Mistakes In Clinical Trials


Mistakes In Clinical Trials  

Mistakes in clinical trial although not common but has raised concern after few repeated incidents that had occurred in the near past. Safety is a paramount importance for any clinical trial study. The responsibility of such an important aspect does not lie on a single department. This responsibility is being shared mutually between the sponsor of the trial, the local site investigator, and the different institutional review boards. Sometimes, even  the regulatory agencies of the country where a particular medicine or the device will be marketed are involved.

The reason behind this widespread sharing is that the trials go through the eyes of many and hence, is liable to prove it efficient and safe.

The primary tasks of the different institutional boards are to investigate the medical safety and ensure protection of the participants who take part in the clinical trials. If required, they may ask the medical research firm to carry out necessary changes in the procedures. The investigators have to submit yearly review report to keep the IRB informed about the progress achieved regarding the study and the safety norms connected with the study.

In March 2006, in the UK, a drug named as TGN1412 resulted in multiple organ failure in the individuals who received the drugs during the first human trial session. Again in April 2010, Pfizer was warned by the US FDA to end their clinical trials of an antipsychotic drug named Geodon. This trial affected a minimum of 13 children who were administered overdose and the pharmaceutical company failed to ensure correct monitoring and detection of the overdose.

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Statistical-Analysis-Plan-For-Clinical-Trials      Statistical Analysis Plan (SAP) is a distinct section in a clinical research study which is approved prior to the commencement of the research. The scope of a SAP is to take an account of the details of the planned statistical analysis which are linked to any clinical research. An analysis is designed taking into consideration the desired job results and has to be conducted in a steady manner. More..


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