I tried to tally them all, but there were just too many. I stopped counting at 153 pre-packaged laboratory kits that had expired before we ever had a reason to use them in the latest ongoing trial at our study site.
Receiving a shipment of such kits from a central lab is a routine occurrence for sites like ours that run research trials. Many are the study coordinators who have worked with the big-name labs—the ones whose kits come in bags or boxes, stuffed full of tubes, needles, vacutainer connections, and various bags and labels for packing and shipping.
Yes, they provide a convenient way to ensure proper blood collection at scheduled protocol visits. Yes, they make our lives easier as coordinators at busy sites…but at what cost to the sites and to the environment?
A Sisyphean Task, Among Many Others
Recently, I spent two hours breaking down the pictured mountain of now-useless kits. Completing this task gave me time to think specifically about protocols and the practices surrounding such lab kits. I considered the complexity of the protocol our site had at hand, the contracted number of subjects we had agreed upon with the sponsor, and the amount of work it had taken to agree on a budget.
This is an early-phase trial with strict entry criteria, and the kits I broke down were for bloods to be drawn at specific time points. Our site has been open since last September, and we have only drawn screening samples on a participant’s first visit on two occasions. Even if we had enrolled more subjects earlier, a large majority of the kits shipped to us last year would have expired by now. Why such a large volume of kits for the initial shipment? How much money was wasted on the ones that expired?
Collectively, as an industry, we must address the issue of waste. Let’s consider study start-up; why not begin with a smaller number of start-up kits? Why not consider initial rate of enrollment and the length of time between visits?
In the past, I have asked a large central lab not to include 18 gage needles because we don’t use them; we draw bloods with a butterfly, which provides a more comfortable experience for the subject. The response I received was that the kits are pre-packaged and this was not going to change. Why could we not compromise or have site-specific kits based on need?
Looking for a Challenge?
There must be companies who would love to take input on this challenge from all sides and synchronize this basic aspect of drug research and development between sites, sponsors, and central labs. Possibly the way to go is to use an online portal through which sites can resupply in smaller quantities, or an automatic resupply program to keep sites up to date for whatever time period is decided upon once a subject is enrolled. Whatever the means, let’s keep it simple and easy to navigate, with the shared goals of cutting down on expenses and being environmentally conscious.
I would be happy to work with a central laboratory or sponsor or vendor firm on such a project, and I am sure there are others in our industry who would lend their expertise.
As I mentioned, I stopped counting at 153 pre-packaged laboratory kits that had expired. Just look at that picture [see blog post noted below] and try to tell me that this doesn’t represent a significant amount of waste when you consider that it happens at sites everywhere. Fiscal and environmental responsibilities should be shared between sponsors, central laboratories, and the sites.
Who wants to work on a project?
Feedback (or Not) from the Real World
In fact, since I first raised this topic for discussion by posting the preceding text on the ACRP Blog site in June (https://acrpnet.org/2017/06/19/tackling-waste-clinical-research/), I am reminded of how George Bernard Shaw said, “Progress is impossible without change, and those who cannot change their minds cannot change anything.” Let us consider these wise words as we move into further discussion on waste in clinical research.
It seems the site where I work is not the only one that has tremendous waste. I was pleased to have responses from many of you, and I appreciate all your comments and suggestions. I heard from research nurses and coordinators who are now known as “the office recycling person” who splits expired kits to “donate our extra or expired lab tubes to a school for phlebotomists.”
“This all takes time, and it is by no means a money-making venture,” says one Certified Clinical Research Coordinator. She can sleep better at night knowing at least she has done something to “save the environment.”
Another respondent said, “I have felt the same frustration with breaking down those expired lab kits” and yet another added, “It is a lot of waste and must (increase) the cost of developing new drugs.”
I applaud these research professionals who break down, separate, donate, and recycle, and I do not blame those who throw kits in the trash. On the other hand, I’ll admit I was disappointed I did not hear from industry.
The study that had those 153 expired kits involved a small company. I sent my blog to their medical director with an invitation to discuss how planning can minimize waste in future projects. I’m waiting to see if I get a response.
Not one sponsor or laboratory company responded to my blog with comments, defenses of their purchasing practices, or thoughts on how customization might increase budgets. We—those who do clinical research—are part of a tripod; in my humble opinion, the sponsor, the monitoring team, and the research team must look at this challenge as an industry.
Hope for the Future
Each response I got offered to be part of the solution. Even in my own institution, a group of research nurses wants to start a program for recycling.
The thing is…I want change. As I said, I think all parts of the clinical trials tripod need to work together on this. By no means do I believe this is an easy issue to tackle, but if the tripod worked together and made progress, we would be taking the lead in innovation for cost saving in clinical research.
As British architect Richard Rogers said, “The only way forward, if we are going to improve the quality of the environment, is to get everybody involved.”
Joy Jurnack, RN, CCRC, CIP, (firstname.lastname@example.org) works in the research program of the Division of Kidney Diseases and Hypertension at Northwell Health and is a member of the Academy Board of Trustees for ACRP