Between the year 2000 and the year 2005, the number of clinical trials increased from nearly 4000 active trials to just over 12,000 for a shocking trebling in a mere five years’ time. In 2010, there were over 80,000 active clinical trials—nearly seven times more trials than five years before. In 2015, there were 183,000 active trials— “only” over two times as many. Now, in late 2017, the number of trials is nearly halfway to be on course for doubling by 2020.
The number of clinical trials ongoing is entering a phase of exponential growth. But how, why, and what does it mean?
Critical Stumbling Blocks Unstuck?
A recent estimate cited by Roche in their “Understanding Clinical Trials” publication puts the entirety of the drug development pipeline at about 12 years. Other estimates have it at 8 years. If it takes between 8 to 12 years to move from the lab to the market, how can the number of clinical trials be increasing so rapidly?
One major piece of the puzzle is that trials don’t end the same year they start unless something goes drastically wrong. Trials are multi-year affairs, meaning that the number of registered trials each year will include old trials that are still running as well as the upstarts. There’s still no escaping the fact that the number of trials is increasing by a massive amount, though—have drug developers figured out a new trick to make drugs go from the laboratory to the clinic?
Probably not, but part of it seems to be a general recognition of the “valley of death”—the inability for most drug candidates to make it through the clinical trial gauntlet and reach the market in one piece. Since most drugs won't’ make it through their trial, an alternative strategy is to put as many drugs through trials as possible to see what sticks—immensely expensive, but still potentially profitable if you’re a massive pharmaceutical company.
The difference between the total number of studies and the studies with results worth discussing is also a relevant topic. Per Clinicaltrials.gov, the number of studies which post results is increasing over time, but not nearly at the same lunatic pace as the number of registered studies. It’s clear that researchers and clinicians still need to invest heavily in making their studies work, lest their negative results render the number of registered studies less impressive.
What Does It Mean For Researchers and Clinicians?
The glut of new studies means that keeping up with cutting edge research areas like Alzheimer’s will be tougher than ever for researchers. In breakthrough research areas like Alzheimer’s, the number of clinical trials can double even faster than five years, with one estimate being three years.
Breakthrough research areas might not necessarily coincide with the disease areas you’d suspect, though. Thanks to legislation regarding “orphan” diseases, rare diseases have had investigation, drug development, and subsequent clinical trial advancement at a high rate. If the pace of rare disease drug development and subsequent clinical trial initiation continues, it’s entirely possible that rare diseases as a group may have more clinical trials running than the bulk of more common disease areas.
Time will tell if the increasing number of clinical studies that are being initiated will lead to a cornucopia of new therapies, but for the moment, it seems like a bet worth taking.