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.

Sunday, October 18, 2009

Biostatistics conferences/workshops

When I started my career in biostatistics, I joined the American Statistical Association (ASA) and attended its annual meeting (Joint Statistical Meeting) rotated in different large cities in North America (US and Canada). I have enjoyed the atmoshpere of the conference and networked with friends and professors in the statistical field.

For two consective years, I have skipped the meeting. Instead, I attended the FDA/Industry Statistical Workshop. JSM may be good to the students, but may not be good for professions (especially for statisticians who are working in drug development area). JSM has a lot of sessions/presentions that are unfiltered and too theoretic. A lot of stuff may never have the value in application. Even though it may be applicable one day, it may not be acceptable to the regulatory agencies.

The statistical conferences, symposiums, workshops with focus on clinical trial and drug development have thrived in recent years. Twice a year, FDA holds its workshops: one with Drug InformationAssociation "FDA/industry statistical forum" and one with ASA "FDA/industry statistical workhop". These conferences are more specific to the biopharmaceutical field and the topics are more relevant to the daily work of biostatisticians.

There are also several societies with focus on biostatics, for example, the International Society for Biopharmaceutical Statistics (ISBS) and the International Society for Clinical Statistics (ISCS). The International Chinese Statistical Association (ICSA) is also adjusting its focus to the biopharmaceutical field. Within ASA, biopharmaceutical network has been formed.

To get a flavor of the topics in these meetings, see the following links:

Sunday, October 04, 2009

Positive Psychology - science to find happiness

When I see a news headline about "what is the most popular course in the Harvard University?", my curiosity drives me to find out what the course is. This leads me to the concept of "Positive Psychology". The most popular class is the Psychology 1504 (ie, positive psychology) taught by Dr. Ben-Shahar.

As mentioned in NPR news, "almost every semester for the past ten years, the most popular class at Harvard has been Intro to Economics, or as Tal Ben-Shahar likes to call it, how to get rich, but today there's an even bigger class on campus. It's Ben-Shahar's course on what he calls, how to get happy."

According to Wikipedia, Positive psychology is a recent branch of psychology that "studies the strengths and virtues that enable individuals and communities to thrive". Positive psychologists seek "to find and nurture genius and talent", and "to make normal life more fulfilling", not simply to treat mental illness. In other words, the positive psychology deals with love, happiness, job satisfaction, ...

In contrary to the Positive psychology, there should be a concept of negative psychology. However, even though the current psychology is so focused on the negative side (depression, fear, anxiety, mental illness,...), there is no formal definition of negative psychology.

Further readings about the negative psychology:

Unlike the negative psychology which belongs to the medical science, the positive psychology has its applications in corporate business. It could be used to promote the positive culture, attitudes, employee's job satisfaction,...

However, there is also negative side about the positive psychology. See Dr. BARBARA S.HELD's argument.

In practice, Positive psychology encompass a variety of techniques that encourage people to identify and further develop their own positive emotions, experiences, and character traits. In many ways, positive psychology builds on key tenets of humanistic psychology. Whether or not the positive psychology techniques work will eventually rely on the evidence from the clinical trials. Since the psychology measures are typically intangible, how to design a trial or intervention, what to measure, how long to measure, what instrument to use,... could be challenging even more than the typically psychology measures (with the focus on disease or negative psychology). The following paper discussed this issue.