Non-adherence in clinical trials is a big issue leading to lack of study power, increase in sample size and additional costs. It even might masquerade as drug resistance and diminish the apparent magnitude of the drug effect. This caveat can be overcome by optimized candidate screening and randomization procedures, as recommended by the FDA for the enrichment of clinical studies. (FDA 2012)
Selecting the right study participants for inclusion in a clinical trial should involve more than just meeting the clinical criteria. It should ideally identify each candidate’s likelihood of staying in the study and adhering to the protocols, as well as provide insight into what each participant uniquely needs to stay engaged.
Now is the time to enrich your clinical trials and change the way you select your study participants.
STRATUM™. It’s Time for a Revelation.
FDA Guidance for Industry 2012
Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products
Strategies for More Successful Drug Trials
FDA Voice 2012: http://blogs.fda.gov/fdavoice/index.php/2012/12/strategies-for-more- successful-drug-trials/