Make Your Trials More Patient Centric: Use Local Labs Instead of Central Labs, Where Possible
by Hugh Levaux, on Jul 22, 2018 6:24:27 PM
Clinical Trials are getting more and more complicated by the day - complex protocols, more data points and an increasing number of interconnected systems. The goal of clinical trial management is to control this growing complexity, while making sure the data is reliable and clean. The challenge is to achieve this without increasing the burden on the sites or the patients participating in the trial. This is where the tension between Central Labs and Local Labs arises. In many therapeutics areas, lab tests make up 40-80% of all data collected.
Central labs are the gold standard in making sure that lab results are consistent across patients and sites. Central labs are critical in consolidating and harmonizing data from different clinical sites. The goal of central labs is to avoid biased test results among disparate labs. Patient data is derived from the same analytic method platform so the results are correlated and standardized. This standardization is excellent, and is a must for endpoint data and other critical values like Pharmacokinetics.
Data consistency for safety labs however is not nearly as important, yet many sponsors and CROs chose to run all their labs out of central labs for operational simplicity. Indeed, while local labs are convenient for both sites and patients, they are difficult to manage operationally. Each local lab uses different normal/ reference ranges for each test specimen (“analyte”) and those ranges vary by patient characteristics - age, gender etc. When reporting local lab results, the site needs to report values, units and ranges - a very burdensome task. To lighten site burden then, Sponsors and CROs can either centrally manage lab ranges for each lab and for each patient category (a significant operational nightmare), or chose the “easy” way out and send them all to a central lab.
The choice of central labs is usually framed in terms of data quality and operational simplicity. However, the logistics, not to mention the costs, are demanding. In most situations, central labs demand a visit to the site by the trial subjects and lab results often take significantly longer - a double whammy if you want to be patient-centric! Local labs provide a great value and opportunity for Sponsors. They provide a much more patient-centric, familiar and convenient environment. This is especially true in oncology and immuno-oncology where you need to constantly monitor safety signals. Any visit to the site that you can avoid, drives patient satisfaction through the roof. An excellent opportunity is to combine home visits and local labs together.
In short, the slight discrepancy across local safety labs is consistently outweighed by the benefit of patient convenience and the speed in obtaining actionable test results. The question is: Is there a way to take advantage of local labs in clinical trials and get the benefits of both local labs and central labs without the downsides? The answer is, absolutely!
By integrating the Sites’ EHRs directly into the Pharma’s EDC. This way, you leverage billions of dollars invested by clinical sites, to make their EHR systems ingest local lab data and make them electronically available immediately. Up to now, the problem with this approach was that you would still need to manually transcribe the data into EDC while the data is already available electronically in the EHR. This drives sites, site users and PIs absolutely crazy. That is where new technology comes along. Clinical Pipe solves that problem.
Clinical Pipe is a stand-alone, system-agnostic application, that can connect any EHR to any EDC. (Well, in truth, we currently only cover ~80% of the EHR and EDC markets, but we are rapidly expanding the connectivity to other EHR and EDC systems.)
Clinical Pipe allows sponsors to take advantage of local labs without the operational downside. This decreases the hassle and headaches associated with Central Labs, and offers faster test results that help bring down the rising cost of those Central Labs. The automation of the EHR to EDC data transfer, with Clinical Pipe, further allows for the elimination of SDV on those lab results. One less headache for the CRAs and Data Managers.
By using Clinical Pipe, you avoid managing local lab ranges and manual data entry, an operational nightmare. You get lab results both faster and cheaper. You also have happier sites, and most importantly, you place the patient at the center of your trial. All very good things!