Life Science Leader Magazine Supplements

CRO Supplement 2015

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THE CRO LEADERSHIP AWARDS 2015 LIFESCIENCELEADER.COM 16 ROUNDTABLE leaders KIM: According to Pew Research Center, among cellphone owners across 32 countries, 76 percent use text mes- saging via their phones. This is similar to the 83 percent of cell owners in the U.S. who text. Since the invention of the cellphone, the comfort with which we text each other has skyrocketed globally because of bigger screens and how text threads are organized. Data also shows that texting is exploding across all age groups, even those older than 65 years of age. My mother, who is 70, is even using a video instant message app, and she just got her first smartphone this year. The upsides to texting are numerous — the user dictates the cadence, content is short, enduring (enough), and today it's quite normal for threads to go on for days and weeks. Responding to a call to action via text allows potential volunteers to easily weave their engagement into their busy lives. In a previous life, I saw more than one-third of research volunteers responding via a text modality. Contrast that with call centers, where patients are in for an unknown time commitment, or visiting new websites, which have their own learning curves. Cutting the cost of trials is a concern for most pharma executives. What trends in technology and data collection do you feel will have the biggest impact in this area? DAVIS: The opportunities mobile solu- tions hold for the clinical industry are vast, with the potential to reduce the major financial burdens as a result of increasing pressure to progress drugs through clinical trials faster. With trials now commonly being conducted on a global scale, increasing efficiencies in data management is critical, and a "device inclusive" approach (enabling the use of any connected device during studies) can deliver return on investment through a number of avenues. Additionally, the (the size of the message and the content) that are easily surpassed by an HTML email. However, this is still a good way to make an initial connection that can then deepen over time. In addition, technology can support this with text-based remind- ers when a patient is on a protocol. In both situations, privacy will likely be the greatest concern. STEEL: As we become more dependent on technology as a society, and more comfortable with the ways in which it permeates our lives, the idea of recruit- ing via text message becomes more appealing. While texting may provide a greater level of convenience and imme- diacy, it also has several potential pitfalls. Autocorrect, for example, can completely change the sender's intended message. Errors that are commonplace and social- ly accepted in casual texting can have disastrous results in the context of clinical trial recruitment where accuracy is imperative. While most cellphone plans include unlimited free texting, some people still pay for texts, especially outside the U.S., and may not appreciate a recruitment screening model driven through back and forth text messaging. However, given the convenience and widespread use of tex- ting, the trend of using it as a recruitment tool is likely to grow. use of a familiar and engaging method of capturing data can reduce missing data points and hence increase quality. This, combined with greater retention of patients, can reduce the need to "pad" the sample size. In large events-driven outcomes trials, by retaining the maxi- mum pool of patients in which to observe events, studies can be brought to an ear- lier close, reducing their overall cost and duration. KIM: The idea of central or remote monitoring has a huge potential to decrease costs, given that the lion's share of costs is related to monitoring. In order to do this, the industry needs to explore going digital with its activities, which is of course easier said than done. But, maybe the more challenging thing is to make sure local regulations allow for this approach, for all study-related activities. If you've created conditions for 99 per- cent of the data to be remotely monitored, that remaining 1 percent will still cre- ate the need for a monitoring visit by a human. STEEL: Most definitely, the biggest breakthrough in clinical development will be the increase in patient-centric studies. These studies are built around the patient, reducing the burden on sites and patients. Today, there are a tremendous number of channels with which to communicate with patients. The Internet has not only facilitated increased patients' access to information, but it has also enabled new pathways for patients to find and access research. As we get the patient voice more involved in the design of trials, I think we will see better data and better reten- tion, which will help to reduce the costs. Incorporate that feedback into bring your own device (BYOD) models, study-specific mobile apps, and disease-specific medical devices (i.e., wireless glucometers), and our industry will certainly see a reduction in overall trial costs. BORBAS: Based on my experience, data costs are about 20 to 25 percent of a total The idea of central or remote monitoring has a huge potential to decrease costs. J O E K I M By E. Miseta TECHNOLOGY AND DATA COLLECTION: WHAT HAS THE POTENTIAL TO TRANSFORM CLINICAL TRIALS?

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