goBalto takes London
Last week, I had the pleasure of speaking at one of Informa’s latest conferences in London, England: Site Feasibility and Study Start Up. For me, the first milestone was when I boarded my first flight to Heathrow. Even with 80+ mph winds at our rear and a 3 hour shorter flight than the return trip, the flight out was brutally long.
I left on Sunday afternoon and returned late Friday night, gone from my office a week. It was a great conference and a productive week and I want to share just a few of the highlights.
You cannot escape the majestic feel of London, and the people with whom I had the pleasure of speaking with were polite and good-spirited – cheerful, and in general, a pleasure to engage in conversation.
It was well worth the trip and an honor to represent! The staff at Informa’s Site Feasibility and Study Start Up and the program chair ran an information rich, high-quality, and impactful event. goBalto was the main sponsor and as such received meaningful recognition from the Informa staff and the program chair. And for that I would like to say “Thank You”.
The Conference 
The conference was two very full days and attended by approximately 50 people. About half of the attendees were from pharma, 30% from CROs, and the rest other (mostly technology) vendors. Sadly, sites were ill-represented. If you were a clinical research professional from any of these company-types I would highly recommend this type of venue. If you find the appropriate content in this more intimate setting, the conversations that ensue and relationships made cannot be compared to those typical of the big events.
A couple key take-aways I noted were regarding the evolution of the feasibility portion of trial management and the role of data in trial management. I am certain that we will have more content on both topics in the future, as each is a large topic in and of itself.
The feasibility process is under scrutiny and caught between sponsors and CROs like a clinical trial tug of war. Some questions worth considering:
- Should sponsors pay (or pay more) for this piece of the process?
- Are sponsors getting the most out of feasibilities? Are they paying off?
- Is 10 days a reasonable amount of time to expect anything accurate or of value?
- What is the quality of the information typically gained in a feasibility analysis?
Quick story to drive the point:
One of the speakers at the conference made a great analogy. He pointed out that when a sponsor receives a feasibility analysis from a CRO any given parameter within the analysis is adjusted up or down by a fudge factor of 2. If you were being told to multiply by a fudge factor when reading your blood pressure, would you not question the quality of the machine?
I was later in a meeting and told this story to a director of clin ops at a CRO and she laughed, saying we already adjust “down” by 2, presenting a more “conservative” view to the sponsor.
We should probably scrutinize away regarding the feasibility process with such a high degree of variability and mistrust in data.
Whether from a sponsor, CRO or one of my technology vendor counterparts, it seemed that mention of data was in more than every other presentation. People do not just want more of it. It is more about the availability of new data, the timely capture of data, knowing what is and where to get the right data.
Clearly, beginning with the feasibility process and continuing throughout the entire management of a clinical trial, the utilization of relevant data has never been more important. And lets face it – data has never been so abundant, at our fingertips and attainable.
Making great use out of data entails a healthy mix of transparency. More than just the technology vendors at this conference spoke of leveraging The Cloud to find ways of improving efficiency and data sharing.
The storm is brewing, and at this conference you could feel it. It won’t be too long before the process of managing clinical trials will involve sharing of data on a scale unlike anything in our past. This will transform some of the business side of managing clinical trials. Much the same the way a mass sharing of data related to human health has had an immense impact on the science of clinical trials.
Kudos…
Kudos to Tufts Center for the Study of Drug Development (Tufts CSDD) for their presentation at the conference! There was an update given on the ‘state of clinical trials’ with data provided by Tufts and CenterWatch. There was also an overview of their benchmarking study in which goBalto is collaborating. People representing several new sponsors approached us about participating… the study grows larger!
One of my favorite stats from this presentation – the cost of a protocol amendment. Would you believe – $450,000?!
Conference Quotes of the Day
“The only thing predictable about clinical trials is that they are unpredictable.”
“Whenever you get a room full of clinical research professionals, conversation eventually ends up being about patient recruitment.”
So true!! And true of this conference as well. In the end, it is all about the patient.
Two questions I walked away with:
1. What is the life expectancy of the feasibility questionnaire the way we know it today? There are better ways to obtain and share the information contained within these documents (soon to be a thing of the past?).
2. What the heck is everyone’s problem with esignatures?? Of the 50 people in attendance, when asked: “who has used esignatures in their trials?”, one person half-way raised their hand. I’m confused – it’s so simple. It’s secure. I don’t believe the agency is opposed….
In parting, one final comment on England. 
If you know anyone from Wisconsin, the cheese capitol in which I dwell, you know that we celebrate our Friday night fish fries feverishly! Well, our brothers and sisters across the pond have it figured out – Fish n Chips anywhere, anytime! Yum!
Cheers mates!
-Dan Manak
About the Author
Dan Manak is the Director of Business Development at goBalto and a graduate of the University of Wisconsin – Madison. After earning his bachelor of science degree in Molecular Biology he began his career in pharmaceuticals with Hoffman-La Roche, holding positions in sales, sales management, and training. He has worked in pharmaceuticals, health care, and clinical research for over 20 years with Fortune 100 companies as well as start-ups. For the past seven years he led a small clinical research service organization as the President and Director of Business Development. His expertise and passion exist specifically in the area of clinical study start-up, having worked on several hundred protocols and initiating close to a thousand investigative research sites. In his spare time, Dan is a volunteer EMT and martial artist/Instructor.
{ 3 comments… read them below or add one }
Dan, great post. Wished I was there. There’s always next year!
-Jae
Great comments Dan.
Feasibility studies that are conducted in 10 days or less are often “off the top of your head” estimates and that is why those who conduct them often temper the information gathered with their own experience and with a desire to earn the client’s business.
Many investigators will overestimate what they can deliver to be chosen for the study and some investigators will underestimate their recruitment rates, so they can exceed the expectations they create. I myself have often used the “Krupa’s Rule of Four” which holds that investigators will tell you they can recruit twice as many patients in half the amount of time.
Companies are moving toward creating databases tracking site performance. In these databases, three metrics are of particular import for each investigator: enrollment, active investigator months and rate of enrollment. The enrollment and rate of enrollment at a site are compared to the investigator’s original commitment. The Active Investigator Months is compared to the original targeted timeline of the study.
Better feasibility studies are a key to shortening the overall length of time to conduct a protocol.
Tim Krupa
Hi Tim,
Could you point databases are mentioned in youyr comment? Citeline, Aqurian, ….. (?) Who else?
Who is most reliable?
Thank you,
Vladimir