If you write a musical score or contribute intellectual property toward a commercial invention, you benefit from royalties. But what happens if you contribute to the development of a drug by participating in a clinical trial? You give developers your data and your time, but what exactly do you get and how does your community of patients benefit?

It may seem an almost impertinent question if you’re a drug developer. After all, the often-used response that investigators give to trial participants has been ‘good enough’ for decades: patients’ health may benefit from participation, and, whether they are in the active or placebo arm of a study, they have the satisfaction of knowing that they helped others with their disease by taking part. It’s true, and yet, today, it feels as though it falls short.

Patients living with life-threatening diseases have all their skin in the game.  Their time equals life, the ultimate valued commodity. These are the ready, motivated participants for clinical trials, and in exchange for their time and data, they and the organizations that advocate on their behalf should benefit from drug development through royalties that directly fund future research and advocacy priorities. When communities’ needs converge, great change is possible.

More Efficient Fundraising Drives More Immediate Patient Benefit

For decades, patient advocacy groups have looked to galas, walks and events as the prescribed formula to raise essential funds.  These gatherings are important opportunities to rally society, unite allies and sustain community, but they also take time, and the need for speed calls for creativity in advancing science.  Advocates should look beyond filling tables of 10. Their strategic plans should include partnering with contract research organizations (CROs) as pathways to advance drug development as well as fostering awareness, advocacy and treatment as part of their missions. 

The currency that makes this possible is the exchange of data, which are essential to all therapeutic advances. That requires patient advocates to think differently about working within their communities and with academic centers, contract research organizations and industry.

“The need for diversity and greater decentralization in clinical trials will requires new kinds of data exchanges with patients,” notes Irfan Khan, MD,  CEO, Circuit Clinical. “With our industry’s need for these novel collaborations also comes the chance for real change.”

Data as Currency

Amazon, Apple, eBay, Facebook, Google, and a host of other immense social communities prove repeatedly that data are essential currency for economic success. Giants in consumer data analytics get smarter by tracking online information, transforming searches into “what to buy next” prompts. Whether we accept or reject their approach to user privacy, we must also acknowledge their mastery of data monetization.

The concept should be nothing new for academic research centers, which have long monetized health data. Google Scholar and University of California-Berkeley Professor Dawn Song created a secure path for patients to share data with researchers by launching software company Oasis Labs. Why can’t patient groups also benefit from this approach?

Paddy Padmanabhan, co-author of the best-selling book Healthcare Digital Transformation — How Consumerism, Technology, and Pandemic are Accelerating the Future writes, “As traditional healthcare enterprises confront emerging competition from non-traditional players, some of them have started realizing the competitive advantage they have in the form of vast amounts of data they have on healthcare consumers’ medical histories.” Those ‘non-traditional players’ don’t just mean Amazon or Google — they may well be the patients themselves organizing to ensure they have greater sway in setting clinical priorities.”

Facilitating — and Funding — Innovation

Patient advocacy groups can build models that amass more information for clinical research and even work to fund these initiatives as partners. Before planning their next virtual gala or whiteboarding ideas on determining their “Ice-Bucket Challenge” moment, they should also look at how the ALS Association applied those monies to increase research funding and accelerate clinical possibilities. Beyond simply providing capital to fuel innovative ideas, they became drug start-up companies’ investment partner.

There are many ways to use data to create mutually beneficial partnerships. The GenTAC Alliance (National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Related Cardiovascular Conditions), launched by NHLBI and NIAMS, enrolled more than 3,600 patients between 2006 through 2016. By putting this registry to work, The Marfan Foundation is looking to partner with biopharma companies to fulfill its patient-support mission to discover new treatments and cures for life-threatening genetic aortic conditions.

Biopharma companies already want patients and their communities to have a seat at the table, but collaboration is more than simply communicating. It’s about creating common ground for mutual success. Economic models that address multiple interests may be a new remedy to make that happen more frequently, and groups such as Let’s Win for Pancreatic Cancer and The Christopher and Dana Reeve Foundation have taken on pinpointing cutting-edge research that may sustain life, bringing collaboration with drug developers to another level.

The culture of drug development is shifting. In the new edition of Alzheimer’s Disease Drug Development – Research and Development Ecosystem, edited by Drs. Jeffrey Cummings, Jefferson Kinney and Howard Fillit, there is a chapter dedicated to “The Role of Professional and Patient Advocacy in Advancing Alzheimer’s Disease Drug Development.” I was privileged to co-authored this chapter with neurologist and psychiatrist Amir Kalali, MD where we note: “While fund-raising efforts such as walks, galas, golf outings, and conference sponsorships still occupy their workflow (of advocacy groups), the focus on these monies in the digital era has shifted from awareness building to being leading sources of research funds.”

Can Patient Advocates be Agents for Patient Data?

Companies such as Hu-manity.co pose an essential answer to the question, “who owns your data?” Its Founder and Board Chair Richie Etwaru wrote, “…the simple idea that we should put the consumer (the patient) into the center of the healthcare data supply chain with ownership rights literally at their fingertips is both powerful, and timely.”

This is a movement in the making. Biopharma companies might find that by advancing this idea, they can accelerate mutual interests. Craig Martin, CEO for Global Genes Foundation Alliance, a rare disease advocacy community with more than 600 member organizations, advocates for a more inclusive partnership between patient groups and the biopharma industry.

Industry so far seems receptive. Led by Co-Chairs Amir Kalali, MD, and Craig Lipset, The Decentralized Trials & Research Alliance, a 150+-member organization uniting industry, academic centers, contract research organizations (CROs), regulators and patient advocates, is sparking the conversation among a research community that speed, diversity and inclusion in bringing new therapies to market — and to patients — is in everyone’s best interests.

It’s Not About Going Virtual — It’s About Collaboration and Mutual Benefit

Apple, Google and Microsoft are dominant companies to follow for trends and developments in technology. But they are also advancing collaborative economic models that drug developers and patient communities should emulate. They pioneered the idea of mining unpolished data and turning it into a new currency for commerce.

All drug development is built on clinical research, in which patients’ participation is essential in defining safety and efficacy. Increasingly patient groups are realizing the vital importance in the role they play. What might happen if industry more equitably includes patients and their advocates? Could timelines be advanced if patient groups had benefits similar to research sites and CROs? What might happen if Food and Drug Administration Advisory Boards were required to meet with patient advocacy ambassadors to accountably explain how their recommendations impact future care and innovation?  

We know the past.  We have attended enough patient advocacy galas to acknowledge the need to learn from other successful models. Deploying data is the obvious, simple economic pathway for accelerating decision-making and growth. But, less obvious, data are also the currency that may enable patients and advocacy groups to accelerate their own missions, becoming full-fledged partners in driving innovation and drug development, while becoming stronger, more sustainable communities.