Contract research organizations (CROs), which are used by much of the pharmaceutical industry to outsource research regulatory requirements, should be the epitomes of high-quality data collection and trial standardization, but they have developed a checkered reputation among clinical trial investigators.
In the December 2017 issue, ASH Clinical News Editor-in-Chief Mikkael A. Sekeres, MD, MS, and the members of the Editorial Board (with insight from research nurses, coordinators, and colleagues at their and other institutions) offered several solutions to “the CRO problem.”
Readers from around the world (including members of the CRO enterprise) wrote to share their frustrations with CROs and offer their own solutions.
The December 2017 editorial (“Solving the Contract Research Agonization Problem”) sounds funny, but the issue of how CROs act at sites is a real problem. My problem is that I am part of this system.
When I started as a contract research associate (CRA) at one of the biggest CROs, my job was to read hundreds of standard operating procedures (SOPs) and attend several training meetings via WebEx or recorded trainings. Learning effect = none!
It is not much better at the new CRO. In my first four weeks, I read hundreds of SOP documents from my CRO and, because my position is sponsor-based, hundreds more from the pharmaceutical company. Again, learning effect = none!
The training on topics we have to discuss with the sites is endless, but, in the end, I don’t have the appropriate knowledge about the medical disease and the trial protocol. And, because I work on so many different trials in different medical fields, I sometimes look stupid at sites when I am telling a highly professional team how they have to work. I am lucky that most sites are sympathetic and don’t blame me – or don’t blame me too much.
Compared with most CRAs on the market, my background couldn’t be better: I worked as a registered nurse in a hematology/oncology inpatient ward for several years in Germany and the U.K. before I started as a study coordinator and later project manager at a German university hospital. I like to learn new tasks and read medical articles in my private time.
At my CRA job now, I try to shorten a site-initiation visit as much as possible, and I don’t tell any principal investigator about his or her responsibilities because I am very sure that physicians already are treating patients with their best interests in mind – and that their treatment will comply with the guidelines for good clinical practice put forth by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.
I don’t write many queries because I sit with the study coordinator or research nurse at the end of my monitoring visit and discuss “my findings.” We can avoid too many queries by making direct changes in the electronic case-report forms together or clarifying some items that I might not understand. What I cannot avoid, though, is asking the staff to sign so many logs and papers. And when a pharmaceutical sponsor attends any visit, I have to conduct the complete and long procedures and visit.
For me, it is difficult to explain to older CRAs that it is better to communicate with sites on another level than what is described in our training. And when I teach new CRAs about my working process, I have to explain myself to my manager.
I believe that the work we do as CRAs is important, but the way we have to do our work is, in my opinion, wrong. Doing my work with joy can sometimes be challenging because of these problems. Also, the problem is not created only by the CROs: Pharmaceutical companies support this “behavior” in many ways, and the differing opinions of ethic commissions, local authorities, and other stakeholders create inefficiencies in the system.
Again, this is a great article, and there has to be a change in the clinical trial world.
Best regards from Europe,
Bergisch Gladbach, Germany
Loved this editorial! I would have written it myself, but I was clearly too busy signing lab values, doing Firecrest training, and driving to meetings with site monitors to hear them say, “Great job, nothing to report.”
—Jonathan Ducore, MD, MPH
Co-Director of Hemophilia Treatment Center
University of California, Davis
I feel for you about the insanity of using trial-specific equipment! I have a room full of electrocardiogram machines (14 at last count – as well as all the boxes that they were shipped in that I have to store so I can eventually ship them back to the sponsor), trial-specific pregnancy tests, blood pressure cuffs, needles, scales and 10 kg weights to calibrate the scales (we use one as a doorstop), and all other kinds of equipment that I eventually give to medical missions or – God forbid – have to throw away. I wish I could trade it all in for a decent intravenous infusion pump.
I have a laptop from one company that has never been used, but the company won’t let us send back; it is still sitting in my office.
Also, I have at least one of every size of battery known to man.
—Catherine Hubert, RN, BSN
Manager of Clinical Research