Lilly Expects Patient Centricity, Adaptive Trials, And New Technologies To Deliver In 2016

By Ed Miseta, Chief Editor, Clinical Leader

As the VP of Portfolio Management at Eli Lilly and Company, Anne White spends a good deal of time staying close to clinical trials, patients, and the latest trends affecting them. In her 24 years in pharma, most of them at Lilly, she has served as VP of Oncology Development Operations and Senior Director of Global Strategic Planning and Patient Tailoring. She also spent five years at Tigris Pharmaceuticals where she was COO and VP, Clinical Operations.

In this Q&A article, White shares her thoughts on pharma becoming more patient-centric and the increasing move towards more adaptive trials. 

Ed Miseta: Is Lilly doing anything to help patients locate an appropriate trial?

Anne White: We believe it is important to educate patients on trials. As a result, one of the key patient-centered efforts we have undertaken is the launch of a website called TrialGuide (www.lillytrialguide.com). The goal is to help educate patients on what is involved with a trial and the benefits they provide. Lilly has also produced a nine minute documentary on research volunteers and how their efforts help future patients. In the video, migraine sufferers discuss the factors that made them want to participate in clinical trials. The industry needs to share messages like this on social media so more patients are aware that clinical trials are an option for them.

Miseta: You have worked in oncology, an area where enrollment is surprisingly low.

White: That’s true. Enrollment in oncology clinical trials is between five and ten percent of patients. This is especially surprising in oncology, where you would expect trial participation to be much higher. Making those trials a little less of a mystery to patients, and more likely something they will ask their doctor about, is an opportunity we think will both accelerate bringing new medicines to patients as well as help the patients themselves. We cannot rely only on doctors mentioning trials to their patients.

There are really three pieces to this effort. The first is to help more patients be aware of clinical trials. The second is making it simpler and less bureaucratic for patients to join trials. The third focus is to keep these patients involved in the trial and make the trial much more patient-friendly. A key to keeping them involved is in making the trials less time-consuming. In pharma, I think we can become a little insulated from what is actually doable at a site. We may add so many procedures to a visit that patients have to spend six or eight hours at a clinic. That is an unacceptable amount of time and it has to change.

Miseta: Are there other opportunities to help patients learn from other patients?

White: Patients definitely respond best to other patients. On the TrialGuide site, we have patients give testimonials of what the experience was like when they participated in a trial. We also have them share why they did it and why they think it matters. I think this will help, but we also need to do a better job of letting patients know the results of a trial. The information on ClinicalTrials.gov is written for scientists and it is very hard for the layperson to understand. We know patients are interested in those results. If we can get better at sharing those results, I think it would incentivize more people because they would feel like they are truly part of the whole clinical trial experience. This might also help to eliminate a lot of the skepticism that still exists around clinical trials.

Miseta: New technologies seem to be gaining momentum in trials. Do you expect that trend to continue?

White: Absolutely. Society as a whole has become much more reliant on mobile devices than we were just two or three years ago. The greater use of technology in trials was simply inevitable. I think the next step will be getting physicians more comfortable with the fact that their patients can get the same quality of care with fewer visits to the clinic. This will need to be a concentrated effort by all companies in the industry. The physician/patient relationship will remain important, for example in the reporting of adverse events, but the way they interface might be different. Think about it, just three or four years ago there were people saying they would never pay for anything with their iPhone, but today people of every generation are very comfortable doing just that.

Miseta: Will age play a factor in the adoption of technology?

White: There is a generational impact in everything, and you can definitely see it in healthcare, with both physicians and patients. I think this newer generation of patients will be more comfortable with doing things like monitoring their diabetes on their iPhone or using that same device to report events. It might take a little more time, but I think eventually you will see younger physicians graduating from medical school with a whole different level of comfort with using devices to interact with patients.

Miseta: Any other trends you see?

White: I think one of the big ones is adaptive trials. We are doing more of this sophisticated development at Lilly and it is accelerating timelines. This includes using real-time data as it is coming in, while ensuring you maintain the blinded component and statistical rigor of the study. By incorporating this data as you go, the study can adjust if fewer patients are needed on one arm of a study or more on another. These advanced analytics can also allow you to evaluate if the dose you chose for a Phase 2 study is the right one. Anyone who has been in this industry a while has experienced the frustration of getting to the end of a trial and realizing you needed to treat a patient longer, treated a patient longer than was necessary, or had a sample size that was 20 percent higher or lower than necessary.

Obviously, any of those scenarios can result in costly time delays for both patients and the company. We now have a group in our advanced analytics area making sure we can use real time data appropriately and, at the same time, make better use of all the competitive data that is out there. Your statisticians can then adjust your models based on those analytics.

Miseta: I still hear some folks expressing regulatory concerns.

White: They shouldn’t be. Compared to when I started doing clinical trial work 20 years ago, this is really an amazing development. Using this approach, we can adapt a clinical trial to the specific questions being asked in a way that is as efficient as possible and still ensures confidence in the results. I believe the FDA has been one of the primary proponents of ensuring you only treat the number of patients needed, and recruit a sample size that is appropriate. We currently have several adaptive trials ongoing, with FDA input on those trials before they began. We all recognize that it is just a smarter way to perform drug development.

Miseta: Anything specific you can point to that has helped enable this trend?

White: This has certainly been enabled by the ability to rapidly process large amounts of data, which is something we were not able to do just 5 or 10 years ago. Additionally, in the last few years, pharma companies such as Lilly have been able to attract statisticians and data management folks who not only have the ability to understand how to manage large amounts of data, but also get it into the right format for the rest of us to understand. It’s easy to get completely overwhelmed with data. These days the problem isn’t generating the data, it’s that we need to be able to process and understand large amounts of data and use it effectively to support the decisions we need to make. I am very impressed with the talent that has emerged in this area.

Along the earlier theme of patient centeredness, there will also be a greater focus on delivery devices. Companies will be hiring more people that can enable delivery devices to be put into trials quickly and efficiently. The development of these devices requires long lead times, and can delay development programs. We are now working to come up with prototypes earlier that we can then test in Phase 1 and Phase 2.