standardization : We don ’ t use the results . Central laboratory findings return days after they have been collected , at which point we have already reacted to results obtained at our own institutions , and ECGs in the absence of cardiac symptoms have limited clinical utility .
Why not have an independent entity certify our facilities , equipment , and laboratory results once per year for all clinical research , or accept the findings from agencies that already certify them regularly ? It would save us all time .
Recognize that our signatures are meaningless . Yes , there are days we wish we were famous athletes , or rock stars , or even reality TV stars , and that our signatures were collectible and fetched a high price . But the hard fact – and we have to face this daily when we stare in the mirror and see ourselves for the hematologists we are – is that our signatures are worthless .
Having us sign central laboratory results , or worse still , indicate whether those results are clinically meaningful ( By whose standard ? What gives “ meaning ” to a lab result ?) becomes almost existential . Worse yet , requiring our signature on blank reports from central labs for specimens never received or for failed tests transports us from existential to the realm of crazy .
We can place into the latter category the practice of sending us emails with forms we must print out , sign , scan , and email back to confirm our email address .
Here ’ s another ugly truth : We don ’ t always read what we sign . Because when we are asked to sign and date the signatures of the 20 people from our site working on the study , 50 pages of lab results , or adverse events ( AEs ) that occurred in clinical trials being conducted for other cancers , at a certain point , we can ’ t assimilate the information we are reading , and we just sign papers to get through them .
When signatures become an exercise in futility , we should stop the exercise . Let ’ s limit required signatures to serious AEs occurring on the clinical trial in which we are participating ( because this is important information as we counsel patients about risks and benefits and recognize toxicity trends ) and to just one investigator acknowledging responsibility for trial conduct . All of the others just waste ink and time .
Please , don ’ t make us make your life easier . Your electronic data-capture ( EDC ) systems are bulky , counterintuitive , and time-consuming . We never remember the instructions on how to navigate them – if we ever remember our usernames or passwords to access them . These systems send URGENT emails inviting us to the “ CTP Portal ” or to another training session on “ Firecrest ” and demand IMMEDIATE ACTION ( your words and caps , not ours ), inundating our inboxes .
While electronic trial management systems enhance your efficiency , their structure and automated emails suck the will to work out of us . And we recognize that you are trading your time for ours . Nobody likes to be told that his or her time is less valuable than someone else ’ s .
We suggest you take ownership of your EDC systems , meaning that an accessible employee from the sponsor or the CRO can troubleshoot problems and answer questions . On visits or in emails , prioritize what is truly URGENT . We will provide one online signature covering all activities , to be performed either on a single and centralized site all CROs agree to use or with a clinical research associate to walk us through logging onto the website and to show us which buttons to click .
Stop the incentives for obnoxious behavior . We know “ time is money .” We are just as anxious to open trials and enroll desperate patients as you are . We recognize the importance of notifying you about AEs quickly . We hold our research employees accountable for their efficiency .
Emailing us daily , or multiple times per day , doesn ’ t make any of this happen faster . In fact it takes time away from opening a trial or entering data . The introduction of perverse incentives , such as “ pay by query ” models or bonuses for meeting data deadlines , has paradoxically slowed us down in delivering what you ’ re asking for . We propose setting reasonable deadlines for data – and “ EOB tomorrow ” is not reasonable , unless you ’ re treating acute leukemia . Don ’ t escalate issues to the principal investigator unless one of our research personnel truly is not doing his or her job . Eliminate the incentives that created this environment of animus between CROs and trial sites – and for which downstream consequences were utterly predictable .
All of our suggestions boil down to issues of trust and mutual respect . If you trust and respect us , we will provide you the information you need .
And we will actually respect you a lot more .
Mikkael Sekeres , MD , MS Editor-in-Chief
On behalf of the ASH Clinical News Editorial Board :
Beth Faiman , PhD , CNP Alice Ma , MD
David Steensma , MD Keith Stewart , MBChB , MBA
The editorial board of ASH Clinical News thanks the research nurses , coordinators , and colleagues who provided input for this editorial .
ASHClinicalNews . org ASH Clinical News
15