An interview with Christine Obercian, PMP, MS, Director of Clinical Operations at a small biotech firm
Home health visits may not be a new operational innovation for clinical trials, but for many sponsors and sites it is a service they might not have used before. In rare disease, especially, home health visits have the power to ease the process for patients, sites and sponsor alike—if you choose well.
Why We Chose Home Health Care for Our Clinical Trial
We were entering a first in human phase 2 rare disease study with a complex study design and a very tight timeline. The study design required patients to receive IV infusions several times a week. Due to the nature of the disease, we had selected sites based on qualifications, not location, so we knew it was likely that several patients would need to travel to the site, some perhaps across the country, and spend the night for each site visit. And we needed to see 24 subjects within a 12-month period.
The therapeutic area, the protocols and the timeline were all challenging, so we intended to use home health services from the beginning. As a small biotech company, we rely on our vendors to be true partners—knowledgeable experts in their fields. It was critical we find the right home health provider.
Vendor or Partner: Assessing Your Home Health Visits Provider
We were running an infusion study but had no in-house infusion experts, so we knew we would rely on our home health care provider for their expertise. After working with one home health service provider for several months, we realized we needed to search for a replacement–and fast.
Following are the red flags that led us to switch home health care providers and the questions we used to find and assess a more suitable home health visit partner for our clinical trial.
#1 Have they prepared?
Does the home health visit provider understand your company, product and goals? It should be clear they’ve taken the time to not only fully understand the information you’ve given them but have applied some critical thinking. They should have questions at the very least, and leading home health providers may even be astute enough to identify issues early on and suggest how to address them. In short, it shouldn’t feel like they’re trying to “sell” you when you first meet.
#2 Can they answer your questions?
If a prospective home health visit partner can’t answer questions about their process, startup timeline, ancillary equipment requirements or any other basics, you might consider looking elsewhere. Look for a team that can walk you through the process starting with what they know of your study, what needs to be accomplished and what their recommendations are based on their experience and your needs—technical details related to operations, clinical, regulatory, etc.
#3 Do they offer proactive solutions?
The best partners are those that ask questions you’ve never thought of—and then come up with a possible solution. You’re bringing in a home health provider to manage the home health visit component of your study for a reason. They should be experts in all aspects of designing, managing and reporting on study visits, including possible pitfalls or suggestions for improvement that sponsors and sites may not have considered.
#4 Are they transparent about cost?
Sponsors are skilled at projecting costs for most clinical trial vendors but are unaware of the cost for adding home health care services to a study design. Look for a partner that is upfront about estimating costs in general and for your study specifically. Home health service providers that are transparent about cost are more likely to be transparent about other aspects of the engagement.
Conversely, while home health care services may front-load your budget, they will likely save time, and therefore money, on the back end as the last subject first visit (LSFV) target date approaches. This service can be the trick up your sleeve when managing inevitable milestone lags and subsequent managerial expectations.
#5 Are they accountable?
While home health visits are just one aspect of a clinical trial, your provider should be accountable for actively contributing to a well-run and timely study. A vendor might be able to perform home health visits, but a collaborator can help create a faster, more comprehensive study with fewer risks. Strategically, home health care can give sponsors an edge—but only if you work with a good partner.
Christine Obercian, PMP, MS, was interviewed by Firma Clinical Research in December 2019 about the decision-making process a small biotech company goes through when selecting a home health care service provider for a clinical trial. Firma is a boutique contract research organization (CRO) that believes a patient-centric approach is the key to unlocking positive outcomes in the drug and medical device development process.