Guest Post: Patients as research partners - Rethinking patient access to clinical trial data

Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today’s challenges and opportunities. The Catalyst welcomes guest contributors, including patients, stakeholders, innovators and others, to share their perspectives and point of view. Views represented here may not be those of PhRMA, though they are no less key to a healthy dialogue on issues in health care today.

We are pleased to share a blog post from Janssen’s Andreas Koester, M.D., Ph.D., Vice President, Innovation, Janssen Research & Development Operations.

As we celebrate Clinical Trial Awareness Week, it’s important for us to recognize patients as our partners in clinical trials – their participation is vital to our ability to bring new medicines to market. With this in mind, trial sponsors can do a better job listening to patients and addressing their needs to improve clinical trial experiences. In particular, we’re hearing more from patients that transparent access to clinical trial data such as laboratory results is high on their wish lists. At Janssen, as one part of our Patient Engagement initiative, we are working on ways to provide patients with access to their data from screening before any drug is administered or after a trial is over. We also want to take it one step further by finding ways to give patients access to some of their data while a clinical trial is still underway.

In today’s environment in which patients are becoming more active participants and decision-makers in their own healthcare, data is an important tool. Not only has research shown that patients who have easier access to their health data are more engaged, it’s ultimately the right thing to do. We’ve heard from patients that if the data comes from their bodies, they feel like they are entitled to receiving it in a timely manner and presented in a way that is easy to understand. They may also want to share certain data with doctors and loved ones.  Sharing data is the way regulatory agencies are moving outside of clinical research, too. In 2014, the FDA amended the Clinical Laboratory Improvement Amendment of 1988 to give patients direct access to data when requested, instead of going through physicians.

Many patients see multiple providers, not just a trial investigator, so gaining timely access to their trial data may help patients better manage other health issues with their entire care team, as well as avoid repeat tests.

Of course, many trials are blinded and not all data can be shared during the blinded period. However, our philosophy at Janssen is that just because patients can’t receive all data collected, doesn’t mean they shouldn’t receive any of it. We’ve created a framework to consider, at the outset of a trial, what data can be shared with patients at what point in time. We are piloting our first program to enhance patient data access in a large-scale, multinational Phase III trial. This will help us give patients actionable healthcare information, moving them beyond the traditional role as “subjects” in trials toward treating them as true partners.

We commend other sponsors for paving the way by giving patients access to data once a trial is completed. We are hopeful that this trend signals a willingness across the pharmaceutical industry in making data available for patients more broadly.