Data Management and the Publication Plan

   The approach to publication review, data analyses, data storage and information development can vary widely among industry professionals.  Additionally, this information can be used to assist in establishing curriculum for educational programs  – this can be possible through the subsequent analyses and identification of clinical gaps, scientific gaps, and knowledge gaps throughout the referenced material.  This process of collection and analysis of data leads to a standardized approach toward data management and knowledge transformation techniques within a MSL group, which in turn can evolve into best practices.    

A company should hosts a vast repository of data and information  - this database should include trends established within the field that have been formulated over the last several years. Some current system of data management and transformation relies almost entirely on manual means of analysis and trend identification: it also relies significantly upon individual MSL team member’s memories and recollections of historic and stored data when tasked to perform information queries. Although these techniques were once effective, the inability to effectively query data electronically, coupled with the continuous growth of stored information has expanded beyond the ability to effectively and efficiently derive deliverable knowledge in a timely manner. As such, effective data-mining and data triangulation are becoming less effective and labor intensive. A well-formulated data collection and transformation process should include steps that develop data and information into actionable knowledge – actionable knowledge that is both easily accessible, easily maintained, and robust enough to support continuous input and output requirements.    

A MSL team should have the ability to collect, store, data-mine, triangulate, and transform increasing amounts of raw data and information into actionable knowledge that will support the MSL team’s tasking, the MSL team’s stakeholder requirements, and improve utility. Second, and subsequent to the initial information management system project, the MSL team should put in place a Publication Plan. The primary goal of the publication plan, which is the recognized steps for information gathering and analysis, is to formalize and add transparency to data gathered by the MSL and share this scientific information in a professional way for publication.

Objective  

The objectives of the following sections are to further develop and identify the concepts surrounding the purpose of the envisioned Information Management System; to highlight the processes and requirements utilized in developing MSL data; and to further identify the framework for the proposed MSL Publication Plan.  

Purpose of an Upgraded MSL Information Management System  

The purpose of an Information Management System is to more effectively and efficiently enable the MSL team to collect, store and develop data and information into useable and transferable knowledge. It is my belief that developing leading-edge knowledge from the plethora of professional documents, articles, and scientific studies from around the world will place a company in the forefront of our professional communities and in front of our peer competitors. The information garnered from a robust information management platform will also enable the MSL and the MSL team to:

• More accurately identify and keep abreast of the state of the scientific landscape now and into the future through the use of computerized analyses and triangulation of data,
• Consider unanswered scientific questions from the scientific/medical community and suggest publications that may be able to assist in answering those scientific questions,
• Address unmet medical needs for particular disease states and specialties,

• Develop a Publication Plan that outlines the processes and sets the framework for the management of data within a company Library,
• More efficiently and effectively utilize MLS personnel. 

   A refined modern information management system will provide a more robust infrastructure for data storage and analysis and provide a means for the timely output of information from larger and more complex data sets. This would be a more scientific approach to data analyses and provide a laser-focus on specific areas of information and knowledge while also facilitating gap identification and analysis.

Gap Analysis  

The MSL team concentrates on the disease states within the therapeutic arena.  We currently characterize how topics are addressed through public literature, congress proceedings, and other communications both in terms of breadth and depth. Gaps are defined and identified as areas that are either not covered, or not covered in sufficient depth.  

We strive to identify unaddressed issues in literature, which may represent educational opportunities and needs requirements for the medical community – it also include identifying medical and scientific communication needs and deficiencies. Data gathered and analyzed by the MSL team provides the company with information required to achieve mission critical tasks and meet organizational goals. We utilize the term gap analysis to describe the process of refining and transforming data and revealing information. A modern computerized information management system could more effectively accomplish this task, and more efficiently:

• Identify information or data gaps within existing data sets as well as in the published literature regarding a particular product or disease state,
• Identify bona fide scientific and medical needs supported by adequate data that when addressed, advance the field of medical knowledge,
• Enable more precise assessments that could be routinely completed every 12-months.    The following gap analysis methods and their output would also be enhanced through a modernized information system and become integral to the workings of a publication plan: 

External Gap Analysis:–– Used to identify informational or data gaps within the existing published literature for a particular product and its competitors, therapeutic arena, or general disease state,–– Used to provide additional insight to unanswered scientific questions regarding a product or disease state.

1. Internal Gap Analysis:

–– Used to identify gaps in a current body of data that would be helpful to answer any identified unanswered scientific questions regarding a product or disease state,–– Used to determine if there are any completed analyses or potential post hoc analyses that may be helpful for identifying further insights to unanswered scientific questions.

1. Publication Gap Analysis:

---- Used to identify key topics and educational areas related to therapeutic areas, indications, and disease states.Proposed Publication Plan   The Publication Plan is simply a formalized methodology used by the MSL team to facilitate their work and to better contribute to, and collaborate with, other departments within the organization.   The publication plan (or process) will facilitate the transparency of information gathered and the knowledge gained and warehoused by the MSLs within a company. Contributions and collaborations within this company will be required – with the potential output to be shared.Contributors to the Publication PlanThe key collaborators to the publication planning process include:

• MSLs,
• Clinical Affairs,
• Research and Development,
• Legal,
• Regulatory Affairs. 

Publication Gap Analyses    Publication gap analyses is comprised of a multitude of individual publication reviews with each review focusing on identifying and compiling data on recognized information sets (key areas of interest) and topic areas. The areas and information included in a publication gap analysis include, but are not limited to:

• Therapeutic Indication,
• Publications by volume and quantity,
• Audience type (Physicians, Nurses, Pharmacists),
• Types of articles (primary data, reviews, case studies, guidelines),
• Quality of data based on strength and evidence,
• Profiles of publications and presentations over time,
• Types of Journals or Congresses,
• Ongoing clinical trials (clinical trials.gov).

    Areas and information not included in a publication gap analysis include:

• Marketing related data literature,
• Advisory Board input,
• Decision resource report.

Conclusions: The publication planning guidance document would provide a practical, yet specific framework for how a publication professional at a Medical Device Company should approach the development of, and update processes for, a publication plan. This database would be beneficial to the MSL team, Clinical Affairs and the company for a clear execution and education strategy based on up-to-date information. References

1. Office of the Inspector General, US Department of Health and Human Services. 2012. http://oig.hhs.gov/compliance/corporate-integrity-agreements/cia-documents.asp. Accessed 02 March 2012.
2. Babcock T Kendall J, Rains C. Corporate Integrity Agreements 2007-2011. 8th Annual Meeting of the International Society for Medical Publication Professionals; Baltimore, MD, April 23-25, 2012.