Lessons Learned Moving Forward – Site Support & Remote Close Out

Nearly every aspect of society, including the way scientists conduct the testing of medicines has been affected by the COVID-19 pandemic. Although the FDA suggested shifting to remote monitoring in 2013, the industry has been slow to adopt remote monitoring technology until the COVID-19 pandemic made traditional monitoring impossible, as travel restrictions, and lockdown conditions prevented CRA in-person visits.

Early on in the pandemic, social distancing measures forced a rapid and widespread adoption of digital technologies to support safer communication between patients, site, and sponsors.

As a result, during the last few months, most clinical trials used a “hybrid” approach using both remote and onsite monitoring where possible. This hybrid approach helps to ensure that many clinical trials continue, and researchers are able to continue to monitor patient safety and collect as much data about the efficacy of the study medicine as possible.

However, this has necessitated a lot of changes and effort from the sites, as well as flexibility from the CROs and Sponsors. At Scimega, our relationships with sites are of utmost importance, and our team carefully and collaboratively developed strategies to ensure continued communication, and effective monitoring and close-out activities.

Dynamic, Diligent Site Support

At the same time site personnel were implementing new internal processes for the continued care of their patients, clinical trials were ongoing, and it was imperative trial monitoring continue to ensure patients’ safety. Recommendations about safety and restrictions were subject to rapid change, sometimes from one week to the next new policies were in place on site.

In the face of this dynamic environment it became very important for CRAs to show flexibility, and to diligently inquire of their main contact at any site what new procedures were currently in place. Our CRAs showed understanding and a willingness to adapt to each site-specific guideline. The key to providing dynamic, diligent site support, more than ever, required effective and timely communication between the site and the CRA.

Scimega has implemented numerous tools to provide remote site support and monitoring, which are very much appreciated by the site personnel. With all of us in the same boat, the overarching objectives to treat patients and collect high quality data are the mutual focus. As such, team work and the ability to empathize with each other’s reality is key. From this standpoint Scimega CRA support to site personnel has been very efficient, and we’ve been able to nurture and sustain relationships of trust throughout the pandemic. Thanks to our collaborative approach, working together to work smarter.

Remote Close-Out Visit Essentials

Some studies came to a planned conclusion during the pandemic. For these studies, while most of the monitoring had been done in person during the course of the study, many of the Close-Out Visits were to be completed remotely due to Covid restrictions.

Remote COVs was a new procedure for the majority of the sites and together we’ve learned a lot for future remote COVs, the essentials of which are as follows.

1. Plan, plan, plan ahead! There are many documents to be checked and filed during a COV, with site personnel often working remotely several days a week. Giving them time to adequately prepare is a must.

2. Be very clear and share a single list of all that will be needed from site personnel well ahead of time, including pending documents, actions items, etc. Multiple lists/emails are to be avoided to prevent confusion and/or overwhelm of site personnel. Scimega has developed a COV worksheet that summarizes everything a CRA must address to properly support site personnel’s preparations in advance.

3. Offer to schedule several weekly preparatory meetings prior to the COV date where necessary. For sites that need added support or have an extraordinary number of outstanding actions items more preparation time is necessary. Scheduled weekly meetings in advance of the COV date help to ensure everything is addressed in a timely manner, and allows the CRA to monitor site progress weekly ahead of the COV.

4. Adequate lead time is essential. Prior to the date of the COV sites require enough lead time to do three things: 1) gather all of the pending documents; 2) review the ISF to identify if any documents are missing; and 3) submit a request to the CRA to send any missing documents via email.

5. An effective alternative to onsite drug accountability – remote pharmacy close outs.

Lessons Learned for Future Drug Development

Biopharma companies launched hundreds of clinical trials in the midst of the pandemic and the number of trials continues to grow. To help navigate clinical trial barriers during COVID-19, the U.S. Food and Drug Administration (FDA) as well as other health authorities published multiple guidance documents for industry, investigators, and institutional review boards regarding the conduct of clinical trials during the pandemic, and these were constantly revised as new information became available.

With recent events the ongoing shift to remote/virtual clinical trial monitoring has been accelerated. Remote/virtual site access and monitoring platforms are now an essential element of the clinical trial process and a vital connection between the sponsor, clinical research organization (CRO), and the research site.

Going forward, there is a significant opportunity for the industry to improve collaboration and execution of clinical trials. Sites have the most to gain, especially with improving productivity and reducing delays that impact trial execution. These types of hybrid visits or remote visits are likely to become increasingly widely used, making the lessons learned applicable for future drug development, long beyond our fight with COVID-19.

Scimega Consistently Goes Above-and-Beyond

With 24 years unparalleled Canadian oncology experience Scimega Research has an optimal operations design critical to its ability to consistently go above-and-beyond for every one of your studies.

Scimega is a Canadian niche oncology CRO that serves small to medium size biotech companies in clinical development of cutting-edge oncology therapies. We consistently deliver our services with a strategic focus on Sponsor program success with clinical trial start-up times 50% faster than the North American average, premium quality data, and trial sites that are often among top enrollers in our Sponsors’ global oncology studies.

 Contributed by: Maëva Roques, M.Sc, Clinical Trial Leader & Program Specialist (Clin Ops Oversight)