From The Editor | March 22, 2016

The Future Of Data And Technology In Clinical Trials

Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical

The Future Of Data And Technology In Clinical Trials

In advance of its upcoming Data & Technology in Clinical Trials 2016 conference, eyeforpharma has released a report on the future of data and technology adoption in clinical trials. An Industry View Point: The Future of Leveraging Data & Technology in Clinical Trials takes a detailed look at the impact of data collection and analysis methods, current challenges, and patient centricity.

Although all of the respondents to the survey worked in the clinical space, they expertise represented a range of functions. Most were from the areas of research (22 percent), general management (21 percent), and operations (20 percent). Other functions included development, data, design, and outsourcing.

The first noteworthy trend identified in the survey was the growth in risk-based strategies. When asked about which trial methods were most likely to be adopted in the next two years, over 58 percent of respondents noted risk-based strategies. This was followed by adaptive trials at 53 percent, small patient studies at 44 percent, applied real world data in trial design at 43 percent, and data modeling/simulation at 29 percent.

When asked about which methods would have the largest impact on trials in five years, adaptive trials and risk-based strategies remained at the top of the list. Surprisingly, small patient studies, currently the most frequently deployed methodology, fell to the bottom of the list. A report by Metrics Champion Consortium (MCC) in 2014 supports the risk-based findings. It found 55 percent of firms in North America were already using risk-based approaches, with another 39 percent planning to use them. The percent of respondents in that survey who were using or planning to use the technology was 87 percent in Western Europe, 78 percent in Eastern Europe, 79 percent in Asia, 73 percent in Latin America, and 67 percent in the rest of the world. The primary reasons for the high adoption rates are reducing monitoring costs, improving data quality and quality oversight, and ensuring patient safety, as noted in a different MCC survey conducted in 2013.

Future Investments Will Focus On Data

Moving forward, data will continue to be an area of interest and investment. Respondents indicated investment in the next two years would be largely directed towards data, with the order of potential investment being research, development, operations, and design. Improving the collection, analysis, and management of data was on the minds of most executives, with over 85 percent agreeing it would have the largest impact on how trials would be conducted in the future.

There was a little less agreement on the best strategy to use to better invest in data. Several respondents noted real-world data would be important, as the clinical process requires data to be as close to real-world data as possible. They also felt the collection of real-time data would be the biggest opportunity for better use of clinical data in the near future. Real-world data allows information to be gathered faster, will demonstrate value to patients more quickly, and can help increase patient recruitment.

A significant number of respondents also cited big data as an area of potential investment. Those responders noted big data facilitates the challenge of discovering innovative therapies. Big data allows for the identification of sub-groups of patients that can then be targeted with the right therapy. It also allows for the integration of patients and patient groups into the clinical process, so as to identify the right biomarkers. Respondents also noted the way to achieve better use of big data is through data-mining and meta-analyses, as well as data sharing between companies for the common good of the industry and patients. That sharing should include data from both successful and failed studies.

Become More Patient Centric

Patient centricity was another factor cited as essential to improving the quality of data in the future. Over 66 percent of respondents noted their biggest focus would be on running more patient-focused trials. Of course what exactly defines patient centricity is also open to interpretation. In the survey, respondents referred to it in a variety of ways, including the need for personalized data and specialized medicine. To get data directly from patients, some responders referenced the increased use of patient-reported outcome measures.       

Making studies more patient friendly will involve putting yourself in the shoes of the patient. Adding some analysis to the report, Joe Kim, Senior Advisor in Clinical Innovation at Eli Lilly, notes “Participants aren’t an amalgamation of what you read in scientific papers. They aren’t a faceless person. They are your wife or brother. If your loved ones are about to enroll in a clinical trial, what would you want for them to make it patient-friendly?”

Even so, moving patient centricity from an industry buzzword to a standard method of doing business will take some work. Kim recommends putting yourself in the role of the patient. Ask yourself what you would want as a patient, and then act on what you believe the answers to be. When properly executed, a good patient-centric strategy will not only better meet the needs of patients involved in the study, it will help with patient recruitment and retention efforts, and also help to discover unmet patient needs.

Going forward, respondents identified many challenges they would continue to face. Not surprisingly, they did not all focus on budgetary concerns. While budgets were ranked the highest by most responders, several other challenges were cited highly in terms of the level of concern. They include identifying and maintaining patients, finding and implementing new systems and software to manage data, managing timelines, reducing silos between departments, implementing new technologies, and CRO selection/relationships.

A complete copy of the report can be obtained here or by contacting eyeforpharma.

If you would like to be part of this discussion, plan to attend Data Quality & Technology in Clinical Trials 2016. The industry’s most innovative companies have stamped it a “must-attend” event – so make sure you don’t miss out on the strategy, insights, learning, and networking. Use ‘C-LEADER’ and get $100 OFF.