In her April 15 blog, my colleague KK Rumrill described how sponsors have been taking advantage of strong communications channels established with site engagement tools to keep sites informed as the COVID-19 crisis progressed.
During the past months, we have seen the trend of increased communications activity through the IQVIA Investigator Site Portal (formerly DrugDev) continue – and it’s having an impact. Sponsors with centralized study portals are reporting that inquiries requiring direct clinical research associate (CRA) follow-up have been minimized – solely because their site teams have so much information available at their fingertips. Self-service access to current, trusted information is more productive for everyone involved in a study, especially when in-person visits are minimal.
With so much new and updated information being shared on nearly a daily basis, it’s important to consider the most effective methods of organization and distribution. Here are some best practices we’ve compiled from working with sponsors and sites of all sizes and specialties during the COVID-19 pandemic.
Keep sites informed
Sponsors are using the IQVIA Investigator Site Portal as a single source for all important study-related COVID-19 updates and documentation. The first step is to collect, upload and centralize all important information for easy remote access. Organize it in your study portal’s document library under broad categories such as these:
- FDA Guidelines and Recommendations
- Study-Specific Patient and Visit Guidance
- Sponsor-Specific Patient Management Guidelines
- Business Continuity Documents
- Investigator Letters
- Protocol Deviations/Modifications
The Investigator Site Portal provides a number of communication methods to distribute and reinforce the availability of information and guidance. When uploading new and updated documents into the document library, many administrators select the option to automatically create a new post that calls attention to the latest information.
We recommend creating a frequently asked questions (FAQ) section that provides answers to the most common inquiries from sites. Critical updates should be sent via email blasts to all targeted roles and impacted site personnel.
Tracked email reports and document download logs provide transparency into who is reading your communications and downloading documents. This provides insights needed to add focus on sites that may not be as engaged as others, which is particularly valuable when on-site visits are not possible.
It’s important to have a portal with robust capabilities, but just as important that it’s intuitive to use and navigate. One of the most popular and convenient capabilities of the Investigator Site Portal is the search feature. Our metrics show that site and site-facing personnel rely on search to quickly find key information via keywords and phrases. Adding tags or metadata is not necessary - the portal indexes all content.
Offer support to sites
As we all know, sites are experiencing an unprecedented interruption to their business. They are concerned about issues ranging from patient safety to data integrity to staff furloughs. Thus, sponsors need to be proactive in reaching out to sites regularly to ensure they have the most up-to-date information. Here are some suggestions:
- Gather all your key contact details for issues related to COVID-19 and provide them in a single tab in the study portal
- Provide solutions to mediate negative impacts on trial timelines and quality
- Offer guidance and details for how to handle processes that may be impacted, such as trial initiation or trial execution, and craft your posts with a tone that is empathetic to the site’s current situation, e.g.:
- We would like to share with you some guidance to assist you in managing patients participating in this study during the ongoing outbreak of COVID-19…
- We understand that travel restrictions and quarantines may make it difficult to adhere to protocol-specified visits…
During this extended period of uncertainty, many sites are moving forward and finding innovative ways to retain and care for their patients. It’s important to recognize their efforts to overcome difficult circumstances and validate employees for their determination to carry out their professional responsibilities.
The Investigator Site Portal features tools that have been used for more than a decade to engage and recognize sites across a trial network. Instead of competitions and leaderboards, these tools are now being used to share and applaud successful accommodations made by sites and site staff, as well as to understand and acknowledge current obstacles. Sponsors are celebrating professional victories and maintaining morale by spotlighting specific employee or site efforts, study-related milestones and accomplishments, and general positive efforts displayed in a time of crisis.
Tips for communicating with sites
As a former site coordinator, I can attest to the fact that sites receive a multitude of communications each day, even under normal conditions. It's important that your studies’ news posts and email blasts are conveying information in a clear and concise format:
- Define your audience
- Make it clear what you need them to know or to do
- Use informative titles
- Delete unnecessary words
- Use short, direct sentences
- Add headings, bullets and bold text for readers to easily scan
Adding portals to current studies
Sponsors, CROs and sites are pivoting and adjusting to an environment requiring trial start-up and conduct to be much more remote. Multi-functional study portals have played a key role in minimizing disruptions to study operations by enabling virtual investigator meetings and site initiation visits, remote document management and oversight, e-learning, and more.
For sponsors that weren’t using a centralized study portal before the pandemic, it’s not too late to gain the benefits. We’ve helped sponsors introduce the Investigator Site Portal into new and ongoing trials throughout the COVID-19 crisis, and the technology is being enthusiastically adopted by sponsor and site personnel.
With investigators and site personnel seeking novel ways to meet study obligations and keep patients safe, now is the time to centralize site communications, provide self-service access to documents and offer the support and gratitude that makes a difference in this crisis. If you’d like to discuss your specific situation, please reach out to TDSE_Solutions@IQVIA.com.