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Challenges and opportunities for sponsors in conducting clinical trials during a pandemic

Sanish Davis1, Seema Pai2

  • 1General Secretary, Indian Society for Clinical Research (ISCR), Mumbai, Maharashtra, India.

Perspectives in Clinical Research
|October 9, 2020
PubMed

Insights

The COVID-19 pandemic disrupted clinical trials, affecting patient safety and data integrity. This paper offers guidance for clinical research professionals and sponsors on managing trials during and after the pandemic.

Area of Science:

  • Clinical Research
  • Pandemic Response
  • Drug Development

Background:

  • COVID-19 pandemic significantly impacted global clinical trial operations.
  • Challenges included lockdowns, site closures, travel restrictions, and supply chain disruptions.
  • Protocol adherence for investigational product administration and patient visits was compromised.

Purpose of the Study:

  • To provide guidance for clinical trial professionals and sponsors in India.
  • To address challenges in continuing ongoing trials and resuming activities post-COVID.
  • To offer strategies for managing clinical trials during and after the pandemic.

Main Methods:

  • Position paper from the Indian Society for Clinical Research (ISCR).
  • Focus on practical measures for site-level activities.
  • Guidance on direct-to-patient shipments, cold chain management, and technology adoption.

Main Results:

  • Identified key challenges impacting clinical trial conduct due to COVID-19.
  • Proposed strategies for maintaining trial integrity and patient safety.
  • Highlighted the importance of adaptive trial management and remote technologies.

Conclusions:

  • Effective strategies are crucial for navigating pandemic-related disruptions in clinical trials.
  • Implementation of direct-to-patient shipments and remote technologies can enhance trial continuity.
  • Proactive planning and adaptation are essential for the future of clinical research in public health emergencies.
Keywords:
Clinical trialsIndian Society for Clinical Researchcoronavirus 2019direct to patienthome health carepatient safety

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