New drugs and clinical trials rules 2019: Changes in responsibilities of the ethics committee.

The New drugs and Clinical trials rules 2019 (New rules) was introduced on 19 March 2019 by Government of India. New rules have set specific requirements for ethics committee (EC). The EC is required to follow requirements set as per New rules and to forward their report to Central Licensing Authority (CLA).

Practical challenges in conducting respiratory studies.

Respiratory studies are complex on account of specific therapeutic knowledge that is needed and various instruments that are used for the management of this condition. Monitoring a respiratory study requires knowledge of the specific disease and associated guidelines. The intent of this article is to help clinical research professionals understand the technicalities, challenges, and the nuances of performing respiratory studies.