The Drug Information Association (DIA) held their annual conference in Chicago, IL June 18 through June 22, 2017. The overall theme for the conference was “Driving insights to action,” and included topics related to Big Data/eHealth, Disruptive Innovation, Patient Engagement, Medical Affairs and Scientific Communication, Regulatory, Safety and Pharmacovigilance, Value and Access, and Quality.
One common theme of the DIA conference was driving the speed and quality of submission documents. The current environment leads to tighter timelines, increased submissions, and submitting them to multiple countries at the same time, which is a constant challenge for medical writers. Writing strategies were presented to manage multiple submissions and tight timelines. Many of the suggested methods are currently employed as best practices at MMS including advanced preparation of shells, reinforcing agreements to and adhering to timelines, being proactive with questions, developing trust within the team, and effective communication. Strategies were also presented for working effectively with difficult team members to increase communication and efficiency in the drafting process. One regulator from the Food and Drug Administration, Patrick Frey, noted that limited guidance has been provided to the industry in structuring benefit-risk assessments, and as a consequence, there is significant variation in the submissions. The new ICH M4E(R2) guidelines have introduced structured benefit-risk information into the common technical document, which should help streamline the submissions.
Accelerating the timeline of submissions by increasing the efficiency of collecting clinical data was also a strong theme throughout the meeting. One part of the discussion focused on using data to choose appropriate study centers to execute clinical trials so that patients were enrolled quicker and the study could be completed in a shorter time period. Speakers discussed using digital records to map specific patient populations (i.e., determine where in the US there is the largest population of patients with a disease) with relevant investigator sites (where are the physicians located that specialize in the treatment of that disease) to maximize study enrollment.
Another overarching theme from the conference was connecting physicians, patients, and therapies using digital technologies. A panel discussion chaired by Craig Lipset, Head of Clinical Innovation within Worldwide Research & Development at Pfizer, examined how digital devices could be used in the future to bring the physician to the patient instead of the patient having to drive to the clinic. For instance, smart devices such as Echo, Alexa, or something similar to a Fitbit might someday be used to monitor the physical condition or daily movements of a patient.
The keynote speaker, Alexander Tsiaras, discussed the use of personal health databases to help patients interpret their medical history, which could, in turn, lead to better patient compliance with their medication. The underlying thought being that if patients understand their condition and why they have been prescribed a certain medication, they are more likely to be compliant. The importance of having a structured benefit-risk analysis of products was also highlighted. Currently, the patient-specific product label presents mainly the risks of the drug with little information on the benefits. Future labeling may also include this type of information so patients can be more informed about the favorable and unfavorable effects.
The use of real world data (RWD) to achieve affordable and more personalized medicine was prevalent throughout the meeting. Companies are currently using RWD to evaluate safety and effectiveness for diverse populations, however, the definition and appropriate use of RWD is still being debated. One regulator from the US Food and Drug Administration (FDA), Jonathan Jarow, defined RWD as data that are related to health that are routinely collected and derived from routine patient care. RWD is the data collected outside of a randomized clinical trial. The ultimate goal is to create a repository of patient information for use in clinical trials. This repository would be comprised of a single universal identifier for every US citizen, a standardized data structure, a complete linkage of data between data bases (hospitals, pharmacies, outpatient clinics, social media, death registries, etc.), and an open access system with consent for the full use of de-identified data.
The FDA is in the process of drafting guidelines and a framework for the application of RWD to establish efficacy and this guidance will be developed by 2019. While the prospect of a large database of RWD for analysis in future investigations is exciting, there are many challenges with the collection of this data including patient privacy, security of data, and transparence, among others.