Myth Vs. Reality: Patients Impede the Development Process and Should be Avoided
- by: Rivkah Block, PhD |
November 14, 2025 - Categories:
The idea that the cost of engaging patients in the development process is too much – too much time, too much money, too much work – is the worst sort of myth because it produces adverse outcomes for all parties.
To be sure, many companies have embraced patient-focused drug development as a standard best practice; nonetheless, the myth that patients are best avoided continues to mar the development processes of some in the industry.
If we dispense with the idea that patient engagement is not worth it, a symbiotic scenario emerges – one so breathtakingly simple that we should all attach it to our whiteboards to constantly remind ourselves to work toward it:
When patient engagement becomes routine, patients receive effective treatments that are manageable, and companies offer effective treatments that not only sell, but are born from a trial & approval process less likely to be delayed by unforeseen obstacles.
Let’s dig into the misperceptions perpetuating the myth that patient engagement isn’t worth it.
- Patients say things we don’t want to hear.
- It is a common misgiving. The pre-clinical research is done, the protocols are all but set. Someone suggests running the trial plan by a patient organization or patient council, and the warning signals sound. What if they say the study schedule is unreasonable? What if they want more support service for participants? What if we learn our primary endpoint is of little practical meaning to patients? What, in other words, is the upside? More input means more time, more accountability, and more money.
- Patients aren’t [scientists, HCPs, etc.]. They don’t possess the knowledge we need.
- Basic scientists, translational scientists, marketers, accountants, and a whole host of others have spent years, even decades, developing a treatment and have finally arrived at the threshold of a trial or on the verge of launch. It is a potential source of frustration to ask them to further delay the development process to gather input from patients, i.e. people who are assumed to lack scientific and medical knowledge, disease expertise, or any understanding of what sells and how to sell it. Patients, after all, may not have formal training or do this for a living.
- It costs too much time and money to involve patients.
- The misperception goes like this: We don’t know any patients! We will have to find them and connect with them and even pay them. Doing so is a very involved process that will only slow us down. We must focus instead on [IRB submission, comms plans, launch events, etc.].
The counter to these three misperceptions is the same:
The most thoughtful ways to serve patients and efficiently produce a product that sells are provided by patients.
Patient input shapes trials and protocols that patients will be able to manage. Patients know how many times they are willing to be poked, they know exactly how disqualifying a three-hour drive to the hospital is, they will tell you if sleeping over in the hospital is a dealbreaker but staying in a hotel is OK.
The chemistry-adjacent factors that will directly affect enrollment, retention, and completion—not to mention compliance, adherence, and uptake—provide developers priceless information.
These factors also save money. Recent McKinsey research estimates that a 12-month development acceleration “can translate to more than $400 million in net present value for the sponsor and deliver incalculable benefits for patients and their families.” The research focuses on the many factors causing protracted trial periods, including a growing number of assessments required by trials as well as a growing number of precision medicines requiring specific indications in trial participants.
Among the McKinsey authors’ proposed solutions is to simplify trial protocols and make them “patient-centric”; the time “saved” by not engaging with patients, in other words, adds more time via amendments, re-consenting, rebudgeting, recruiting, and setting up new sites. Which drives up costs.
This idea extends beyond trials. Pharma companies have had to rewrite and reshoot components of marketing campaigns that, after being made without patient input, received negative reactions. Asking a few patients what they think of a marketing plan before creating all the accompanying materials is more efficient than waiting to engage—or not engaging with them.
The final reason to engage with patients is that it establishes trust. After all, treatments are more easily distributed if HCPs and patients trust the pharma company releasing them. Not communicating with patients until a drug reaches commercialization implies that their input isn’t valued and risks damage to a company’s reputation, lest patients think that the company is not invested in anything other than selling drugs. How better to build trust with patients than involving them in the process?
As we say above, many companies have embraced this practice. Doing so illustrates patients’ value and helps developers identify and preempt obstacles.
The symbiosis of a well-planned patient engagement process is that everybody gets what they want: patients receive treatments that are manageable to take and are able to return to their lives as early as possible; companies are able to offer effective treatments, market them meaningfully, and, after experiencing fewer delays, sell them earlier.
To connect with Rx4good and discuss how you can better engage patients in drug development, email Chris Schultz at chris.schultz@rx4good.com.
