At goBalto, we are building what we think will totally “knock the socks off” of how clinical study managers start and manage trials using the web. Having just returned from DIA in Washington DC, we are even more excited than ever. When we showed our user interface and solution to over 50 pharma companies and clinical research organizations, words such as “revolutionary”, “slick”, “amazing”, “game-changing”, “SUPER easy to use”, and even “giggidy” came out of colleague’s mouths.
Just to make sure we were addressing a true customer “pain-point” and that the feedback we received at DIA wasn’t skewed, we polled over 200 clinical research professionals from around the world. We wanted to confirm our understanding of how study managers view study start up by asking 4 simple questions. Here’s what we learned.
Note: We defined study start up as all of the tasks associated with identifying, qualifying and activating investigative sites. (We intentionally excluded patient enrollment and retention from the scope of “start up” as defined here).
1. How much time do you spend starting clinical studies? (130 responses – I mistakenly terminated the survey too early. Dummy me.)
3-6 months is the average time for study start up. We recognize that study start up times can vary depending on phase, region, and indication. However, when speaking with folks the ’3-6′ month timeframe seemed to be the most frequent response.
2. Which area of study start up can use the most improvement? (205 responses)
The most common area of study start-up which needed improvement was EVERYTHING! No surprise here.
3. When starting a new clinical trial, how do you manage and track study start up activities? (205 responses)
Most of you use Excel to manage their study start up tasks. This is astounding. Considering how much time and effort it must take to keep these worksheets up to date if you’re managing tens to hundreds of sites, can’t be much fun! Well fret not, come October, goBalto’s study start up tool, will enable you to replace manually updating your Excel spreadsheet with an automated real-time dashboard, which shows exactly where you are in study start up.
4. How would you describe your clinical study start-up experience? (205 responses)
More than two-thirds of you think study start up is a never-ending or manual and complex mess. We couldn’t agree more. From what we hear, the reason why it’s so inefficient is due to poor “crappy” interfaces built by folks unskilled in the art of creating simple and easy-to-use websites. Plus, all of us continue to be forced to work with multiple systems that don’t speak to each other. Do you really want to learn another system? Groan. This is why, come October 2010, you will be treated to an amazing – dare I say magical? – solution to helping you start your study.
In closing…
October can’t come soon enough for all of us here at goBalto. Incidentally, we are also expecting our third child in October. I’ll be hitting my 4th decade on this planet. This Fall is shaping up to be a momentous ‘moment’? (<–awkward) in the Chung household.
About the Author
My name is Jae and I am the founder of goBalto, the easiest way to start your clinical study on the web. Before goBalto, I co-founded,Celltrion, a leading biopharmaceutical supplier and earned a paycheck from McKinsey & Company. I’m a father of 2, with a 3rd on the way – scheduled for October. I believe drug development can be made more efficient using simple, easy to use yet powerful online tools.
{ 4 comments… read them below or add one }
Jae – Interesting stats from the site’s perspective. I’m interested in knowing thoughts on the first item – length of time from identifying a study to having that study being “ready to go”; 3-6 months. In the last 16 years of running RxTrials we have used that same stat as a benchmark of this activity -it has not increased or decreased appreciably either way over time. Considering this is the “sell time” to secure a new study I have come to accept this as standard and acceptable.
That sad there are areas within that time frame that could be efficient – as your survey suggests – the budget and contract process. This is an area where we see the lag coming from the industry side. Sites are typically now saying they are able to turn the budget and contract along much more quickly then industry can respond. I’d like to hear from industry as to why they are seeing (or if they disagree I’d love to hear that as well) trend.
I’ll stop there and will also look forward to October – not only to hear about the birth of your new baby but also for the 5th Annual Site Solutions Summit (www.sitesolutionssummit.com) to come around where we bring sites, sponsors, CROs and other industry leaders together to talk about these very type of topics and to identify best site practices.
Talk soon and thank you for your gobalto’s commitment to helping us streamline this process. ckp
Jae, thanks for illuminating some of the black box of study start-up. At ConsentSolutions, we like GoBalto believe that the process can be made easier through the use of computer based solutions. We focus on the small, but very key area of condidate consent and enabling remote monitoring the process.
I have to agree with Christine, many of the delays in start up are coming from Industry. Usual delays are from getting the regulatory paperwork together or submitting themselves rather than using local experts. Site inspections – finding the staff to physically inspect a new site (we have been waiting 4 months for one such inspection). We average around 3 months to get a site up and running from final protocol – site initiation/FPFV. 95% of delays come from the industry side. Leaner clinical departments in these companies is a major contributor in delays. Many of the major companies simply do not have enough staff to cope with peak activity periods any more.
Hi all. These comments are interesting and compel me to get involved and share my 2 bits. I have spent a great deal of time in study start-up, from a unique position in between sites and sponsors.
The most important lesson I learned was that it was best if I did not take sides in the arguments about who causes delays. Mine was a job of making both parties happy.
Seriously though, I cannot disagree with the comments above.
The process of managing contracts often does hit a “wall” on the sponsor’s end. Sites are more sophisticated, educated, and effective than they ever have been – they have to be! This includes the area of contract negotiation, and I have seen a significant difference in this process from the site side of things over the past 10 years. In no attempt to defend sponsors, I have to point out and recognize the simple fact that this boils down to a numbers game in some respects.
A typical contract team at a sponsor may be made up of a study manager, project manager, an admin and probably 1 lawyer. Of course there are always variations. My point is that for each study, a site must negotiate terms of 1 contract. There’s no reason this should not happen within a week of receipt of the contract – many sites have goals of more like 24-48 hours before they respond with their language requests.
The majority of sites will send the contract back with SOME language changes. In many trials the number of sites can be dozens or even hundreds. And in the majority of those cases, the sponsor lawyer will have to review and approve the various edits. This means that the lawyer has to go through each individual site contract to review, consider, and respond to the requests. Never mind all the back and forth that goes on once that track changes version has been submitted. The lawyer is a huge stop-gap in the process. (Of course the study in question is never the only thing on that lawyer’s plate either.)
Staffing cut backs have hurt everyone and this industry has not been immune. What were ridiculous delays in scheduling monitoring visits before have become even more ridiculous.
Assuming everyone involved is doing their very best to help make the process of clinical research as smooth, efficient, and effective as possible (of course this is not the case, but in a perfect world…) then what we can really do to make improvements is to improve the processes, without detracting from the end goals of clinical research. ANY efficiencies that are gained will ultimately help bring more good therapies to market sooner; and each efficiency embraced will have profound financial implications.
(I look forward to seeing you, Christine, and many others at the upcoming Site Solutions Summit! I know this topic and many more will be addressed more there.)