As emerging drug therapies and modern chemicals present new opportunities for public health, developmental and reproductive toxicology (DART) researchers work feverishly to determine the effect of those products on contraception, pregnancy and fetal development. This is extremely critical work.
But with the increased focus comes a critical issue. Many study sponsors today simply aren’t getting the research they need to support their development timelines.
This is because the number of labs specializing in this research has dwindled while demand for the research has grown. Very few labs today have both the ability and availability to do it well. This is the DART conundrum, and here’s what it means for study sponsors today.
DART Skills Are In Short Supply
To arrive at defensible conclusions on the safety of a drug or chemical, researchers must work with quality data—and interpret that data correctly. In DART research, this is far more challenging than measurements, weights and instrument readings.
A large portion of the work is subjective. Researchers must closely analyze test subjects while determining what observations are within the realm of normalcy. To reduce costs, labs must rely on technical staff to perform this work. To be successful, the technical staff must be trained and observed closely by an experienced DART professional. Without the proper oversight, clients may be at risk for inconsistent data interpretation.
Gridlock is the Reality at Many Labs
Availability is becoming a big hurdle for many study sponsors.
There is much work, high demand and not a lot of space for companies to get their studies scheduled in the timeframe they want them. With fewer labs offering safety assessments, more DART work is going into fewer labs. And as a result, those labs have backlogs for this type of work which makes it extremely difficult to get a new study on the schedule.
Personal Attention is Often Lacking
With the increase in demand, and decrease of quality labs, many sponsors feel they don’t receive the personalized service they need and deserve.
It often may feel like you’re in line at the DMV—taking a number and waiting anxiously for someone to call you forward. Many sponsors feel like they’re kept in the dark during their study, raising anxiety during the course of the research. Sponsors and study directors should feel confident in their lab partner.
The study directors at Battelle maintain a close relationship with their sponsor representative throughout the course of the study so that sponsors know what’s going on at any given time.
Results Can Be Inconsistent
Without experience and proper oversight, some labs may present research findings that are inconclusive. They may note an observation that may have been caused by the drug or chemical. Unable to adequately explain the observation, they will often request additional studies to get to the bottom of the issue.
This is why it’s so important to be able to feel that you can trust the lab conducting your study. If there is an observation, you want to know that its merited and the additional studies really are necessary.
When it comes to DART research, who you trust can make all the difference in the world. What should you look for when finding a CRO or lab to perform your study? Download our white paper: Is Your DART Study Set Up to Fail? Inside you’ll learn key questions to ask to ensure you select the best partner for your research.