The coronavirus disease 2019 (COVID-19) pandemic has introduced changes to patient care, particularly during times of heightened COVID-19 caseloads in different geographic areas. For patients with cancer, the pandemic might have resulted in changes to treatment, a facilitation of disease assessments, and/or a shift of many in-person visits to telehealth platforms.1-5

In the oncology space, the COVID-19 pandemic has also led to adaptations in clinical trial protocols that affect how patients customarily participate in studies. In response, the US Food and Drug Administration (FDA) and the Clinical Trials Transformation Initiative (CTTI) published respective guidance documents detailing the best practices for clinical trial protocol changes to address the risks that patients may encounter when participating in a clinical trial during the COVID-19 pandemic.1,2

Although many aspects of clinical trial participation remain the same, across disease settings, some modifications—which may differ depending on the area in which the patient resides, the nature of the clinical trial, and the institution conducting the trial—warrant consideration. Cancer Therapy Advisor reviews these factors below.

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Continuing or Discontinuing Clinical Trials

During the COVID-19 pandemic, some clinical trials may been temporarily or permanently halted.1,2,5 These suspensions may be due to current or anticipated staff shortages, potential supply chain issues, or investigator or sponsor sentiment that patient safety could not be upheld under the circumstances.1

Patients should be aware that clinical trial staff will communicate with patients if the clinical trial is halted or if any parts of the trial are delayed or otherwise changed.2 It is also important to recognize that patients currently enrolled in a clinical trial who have not yet started an intervention may be delayed in initiating the treatment while others may continue receiving the intervention as planned.

Study Visits and Assessments

Clinical trials frequently include multiple study visits, during which patients are screened for enrollment, assessed for adverse events or disease status, and/or provided the intervention.3 During the COVID-19 pandemic, many institutions shifted in-person visits to telehealth visits to limit patient contact points, thereby decreasing the risk of SARS-CoV-2 transmission. The same principle applies to clinical trials; many trials converted some in-person, per-protocol study visits to telehealth evaluations.2-5 Patients enrolling in clinical trials during the pandemic should be aware that some study visits will likely be conducted virtually, meaning that they may need a reliable internet connection to complete their visits.

Further, patient assessments such as imaging or specimen collection (eg, blood draws or biopsies) may be delayed to reduce the risk of SARS-CoV-2 transmission and ensure sufficient staff are available to safely conduct the visit.1,3,5 In addition, some trials may allow assessments to be conducted by centers closer to the patients to reduce travel.3

For study visits and assessments that occur in-person, patients will be asked about symptoms associated with COVID-19, as well as any known exposure to an individual who has tested positive for SARS-CoV-2.4,5 Patients might also be required to undergo testing for SARS-CoV-2 and show proof of a negative result prior to their respective visits. Alternatively, they might be tested during their visit.1,4 Any local or institution mandates will also apply, such as wearing a facial covering and abiding by social distancing guidelines.1

Interventions/Treatments

Trial investigators and/or sponsors may determine the risk of halting treatment to either outweigh or not outweigh the risk of possible SARS-CoV-2 transmission.1 Accordingly, some trials may alter the treatment interval (such as switching weekly dosing to twice- or thrice-weekly dosing) to limit the number of in-person visits. Some trials might also include an intervention that is taken orally or can be given at home; in these cases, the trial may decide to distribute the study drug differently or assign a nurse to travel to the patient’s home to administer the medication. Oral drugs may be distributed by a local pharmacy or mailed to the patient’s home rather than at the institution conducting the clinical trial.

For patients who receive an intervention that requires the patient to spend a period of time at an infusion center, in the hospital, or another inpatient facility, it is important to be aware that visitors are likely to be barred from accompanying or visiting the patient during their infusion or inpatient stay.4

References

  1. US Department of Health and Human Services Food and Drug Administration. Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency. Updated December 4, 2020. Accessed January 11, 2021. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency
  2. Clinical Trials Transformation Initiative. Best Practices for Conducting Trials During the COVID-19 Pandemic. Accessed January 11, 2021. https://www.ctti-clinicaltrials.org/sites/www.ctti-clinicaltrials.org/files/best_practices_for_conducting_trials_during_covid_041320.pdf
  3. Nabhan C, Choueiri TK, Mato AR. Rethinking clinical trials reform during the COVID-19 pandemic. JAMA Oncol. 2020;6(9):1327-1329. doi:10.1001/jamaoncol.2020.3142
  4. Marcum M, Kurtzweil N, Vollmer C, et al. COVID-19 pandemic and impact on cancer clinical trials: an academic medical center perspective. Cancer Med. 2020;9(17):6141-6146. doi:10.1002/cam4.329
  5. American Society of Clinical Oncology. ASCO Clinical Trial Site Survey on the Early Effects of COVID-19 on Clinical Trials: Report of the Findings. May 12, 2020. Accessed January 11, 2021. https://www.asco.org/sites/new-www.asco.org/files/content-files/research-and-progress/documents/ASCO-COVID-19-Trial-Site-Survey-Report-042020.pdf

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Fact Sheet General Oncology