Best Practices for Medical Information Global Response Documents from phactMI and MILE

Abstract

Medical information departments within pharmaceutical companies play a critical role in addressing unsolicited healthcare professionals’ inquires with accurate, evidence-based, and balanced medical information through scientific response documents. Global response documents (GRDs) aim to harmonize information between global and local teams and the end product, the scientific response document. To address the challenges associated with the development and maintenance of global response documents and this harmonization, phactMI and Medical Information Leaders Europe (MILE) convened an international expert panel representing 11 major pharmaceutical companies. Over months of discussion and deliberation, the panel developed consensus-based best practices for the creation and management of global response documents. The experts contributed nuanced insights regarding optimal document structure and format that consider various stakeholders while maintaining medical accuracy. Consensus was achieved via a structured survey with a 75% approval threshold for each best practice. Overall, GRDs are essential tools for pharmaceutical companies, offering accurate evidence-based responses to healthcare professionals. While companies may respond to patient inquiries as well in different formats (verbal vs written), GRDs are exclusively intended for healthcare professionals currently. Best practices for GRD development include: being focused on a single topic, developed in a label-agnostic manner, utilize the most robust scientific information available, developed up to 12–15 months prior to launch, have regular feedback in a structured approach from local teams, follow internal guidelines and work instructions, and be peer reviewed internally whenever new data are added. In addition, local response documents or scientific response documents should be based on a GRD that is localized with appropriate documentation. Overall, GRD development is a collaborative and innovative approach (including interactive formats), supported by defined metrics (including response time) and ongoing updates to ensure global relevance and compliance.

Key Points

Global response documents are vital tools for medical information teams, offering accurate evidence-based responses to healthcare professionals.

Global response documents should be label agnostic and adaptable to local regulations, incorporating relevant disclaimers and studies.

Using engaging formats and tracking performance metrics ensures global response documents remain effective, relevant, and responsive to evolving needs.

Introduction

Medical information departments at pharmaceutical companies receive unsolicited queries from healthcare professionals (HCPs) covering a range of topics including efficacy, safety, dosing/administration, drug interactions, pharmacodynamics/pharmacokinetics, storage/stability, and use in special populations. It is the responsibility of the medical information department to respond to the HCP queries by providing scientifically accurate, evidence-based, current, non-promotional, fair, and balanced responses. These HCP responses are based on scientific content summarized within a scientific response document (SRD). These SRDs must align to internal procedures and policies as well as meet regulatory requirements [1]. In 2019, phactMI™, a non-profit consortium of medical information leaders from the pharmaceutical industry, published suggested best-practice guidelines for SRDs [1].

Over 60% of medical information departments have global responsibilities [2]. The global medical information team assists and supports local medical information teams to ensure consistent and complete responses [3]. Local teams can focus on a country or region and be called local, regional, or affiliate. This article uses these terms interchangeably, referring to them as local medical information. Global and local medical information teams need to collaborate and harmonize their methods of working, enabling them to become more efficient and provide timely and consistent responses to HCPs. Global medical information is responsible for guiding the creation of global response documents (GRDs) to ensure consistent messaging regarding safe and effective product usage and are exclusively intended for HCPs. The localized version of a GRD is an SRD. Developing actionable GRD best practices can improve document creation efficiency and output quality.

Although inclusivity was a goal, the authors recognize that companies differ in their structure and processes, and not every best practice will fit. Medical information specialists, as the team who develops content for GRDs, must have advanced scientific and medical degrees with advanced skills for medical writing, biostatistics, and content development. This expertise includes foundational knowledge of medical writing and the scholarly process, including copyright. Additional discussion on personnel expertise is out of scope for this article. phactMI and Medical Information Leaders in Europe (MILE) are dedicated to supporting HCPs by ensuring the safe and effective use of products, enhancing patient quality of care, and providing accessible, accurate, and balanced medical information [4, 5]. This paper aims to provide actionable best practices for developing GRDs, enhancing collaboration between global and local medical information teams.

Panelist Selection

An international panel of GRD experts first convened in 2024. Panelists were selected based on company nomination, their expertise with GRD development, and leadership in global medical information. The panel include experts from 11 companies based on their experience with GRDs in medical information and diverse geographical and company backgrounds (Table 1). Nominating companies were members of phactMI and/or MILE. The panel met virtually over 12 months and addressed areas of best practices for GRDs based on their discussion. These included structure of work, localization (adapting GRDs for local use) and feedback (from HCP and local medical information teams), content and format of GRDs, procedures and process (developing, updating, translating, and quality review), and metrics and key performance indicators (KPIs) for GRDs (to evaluate utilization and impact). Panelists described their current or previous experiences for each section. De-identified summaries for each section were compiled with suggestions for best practices. To reach consensus for each best practice statement, panelists participated in an online 11-question survey assessing agreement, requiring a predefined threshold of 75% for each best practice [6]. Diamond et al. [6], in a systematic review of 100 studies, found that 75% agreement was the typical standard for consensus.

Table 1.

Expert panel demographics

Companies		Countries
Small	Ipsen Seagen	Germany Poland Switzerland USA
Midsize	Merck KGaA Gilead
Large	AbbVie Astellas Bayer Eli Lilly Johnson & Johnson Novartis Pfizer Sanofi

Company size based on 2022 revenue: small < $10 billion; midsize $10–28 billion; large > $28 billion

Best Practices

The following output is based on the discussion and consensus of the expert panel for the process of creating and localizing GRDs. Table 2 summarizes the best practice statements.

Table 2.

Best practices for GRDs

	Best practices
1.	GRDs should be focused on a single topic or multiple similar topics, allowing for easy localization
2.	GRDs should be developed in a label-agnostic manner
3.	Local medical information can base their responses (SRDs) on the GRD, typically removing the core data sheet or other label information and replacing it with the local label
4.	GRDs should include the best available information, starting with the published literature but may include DOF
5.	Global medical information should begin the development of GRDs 12–15 months prior to launch based on a list of topics addressing anticipated frequently asked questions, including mechanism of action and safety supplemented by expected topics with insights from local teams and business partners
6.	Localization entails the addition of local labels, disclaimers, relevant studies, as well as potentially the incorporation of local guidelines. Translation to the local language is a key localization step in many countries
7.	Localized responses warrant a local review; however, if only the local label and disclaimers were added, then a local review may not be necessary
8.	Feedback for GRD from local teams should be conducted on a regular basis and in a structured approach
9	Internal guidelines and work instruction on GRD development, including the authoring process, review, formatting, and style should be in place
10.	It is recommended that GRDs are peer reviewed internally whenever new data are added. If there is a special need (i.e., transition periods), the review can be done externally

DOF data on file, GRD global response document, SRD scientific response document

Structure of Work

It is important to understand that organizational differences will impact the interaction between global and local medical information teams. In general, GRDs are documents based on published data and data on file (DOF), such as the core data sheet, manufacturing data, data from regulatory filings (e.g., common technical document), and clinical study reports. An organization’s internal structure affects how GRDs are primarily developed. Using a dedicated global medical information department is one approach. Alternatively, a local medical information group may take on this global function. For clarity, this article refers to GRD creation as a global medical information function. Figure 1 summarizes the structure of work between global and local medical information teams. One key lesson is to balance between global consistency and local adaptability.

Fig. 1.

Structure of work between global and local medical information teams. *For example: if the only change was addition of local label, a local review may not be needed. GRD global response document, HCP healthcare professionals, SRD scientific response document

Global response documents may range from a tailored document answering a specific question to an extensive document, encompassing multiple topics providing a broader perspective. The local medical information group may tailor extensive GRD documents to answer specific questions. Global response documents can also be written in a label agnostic manner, with only the cover letter containing the local label's language, allowing the local team to use the unmodified GRD. Global response documents do not cover local matters such as pricing and reimbursement.

The creation of GRDs often aligns around the time of regulatory filing for approval. Global medical information develops a topic list for GRDs addressing anticipated frequently asked questions based on product type, indication, clinical study results, draft labeling, and competitive landscape. Global response documents include a broad range of topics from storage and stability to pharmacodynamics and pharmacokinetics to efficacy and safety. As the focus of GRD creation is anticipatory, unanswered time-sensitive questions from clinicians are handled as a custom response either by the local team or escalated to global. Global medical information may closely collaborate with other global teams during writing (such as medical directors, medical communications, pharmacovigilance, legal/compliance, regulatory affairs). Global medical information is often on a rapid response team to address real-time questions after the first product launch to fill gaps within the GRD library.

Localization and Feedback

Localization is the process of adapting a GRD with local information to create an SRD by local medical information groups. Local medical information teams should collaborate with global to tailor content for local use. During localization, DOF may be removed or other modifications made to comply with local laws, regulations, internal standards and procedures, and best practices. Linkage between the GRD (parent) and the local response (child) document may be established within a content management system. Local teams need to meet customers’ needs, for example, answering medical information requests and adhering to local regulations.

Local teams usually have the autonomy to tailor the GRD towards their specific requirements and HCP queries. When the GRD is extensive, the local team only uses relevant section(s) that addresses the question. This ensures that the local content aligns with the quality expectations of an SRD. However, local teams are sometimes only able to add label information based on company policy and the desire to maintain consistency in responses.

When there is no available GRD, the local team may escalate the request to global medical information or create a custom local response if it involves a local product or topic. If the request is escalated, global medical information provides content that can be used by the local team to create the SRD and fulfill the request.

While all GRDs are reviewed on a global level, local level reviews can be conducted. Newly localized responses warrant a local review in most companies even with unchanged content. Some companies forgo an additional local review if the GRD was taken as is with only local labels and disclaimers added. Local reviews may occur depending on local regulations or company policy. In some countries DOF, congress material is allowed, while in other countries, because of company policy or local best practices it is not permitted. Local reviewers are responsible for following local governance.

Different approaches exist for gathering feedback on GRDs. Some companies hold regular meetings (monthly, quarterly) with global and local medical information groups, while others rely on informal collaborations via channels such as TEAMS and e-mail. While not all companies have a specific process or channel in place, all are working on enhancing feedback and collaboration. Constructive and consistent feedback is necessary for improving GRDs with two-way communication between global and local medical information.

Regular communication between global and local teams ensures alignment of resources. Some companies have processes for local teams to provide feedback on GRD creation and format or to request new or updated GRDs. Regular meetings or communication channels facilitate the exchange of information and ensure resource alignment. Despite no universal goal, setting a target (e.g., ≥90% of requested GRD updates from local teams addressed within 3 months) could encourage and increase the impact of local feedback.

Local teams should have early visibility of planned GRD library updates, if feasible. This helps local teams understand the localization workload, adjust timing, manage resources, and ensure local resource governance.

Despite the benefits of GRDs, there are challenges in achieving global harmonization while addressing local needs. The variability in local regulations and the diverse requirements necessitate a flexible approach to GRD creation and localization.

Leveraging technology introduces an innovative approach to improving and streamlining GRD development and localization. Many companies are beginning to analyze these technologies including artificial intelligence and large language models.

Content and Format

Companies vary in the structure of content creation teams and support for GRD creation, yet some general practices in the creation and utilization of these materials exist. Below are some generally accepted approaches and best practices in GRD content creation and utilization.

Label Agnostic Documents

The foundational concept of a centralized GRD approach is to make core content shareable globally, excluding local labels or requirements. Some companies may provide label information in GRDs; however, these responses are updated at the local level. Typically, there will be some designation that identifies a GRD as global content that does not include specific local information (label agnostic).

Providing Local Specific Information

Some companies use links in the cover letter to share local label information or other local-specific content. The local team can also add links in the response to direct customers to local data or guidelines. A company’s approach to crafting and sharing responses to unsolicited inquiries depends on their inquiry management systems. If links are only in the cover letter, it is crucial to ensure they are also shared in another manner if the response document is accessed via other channels where a cover letter may not be available. Additionally, as part of any review or update to the response document, the validity of the link should be checked and updated.

Innovative Formats

Regarding format, while most companies continue to use Word for GRDs, some are exploring alternative formats. These formats enhance customer experience through concise summaries with interactive features, adapting to rapid technological advancements. Global response document formatting can include the use of infographics, interactive content, and modular content. These innovative content elements require a specialized skillset and additional software programs, resulting in a greater effort to create, update, and maintain. There may be additional costs and system complexities associated with the development of innovative assets. Companies must thoughtfully choose topics for innovative formats, prioritizing those that derive the greatest value, minimizing the need for frequent updates and avoiding promotional or misleading content.

Incorporating infographics into traditional “text heavy” GRDs can visually summarize complicated data and improve customer experiences. Infographics can enhance retention, increase engagement, improve patient education, allow for easy sharing with HCPs, and support decision making [7–9]. To prevent search problems in GRDs, create infographics directly in the document, as content in inserted images is not searchable. Furthermore, producing original infographics eliminates the high costs of licensing visuals (i.e., tables, graphs, and other assets).

Interactive content includes interactive portable document formats (PDFs, iPDFs), slide decks, or website-based content. This includes features such as buttons, links, and videos, which allow for enhanced customer engagement. Interactive content adapts to evolving customer preferences and technological development. Studies show interactive content can significantly affect comprehension and attitudes or evaluative response to medical information [10, 11].

Key considerations, in addition to the above, exist when planning on integrating interactivity into the GRD strategy. Responses with interactive content may complicate localization and translation. These documents may require links to more comprehensive responses to provide context. Moreover, to foster content creation innovation, avoid overusing colorful templates and excessively brief summaries, which may seem promotional or misleading. For digital platforms to function correctly, interactive materials must be in HyperText Markup Language (HTML).

Modular content is a content management approach that divides information into reusable modules for different uses. Modular content offers efficiency, speed, flexibility, consistency, accuracy, scalability, personalization, cost effectiveness, and collaboration benefits [12]. Tiered modular content can be created by merging interactive PDF features and modular content.

Procedures and Process

When creating a GRD, the DRESS acronym is a useful scientific method tool [13]. This process—Defining the question; Researching the data; Evaluating the evidence; Synthesizing a response; and Sharing a response—provides a roadmap for the development and systematic approach to a well written GRD.

The use of the response across the organization is an important indicator of a GRD’s value. Usage data analysis assists in refining GRD content. Resources can be reallocated to create new responses by retiring responses rarely used. Companies may struggle to accurately and effectively collect utilization metrics for global responses. With integrated content and customer fulfillment systems, companies can track the direct response use. Tracking the parent/child relationship enables full measurement of global content usage at the local level within the content management system. However, incomplete local reporting limits a full picture of GRD usage. Website usage must also be monitored to track direct customer queries. Several member companies reported creating dashboards and reports, providing easy access to GRD metrics.

Routine Updates

Regularly updating GRDs with current data is critical to ensure their continued value. Companies vary in both frequency and triggers for updating a GRD with many using an annual review cycle, supplemented by updates throughout the year as new key data emerge. However, this may vary throughout the life cycle of the product. Whenever a change or retirement of a document occurs, there should be a notification and a process to ensure that parent/child content is updated synchronously, preventing child responses from having outdated content. This approach preserves the integrity of the GRDs and provides HCPs with the latest data. However, the challenge lies in managing updates with available resources. Efficient solutions for maintenance of GRD libraries may include adjusted review cycles or inclusion of different grades of information based on the product’s life cycle.

Tracking Translations

Translations of GRDs are often required to meet specific customer needs and may be done routinely or selectively based on usage or request. While content management system metadata enable tracking translations, companies may not fully understand or monitor the extent of localization efforts.

Quality Review of Documents

Accuracy and completeness of GRD content are paramount, as inaccurate or incomplete information can lead to medication errors, adverse events, and regulatory non-compliance. Peer review of GRDs by medical information specialist peers and other medical colleagues ensures their quality. In addition, other departments, such as regulatory, legal, safety, and others may also review as necessary. A standardized GRD quality checklist, along with a quality-control tool, could help assess accuracy and completeness.

Metrics and Key Performance Indicators (KPIs)

Analyzing GRD metrics and KPIs are essential for ensuring effectiveness, efficiency, and impact of GRDs to satisfy internal and external customer needs [14]. Medical information departments use optimized metrics and KPIs to define augmented strategies to enhance patient outcomes. Though metrics and KPIs differ between companies, most companies evaluate GRD efficiency using usage analytics, escalation rates, and turnaround time (Table 3).

Table 3.

Metrics and KPIs

Metric/KPI	Description	Suggested targets	Metric/KPI impact
GRD usage rates	How frequently a GRD is accessed through fulfillment or local team feedback	85% for frequently asked questions ensuring GRD library relevance	Retire or archive rarely used GRDs, if used by one country, local team responsible for future updates
Inquiry escalation rate	Percentage of inquiries that local cannot answer and need to escalate to global teams	Below 10–15%	Higher escalation rates may indicate new or revised GRDs are needed for emerging topics
Escalation turnaround times	The time to provide an escalation response	90% of escalated queries within 48 hours (about 2 days). Targets may need to be adjusted based on the product’s life cycle stage	Evaluate GRD creation and update efficiency
Turnaround time	Time to provide a response to local customer (non-escalated)	Usually within 1–2 business days	Indicate if the GRD/SRD library is adequate
Customer satisfaction	Assessed via customer satisfaction score, net promoter score, or customer effort score	Scoring depends on scale used	Improving quality of GRDs/SRDs to meet customers’ needs

GRD global response document, KPI key performance indicators, SRD scientific response document

Monitoring GRD usage helps prioritize updates, ensuring that critical information is readily available to HCPs. A GRD’s usage is heavily impacted by company structures, medical information processes, and product portfolios.

Monitoring the escalation rate provides insights into the effectiveness of GRDs handling local queries. Escalation rate and response time targets should consider the product’s novelty and HCPs familiarity, ensuring adequate support during launch and early adoption phases. Regularly monitoring query topics is crucial for identifying emerging interests and potential data gaps. Regularly monitoring query topics (monthly, quarterly) helps companies identify trends and responds by creating or updating GRDs.

Robust GRD and local SRD collections are vital to ensure appropriate turnaround times for responses to the HCPs. New products may require faster responses, as HCPs have limited familiarity with them. It is important to remember that HCPs usually need the information as soon as possible to continue caring for the patient. An additional factor to consider is the speed and ease of accessing information and the channel being used. New and high-demand products benefit most from this indicator, highlighting content gaps.

Ensuring customer satisfaction is crucial for building trust and providing valuable medical information that supports better patient care, ultimately improving health outcomes. Satisfaction should be gathered as close to the interaction as possible in the most convenient channel for the customer [15].

Implementing these metrics and KPIs facilitates continuous improvement of GRDs, ultimately helping local teams, HCPs, and patients. Furthermore, inadequate reporting mechanisms in some companies or local teams can hinder precise GRD usage tracking. Continued process improvement and leveraging technology are crucial for companies to overcome these challenges. The overall goal is to ensure the highest quality of medical information disseminated in a timely manner.

Conclusions

The working group’s output highlights the importance of balancing global consistency with local adaptability in the development and use of GRDs. The continuous improvement of medical information responses is facilitated by this balance, ultimately benefiting HCPs and patients. For those organizations that have a global/local model, GRDs can be tailored to ensure local content and compliance is met and enhances the relevance of the information provided. Local team feedback, regular updates, and innovative formats are key for maintaining the accuracy and effectiveness of GRDs. These best practices not only enhance the efficiency of medical information teams but also ensure that HCPs receive timely and accurate information. While specific targets and processes may vary across organizations, the overarching goal is to ensure the timely delivery of quality medical information while maintaining a unified medical voice. Through technology, process improvements, and solutions for resource and reporting issues, medical information departments can enhance their effectiveness, ultimately better support HCPs and contribute to improved patient care. Future research should explore the impact of digital tools on the efficiency of GRD development and localization.

Funding

No funding was provided for preparation of this article. phactMI provided the open access fee.

Declarations

Conflict of Interest

Susan Wnorowski is employed by Ipsen, and owns stock in Ipsen Biopharmaceuticals, Inc. Faith Niemoller is employed by Biogen, at the time of manuscript development she was employed by Eli Lilly and company and owns stock in Eli Lilly and Company. Anja Glaetzer is employed by Sanofi, and owns stock in Sanofi and Johnson & Johnson. Robert Tamburri is employed by J&J, and owns stock in Johnson & Johnson. Elissa Vine is employed by J&J and owns stock in Johnson & Johnson. Franziska Flick is employed by Merck KGaA, Darmstadt, Germany. Meera Patel is employed by Bayer, and owns stock in Bayer. Evelyn R. Hermes-DeSantis is employed by phactMI.

Ethical Approval

Not applicable.

Consent to Participate

All surveys were voluntarily completed by participants. All data were anonymized.

Consent for Publication

Not applicable.

Availability of Data and Material

Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study.

Code Availability

No coding was used in the article.

Authors’ Contributions

All authors substantially contributed to all aspects of authorship, including conception and design; interpretation; drafting and revising the final work. All authors read and approved the final manuscript draft for submission and agreed to be accountable for all aspects of the work.