By Dana Randall, PharmD and Kevin D. Pawley Academic scientists share a mantra: “Publish or perish.” The cornerstone of the scientific process—and the accurate record of it—is peer-review publication of studies in scientific journals. Without publications in such reputable journals, flawed studies and their results may gain impact and real scientific advances may be lost. The continual practice of holding scientific developments up to peer review and documenting by publication the scientific process from concept through completion guarantees those continual developments. Similarly, publications in reputable peer-review medical journals guarantee continual development in the world of medicine. But in the world of medicine, lives may be at stake…making the rapid publication of important medical developments vital. Today’s highly regulated world creates challenges to rapid publication, but my tenet remains, Physicians like data, but they don’t like “data on file.” Thus, the challenge for pharmaceutical companies is to engage the peer-review and publication process efficiently or risk significant delays and roadblocks in a product’s reaching its full benefit and potential. To overcome that challenge—to engage the process efficiently—pharmaceutical companies regularly develop publication plans: planning and disseminating scientific and clinical data on a drug to healthcare professionals (HCPs) by presentation at medical congress/society meetings and publication in peer-review journals. Such planning accounts for a number of variables affecting:
1. Benefit to your product by maximizing the reach and clarity of your clinical data. Plainly stated, clinical data define a product—its use, dosage, benefits, risks, appropriate patient selection…it is the heart and soul of a product. It underwrites the new drug application; it defines clinical use; it creates perceived value. Thus how the drug is introduced, used, and perceived will be based (certainly at launch) on the quality, scope, and scale of the published clinical data. It falls to the owners of the data to create a plan for comprehensive and cohesive disclosure of data to those who need it most—prescribing clinicians. But publication also satisfies legal, ethical, and industry obligations:
2. Benefit to the market by placing your product “in context” within the current therapeutic area. Development of a publication plan is a process of thorough analysis of existing literature about the full therapeutic area, the disease and its diagnosis, as well as treatment options and practices. Additionally, an important element of the process is a “gap” analysis—finding things that aren’t yet well-defined, finding gaps where new clinical data or expanded expert opinion may enhance clinical understanding and practice. If a product is first-in-class, a comprehensive publication plan is particularly important, for example, to introduce a new mechanism of action or define where the drug fits in the clinical picture: Will it be used as a first-line agent? Second-line agent? Concomitant with other drugs? After other therapies fail? Publication of new clinical data expands the existing literature and expands the foundation of evidence-based decision-making. Timely publication of clinical data positions your product to be included in new or updated treatment guidelines. Planned publications that account for the full context of a therapeutic area—diagnosis and treatment—can help place your product in a clearly defined position at launch. 3. Benefit to prescribing HCPs by fostering consistent delivery of scientific communication points across all media. By planning and carefully executing publications, a consistent scientific foundation is established to support the product—consistent language describing mechanism of action, product features, and clinical efficacy and safety. This published body of evidence supports all future product communications, from press releases to promotional materials to patient- and HCP-education materials. 4. Benefit to all members of the product development team with a systematic dissemination of all data. A publication plan provides a roadmap and systematic approach to data dissemination for all product stakeholders—drug discovery, clinical development, health economics and outcomes research (HEOR), regulatory affairs. Naturally, each aspect of drug development contributes to the product’s comprehensive profile and clinical use. Publication planning keeps everyone aware, coordinated, and consistent throughout the life of the product. 5. Benefit to all members of the treatment team by delivering key data to key audiences…who needs to hear what and when. A publication plan should address the varying information needs of HCPs across the spectrum of care—specialist and general physicians, nurses, nurse practitioners, physician assistants. Different audiences may need to understand preclinical data versus clinical trial data versus HEOR data. For products with multiple indications, the publication plan should target multiple specialties or multiple types of prescribers; for other products, specialists may be the chief prescribers and thus the main audience; but primary care physicians and allied health professionals need appropriate information, too. 6. Benefit to regulatory bodies and payors by providing clinical context for safety and efficacy, establishing evidence-based value for a product. In a single peer-reviewed publication, authors provide a clinical context and a rational for the trial, and the clinical significance of results. But with today’s escalating healthcare costs and growing demands to control them, regulatory bodies and payors compile data across published studies to establish an evidence-based “value” of a product (ie, AMCP Dossier, Global Value Dossier). A publication plan coordinated across clinical trials ensures a peer-reviewed source for establishing a product’s value in the context of existing medical literature and usual clinical practice. 7. Benefit to the patient by clarifying and addressing all issues that may affect acceptance and appropriate use—even optimal use—of the product. Clinical trial-based data form the core of a publication plan, but additional types of publications may enhance acceptance of your product and directly benefit patients’ understanding of their therapy, ie, a publication describing how an injectable’s unique delivery system improves medication adherence compared with existing delivery systems. HEOR data are increasingly important for acceptance of a new agent in a crowded market, ie, a cost-effectiveness analysis that demonstrates a lower annual cost of your product compared with a well-established competitor or long-term outcomes data demonstrating a reduction in hospitalizations or improved quality of life among patients receiving your product versus a competitor. After a product has been on the market, feedback from the field (eg, medical science liaisons, sales representatives) may inform additional analyses and publications that could provide prescribers with additional patient-centric data. 8. Benefit to the world of medical science by advancing and enriching peer-reviewed medical literature. The peer-reviewed publication process serves a medical/scientific need to validate the data within the medical/scientific community. The medical literature included in PubMed (the US National Library of Medicine and National Institutes of Health online library), includes more than 27 million studies—a phenomenal collection of the progress of mankind’s knowledge and understanding. Where once many illnesses had no name, now they are well-defined and treatable, even curable. Where once disease processes and treatment mechanisms were unknown, now they are clearly understood. For example, over the decades the discussion of autoimmune diseases has moved from inflammation to immune response, from anti-inflammatories to immunomodulation and biologics. Effective publication planning creates a path for advancing and enriching our knowledge. Publications and the publication plan are the core of a pharmaceutical product’s entry to the market and to its acceptance in clinical practice. Thus, publication planning should begin early in the product life cycle, anticipate change, and be adaptable as additional data become available and as the market evolves…because the goal is to provide benefits across the spectrum.
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