ASA-Statistical Consulting
Session Slot: 10:30-12:20 Wednesday
Estimated Audience Size: 100-125
AudioVisual Request: One Overhead and One Slide Projector
Session Title: The Client*Consultant Interaction in the Pharmaceutical
Industry
Theme Session: No
Applied Session: Yes
Session Organizer: Boyd, Michael N. Pharmaceutical Research Associates, Inc.
Address: Pharmaceutical Research Associates. Inc. 2400 Old Ivy Rd. Charlottesville, VA 22903-4826
Phone: 804-977-2772
Fax: 804-293-7084
Email: mike@pra-ww.com
Session Timing: 110 minutes total (Sorry about format):
Opening Remarks by Chair - 5 minutes First Speaker - 25 minutes Second Speaker - 25 minutes Third Speaker - 25 minutes Discussant - 20 minutes Floor Discusion - 10 minutes
Session Chair: Boyd, Michael N. Pharmaceutical Research Associates, Inc.
Address: Pharmaceutical Research Associates, Inc. 2400 Old Ivy Rd. Charlottesville, VA 22903-4826
Phone: 804-977-2772
Fax: 804-293-7084
Email: mike@pra-ww.com
1. Statistical Consulting in a Major Pharmaceutical Firm
Liddle, Roger F., Glaxo Wellcome, Inc.
Address: Director, US Clinical Statistics Glaxo Wellcome, Inc. P.O. Box 13358 5 Moore Dr. Research Triangle Park, NC 27709
Phone: 919-483-5375
Fax: 919-483-6357
Email: liddle-rf@glaxowellcome.com
McSorley, Ellen, Glaxo Wellcome, Inc.
Abstract: The clinical statistician has a critical and well-defined role in the drug development process. Members of the internal drug development team from clinical, regulatory, planning and writing represent one set of clients. Regulatory authorities and the medical community are also clients, and interaction and communication are quite different in this setting. Opportunities to broaden the current role of the clinical statistician will be presented. Comparisons will be made to other opportunities for a consulting statistician.Another role for the pharmaceutical statistician occurs when statistical analysis is contracted out and the consulting statistician becomes the client. Various models for contracting out statistical work will impact the client/consultant relationship, but communication is the critical success factor in all of them.
A large pharmaceutical firm also holds interesting challenges for the pre-clinical and non-clinical statistician. With problems ranging from research to manufacturing, there are numerous opportunities for the consulting statistician to add value. Examples will be presented.
2. Interaction between the Client and Consultant in the Data Management, Analysis, and Reporting of Clinical Trial Data
Flora, Roger E., Pharmaceutical Research Associates, Inc.
Address: Pharmaceutical Research Associates, Inc. 2400 Old Ivy Rd. Charlottesville, VA 22903-4826
Phone: 804-961-2183
Fax: 804-293-7084
Email: floraroger@pra-ww.com
Abstract: In the pharmaceutical industry, consultants and consulting organizations are being used more and more to provide the necessary data management and statistical services for accomplishing drug development. Services that may be required by a client cover a broad spectrum, and the specific needs must be communicated. Methods of analysis and the presentation of results for a given trial or drug development program can vary and require decisions to be made at various stages of the analysis and reporting process. Specific requirements in this regard, and the level of decision-making authority to be assigned to the consultant or organization providing the services, must be clearly delineated. Finally, both parties are responsible for certain activities in the process, and careful coordination of these activities is required in order to meet timelines and to provide a well-integrated final product.The key to a successful client-consultant interaction in accomplishing the required tasks is good communication throughout the process. This presentation will address steps that can be taken by both the client and the consultant to ensure that the interaction required for the successful completion of a project occurs. Specific experiences will be used to illustrate the ideas presented.
3. An FDA Reviewer's Perspective of the Client-Consultant Interaction in the Pharmaceutical Industry
Kammerman, Lisa A., US Food and Drug Administration
Address: Division of Biometrics II (HFD-715 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857
Phone: 301-827-4257
Fax: 301-827-4264
Email: kammerman@cder.fda.gov
Abstract: From my perspective as an FDA statistical reviewer, consultants to the pharmaceutical industry are primarily university faculty, independent consultants, and members of CROs. Their familiarity with the regulatory process and requirements is wide-ranging. Consultants provide support in two general areas: (1) the regulatory process from the development of INDs through the submission of NDAs and (2) the development of statistical methodology for the design and analysis of clinical studies.For each of these areas, I will discuss the impact of the background of the consultants and their familiarity with the regulatory process on the success, from my perspective, of the client-consultant interaction. A common theme to a successful outcome is the consultant's knowledge of the drug class, indication, and regulatory requirements. Additionally, in the case of an NDA submission, the consultant's knowledge of the database is crucial.
Discussant: Koch, Gary G. University of North Carolina-Chapel Hill
Address: Department of Biostatistics McGavran-Greenberg, CB#7400 University of North Carolina Chapel Hill, NC 27599
Phone: 919-966-7282
Fax: 919-966-3804
Email:
List of speakers who are nonmembers: None