Friday, July 29, 2016

Patient Centricity and Improving the Clinical Trial Process

The Partnerships in Clinical Trials team were able to sit down with Jack Whelan for an exclusive interview. Jack will be joining the speaking faculty at the conference in October and is a very active research advocate determined to help improve the clinical trial process. Jack himself has participated in seven clinical trials, and is an eight year survivor of a rare incurable blood cancer. The unique patient perspective that Jack is able provide is one you won't soon forget. It is time for some fresh new thinking about clinical trials.

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What are the trends or the current challenges the clinical trials industry is facing?

JW: As the biopharmaceutical industry begins to fulfill many of the promises of the human genome project and introduce safer. more effective targeted therapies using what we’re learning about genetic and genomics, we must change many of the out-of-date assumptions associated with clinical trials.

For example, we must urgently move away from “batch data collection and reporting” of patient response data "after the fact” with a retrospective look and collect and report on that data, which indicates a positive or negative response, refractory to the therapy, relapsing, or acquired resistance, now emerging as a seriously looming threat to clinical trials participants and the industry.

What are your top three biggest concerns about the industry?

JW: My three primary concerns: 1) The biometry used in today’s clinical trials is out-of-date. As more reliable data collection, reporting and big data, structured data is becoming more readily available for better actionable research, we must look at randomization, double blind and placebo-controlled studies should be seen in the rear view mirror. 2) Biotech and Pharma must do a better job educating regulators about new technologies, especially the new research methodologies such as gene editing that can bring us more precise therapeutics and dramatically short-cut the clinical trials process while improving the risk and safety profile. 3) We must move away from the many old business processes and templates which in the past helped achieve and FDA approval if followed. Many of these processes and templates are now sorely out-of-date.

What do see as the biggest disruptor in clinical trial over the next few years?

JW: We will move toward a more “patient centric” rather than the present “research centric” approach to conducting clinical trials. Emerging ePRO (electronic Patient Reported Outcomes) and COA (Clinical Outcome Assessment) data collection and reporting tools in the hands of patients and clinicians will help researchers, particularly Principal Investigators (PI) make better decisions about good research with a more balanced approach to patient care.

What role will innovation play in the future of clinical trials?

JW: Innovation centered on gene editing and a new generation of Information Technology will dramatically improve clinical trials and outcomes. More reliable, actionable predictive and prognostic molecular level biomarkers will be identified to help guide research and care.

What do you hope to learn more about / who do you want to hear from at the PCT conference?

JW: I hope to deliver my fundamental message that if you or someone for whom you care is diagnosed with a lethal disease such as cancer, do not settle for “standard of care”. Bet on forward-looking science, what’s behind door number three which is more likely to be safer and more effective that conventional chemotherapy. I hope to hear meaningful updates from leaders in biotech and pharma, new research methodology from CRO who pose the greatest “shared resource” in life sciences. I hope to hear how biotech and pharma are embracing the much needed Companion Diagnostics (CDx) that enable the road to Personalized Medicine still under construction. I hope to hear much more Patient Centric thinking, not just a “stamp of approval” that we’re patient centric but real actionable, meaningful change in business processes at every department in each company represented. The industry does not yet fully understand Patient Centricity.

To learn more about Jack's story, get more insight, and explore clinical trail innovation, join him at Partnerships in Clinical Trials this fall. Click here for more information.

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