Clinical Research Speed Bumps
By Jacqueline Stader

I love speed! For me it doesn’t matter if it’s derived from driving, boating, roller coasters, or even walking. I love the feel of air across my face, the adrenaline release, the action of being in motion, and the power of forward movement. What I don’t like, are speed bumps! If I know which roads have speed bumps I can avoid those roads and choose alternative routes that won’t impede my travel progress. But can we avoid the speed bumps in clinical research? Can we choose alternate routes or courses of action that will eliminate the frustrations we face when these pesky obstacles are encountered?

On streets, the purpose of speed bumps is to provide safety for others by limiting the speed of which one can travel.

In clinical research, speed bumps could be viewed as the safety mechanisms that are put in place to keep human subjects safe. But there are also speed bumps that aren’t intentionally set in front of us for safety purposes.

Sponsors and CRO’S can hit speed bumps from drug/device inception to protocol development, site selection, recruitment timelines, and numerous others on their road to FDA approval.
Principle Investigators can hit speed bumps from research participation preparation, to protocol selection, to study coordinator employment and training and numerous others along the path of clinical research participation.

Study Coordinators face speed bumps as well, from becoming knowledgeable about functioning in the study coordinator role, to working with the sponsors and CRO’S, their PI’S and then let’s not forget the IRB’s, and the countless speed bumps when recruiting, to the daily efforts of keeping the study flowing smoothly and properly.

Providing services on multiple levels and to different entities such as the Sponsors, CRO’S, PI’S, and the Study Coordinator’s it’s apparent from this vantage point that every aspect of clinical research is riddled with speed bumps. So how do we learn to spot these protrusions before we collide? And how can we identify which has been placed there intentionally as a safety measure?

1) Clarity – is required on all levels. The sponsor/CRO must clarify their needs, such as timelines, expectations for the project, participation levels of all the participants, and other related information to the sites. The PI must clarify the sites responsibilities to the Study Coordinators, members of the research and office staff as well as to the patients. Study Coordinators must clarify their needs to the sponsors and the PI’s, as well as the patients.

2) Understanding – or knowledge is required. Sponsors/CRO’S must understand and address the individual needs of the sites selected. PI’s must understand the responsibilities of the agreement in which they have entered into with the sponsor. PI’s must also understand the value and need for knowledgeable, trained study coordinators. Study Coordinator’s must understand the impact of their role in the study.

3) Unity – A totality of all our related roles, which forms an entity that is a complex and systematic whole.

Only with a unified effort of clarity, understanding, education and training that includes implementation of marketing/recruiting plans and detailed study designs and support for all, can we even begin to reduce the speed bumps in clinical research.

“Knowing is not enough, we must apply.
Willing is not enough, we must do” – Johan von Goethe

“Performance releases pressure” – Fisher

Is it possible, you ask? I believe it is.

Jacqueline Stader is a Clinical Research Lecturer and Trainer. She supports clinical research personnel by sharing proven techniques, strategies, information and tips that inform and educate.

Visit her website at www.ortsedu.com
Copyright © 2006, by Jacqueline Stader. All rights reserved.