We Still Love Paper

Laboratory tests in clinical trials are used to test the efficacy of the study medication, evaluate its safety and select subjects for inclusion in the trial. In the setting of a clinical research study, the stakes are high since any erroneous results have implications much broader than the tested patient. Future use of the investigational product often depends upon biomarkers measured in clinical laboratory testing. For many clinical trials, laboratory data makes up the majority of the volume of data stored and reviewed for the study. In addition, laboratory data is often a primary or secondary endpoint in the trial. Also, laboratory results typically play a role to ensure subject welfare and safety is continuously protected.

The paper trail

Labs are often collected at each study visit. Even with this critical role we use the same approach to laboratory collections in clinical trials that we did over a decade ago. Our every day experience at a clinical trial site includes a barrage of paper to facilitate this process. Paper manuals, paper requisitions, cardboard boxes filled with tubes and supplies, and more boxes for shipping of samples back to the lab. The sites must find space to store all of these supplies in addition to any specialized clinical supplies for the study. Sponsors must pay to create extra kits and shippers to supply to sites; ultimately we know that at least some of this effort and expense will be thrown away.

Study start can be delayed as sites wait for kits to be shipped to their site. Ongoing enrollment can be delayed if resupplies are not timely. Protocol amendments are common and when they result in changes to the laboratory collections there is added cost and time to adjust the kits, manuals and site supplies.

Preventable errors

The paper process leads to errors at the collection point that could be prevented. Because each kit and collection has no link to anything else, simple mistakes can lead to hours of labor in cleaning lab data. In addition, there are no built-in logic checks for paper requisitions. A site can select a kit that does not make logical sense with the progression of the study visits. These errors are not caught until the point of analysis at the lab or during the data cleaning process.

By now you are starting to get the picture. This is not news to those of you that have spent time working in clinical trials. Why don't we challenge the process? There is a better way. We can leave paper requisitions and lab kits in our collective past. We can apply the power of electronic health records to clinical trials, let's call it a lab electronic source record (LESR). An electronic system at the point of collection can eliminate or reduce the problems just identified.

Case study

DaVita has done this by modifying its own internally developed electronic health record. It took its platform and modified from a system that meets the needs of a clinic to a system that meets the needs of a clinical trial site. Using a web-based interface there is no requirement to install or maintain software. Most sites do not have barcode printers. These are relatively inexpensive and can be provided for the duration of the study. Study visits can be pre-programmed into the LESR. Sites need to enter each subject only at the time of screening. At each subsequent visit, the appropriate subject can be selected from the site's screened subjects. Basic logic can be programmed such that at the point of collection the only visit available to the site is the next logical visit. Labs can be prepared for the incoming specimens since they will have visibility into the upcoming workload. Labs can ship bulk supplies to the sites.

Positive effects

The benefits to ordering and resulting clinical trial labs electronically are numerous. By using a LESR the expense and time required to prepare and ship lab kits is eliminated. Sites no longer need multiple storage closets to store lab kits. Costs of excess supplies are reduced. Protocol amendments can be executed more swiftly. No need to destroy kits at the site and no need to make new kits. Central changes to the available visits can be rolled out to coincide with a central IRB approval. Any new tube types or supplies that were not already specified in the original protocol can be shipped in bulk again.

Efforts at the site can be reduced. Since sites only have to enter a study subject into the LESR one time, the redundancy of entering the same information about the subject at each study visit is eliminated. This carries through to the monitoring effort as well. In addition, basic logic checks can be put into the system to help eliminate common errors such as entering the collection date as the date of birth. Care should be taken when considering logic checks at the point of collection. Too many can frustrate the sites and slow down work flow.

The resulting aspect of using a LESR also has benefits that can't be achieved using paper. Investigators can view laboratory results from wherever they are working using a web-based interface. Lab data can be viewed in multiple different ways. It is often helpful to look at laboratory parameters over time rather than just as single data points. To do this in traditional clinical trial results investigators must flip through multiple pages of data. Trending reports can be accessed in a LESR to aid in quick review of critical results, keeping subject safety intact. These reports can also be accessed by study monitors and the data and safety monitoring board members to facilitate the review of endpoint and safety data.

Change is hard. Clinical trial labs have been done this way for a long time. Moving to an electronic system will challenge all key stakeholders from sponsors, monitors, CROs, labs, and sites to change the way they collect, view, and receive laboratory information. The entire study team must be onboard and supportive to make the changes successful. We can move away from paper.

Amy Young, BA, CCRC, is Vice President, Clinical Services at DaVita Clinical Research, www.davitaclinicalresearch.com.