Q&A with Abramson Cancer Center: How Sponsors Can Better Support Sites

There is an ongoing crisis at research sites: As the volume of drugs and biologics increases, so do the demands on sites. However, more than half of sites are struggling to take on new studies.

The good news is that there are also solutions. I recently had the pleasure of hosting a discussion with Meghan Blair, the Director of Regulatory Affairs for the Abramson Cancer Center at Penn Medicine. The center has 450–500 active clinical trials at any given time and collaborates with more than 300 industry partners, including sponsors, CROs, government network programs, and advocacy groups.

Meghan shed light on key challenges sites face, including increased protocol complexity and the administrative burden of working across partners with non-standard systems and processes. She also shared solutions that sponsors and CROs can use to better engage and support sites.

Below is a summary of our discussion, which has been edited and condensed for clarity.

Bree Burks: Can you share key organizational challenges you’re having today, including with document exchange?

Meghan Blair: At the site level, we have fewer PIs and resources to start up and maintain our trials. This means existing PIs are often taking on more responsibilities for more trials.

We’re not interested in reducing the number of trials that we’re running. Instead, we’re looking to run trials more efficiently and effectively and drive down administrative burden so our PIs and site staff can focus on what’s important, which is the care of patients.

Part of the challenge is that protocols are increasing in acuity and complexity and take longer to run. Basket trials are a dime a dozen now. That’s not how the industry worked 20 years ago — every new drug would have its own trial. Now, we’re seeing trials in which every arm is a different protocol.

Every time you make a trial more complicated, it likely translates to more technology: more portals, more systems to access, and more documents to exchange with partners.

It can also be challenging for us to understand where documents on a given trial are coming from. For example, commercial central IRBs will approve the newest version of a protocol, and that might be the first time we hear about it. We’re expected to immediately comply with the new protocol, but we never received it from the sponsor. We might be working with a CRA, or we might be working with a medical monitor. We’re not sure who we’re supposed to be receiving that document from or when — and these processes differ from partner to partner.

We might also receive the same protocol from four different people within an organization and have to check and recheck to make sure we have the most current document. We try to implement amendments as quickly as possible because we know those changes often affect eligibility criteria and safety monitoring.

BB: Do you think the aforementioned industry site shortage, as well as manual processes for document exchange, impact the lives of site staff?

MB: Yes. Individual employees take on more responsibility, and they know they’re the go-between the sponsor and patients receiving the therapy. It feels personal, and people can be overwhelmed by the sheer volume of things that have to happen. Burnout is high, and the complexity and volume of document exchange contributes to the tenuous employment and retention strategies we have with our clinical research professionals.

BB: What are the most important ways sponsors and CROs can reduce the burden of document exchange and improve the site experience?

MB: The following things are priorities for us:

A direct connection between sponsor and site systems: This reduces questions and clarification emails, as well as ensures we have the right version of key documents like the protocol on file at any given time.

Clear sponsor contacts for each study: Often, we know who the medical monitor is — it’s on the first page of the protocol — but we don’t have their email address. We need a way to click, see who the right contact is, and send a system notification rather than a series of emails. We also need a way to efficiently escalate questions or concerns related to direct patient care.

Clear delineation of the systems for each study: We spend a lot of time trying to figure out where each study portal is, which portal it is, how many portals are there, and what training we need to do to access said portals. As a cancer center, we have new personnel coming onto a study across its lifecycle, especially in curable cancers where we follow survival for a very long time. Site staff, as well as sponsor and CRO staff, may turn over at various points. We need a way to track all our systems on a study, track our training, and drive down start-up times.

A single source for all study information: Collapsing all the information for a study into one place helps us as a site be more organized, position ourselves for site initiation visits (SIVs), and decrease the amount of time spent in training both initially and in an ongoing manner.

A streamlined approach to study archival: There’s a lack of industry alignment about what should happen when a study is done. There’s a celebration, and we’re always hopeful that the data is positive, but then we get giant casebook PDFs — huge zip files, sometimes on physical CDs. You’re like, “What am I going to do with this CD?” We want to maintain document management and archiving compliance for the integrity of the trial data, and to make sure that we can produce this information for a health authority inspector later.

BB: Do you have any other tips for how sponsors and CROs can improve site engagement?

MB: I have three main tips for sponsors and CROs to improve site engagement:

1. Plan early how you will connect with sites during your studies: These decisions need to be made early on. We will get offered a trial opportunity, and our sponsor collaborator has not yet made key decisions about things like their EDC, eTMF, or eISF. The sponsor will propose the trial opportunity to us as an early engagement site, and it’s a good time to start ironing out these details together so we can be the best business partners to each other.
2. Embrace consistency: As a site, I did not initially heed this piece of advice myself. When we first implemented our eISF, we dug in our heels and wanted to implement processes that were very specific to Penn Medicine. That’s very inefficient, though. It prevents you from working efficiently across business partners. If we lean into what the federal or health authority requirements are and find a technology solution that meets those requirements without bringing too much baggage to the table about our own preferences, that helps standardize processes across business partners. I started to heed my own advice about two and a half years ago: We need to let go of what we did before. We don’t want technology to mirror the paper processes we previously had. This new mindset has worked extremely well.
3. Learn from each other: I would like an open forum for conversation, especially during the protocol development phase. I want a sponsor to challenge my thinking, and I want to challenge a sponsor’s thinking. I want us to find the best joint solution. I don’t want sponsors to say, “What’s the best way to work with Penn Medicine?” I want sponsors to say, “What’s the best way we can work with all sites?”

“We need to let go of what we did before. We don’t want technology to mirror the paper processes we previously had.” Meghan Blair – Abramson Cancer Center at Penn Medicine – Director of Regulatory Affairs

BB: This is great feedback. As you know, Veeva Site Connect is our solution to simplify and standardize sponsor-site collaboration. It creates one place for automatic document exchange, safety letter distribution, study communications, payment information, and more. What has been your experience with Veeva?

MB: Our experience with Veeva has been very good. Veeva has been a great business partner with Penn Medicine and has always kept its finger on the pulse of what sites need and what sponsors need — and has been an intermediary between the two.

Site Connect’s automatic document exchange feature is revolutionary. It introduces the potential for seamless document exchange between the sponsor eTMF and the site eISF, which translates into time savings, increased accuracy, and reduced monitoring efforts.

Beyond that, Site Connect offers a solution to have one place to find all the systems and sponsor contacts for a given study and streamline sponsor-site communications.

Read more about how sponsors will step up to solve site capacity issues in 2025.