing Director
View profile
Dr Tim Hardman is Managing Director of Niche Science & Technology Ltd., a bespoke services CRO based in the UK. He is also Chairman of the Association of Human Pharmacology in the Pharmaceutical Industry, the representative industry body for early for early phase clinical studies in the UK, and President of the sister organisation the European Federation for Exploratory Medicines Development. Dr Hardman is a keen scientist and an occasional commentator on all aspects of medicine, business and the process of drug development.

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