Table 1.

Obstacles in clinical research and their changes during the pandemic

Obstacles in clinical trial research before the SARS-CoV-2 pandemic	Deterioration during the SARS-CoV-2 pandemic
Excessive burden of administrative tasks	More difficult to accommodate with restrictions in clinical and research activities
Organizational, resource, and staff limitations to accommodate a growing number of novel-design clinical trials	Pandemic and quarantine policies significantly affected research staff availability and their burnout levels; significant reduction in clinical trial performance; inability to rapidly adapt to new research and clinical conditions
Excessive time in research meetings (local visits, audits, and data monitoring events)	Extremely difficult to accommodate with lockdown policies and reduced staff available
Length and complexity of informed consent	Patient empowerment reduced due to the distancing between investigators, patients, and caregivers; more reconsents needed
Patient difficulties to access research centers (living far, elderly, comorbidities, economic conditions)	Aggravated following lockdown measures and quarantine policies
Disproportionate/unnecessary number of time-demanding clinical trial appointments for patients	More difficult to maintain following lockdown measures and changes in hospital-care and research pathways
Restrictive eligibility criteria and under-representation of real-world population	Increased difficulty to keep enrollment goals with many patients reducing their hospital visits; low representativeness of patients at a higher risk of death from COVID-19 (e.g. elderly; patients with cancer or heart dysfunction) in vaccine pivotal trials.
Weak correlation between some surrogate endpoints and clinical meaningful outcomes	Unprecedent short landmarks in time for (COVID-19) vaccines efficacy considering the global urgency.
Significant dropout rates from clinical trials due to excessive administrative load, visits, or uncertainties with treatment efficacy and toxicity	Patients refraining from visiting cancer centers for treatments or follow-ups

COVID-19, coronavirus disease 2019; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.