It has been recognized by the FDA that Coronavirus Disease 2019 (COVID-19) pandemic may impact clinical trials for drugs, medical devices, and biologics. Site closure, quarantines, and travel limitations are just some of the prevention factors that may make it problematic to conduct clinical trials. Alternative approaches and considerations are needed at this time in order to assure the safety of trial patients, good clinical practice, data integrity, and minimize risk.
On 18 March 2020, the FDA released a guidance document in order to assist the Sponsors, Investigators, and Institutional Review Boards (IRBs) on how to continue during the current pandemic. After reviewing the guidance document, here are some questions and discussions worth having with Sponsors, Investigators and/or IRBs regarding other consideration for ongoing trials.
- Can the protocol be modified in order to ensure trial patient safety?
- Should the trial stay ongoing or does discontinuation of the trial and/or use of the study product necessary?
- Are there any alternative ways to get in touch with trial patients to assure safety?
- Can monitoring approaches be altered?
- Do trial patients need to withdraw because the study site is closed and/or they cannot access investigational product?
- Can recruitment be postponed or stopped?
- When screening patients should sites start testing for COVID-19?
- How should we engage with Sponsors, Investigators, and/or IRBs when urgent protocol modifications are needed?
- What restrictions related to COVID-19 will be faced?
- What “specific” information needs to be collected during study visits?
- How will product accountability be ensured if alternative administration can occur?
- Will there be efficacy endpoints that cannot be measured during this time?
- What statistical analysis plans need to be considered prior to a data lock?
- What will be the remote monitoring plan or is there already one in place?
As you can see discussions need to occur as soon as possible because there are many things to consider. Additionally, once alternative plans are discussed, established, and implemented; we need to be mindful that protocol amendments may be required. It is also imperative that documentation of changes and trial impacts are being made by Sponsors, Investigators, and IRBs because when looking back to this time, it needs to be clear that certain measures were taken to ensure trial patient safety and data integrity during COVID-19.
What alternative approaches are you making for your clinical trial?
Image Credit: https://www.fda.gov/