Tools for Successfully Managing a Clinical Trial

16A few days ago, I was trying to finish my work, keep my 1½ year old happy, put away the dishes in the sink, fold the laundry, get my 7-year-old a snack, pack our suitcases for our family trip to Maine, empty the garbage cans, pay a couple bills, paint my toenails (you can’t go to the beach without painted toenails!), make dinner, and water the flowers before we left. Oh-and make sure the cat had enough food and water. While I was going about my fairly NORMAL day, I thought to myself “life is sort of like managing a clinical trial.” There are numerous pieces … all of which must be completed (although, my husband would probably tell me I can skip feeding the cat … haha), and a strict timeframe in which it has to be done! News Flash: Planning, organization, and time management are HUGE factors of our personal and professional life … 3 “skills” that I would confidently say I have mastered (except for on this particular day because I didn’t make a LIST!). I let my usual method of organization slide … and it resulted in a disorganized, stressful day. One could say managing clinical trials it’s pretty straight forward if you’re a planner, organized and good with time management (oh-and can read the guidelines!). This is of course a great start, but through experience, you will find there are other tactics that can separate the “good” from the “great” (like keeping a LIST!) and ultimately, you have to stick to what has been proven to work (like keeping a LIST!). So-let’s hear some “proven” ideas for making the management of a clinical trial successful. It’s a juggling act really!

And on that note … I would like to take a moment to introduce you to another member of the McCormick LifeScience team, Cathleen Gorman.

Cathy holds a BS in Clinical Laboratory Science, a MS in Clinical Chemistry and a Master Certificate in Applied Project Management. Cathy has been in the pharma/biotech industry for 13 years and her consulting services have focused on clinical project management and pre-submission audits.

Soooo … trials will run into speed bumps; it is inevitable. However, attention to detail when considering your clinical trial needs, anticipating potential issues and identifying potential risks along with having a solid plan to mitigate those risks goes a long way toward having a successful trial-within budget!! Many of us know the “standard” start-up and initiation processes to a clinical trial. They can actually be quite boring and redundant. However, here are just a few things that would appear very basic and are sometimes overlooked that I have learned are key to clinical trial management:

Write a clear, concise protocol and “keep it simple.”

I know what you’re saying … I have written MANY protocols … This is a piece of cake!! I know what I want the site to do!! Sound familiar??

Just a few of the misconceptions we all have. As a Consultant, I typically come into the process midstream; I am thrown the ball and told … run with it!! I read the protocol and come back scratching my head. And if I am, I can guarantee you the site staff will be also. An unclear protocol of course is never intentional; however, when you have been planning this study for over a year and know it like the back of your hand, sometimes the important details are omitted. This will open you up to sites being non-compliant, which may compromise your data and possibly the outcome of your study.

Also keep in mind that your initial protocol is typically not a rate limiter to your study start-up; HOWEVER, an amendment to a protocol can be a show stopper depending on its scope. Amendments can affect everything from patient recruitment, data collection and protocol endpoints to your study budget!

Who is managing this study … YOU are! Be the face of your clinical trial!

I cannot stress this enough. Most aspects of a clinical trial are outsourced today. I see more and more pharmaceutical companies becoming just a name on a protocol. A good rapport with your Investigators and study staff will go a long way when it comes to a site’s patient enrollment, protocol compliance and data integrity. Remember, a CRO gets paid whether the trial is successful or not. The Sponsor is the one with a vested interest in trial success.

Choose sites wisely!

The “big name” isn’t always the “best site”!! Make sure the site has the staff and time to dedicate to your study and has access to the appropriate patient population for your study. Questionnaires are key in order to extract the appropriate information from a site to determine if they are a good fit.

Engage those sites!

Remember … out of ‘site’ … out of mind!! Have routine calls with your site study staff at the onset. Find out how patient enrollment is going; ask what is working for them, or more importantly, are they having any issue with patient recruitment and/or retention. Generate study tools for the study coordinators. Anything you can do to make executing the protocol at the site level simple will work in your favor! Share the site’s successes and issues with other sites. This is a great lead in to your “monthly newsletter.” This is a good way keep your sites motivated and engaged. Not only will it keep your Investigators current on the study progress/metrics, it will also let them know who is enrolling along with how well other sites are doing with enrollment-nothing like a little friendly competition to get or keep an Investigator motivated!!

Train and re-train your study staff and monitors!

There can never be too much training. New monitors come on-board; study staff transitions, enrollment is low so the protocol has not been front and center at a particular site. These are all opportunities to do refresher trainings.

MONITOR, MONITOR, MONITOR your sites for protocol compliance-data integrity is key to moving a product forward to market.

The best clinical trials will be the ones that have excellent preparation; a solid protocol, appropriate clinical sites, realistic time lines, good study plans and tools and training are all a part of executing a successful trial.

Toto's Tips

  • When it comes to your protocol-put yourself in the shoes of the site staff AND the patient.
  • Your study is never as important to the site as it is to you-keep yourself front and center!
  • Don’t forget that newsletter!! A little competition between Investigators never hurt a trial. Keep the newsletters interesting by including site successes or positive feedback from patients; metrics are great, but we all know how boring they are!
  • Manage your CRO; don’t let your CRO manage YOU!