Is A Pilot Study Useful?
Before taking the plunge and carrying out a full-scale bioequivalence trial, it is typically desirable to dip your toe in the water, and often makes a lot of business sense, to first conduct a pilot trial.
Often referred to as a ‘pilot study’, ‘pilot project’, or ‘pilot experiment’, these generally small-scale preliminary studies are conducted in order to evaluate the feasibility, duration, cost, adverse events, and indeed improve upon the study design prior to the start of a full-scale research project.
During the development of generic drugs pilot trials are usually used to test candidate formulations to be sure the right one is chosen for the larger pivotal trial. However more than that, it also allows for the sampling scheme to be adjusted, the feasibility of atypical measurements to be verified (such as sampling for endogenous levels characterization or urine sampling), and last but not least, one of the strongest arguments for starting with a pilot study is of course for drugs with publicly unknown variability, especially in cases of high variability suspicion.
Rather than starting a full-scale pivotal study from day one, which can be intricate, take longer to design, and can often require many, many volunteer subjects, a pilot on the other hand can run with as few as 12, and usually not more than 24 subjects depending on the goals, primary parameters tested and also the characteristics of the formulation.
In conclusion, when conducted in preparation for a larger investigation, and by its very design, used to increase the likelihood of a successful full trial while exploring the efficiency, internal validity, and delivery of proposed trials, it’s fair to say that pilot studies are an invaluable step towards a successful full clinical trial.
QUINTA-ANALYTICA with their two decades of experience offers both pilot and comprehensive full-scale trials using their in-house facilities. Get in touch to find out more.
August 5, 2021