In the last 6 weeks, COVID has affected nearly every study that was in planning or already underway and sponsors must continue to determine how to manage clinical trials in this unprecedented time.
Dawn Furey, Vice President, Head of Portfolio Delivery Options at Janssen Pharmaceutical Companies of Johnson & Johnson, advises that sponsors develop an objective decision framework that centers around the data and science behind each clinical trial. In other words, go back to the science of the compound and the profiles of the target population. From here, you can determine the longest duration between visits and lab draws, number of required visits, what can be done virtually or remotely, the best way to distribute drug, and whether home visits are right for your trial. “Generally, we like to collect more data than less, because we have the ability to. But in this situation, we need to determine what the bare minimum is while still ensuring that patients have care,” says Furey.
Sponsors will also need to determine how they can piece together the information collected virtually, any missing data, and previously collected data to form complete pictures of clinical trial patients.
David Borasky, Vice President of IRB Compliance at WIRB-Copernicus IRB, discussed new issues that have been brought to the attention of their IRB.
Patient Compensation in Clinical Trials
The IRB’s role is to protect against undue inducement, and maintaining or reducing patient compensation should not affect this. Research sites may continue to reimburse patients for visits that are completed remotely or virtually and may also choose to reduce or eliminate payments to reflect decreased participation.
Informed Consent/Re-consent in Clinical Trials
During COVID, there are many options that sites can use to conduct the consent process such as eConsent. The FDA recommends that sites utilize other technology to facilitate, enhance and document the process. In any situation where the consent process cannot be documented in real time, witnesses should be used to confirm that consent was completed. Important to note is that not all electronic consent tools are compliant with Part 11 of the FDA regulations and the FDA has not indicated whether they will soften requirements here. Make sure that any eConsenting technology used is Part 11 compliant.
New Information & Reconsent
According to Borasky, “The consent process is not a document. Although it is a significant part of the process, re-consent itself is not a regulatory term. Re-consent is just one method to provide new information or changed information to subjects.” While sites may elect to provide revised consents to subjects, there are many other ways to communicate study updates to research participants (e.g. addendums to ICFs, site memos, phone calls). WCG has requested that sites submit any letters to participants on changes for review and IRB approval.
1572 Documents in Your Trials
There is a previously published FDA guidance on 1572 documents and it addresses when they should be updated and signed. Usually a new 1572 is required for new or updated protocols or when a new investigator is added to a study. It is unlikely that the transitions to telemedicine or use of alternative labs will warrant new 1572s, but documentation should continue to be done locally.
On the subject of future clinical trials, the two experts warn that it may be difficult to include provisions for pandemic management or similar situations in protocols, as one solution may not fit all. We have seen how the impact of the pandemic has varied between sites and sponsors, so incorporation of contingency plans will be challenging. That said, Furey and Borasky do recommend that sponsors and sites create their own “ready to implement business continuity plans” that will allow research to move forward in future crises.
- Dawn Furey, Vice President, Head of Portfolio Delivery Options at The Janssen Pharmaceutical Companies of Johnson & Johnson
- David A. Borasky, Vice President of IRB Compliance at WIRB-Copernicus IRB Group
- Lindsay McNair, Chief Medical Officer at WCG (Moderator)
For more information on going remote, watch the full WCG webinar.