Building Blocks for Strategic Patient Support in Clinical Trials

Let’s talk about some tangible building blocks necessary to achieve the next evolution of patient support. When I talk about “support” I really mean everything that goes into supporting a patient from A to Z, from the moment they are identified, pre-screened, screened, and throughout their participation in a trial. I also include caregivers in the conversation when I refer to the patient, without caregivers many patients would never have the opportunity to join a trial, let alone have the fortitude to make it through to completion.

We’ll review 3 areas today, and highlight 3 more that we’ll cover in the future, that we at Block Clinical feel are important to any successful patient support program.

BLOCK P – Payments

The bare minimum of any program is to ensure that your Patients, Sites, and Suppliers are all getting paid in an efficient, cost effective, and timely fashion. One of the biggest things we can strive for is to minimize the out of pocket costs a patient and their caregivers spend. Imagine that all patients who volunteer for a trial, spend nothing out of pocket. Pre-paying for logistics and services on the patient’s behalf is the least we can do. This reduces their financial burdens, and creates a more diverse patient population making clinical trials accessible not just to those who can afford it. When making stipend payments, make them as soon after a Visit as possible. There’s no reason stipend payments can’t automatically be paid as soon as the Visit is confirmed complete. And if there are incidental reimbursements, for food, mileage, etc… these can be paid immediately upon approval.

For Clinical Sites, one of the biggest issues is the lack of transparency and time it takes to receive their payments. Sites are businesses that must perform to their clinical trial agreements. High performing Sites invest their time and effort towards the trials that include the best patient support services, and where they’re paid for services rendered in a timely fashion. For example, we have supported studies where Sites have received startup payments within 48hrs of their SIV, and this includes approval workflows, and transfer of funds all the way to their bank accounts. Visit related payments should be automated, thus reducing the time it takes for CROs and Sites to manage the invoice and payment processes. Lastly, providing transparency to pending invoices and payments improves the relationship between Site, CRO, and Sponsor which in turn helps improve the performance of the trial.

Suppliers are a key part of any clinical trial, without their expertise in a given area patients, sites, CROs, and Sponsors would suffer trying to deliver these services on their own. There could be well over a dozen suppliers who come together to support a single trial. Reconciliation of supplier activity, and supplier payments can therefore be a nightmare, not just for study managers but for the suppliers themselves. Like sites, suppliers rely on prompt payment to continue to provide high quality service. Reconciliations can be as easy as clicking a button if you’re tracking transactions in real-time, in a central system. Alternatively, if handled in a traditional manual fashion, it could take weeks to break down all supplier invoices at the patient or visit level. Much like site payments, many supplier payments can be automated and remitted in near real-time based on services rendered.

One additional overall comment about payments: Sponsors and CROs should not be required to provide massive deposits to downstream suppliers either. Instead, “on-demand” funding models give Sponsors or CROs direct line of sight to study level payment account balances, which can be funded as needed as the trial grows and spending increases, or winds down and decreases.

BLOCK B – Budgeting & Analytics

Planning for a clinical trial is nothing short of a herculean effort. Budgeting, and more importantly, forecasting spend over time is another important factor in cash flow management. Costs related to patient travel and logistics are traditionally hard to predict – you won’t know the needs of a patient until they enroll. By leveraging technology and data you can more accurately estimate total spend, and project costs over time (which follows a bell-curve) based on known study parameters.

Once a study moves into an active state, as Sites are on-boarded, and as patients enroll, you can analyze actual vs budgeted spend, and continually re-forecast as needed. This further aids the Sponsor or CROs ability to fund on-demand, because without this level of data you’re stuck with applying a linear model, or worse case, guessing.

If you’re interested in what this looks like, we’ve created a free version of our budgeting tool and posted on our website. We customize this tool for our clients to ensure we’re capturing other cost categories that may not be included in the free version. (https://blockclinical.com)

Block L – Logistics

Last but not least, logistics. The way we define logistics is in the very broad sense, anything logistically that will support a patient (or site) from A to Z. For a patient, this could be to travel to and from a clinical site. Or @home and direct-to-patient services in support of hybrid or decentralized trials which may include device, pharmacy, and supplies distribution, or telehealth sessions. Our perspective is that as trial design continues to shift, and new logistics suppliers enter the market, our clients should have the choice to align the logistics services needed to support a specific study and patient population. As technologists, we can remove some burden from our Clients by doing the dirty work of integrating with logistics suppliers of their choosing, and create a marketplace of logistics suppliers who can be booked (and paid) with just a few clicks. As the industry identifies new, innovative suppliers, the integrated marketplace grows, providing access to these new logistics supplier.
In summary, I would consider these three areas as the minimum to any successful, strategic program.

The next 3 building blocks we’ll tackle are:
BLOCK C – Communication – communication is huge, and the network of key stakeholders involved in patient support is broad. The future solution may look something like “slack”, for all parties involved in delivering and receiving the collective services outlined above.
BLOCK S – Service – a program is only as good as the collective service that supports it. What good is $0 out-of-pocket for a patient if they’re stuck planning and managing their own logistics?
BLOCK P – People – how do you provide a single point of contact for the patient (and site), on a global scale? The future solution may leverage concepts from the “gig-economy” to provide qualified, trained, on-demand patient and site coordinators at scale.

Thoughts and comments welcomed. Stay tuned…