Sunday, October 25, 2009

GxP: a collection of quality guidelines in clinical trial


GxP is now used to represent a collection of quality guidelines in clinical trial. The titles of these good practice guidelines usually begin with "Good" and end in "Practice", with the specific practice descriptor in between. A "c" or "C" (stands for 'current') is sometimes added to the front of the acroynm to form cGxP. For example, cGMP is an acronym for "current Good Manufacturing Practices."

Professionals who are working in the pharmaceutical or biotechnology industry should be very familiar with three common GxPs: GCP, GMP, and GLP.

GCP: Good Clinical Practices is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. The GCP is governed by ICG guideline E6. To learn more about GCP, watch the GCP 101: An introduction at FDA website.

GLP: Good Laboratory Practice. Refer to Wikipedia for detail. GLP is the guidance for laboratory tests, pre-clinical tests, bioanalytical assays/measures, toxicology tests,...

cGMP: current Good Manufacturing Practice regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. FDA has many guidance on cGMP.

Recently, many other GxP terms have surfaced. It looks like that each functional area in clinical trial will have its own GxP. Below are some examples: GRP, GPP, GSP, and GCDMP.

GRP: Good Reprint Practices. In January 2009, FDA issued its final version of the guidance "Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices"

GPP: Good Pharmacovigilance Practices. In 2005, FDA issued its guidance on "Good Pharmacovigilance
Practices and Pharmacoepidemiologic Assessment
" to provide guidance on (1) safety signal identification, (2) pharmacoepidemiologic assessment and safety signal interpretation, and (3) pharmacovigilance plan development.

While GRP and GPP are proposed by the regulatory agencies, there is no officially issued guidance on GSP (Good Statistical Practices) and GCDMP (Good Clinical Data Management Practices). However, the principles of these two good practices have been largely covered in ICH guidances, specifically, E9 (Statistical Principles for Clinical Trials) and E6 (Good Clinical Practice).

PSI Professional Standards Working Party developed a GUIDELINES FOR STANDARD OPERATING PROCEDURES for Good Statistical Practice in Clinical Research.

In several DIA presentations, Good Statistical Practices were said to include the following components:


  • Protocol – Minimize bias – Maximize precision
  • Analysis plan
  • Presentation of results
  • Leadership

Operational Processes

  • Controlled statistical environment
  • SOPs • Productivity tools
  • Data standards
  • Training

Credibility Results

  • Reproducible research
  • Transparent and efficient processes
  • Validated analysis
  • Data integrity assurance

The Good Clinical Data Management Practices (GCDMP) is developed by the SCDM (Society of Clinical Data Management). It provides assistance to clinical data managers in their implementation of high quality clincal data management processes and is used as a reference tool for clinical data managers when preparing for CDM training and education.


Anonymous said...

Oh, I thought GRP is Good Research Practice...

Anonymous said...

Hi Chunqin,

I am a physicist and would like to get into clinical trials and the statistics of trials. Do I need a certificate?


Web blog from Dr. Deng said...

to be a statistician, you will need a degree in statistics (not necessarily Ph.D).

The clinical trial is a very broad area. for some functional areas, you don't need a certificate as long as you can find someone to hire you for entering the clinical trial field.

Some universities and local community schools may offer one or two year programs for clinical trial certificate. For example, in research triangle area in North Carolina, Duke University, Campbell University, Durham Tech, Wake Tech offer courses/programs in clinical trial.

Darsan Clinica said...

Wow, really very great post. Its really very helpful for me. Thanks for sharing nice informative post. It is a good job...

stephenn richardsonn said...

I am very happy to find your post!!

currently I am getting good clinical Practice training from home.