Essential to my job of marketing clinical trial analytics is understanding the behavior of the medical affairs and clinical operations teams that will use them. Of all the job personas of marketed to in the past, including sales analysts, software developers, and pharma execs, clinical operations roles have been the hardest nut to crack.
What’s apparent about clinical operations teams is that at any given time they are juggling multiple highly complicated projects, aka clinical studies. I’ve been getting creative with how I track trends on clinical project management, and clinical operations team behavior. This week I’ve figured out how to use TrialTrends, a free interactive tool the BrackenData team launch two weeks ago, to do just that.
What I’ve found are some statistics about the clinical trial industry that will interest our readers. From slicing the TrialTrends dataset by phase, trial type, and date, I’ve gained some insight to what clinical operations and the industry as a whole have been working on over the last 13 years. Read on to learn six of the many trends I’ve identified.
More on TrialTrends
To understand my method of how I identified these trends I suggest taking a look around TrialTrends. It's free, and you can be using the tool in just two clicks.
TrialTrends looks at Count of NCT ID on ClinicalTrials.gov (CT.g). NCT ID is the unique number the NIH gives to a trial registered on CT.g, therefore the tool is analyzing the volume of clinical trials in a given period. By default, TrialTrends looks at year over year trends, but has the ability to do more. To refine the dataset, we've also setup TrialTrends to only look at trials mark completed. The year for which a trial is attributed is the year it was marked completed.
Using the historical data you see TrialTrends also forecasts trial activity by phase or trial type into 2018.
For a more detailed walkthrough on how to interact with the tool, read our post How to Use TrialTrends. Now, on with the stats!
1. 18.5% More Trials Are Marked Completed in Q4 Than Any Other Quarter
By clicking on the double downward arrows in the top left corner of TrialTrends you can group all data from 2004-2015 by quarter. What you’ll notice is that an overwhelming amount of trials of any type or phase are marked completed on ClinicalTrials.gov in Q4. This makes sense because teams naturally see the end of year as a deadline to complete studies.
30,451 trials in the dataset were marked completed in the fourth quarter of a year. This is 18.5% greater than the second most common quarter, Q2.
Implication: End of year is the busiest time for clinical operations teams, and a poor time to reach out about your services.
2. Drug Trials Are 24% Less Likely to Be Completed in Q1 Than In Q4
By using the same grouping method listed above, we see that 22,776 trials in the dataset have been completed in the first quarter of a year. This is the least common time of year for a clinical study team to close a trial. Q3 is the second least common period with 25,180 trials.
Implication: The first and third quarters are the least busiest time of year for clinical operations teams, and the best time to reach out about your services.
3. 14% of Clinical Studies Since 2004 Have Been Completed in the Month of December
If you click the double downward arrows in the top left of TrialTrends again, you can group all trial data by months. This gives us a more detailing than grouping by quarter, and what we find is that December is far and away the most common time for a trial to be completed. February is the least common month for a trial to be completed.
The exact comparison comes out to 2.2x as many trials completed in December than February. Other low activity months include November, April and August.
Implication: February, November, April, and August are likely the best months to reach out to a clinical operations director.
4. The Industry Has Yet to See Phase 1 Trial Volume Reach 2011 Levels
From 2004 to 2011 Phase 1 trial activity was increasing at an average rate of 13.7% year over year. There were 1,702 phase 1 trials marked completed in 2011. Then 2012 was the first year on record to have a drop in Phase 1 clinical trial activity. The rate of Phase 1 studies dropped again in 2013. We forecast that 2016 will be the first year since 2011 to surpass 1,700 Phase 1 trials, but not all the data has come in yet (more on how that works in our FAQ post How to Use TrialTrends).
Implication: CROs who specialize in early phase trials can look forward to their addressable market beginning to grow again after three non-growth years.
5. Medical Device Trial Activity Has Been Increasing at a Greater Rate Than Any Other Trial Type
The number of medical device trials seen to completion grew over 13x from 2005 to 2015. For comparison, the number of drug studies in the same time period grew at a multiple of 1.8x.
We’ve written about this phenomenon before, and speculated if the volume of medical device trials are truly growing at this rate, of if more the device sector of the industry is becoming increasingly compliant with the NIH and properly registering these trials on ClinicalTrials.gov. Afterall, drug trials and device trials don’t have the same regulations. Read more on that in our post Why There’s an Increase In Registered Medical Device Trials.
Still, no other type of clinical study has grown in volume like medical devices, and we forecast this increase to continue.
Implication: If you work for a trial services company, go after the vertical of medical device research. This trial type will continue to have a higher growth rate than any other in the industry.
6. Phase 4 Trial Activity Has Dropped Since 2012 and There Aren’t Signs of It Going Back Up
I’ve left this one for last because it sparks a more in depth discussion than the other 5 stats on the list. For that reason, it deserves its own blog post which I will post next week.
Our hypothesis is not that late phase trial activity are necessarily decreasing in volume but that the way in which teams label this activity is. Phase 3 is the last phase for a pharma team to prove the efficacy of its product. After this, the NIH requires “drug safety” trials that are sometimes labeled something other than Phase 4. Subscribe to our blog to get our next blog post “What Happened to the Phase 4 Trial?” when we dive into this topic in more detail. We expect to publish it in the next 2 weeks.
Implication: Clinical operations teams are changing the way in which they label late-phase studies.