Clinical Researcher—April 2020 (Volume 34, Issue 4)
CRC PERSPECTIVE
Tara Bresnahan, RN, CCRC, ACRP-PM
As the world faces the novel coronavirus causing COVID-19, a quick trip to the grocery store provides a glimpse of some of the panic growing in communities. Work in clinical trials has provided lessons in focus vs. fright. I share these lessons to help promote focus and dampen panic:
- What’s the data source?
As I write this in March 2020, information on COVID-19 is EVERYWHERE: some wild speculation, some expert opinions, some facts… Just as you would before documenting data on an electronic case report form, consider the source. Is this information from a reliable source (e.g., the Centers for Disease Control and Prevention) or is it based on a viral Facebook post? Consider the source before further documentation.
- Diagnosis isn’t everything…
Eligibility for treatment under a clinical trial is dictated by the defined protocol inclusion and exclusion criteria. If a patient has a disease, it does not necessarily mean that they qualify for treatment. With the wide range of reported symptoms associated with COVID-19 to date,{1} diagnosis is only part of the treatment algorithm. More information is needed.
- Keep objectives in mind and amend the plan as necessary
The protocol details how the clinical trial is to be implemented, sometimes exceeding 100 pages in length. The study objectives section of the protocol clarifies why the trial is being completed. Protocol amendments alter the plan (protocol), while remaining focused on the study objectives. With social distancing measures, school closings, and an increase in telework, implementation plans may require re-evaluation; focusing on meeting the overall objectives.
- Timely and effective communication
Many study communications have defined due dates, action items, and resolutions (think institutional review board/U.S. Food and Drug Administration submissions, monitoring follow-up letters, etc.). This structured communication sets expectations and forms a closed loop of effective communication. While many are now working remotely or in very different working conditions, please don’t assume everything is status quo. Ask, receive a response, and ensure team members are on the same page.
- Risk review
In accordance with Good Clinical Practice guidelines, sponsors periodically review risk control measures for effectiveness and relevance, based on emerging knowledge.{2} Thanks to the dedicated efforts of those on the front lines of this virus, available information is continuously updated. Continue to follow reliable sources for updates in risk control measures.
Please follow the guidance of your public health officials. Thank you to all our first line responders and hospital staff who continue to serve the community. Please stay safe. We will take this one day at a time.
References
- Centers for Disease Control and Prevention. 2020. Coronavirus Disease 2019 (COVID-19): Situational Summary. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/summary.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fsummary.html
- S. Department of Health and Human Services. U.S. Food and Drug Adiministration. 2018. E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry (OMB Control No. 0910-0843). https://www.fda.gov/files/drugs/published/E6%28R2%29-Good-Clinical-Practice–Integrated-Addendum-to-ICH-E6%28R1%29.pdf
Tara Bresnahan, RN, CCRC, ACRP-PM, (tara.m.bresnahan@gmail.com) is a Clinical Research Nurse Manager in the Division of Vascular and Endovascular Surgery at Massachusetts General Hospital.
