Abstract: Oncology is one of the most complex and rapidly changing fields in medicine. Both practicing health care professionals (HCPs) and developers of clinical pathways require information about the latest developments in product-specific medical information in order to incorporate them into treatment practices and treatment pathways, respectively, to ensure the highest quality of care. Pharmaceutical companies that research, develop, and market new oncology medicines hold the most comprehensive and detailed information about their products. Medical information specialists (MIS) and medical science liaisons (MSLs) therefore play key roles within the pharmaceutical industry in providing HCPs with evidence-based medical information. The purpose of this article is to describe the role of the MIS and MSL in responding to requests from HCPs and clinical pathways developers for up-to-date, evidence-based product information to enable them to make informed decisions about patient care.
Received June 15, 2017; accepted July 13, 2017
Medical oncology is a rapidly changing field. As shown in Figure 1, there has been a significant increase in the number of Food and Drug Administration (FDA) approvals of oncology drugs over the past decade.1 The availability of new oncology medications fosters the continuous development of novel treatment approaches as well as improvements in oncology standards of care.2
At the same time, in the era of precision medicine, there is no such thing as a typical cancer patient or diagnosis. Patient-specific factors can result in inconsistent responses to therapy. To make informed decisions regarding patient care, health care professionals (HCPs) require the most up-to-date medical information on current cancer research and treatments. Incorporating the latest developments in product-specific medical information into treatment practices through clinical guidelines and treatment pathways is essential for improving the quality of care.3
Manufacturers hold the most comprehensive information about their drugs, and it is in their best interest to ensure that the most accurate clinical, scientific, and safety information is disclosed to allow HCPs to make well-informed decisions regarding treatment options for their patients. Pharmaceutical companies are obligated by regulatory agencies, such as the FDA, to provide accurate, balanced, unbiased, and nonmisleading responses to questions and inquiries from HCPs, patients, and other key stakeholders such as clinical pathway developers.4 For pharmaceutical companies, the ultimate goal of providing accurate product-specific and evidence-based medical information to HCPs is to optimize patient safety and treatment efficacy.4
To accomplish this, pharmaceutical companies employ medical professionals with a wide range of backgrounds (eg, medical doctors, pharmacists, nurses, nurse practitioners, and others) as medical information specialists (MIS) and field medical associates. For the latter, different companies use different titles, including medical science liaison (MSL), regional medical director, field medical director, and others. For the purposes of this article, we will use the term MSL to represent this role. These medical professionals are a vital part of Medical Information and Medical Affairs departments for communicating current, clinically relevant, evidence-based, product-specific information as a service in response to specific and unsolicited questions from HCPs.5
For oncology in particular, there has been an increase in the demand for drug-related medical information, as measured by the number of inquiries from HCPs and patients. Pfizer’s United States Medical Information data show that over the last 5 years, corresponding to new oncology drug launches, the number of annual inquiries significantly increased from 1118 in 2011 to 4842 in 2016 (Figure 2). HCPs are asking oncology questions relating to safety, off-label uses, and stability/compatibility, as well as other topics (Figure 3). Given the growth in development and approval of novel oncology treatments, this trend is likely to continue.
In this article, we describe the role of medical information professionals working within pharmaceutical companies in responding to requests for medical information. We also describe the process for providing up-to-date, evidence-based product information to HCPs and clinical pathways developers, enabling them to make informed decisions about patient care.
Responding to Medical Information Requests
Medical Affairs departments maintain in-depth information regarding clinical trial data and product or investigational drug-related medical information. Highly knowledgeable about product information, MIS and field medical associates such as MSLs accurately and clearly relay unbiased scientific and medical data gathered in industry-sponsored trials related to their products. Because product labels and established treatment guidelines do not always provide the most current information about a drug, data from clinical study reports and peer-reviewed publications accessed by Medical Affairs may be able to address questions related to appropriate options for patients with concomitant disease, or other factors that make utilization of established guidelines difficult.5,6
Medical Information departments hold extensive data known as data on file (DOF) on each drug and can exercise critical search skills to obtain additional relevant data if available. Because not all data collected in clinical studies, or through pharmacovigilance, are published, DOF are retained, and may be useful for addressing specific requests from HCPs. The DOF include clinical trial data, safety data collected since FDA approval, and pharmacoeconomic data.5,6
MSLs interface directly with HCPs to answer their product-related or research-related questions, as well as understand unmet needs for treating specific diseases and to discuss product-specific data that is currently available or is being collected in ongoing clinical trials. In many cases, MSLs have other responsibilities as well, such as supporting certain aspects of company-sponsored clinical studies and background information needs for investigator-initiated research. MSLs may be contacted directly by HCPs to request a meeting, speak by phone, or obtain information by email. In certain cases, such as important new product safety updates and other new clinical data consistent with the approved product label, MSLs may proactively contact HCPs. Response times are typically within 12 to 24 hours, however, timing may depend on the nature of the information being requested, and the need to obtain input from subject matter experts within the company.
MSLs adhere to strict guidelines when addressing requests for product-related information that is not consistent with the approved indication for that product, and only in response to a HCPs request for information.4,5 Typical examples of inquiries received from HCPs regarding off-label information for an approved drug include data pertaining to use in a different cancer type, age group; use in a different formulation, dose, or schedule. Providing data on compounds still in clinical development only occurs at the request of HCPs. When it comes to therapy decisions for specific patients, employees of a pharmaceutical company cannot provide medical advice on patient care.
Information Requests for Clinical Pathway Development
In recent years, there has been an evolution, as well as an increase, in the development and use of clinical pathways in oncology as a tool to standardize cancer care while adhering to evidence-based protocols for optimizing safety, efficacy, and reducing overall cost of care.7-9 One of the challenges in maintaining clinical pathways for cancer treatment involves reviewing new evidence as it emerges and revisiting past evidence in light of emerging efficacy and safety data.
Oncology pathway developers and formulary committee members can submit unsolicited medical requests (UMRs) to companies that manufacture specific drugs that are indicated for a specific disease to obtain the most current information on those products. Information may be requested along with specific criteria; for example, new evidence related to a given product or set of products used for a certain disease. Questions can include safety concerns, dosing options, alternate doses/schedules, and concerns related to concomitant medications.
In order to support the development of clinical pathways, Pfizer Oncology in the United States has developed an approach in which MIS and MSLs work in tandem to support the product-related informational needs of clinical oncology experts and members of cancer clinical pathway committees (Figure 4). MSLs are able to work directly with medical contacts in organizations involved in pathway development to clarify the specific information requested, in order to provide it in a timely manner. The MSL also determines whether there is any required format or process on the part of the pathway organization for fulfilling the request. The MSL then works closely with the Medical Information team and other internal subject matter experts as needed to determine the information that best addresses the request. Request from HCPs and pathway developers to speak with an MSL can be directed to Medical Information by phone or using a brief online form.
Pfizer’s Medical Information department develops standard as well as customized scientific response documents outlining the specific categories of data available to address inquiries (Table 1). Information is delivered in an organized and detailed manner with referenced sources.4,5 The process Pfizer Oncology uses to respond to UMRs allows clinical pathway organizations to obtain the most accurate, current, and clinically relevant product information for each product.
Conclusion
The collaborative efforts of pharmaceutical company MSLs and MIS provide balanced and unbiased evidence-based drug information. Health care organizations and HCPs can request customized evidence-based medical information from pharmaceutical companies by contacting medical information services and engaging with MSLs. Drug-related medical inquiries can be answered based on all available evidence, saving time and resources for health care teams caring for patients.
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The authors wish to thank Kathy Bucci, Alicia Cadogan, Diana Giorgio, Andrew Kennedy, and Ronit Simantov for their support and review of this manuscript. The authors would also like to thank the Pfizer Works studio, which provided graphic design support. The authors contributed equally to the development of this manuscript.
References
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