The Partnerships in Clinical Trials conference has been around for a little more than two decades, and has focus on strategic relationships within the pharma industry. It's been a place where Pharma companies, contract research organizations (CROs), suppliers and other vendors could come together to exchange knowledge, share the latest information on new products and services, and form business partnerships.
While this year's conference was still very much industry-focused, there's a welcomed expansion in the industry's definition of "partner." This year, additional patient advocates and clinical investigators were woven throughout the conference presentations and workshops, giving attendees a much more well-rounded view of the industry as a whole and helping us to better see where we may be falling short and how we can improve.
We felt that three of the most valuable discussions were centered around bringing clinical trials to patients, implementing patient-centered clinical trial design and partnering with other pharma companies to improve drug development.
Bringing Clinical Trials to Patients
One thought that seems to have taken hold throughout the industry is that we should be working to bring clinical trials to patients, instead of the traditional approach of bringing patients to the trial. A couple of the ideas that were discussed included increasing overall public awareness of clinical trials and providing better information resources to bring the right clinical trial options to patients who can benefit from them.
Clinical Trial Awareness
During a panel discussion titled "Partnering with Patients: What Do You Need from Each Other?" moderator Roni Zeiger asked the audience what they thought was the biggest barrier to clinical trial participation for patients. A large majority felt that it was clinical trial awareness, and the panelists agreed.
Patient advocate Steven Mikita and Lilly VP of Clinical Innovation and Implementation, Jeff Kasher, both pointed out that the key to increasing awareness lies in an overall change in the culture surrounding clinical research. We need to...
- Help patients understand the trials are not necessarily a "last chance" treatment option.
- Help to get doctors more invested in clinical research so they can talk to their patients about trials.
- Simplify clinical trial designs and communicate about them more clearly so that they are easier for patients and doctors to talk about.
- Offer more convenient options for clinical trials participation—visits scheduled at places other then investigator sites, for example—so that they can be integrated into doctor's daily practices and patients' daily lives.
All of these things will require concentrated efforts on the part of trial sponsors and stakeholders. It was encouraging to see that many companies seemed to already have such efforts underway (or were at least thinking about them.)
Better information and ways to leverage it
Another way that we can encourage more awareness about clinical trials is to make information about them more accessible, easier to understand, more useful, and more relevant to patients' needs.
I gave a presentation on our Patients 2 Trials Consortium with Novartis and Pfizer. We are committed to doing a better job of informing patients and caregivers about the trial options that may be valuable and best-fit for them. Right now, we are working to augment data from ClinicalTrials.gov through our open API and allow patients to match their Blue Button health data to the study's criteria. Our open platform approach intends to enable a marketplace where tools, services and applications can be developed to enable patients to match their health traits to trials in their area. Take a look at the presentation slides for more details:
Johan Prove, Global Strategy and Development Advisor at Bayer, also shared information about a European effort to leverage Electronic Health Records (EHR) to support clinical research, "EHR4CR Project Results: Use of EHRs for Study Feasibility, Patient Identification and Recruitment." Its focus is around a platform that allows researchers to access anonymized data from hospitals' electronic health records. Having access to that information allows industry and academia to support research in several ways, including identify patients who may be eligible to participate in clinical trials. According to a video on the EHR4CR website, this means that "hospitals can participate in clinical trials more efficiently, health authorities have access to new and better evidence to underpin health policy, strategy and resource policy, and patients have faster access to safe and effective medicines."
Patient-centered Clinical Trial Design
HMDIS - How Much Does it Suck? That's the question Roni Zeiger suggests that clinical trial designers ask patients and themselves as they put together trial protocols. HMDIS, for example, for a patient to travel 100 miles to a clinical trial site, versus 10 miles to their nearest pharmacy? HMDIS to have to visit a trial site once a week versus once every other week? Paying attention to these kinds of details can make clinical trial participation a more feasible option for many patients.
Roni also pointed out that patients express frustrations at outcomes they see being measured in trials. What seems important to clinical trial sponsors and designers can be quite different from what patients feel is important. For example, patients with rheumatoid arthritis may evaluate a treatment based on whether or it makes them feel well and less fatigued; whereas a researcher might feel it's more important to focus on joint pain and stiffness. Since ultimately the aim of any treatment we're testing is to improve the lives of patients, it's important to understand what's most meaningful to them and design the trial accordingly.
As per Jeff Kasher, Eli Lilly is taking steps toward bringing more patient input into clinical trials. We have worked with SmartPatients to get feedback from breast cancer patients on a Lilly-sponsored clinical trial. We've set a goal to increase patient input on our clinical trials this year, and we'll be transparent about whether or not we meet that goal.
Collaboration Models for Drug Development
Industry Collaborations" by explaining that 15 years ago, such a discussion probably would not have taken place. Highly competitive and historically secretive companies deciding to work together to innovate and provide better resources for patients would have seemed very unlikely.
There is no discussion of saving cost. The discussion is reducing inefficiency to plow that back into developing more drugs... So, in terms of innovation many of these [member] companies would like to innovate further, but are constrained and hamstrung by our own self-inflicted process inefficiencies. And we're trying to tackle some of it. to free up some of the resources for companies to be able to innovate on new drugs and new patient populations.
Too much secrecy and isolation can lead to us standing in our own way when it comes to progress. By being as open and transparent as we can, sharing resources and learning from each other we can find ways to bring new and innovative medicines to the public faster. And what that happens, everyone wins, patients especially.
Here are a few examples of recent industry collaborations:
- Enlight BioSciences
- Accelerating Medicines Partnership (NIH and Pharma)
- Patients 2 Trials Consortium
- Patients Like Me and Genentech
- Project Data Sphere
Get it Fixed
"Get your butts in gear and get it fixed." This was the call to action issued to the audience of pharma industry insiders by patient advocate Jack Whelan. We find this statement to be encouraging for many reasons, but most of all, because it points toward a new reality in clinical research. That reality is that patients as a whole are ready and willing to help point us in the right direction. We need to listen to them and work to break down as many barriers to innovation as we can.
We were also encouraged when patient advocate Steven Mikita said "We want you to succeed and you want us to succeed. We're invested in you, so please invest in us." This is great reminder that we're all—patients, pharma, and industry partners—working toward the same goal. The more we're willing to learn from each other, the faster we can get there.