CROs and Cons

In his June 2017 Editor’s Corner (“Contract Research Agonizations”), ASH Clinical News’ Editor-in-Chief Mikkael Sekeres, MD, MS, called for an end to the bureaucratic madness that contract research organizations (CROs) have introduced to the clinical trials process. The article inspired an impassioned response from our readers, with several writing in to express solidarity and share their own experiences with site initiation visits.

Thank you for your article; it is decades overdue and a hot theme of mine in presentations. I am not a physician, but I train and educate Clinical and Medical Science Liaison teams throughout the pharmaceutical industry – mostly in oncology and hematology, always on communication issues.

There is a covert, risk-averse culture within the clinical research “industry” that prevents common-sense communication. Everyone is either afraid of getting sued, fired, or receiving a “needs improvement” on their performance review. You have eloquently described what I call a “value event,” or lack thereof.

This should be a topic at every National Cancer Institute–Designated Cancer Center and at every Cooperative Group meeting, and with the chief executive officer of every CRO required to attend. For 6 – no, make that 10 – hours. Including signed documentation that records their presence and agreement to cease this madness.

Improvement always begins with the question, “Have you ever been on the receiving end of yourself?”

Best of luck, let me know how I can help.

—George Mooney
2Pario, LLC
Spokane, WA

… And you didn’t talk about the urgent emails that give no indication to which trial the urgent matter is referring. Or the trial website where you have to e-sign even more forms but that won’t let you log in – no matter what you do and regardless of the urgent need to do something within the 24 hours before the “data lock” for a study whose last patient you accrued 7 years ago goes into effect. And so on.

It’s a nightmare in every direction.

—Jeffrey Szer, BMedSci, MBBS
Peter MacCallum Cancer Centre
Victoria, Australia

I loved your column, Dr. Sekeres. Being involved in clinical research and new drug development since the 1990s, I could have written it word-for-word. The real “cancer” is bureaucracy, and it is an expensive one.

Each session of monitoring for any new compound is longer than the previous ones. The real target of all this is not patient safety; it is self-protection of the CROs and the pharmaceutical companies. Who will stop the madness?

Please send your editorial to the U.S. Food and Drug Administration, the European Medicines Agency, the executives of professional organizations, and patient/parent associations.

—André Baruchel, MD, PhD
Pediatric Hematology-
Immunology Department
University Hospital
Robert Debré (APHP)
Paris, France

Mikkael’s article about working with CROs is spot on. I only wish clinical trial sponsors would someday realize how much time and energy is being spent on completing unproductive forms and fulfilling requirements at the expense of the really important information, including disease and protocol knowledge and sensible data capture.

The best sponsors are the ones who don’t use CROs. Somebody should write an article on queries – another area where common sense is lacking. Timelines for Institutional Review Board approval and activation would be halved if we had no CRO assisting with study startup.

—Janet Briel, RN, MBA
Johns Hopkins School of Medicine
Baltimore, MD

I really enjoyed this article. At last someone has a knack for voicing the frustrations in a quite humorous way. Hope the CROs read this article and stop badgering the MDs and principal investigators who have worked on numerous trials.

—Ramachandran Subramanyam
Roswell Park Cancer Institute
Buffalo, NY