In the video below I provide a short commentary of an article recently published in the European Respiratory Journal about potential small risks of serious events following repeated bronchoalveolar lavage (BAL) procedures in idiopathic pulmonary fibrosis research studies (early-phase).
These early-phase IPF trials (starting with phase I – first-in-human trials) normally attempt to measure whether a new drug being tested is safe and reaches its intended targets in the body as intended. For IPF research, bronchoalveolar lavage (BAL) is a procedure by which fluid from deep within the lungs is collected to see whether the drug can be detected in sufficient concentration and whether it acts as planned on target cells. Normally a BAL is performed just before and just after the period of dosing with the study medication.
This article comments on the fact that patient selection and risk mitigation measures are very important in early-phase IPF research as there may be a small risk of serious adverse events (SAEs) following the repeat BAL procedure (which is not routinely employed in clinical practice, but only in research). While research is very important and needs to continue for deadly conditions such as IPF, researchers need to carefully explain the risks involved to trial participants, while monitoring for any indication of changes in health status that may increase the risk while on the trial.