Medical Expert for T2D and cardio-renal comorbidities - October 2023
For one of our clients we are looking for an experienced Medical Expert for T2D and cardio-renal comorbidities
Project name - Exandra: Improving guidelines-based medical treatment
In a world of fragmented care, the management of patients with type 2 diabetes (T2D) and cardiovascular and/or kidney disease or high risk, has focused primarily on the primary care practitioner's expertise which often limits treatment decisions to only a few typical parameters as well as local and individual practices (including programs, initiatives, etc.) that are not necessarily following current guidelines, resulting in increased risk for cardiorenal complications and subsequent unnecessary loss of patient's lifetime.
The service is provided as part of the project “Exandra: Improving guidelines-based medical treatment”. The project aims to develop Exandra, a clinical decision support system (CDSS) for the treatment/management of T2D and associated comorbidities, integrated into the electronic health records (EHR). The CDSS is based on (local) established clinical practice guidelines and targets primary care. This comprises medical doctors and other healthcare providers.
As such, Exandra focuses on a smart and effective tool that integrates into the practitioner's information infrastructure. It analyzes an individual patient file based on the medical information from the EHR, identifies and flags areas of attention, and provides treatment recommendations based on guidelines. For measuring success, physicians can generate reports about their performance and monitor the quality of their approaches.
A standalone solution (not integrated into the electronic health records (EHR) of a practitioner) of the tool was launched in Canada in July 2023. An EHR-integrated solution is in development for Canada and is planned to be launched by the end of 2023.
The service of the external contractor is delivered within the framework of an agile working method.
Background to the assignment:
As part of the product development of Exandra in Germany, the client has started the discovery phase and will aim to leverage all learnings from the Canadian standalone solution, including the definition of user requirements, technological solution setup, digitalization strategy of the current T2D guidelines, methodology for the validation of the system and clinical data generation strategy, T2D guideline translation into decision logic (IF/THEN rules), and thus an external contractor is needed. Because of this, the contractor holds a unique position and provides significantly different services than the internal staff.
Professional consulting regarding the creation of decision logic
Identification of critical patient parameters necessary for the definition of treatment recommendation based on medically relevant patient information and data available in the EHRs
Definition of decision logics (IF/THEN rules) for treatment recommendations based on the chosen guidelines and prescribing information, reporting and communicating those to the development team who will implement those rules as central algorithms of Exandra
Documenting the rationale for the defined rules and providing it to the client
Designing the strategy for rule definition for borderline/ambiguous cases and documenting the rationale behind the defined rules
Defining the individual rules interact (priorities, hit policy)
Defining additional medically relevant medical user information to be included in the tool
Documenting the sources/references of information included in the tool
Identification of potential clinical risks and their mitigations during the lifecycle of the software
Validation of decision logic:
Consulting regarding the definition of a protocol and analysis plan for the validation of accuracy, safety, and performance of the software for the current software and its updated versions (when new guidelines are published)
Definition of patient test cases for the validation study
Validation of the defined decision logic with several experts/societies to reduce bias and improve accuracy
Professional consulting regarding the local KOL network to be involved in the evidence-generation activities, including the clinical validation
Professional consulting in the definition of key performance indicators/ outcome measures for the validation process based on the contractor's expertise.
Providing materials for the Medical Legal Review (MLR) approval process for the prototype / SaMD product which aims to evaluate the system’s content from the medical accuracy and legal standpoint before launch. This task will include a compilation of screenshots of all the features of the application, logic rationale, validation results, and related materials to present the tool to the MLR board
Iterate and Learn:
Professional consulting regarding the local clinical practice guidelines and the German healthcare system
Keeping track of updates in the scientific literature and adverse events databases of similar products (guidelines, product monographs, and local regulatory changes) assesses whether the tool is safe, performs as intended, and that it is up-to-date. Based on this information the contractor may need to initiate a decision logic update, including the validation exercise if needed, based on the contractor's expertise. This information will be documented and provided to the client so that the Tech Team can implement the updates and the Evidence Team keep track of the changes
Providing professional consulting with peer-reviewed publications and other scientific activities owed by the Evidence Team (e.g., literature research)
Provide professional consulting with the development of clinical evaluation plan and report before and after the market phase
Communicating with the local country teams, experts, and societies
Communicating with the UX team and oversight of research activities from the medical standpoint
Analysis of medical feedback from users to identify product updates and improvements, and document required changes
Communicating in project-specific meetings with the technical team regarding improvement/refinement/extension of the decision support algorithm/logic, responding to medical queries from the technical team
Medical /scientific background in Human Pharma holding a MD/PhD degree (life-sciences) or equivalent experience (must)
Medical-scientific knowledge and expertise of T2D and related cardio-renal comorbidities (must)
Familiarity with the local healthcare system and the established guidelines (must)
Experience in working with clinical practice guidelines (interpretation, communication) (must)
Experience working in a pharmaceutical company (e.g., Medical Affairs)
Familiarity with regulatory requirements and internal processes (e.g., Medical Legal Review (MLR), risk Management etc.) (good to have)
Experience in digital health is favorable (is a plus)
Familiarity with the development of medical device, software as a service, and/or SaMD development (is a plus)
Familiarity with digital endpoints, validation frameworks, and real-world evidence (RWE) generation is a plus (good to have)