- According to a study on the running of clinical trials in US between 2005 and 2012 conducted by Mumbai-based researchers:
- The most common concerns raised by the FDA to lead researchers were:
- Failure to stick to the stated plan for investigation (95%).
- Failure to protect the safety of trial participants, including the reporting of side-effects (55%).
- Poor record keeping (40%).
- 80% of these related to drug trials.
- Most common concerns raised among clinical trial sponsors:
- Failure to monitor progress as per the stated schedule (58%).
- Failure to obtain agreement of the principal investigator (35%).
- 1 in 4 of these warnings related to drug trials, the rest related to devices.
- Institutional boards were mainly warned over the failure to follow standard operating procedures and inadequate record keeping.
- In comparison to the results obtained in 1997, regulatory compliance had generally improved but supervision has worsened.
- To protect human rights, wellbeing and safety and to increase awareness of ethical behavior, fair and appropriate procedures for handling violations during clinical trials need to be developed.
- Read at:http://www.thehindu.com/todays-paper/tp-features/tp-sci-tech-and-agri/failure-in-patient-safety-common-in-us-clinical-trials/article6218813.ece