Patient involvement and the future of clinical research [PODCAST]

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Most clinical research treats patients like data points. What gets lost when researchers stop listening to the people they study, and what does it cost the science itself? Niharika Singh is a biomedical engineer and pre-medical student with research experience at Genentech, Abbott, AstraZeneca, and the Keck School of Medicine, and a global ambassador with the United Nations SURGhub. She discusses the KevinMD article “Patient involvement transforms modern clinical research.” You will hear the difference between treating a patient as a data set, engaging them as a collaborator, and inviting their emotional and lived experience into the study design. She walks through the Tiger Project hernia training across India and Ghana, what medical device design verification taught her about surgical research, and why AI in medicine is making patient voice harder to hear. You will hear a research methodology that treats the patient’s voice as data worth collecting, and a case for defending human connection as AI changes how medicine is practiced.

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Transcript

Kevin Pho: Hi, and welcome to the show. Subscribe at KevinMD.com/podcast. Today, we welcome Niharika Singh. She is a pre-medical student. Today’s KevinMD article is “Patient involvement transforms modern clinical research.” Niharika, welcome to the show.

Niharika Singh: Thank you so much. It’s a privilege, and I’m very grateful that you have me on the show.

Kevin Pho: All right. So why don’t you tell us a little bit about yourself, and then jump right into the article, and then why you decided to share this particular article on KevinMD.

Niharika Singh: My background is in biomedical engineering. I hold a master’s from the University of Southern California, and I have extensive medical device research experience at top-tier companies like Genentech, Abbott, Keck School of Medicine, and AstraZeneca, where I led a number of projects.

I pivoted toward pre-medical school because I realized, while I was in the medical device industry, that I understand medicine better when I work in it directly. So this fall I am joining Fordham University to begin the pre-med track and then medical school.

Along the way, because I wanted to understand surgery in detail and how surgical research happens, I joined SurgHub, the United Nations Learning Global Surgery Hub. I took on the role of SurgHub global ambassador, where I advocate for what we learn, explain how clinicians can benefit from the program, and work to understand my own fundamentals of surgery and human medicine.

While I was going through a certification program called Community Involvement and Engagement, I saw an alignment between my medical device background and surgical research. And as I went through the article, I realized that surgery is really not using the patient’s voice.

So why is it not being used? When I went into the deeper technical details, I understood that I needed to advocate, to take my personal perspective from my medical device journey and help clinicians understand that the patient really matters. That is why I wrote this research article from my own perspective: that patient involvement in clinical research really does transform medical research and the physician’s perspective.

Kevin Pho: All right. And for those who didn’t get a chance to read your article, tell us what it’s about.

Niharika Singh: Sure. As I mentioned, it is about the patient’s voice. The program teaches detailed research methodologies, SWOT analysis, and so on, to dig into the numbers as qualitative research. But to bring in the holistic perspective of the patient, it taught me about patient involvement, engagement, and participation.

To me, I thought these were all the same, but from the perspective of research and SurgHub, they are very different. Participation means seeing the patient as a single data point. We get clinical data sets from there, draw inferences from the data, and reach our results. It is as simple as that.

The second is engagement. When we share educational resources with our patients and teach them, they connect with us and understand why we are doing the research, and when we understand the why, we are more involved. The third step is direct engagement. When I say engagement here, I mean making the patient a part of your research holistically and completely.

So when I talk with them about the why, I also take their feedback. When that loop completes, the way an electronic circuit loop completes, you get those added references back. You understand whether the study you created is working well, whether it is moving toward the result you wanted, or whether you are diverging from what the patient expected.

So if we take their voice and give them that power, telling them, yes, you are valuable to me as a resource, you help me better interpret all the tests I have run, you are powerful to me. I value you as a patient. You are not only someone I care for and take care of; you are actually giving a great deal back to me, serving as data at the fundamental, global level.

When I learned this, I thought, yes, I come from the medical device industry, but this kind of enhancement is really needed in surgical research, because we are missing the root, core analysis. We go by the numbers, we go by the qualitative research. So what about the patient’s emotional connection?

The machine does not tell me about that. Why is the patient developing this disease? The machine tells me it is genetics, but there is something more going on, maybe in the patient’s family, maybe their own emotional upheavals, maybe traumas, maybe things we do not know about, the environment, where they are picking something up.

That is what opened my eyes. That is why I wrote this article, and that is what I learned. One more thing I want to touch on: The program gives case studies. There were three case studies, and I will focus on one, the TIGER project. This TIGER project was run as a clinical trial in India as well as in Ghana.

While they were running it, they were trying to understand whether they could give something more to their patients. There was a shortage of surgeons to treat hernia, so they wanted to find out whether, if they gave education and training to non-surgeon physicians, those physicians would be able to treat hernia patients.

Through community involvement, once the policymakers, the hospitals, and the local patients were all involved, it became clear that in India this could not be done, because the laws restrict it, but in Ghana it could. So there were pivotal moments in that research.

The modifications and policies were made, and more educational and research materials were developed for non-surgeon physicians, so that they could begin to operate on hernia patients in Ghana. It taught me that level of detail, and it came from the real world, from the doctors and researchers who had actually done this work and were telling me about it.

I was blown away. I thought, first of all, this comes from the United Nations, and second, I come from the medical device industry, so everything connects. I have not set foot in Ghana, but I know what is happening there. So this is what it is all about.

Kevin Pho: So in general, for these clinical research studies, how much patient involvement typically is there just in general for clinical research studies?

Niharika Singh: I am not aware of the exact numbers, but from what I have seen, we have statistics from the literature review and from current research. If I have 100 patients, for example, not every patient is the one giving me the result I want; some of them may be outliers.

So if I say around 60 to 70 percent, we are using people as patient data. We are not asking, what is your problem? Why is the medicine not working for you? Did you actually take your medicine? Where are those questions? Because if we asked them, if we understood what the problem is and how it started, we would get to that core, and that would give us the feedback.

So patients are being used as a data set, but they are not being involved and engaged. We lack that engagement. We need to pull the complete information out of the patient, because the patient is the one living that life. We only see them for an hour or two at a time in our clinics.

So in percentage terms, I can say we are taking 80 percent of the data from patients, but are we actually capturing 100 percent of that 80 percent? No, we are not.

Kevin Pho: So I’m hearing that whenever patients are included in research studies, they are reduced essentially to a data point, a number, and we’re not getting much of the qualitative input patients have. We’re not giving them, say, free-form responses to capture some of their input. So tell me, what kind of input, what kind of feedback, do you think would be useful to ask patients for in a clinical research study? What kind of questions would you ask them?

Niharika Singh: Great question. Let me give you my perspective. I am also a consciousness educator, so I teach people, and I understand emotional intelligence and emotional questions. If a person comes to me and says, “I am facing suicidal thoughts. I am taking medicine prescribed by a therapist, but it is not making me feel any better,” I would recognize that the medicine is there, but I would ask: Why do you say the medicine is not working?

Tell me about the day-to-day activity you are going through. Have you been meditating? If so, for how long? What sort of people are you meeting every day? What are you reading, and what are you listening to? Are you listening to things that demoralize you?

Are you connected with positive people who pull you up, or are you sitting alone, drained in your own thoughts? Are you really working on your mind? Are you working on your subconscious, or are you just taking medicine? Because when I ask these questions, I understand that there is a connection between your subconscious and the medicine.

For the medicine to even work, your subconscious has to come up to a certain level. So with this knowledge, I ask the very niche, rare questions that nobody else asks, and that is why the patient’s feedback is important. When I get that feedback, I understand: If you are not meditating, if you do not have an understanding of your own thoughts, then where is the subconscious connected?

Without it, I would not be able to work out the correct diagnosis, what medicine to prescribe, or whether I should reduce the dose or change something. Those moments of happiness have to come through. The patient has to tell me through that emotional connection, and I should be able to feel the energy of my patient.

I should be able to tell whether the patient is really telling me the truth. Is he open and comfortable enough to share the truth he holds at his core? Those are the kinds of questions I would ask in addition to the research questions I have formed, and that is where the real truth comes out in my research.

Kevin Pho: Now, in general, do clinical researchers have the bandwidth to interpret this additional, free-form qualitative data you are asking patients to provide? I know researchers are resource-constrained. Do they, in general, have the bandwidth to interpret and assess this whole new batch of data?

Niharika Singh: Great question. That is what the change is about. In the world of AI, we are losing that human connection, and that is why I think this article, my own knowledge, and the current knowledge on the SurgHub platform are important. Because if it opened my eyes, it can open the eyes of clinical researchers who are already practicing.

It can tell them: We are entering the era of AI. We know we do not have the bandwidth, but we need to bring that change within ourselves, so that when something happens to us, we do not let it happen to our patient. That is why we are doctors. That is why we are physicians. We need to bring that change, and when the bandwidth is important enough, I know it gets created, because I can see that change happening in the world of AI in medicine.

AI swept through our systems and our daily lives because it earned the bandwidth, because we started to adapt. It was important. It was giving us something we did not have before. That is exactly what patients are. We do not know what they are facing. We have all of these things. We have protocols. We have diagnoses.

We have our machines. So we need to give that space, and the benefit of the doubt, that something is being missed by the physician’s eyes. We need to keep our eyes wide open, unless AI starts to pick that up, though AI will also lack that human connection, that much is sure. AI has made space in our world, but patients existed before AI, so we need to make that change.

Kevin Pho: Now, you mentioned earlier that you are going into the pre-medical path soon after a whole world of involvement with clinical trials and medical devices. Tell us how your past perspective, with medical devices and clinical trials, is going to influence you on the medical school journey you are just starting.

Niharika Singh: First of all, it was a journey of self-transformation, where I came to understand that I lacked an understanding of my own self. That perspective is important for helping me understand the patient at their core. Can you understand yourself? Can you tell me the truth? Are you comfortable telling me the truth?

That is the first thing that will help me understand patients on a deeper level. The second is that when I do research, whether surgical research or any kind of medical research, I see an alignment with data validation, design verification, and validation. So how does medical device research start?

It starts by understanding the user in order to make the product, and then doing design verification and validation. In validation, I go to the human factors team, and they conduct real-time interviews with the patients as the patients use the devices. We record their dexterity, we record whether the patient is able to read the IFU, the instructions for use, or whether we need to change something.

Design verification happens when we go into the labs and say, we need a 45 degree angle in our prefilled syringes, in our needle. Can we achieve a 45 degree angle successfully? That is device verification. So when I apply the same analogy to surgical research, there is a part of data validation that comes from clinical validation.

So when I engage patients, not just involve them and help them but let them participate and truly engage with them, that is where I pick up the data validation part. In this course, I realized that we built a tool called Hernia Q that validated the patient, so that what we developed is actually used by a patient.

It does not divert from our alignment, in the sense that we are not failing to affect the patient. The patient should be affected. Medical device research and development was based on a core philosophy of patient safety and efficacy, and the same rule, in an even deeper form, applies in surgical research.

So those are the two core perspectives I would bring, and the third is emotional connectivity and receptivity. If the patient is not able to speak, do I still have indirect ways to pick up what he really wants to tell me? Am I good enough at that? I am building on that piece. So these three pieces connect together, giving me a philosophical understanding of global mindsets, because it is not only about understanding patients from Korea, or India, or the U.S. It is about understanding global health equity. Is everybody included? I cannot leave anybody out, because that is what makes a great doctor. They understand people first, before they give a diagnosis. They use their hands, they use their senses, they observe the patient. So these skills have developed in me, and as I read more and am exposed to more books, one such book is The Elusive Body, which came out recently. It taught me that we are missing a lot, and I was already focused on the patient’s voice.

The second book was Psycho-Cybernetics, written by Maxwell Maltz years ago, where he helped us understand that if you want to change the patient, you change the internal core, because if you do the plastic surgery, they may not be able to accept the change. But if they are changed internally, that change will drive their external acceptance of it.

So these perspectives, and my real, lived experiences, meeting people and students with many disabilities, with conditions like Parkinson’s and ADHD, sitting with them, studying with them, learning from them, are the core truth of my existence.

Kevin Pho: We’re talking with Niharika Singh, clinical researcher and pre-medical student. Today’s KevinMD article is “Patient involvement transforms modern clinical research.” Niharika, let’s end with the take-home messages you want to share with the KevinMD audience.

Niharika Singh: First of all, you see the SurgHub icon, but I am more than that. I am here to advocate for SurgHub, which is doing a great deal for the surgical world, because surgery needs to be advocated for.

Real surgical care needs attention. We need to keep our patients safe, help them come out of disease, and treat them well. That is the first and foremost goal. My second message is that in a world where AI is already embedded, and where the systems are further ahead than we can imagine, we should understand our own originality and not lose it.

By that, I mean if you feed the AI something original to your own thought, that is new to it. But if you use data that already exists, that is already fed into the AI, it will give you results that already exist. So focus on that originality. Do not let that originality be lost, because you do not want to make the machines your boss.

You want to be the boss, so be the boss. That is the core message. So: surgical care, originality, and the connection to yourself, because the universe is bigger than this machine. You may not know it, but maybe the universe is operating this machine, because consciousness is the machine as well as you. It is just not decoded yet.

It is not researched, but it already exists. That is why some people are able to read the signs and symbols of dolphins, because dolphins are more emotionally intelligent than humans. We have not yet come up to par with what our environment is offering. So if we bring that perspective into our own diagnosis as physicians, and step outside the data that already exists to see what our own newness is, it will keep us away from false negatives and false positives, and give us a renewed, fresh perspective, the one we miss when we only read the existing data.

So we need to understand the value of giving ourselves that space in our minds. That practice is important. So these are my messages: Save the world with your originality, do not let the machines become the boss, and be the boss.

Kevin Pho: Well, thank you so much for sharing your perspective and insight, and thanks again for coming on the show.

Niharika Singh: Thank you, Kevin. It was a wonderful episode.

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