Ensuring High-Quality Data in Complex, In-Home Clinical Trials

Sep 01, 2018
Volume 27, Issue 9

Patient centricity is an industry obsession—with good reason. It can provide patients easier access to potentiallyEric Hayashi life-changing treatments and can drive scientific progress and generate ROI. In a recent survey, 77% of clinical research stakeholders said it was “very” or “extremely” important that their company embrace patient centricity, and in-home clinical trials offer one of the best opportunities to do so. However, unique challenges in design and execution must be addressed for these trials to yield quality data.

While patients commonly are asked to travel to clinical trial sites in order to participate in research, an in-home trial is a compelling alternative. These trials enable the patient to remain at home, work, or another convenient location, leaving it up to the study coordinator or nurse to travel to them to collect samples and manage monitoring tasks. The benefits to the patient are clear: comfort and convenience, with savings in time and expense. For the research team, benefits include easier patient recruitment, better retention, and better protocol adherence. These are high-value advantages at a time when study subjects are hard to find.

However, in-home studies pose a critical question. Is it realistically possible to get high-quality data from in-home studies with their inherent variability, logistics challenges, and limited oversight? The answer is, yes.

Effectively managing complex in-home studies is critical and becoming more so since the advent of precision medicine. Working with a research organization that has a global laboratory network and sampling logistics is essential. But by also tapping into knowledge gained from companies experienced specifically with in-home clinical research, sponsors will make these complex, in-home trials more manageable while ensuring they provide the high-quality data that clinical research demands.

Supporting complex in-home trials worldwide requires the same streamlined continuity of service and global laboratory capabilities investigational sites always need, with an added layer of organization. Advances such as precision medicine are making protocol adherence, sample logistics and reporting, and collection of high-quality data more complicated. For example, peripheral blood mononuclear cell (PBMC) isolations are gaining importance in clinical trials across numerous therapeutic areas, especially in immunotherapy studies. Samples, once obtained, must be processed quickly by a lab with experienced technicians. In some areas of the world, finding the right lab and getting the samples there in time are nearly impossible without a global network in partnership with an expert in-home clinical trial service provider.

Even more complicated research involving CAR T-cell therapy makes sample logistics and chain of custody more critical than ever. In these complex protocols, the patient is both the beginning and the end of the process, so high-functioning sample logistics is an absolute necessity.

To support complex in-home clinical research and investigative sites, well-designed trials must produce the same high-quality data as traditional sites. New processes and tools must accommodate variability in home sites and caregivers by facilitating sample collection and reporting. For example, clinical kits specifically for home use may include complete supplies for sample collection and shipping with precise instructions for the home health nurse to follow. Other solutions could include simplified methods of reporting for home visits and client informational materials to educate all stakeholders.

Most importantly, logistical expertise and robust systems are required to ensure samples arrive at specialized labs for testing or processing and, for complex trials, that the samples are then returned efficiently and reliably to the patient, with chain of custody intact. In these ways, in-home clinical trials can ensure the data integrity the industry needs while also providing the convenience to improve patient participation and retention.

 

Eric Hayashi, MBA, is President and CEO of LabConnect LLC. 

 

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