GUIDELINES FOR STANDARD OPERATING PROCEDURES

for Good Statistical Practice in Clinical Research

Written by: PSI Professional Standards Working Party


INTRODUCTION

Professional codes of conduct for statisticians, such as those published by the Royal Statistical Society, stress general principles including the need for professional integrity, a primary concern for the public interest and the preservation of professional standards. However, there is a need for more detailed guidance in specific disciplines. Therefore, the PSI “Professional Standards Working Party” set out to provide guidance for the preparation of Standard Operating Procedures (SOPs) for Good Statistical Practice in clinical research.

The development of Guidelines for Standard Operating Procedures (GSOPs) appeared to be a natural step in the process of encouraging and publicising Good Statistical Practice in the analysis and reporting of clinical trial data. In preparing these GSOPs, the objectives of PSI are:

• to ensure that statisticians in the pharmaceutical industry are aware of the principles contained in published codes of conduct
• to provide guidance to encourage adherence to these principles in the application of statistics to clinical trials
• to publicise the principles of Good Statistical Practice for clinical research to other professionals, internal and external to the pharmaceutical industry
• to provide guidance in the preparation of SOPs to ensure compliance with the requirements of international Good Clinical Practice so as to satisfy regulatory requirements with respect to the collection, processing, analysis and reporting of clinical trial data.

The many varied roles statisticians fulfil within the pharmaceutical industry and related organisations (e.g. academic institutions and Contract Research Organisations (CROs)) preclude writing a definitive set of SOPs for all PSI members. Hence the decision was taken to develop GSOPs which would give detailed statements of the principles of Good Statistical Practice within the context of clinical research (thus building on the existing codes of conduct), but which would require that statisticians develop the guidelines into SOPs specific to their own organisations. Conversion of these GSOPs into SOPs appropriate for a specific organisation requires expertise. Care should be taken that the level of responsibility given to statisticians is appropriate to the level and depth of statistical expertise within the organisation. The adaptation of the GSOPs into working SOPs should be carried out to reflect the structure and expertise of the organisation.

The GSOPs address the most common requirements of statisticians practising in the field of clinical research. The areas covered are not exhaustive. In some organisations it will be appropriate to combine some of the guidelines into one SOP or to divide other guidelines into several SOPs.

The manner in which procedures are implemented is as important as the procedures themselves if the procedures are to be effective within the structure of a particular organisation. SOPs which are properly implemented as part of an overall quality system not only improve the quality of the service or product but also improve the productivity and efficiency of the process. For example, good trial design and good case report form design can greatly improve the quality of the data collected in a clinical trial.

The PSI “Professional Standards Working Party” was set up in May 1990 and was responsible for developing 11 of the following GSOPs over a period of approximately 18 months. The development process included input from many members of PSI through written comments and workshop discussion sessions. The development process has continued since then with reviews and revisions of existing GSOPs, as well as the preparation of new GSOPs. This review process takes place over a two-yearly cycle, and is the responsibility of the PSI Public Affairs Sub-Committee.

The GSOPs and the Royal Statistical Society Code of Conduct are now augmented by other relevant documents such as the International Conference on Harmonisation (ICH) documents on Clinical Study Reports and Statistical Principles for Clinical Trials and the Association for Clinical Data Management (ACDM) Guidelines for Writing Standard Operating Procedures.

For detailed of this guideline please see the below source for more details

Source:

http://www.psiweb.org/docs/gsop.pdf and

http://www.uk-legislation.hmso.gov.uk/si/si2004/20041031.htm

Shire selects SAS® Drug Development to Handle Clinical Trials Data

CARY, NC (Jun. 22, 2009) – SAS, the leader in business analytics, today announced that Shire, the global specialty biopharmaceutical company, has selected SAS® Drug Development as the platform for its clinical trials data.

“Shire is excited about our partnership with SAS, and we look forward to leveraging the SAS Drug Development platform to manage our clinical trial data,” said Nick Ronca, Associate Director Clinical R&D, Shire Pharmaceuticals.

SAS Drug Development is available as a standalone or hosted solution with access via a secure, thin client. A centralized repository allows life sciences firms to aggregate, analyze and review clinical trials data to determine safety and efficacy outcomes.

“Our approach at SAS allows our customers, like Shire, to be more focused and efficient in developing and delivering medicines to patients and their families around the world,” said Jason Burke, Global Director of Health and Life Sciences for SAS.

21 CFR and CDISC Compliant
SAS Drug Development allows rapid and reliable validation and implementation, eliminating strain on limited IT infrastructure and resources. The solution is compliant with global agency regulations, such as 21 CFR Part 11, which is often difficult to attain.

“Our hosted global environment contains a single view of the targeted clinical data in a secured and qualified environment so scientists, programmers and statisticians can view the most up-to-date, accurate information” said Burke.

SAS’ scalability and flexibility were features important to Shire, which has grown rapidly through acquisitions and mergers over its nearly twenty-five year history. Shire, which has a presence in 23 countries and markets medicines in more than 45 countries, needed a global solution for managing and processing its clinical trial data.

“Working in unison with SAS allows Shire to focus on meeting its mission, and investing in its product portfolio instead of developing a complex IT infrastructure to support clinical data,” said Burke.

SAS Implementation Team
Relying on the SAS Consulting Group that has successfully deployed SAS Drug Development in the past, Shire believes that the system will maximize the best practices of both Shire and SAS. SAS is demonstrating SAS Drug Development at the DIA 45th Annual Meeting in Booth 301.

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