From The Editor | March 3, 2015

"Virtual" Recruitment Roundtable: What Can Be Done With Social Media, Big Data?

By Anna Rose Welch, Editorial & Community Director, Advancing RNA

Big Data

Social media and Big Data are two buzzwords in the clinical space that will influence recruitment practices in the future. In this segment of Clinical Leader’s “virtual” roundtable, our recruitment experts discuss the challenges that social media and Big Data bring to the industry and how pharma can begin to approach these trends to ensure successful trial recruitment.

AR Welch: What specific challenges or trends in the industry will have the greatest effect on future recruitment practices, and how can pharma prepare to face these challenges?

Data life cycle management needs standardization and advancement. Legacy data that may not have had the best database entry requirements and/or compliance practices applied at the beginning of its life cycle (e.g., greater than 10 years ago) is less granular — and potentially less valuable — than data generated and delivered with a higher overall compliance and quality plan (e.g., data within the past three years). Integrating and analyzing these distinct data cohorts for the application of patient identification should be done by specialists with training and experience in epidemiology, statistics, and database and system development, programming, and maintenance. — Kurt Mussina, VP and general manager, Frenova Renal Research

No doubt, the use of Big Data will be one of the most influential trends. Each passing day represents another milestone in the development and refinement of data collection mediums and techniques. The companies that can leverage the data most effectively will be the winners. Data is already allowing us to understand at a high level where patients are located geographically down to a county or zip code. We can also use data to determine which physician and investigator is treating those patients, and whether the patient is on certain prescription medications or has undergone certain diagnostic testing. Layered together, this data is very powerful, but we have only begun to skim the surface of how data can be used to improve drug development. Where patients look for information, how they look for it, when they look for it, who assists them, how they make decisions about their health and treatment options, and what they do next are all key pieces of information that we can use to personalize healthcare. It is that level of sophistication that will be necessary in order to drive the development of new treatments and significantly decrease clinical cycle times. — Dan McDonald, director, business development, DAC Patient Recruitment Services

Pharma needs to recognize that patients must often come from outside the sites’ practices, for many reasons. Recent statistics indicate that 48 percent of clinical research sites either under-enroll or fail to enroll a single patient. Trials are harder. The most recent data from Tufts indicate that the number of inclusion/exclusion (I/E) criteria and the average number of procedures related to trial protocols have increased over the last 10 years. For example, compared to as recently as last year, the average number of I/E criteria increased from 50 to 54, and the average number of study procedures increased from 167 to 181. Another major problem is that people are simply unaware of trial opportunities, and they have limited education on how to seek out trials that might fit. Pharma can help raise awareness of clinical trial efforts by supporting their own educational programs or supporting non-profits dedicated to raising public awareness. — Roger Smith, SVP, global clinical operations, Acurian

Consider a scenario in which patients in an unregulated chat room are discussing their clinical trial and the “effects” they are feeling, both positive and negative. This situation has the potential to unblind and bias an entire study population and potentially invalidate study results and millions of dollars in research. The intersection of free speech, social media, and clinical research is still complicated and uncertain. Until some governing body has the ability to control content, sponsors will largely be on defense because, while they are prohibited from making claims about a product’s safety or efficacy, patients are not. To start, we should set our sights on improving education, and we should monitor social media outlets more consistently. However, it’s important to note that this will only begin to deal with the problem. — Marc Hoffman, MD, CMO, Theorem

Tune into the previous segments of this roundtable: