Public Trust in Clinical Research

Trial Better host and ERT’s VP of Trial Oversight/Chief Diversity Officer, Otis Johnson, is joined by Ken Getz, Founder and Chairman of CISCRP and a professor at the Tufts University School of Medicine. They explore the public perception of clinical research today, how it’s changed from the past, and what the industry can do to preserve these positive changes going forward.

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EPISODE NOTES:

 

To start off, why don’t you tell us about your experience in the clinical research field and a little bit about yourself.

I have had 30 years of experience as an observer of the clinical research enterprise. First, my involvement in management consulting; then I started a publishing company called Center Watch which captured a lot of data and observations about the research enterprise and published that information. After I sold Center Watch, I moved into academia and the nonprofit world and I have been there for about 20 years.

 

Ken, I know you are quite the advocate for building clinical research awareness, and you have certainly been a reliable source of data and insightful metrics on the clinical research industry. Why do you think the general has such a distrust in the pharmaceutical industry and in pharmaceutical development in general?

This is such a critical issue and is a perennial problem in the industry. This industry has had questionable practices in R&D as well as the commercial side. There are also some unethical practices that have gotten some visibility, particularly among minority community involvement in government-funded and industry-funded research. As an industry, we have not done a good job of educating patients and the public. As a result, we saw a lack of response and misalignment of messages that come from industry and the clinical research enterprise in general. If you look at the way clinical research is depicted in mass media, a lot of clinical research is depicted as studies that have gone horribly wrong with some dark or unethical practice, and that is often the kind of lesson the public gets when they learn about clinical research.

 

Throughout the pandemic, from February to July 2020, the percentage of the US population who gave the pharmaceutical research industry positive ratings increased by 22%. Some even referred to the industry as “cool”, which is welcome but surprising to hear. Why are we seeing such an uptick on confidence now?

This is a very exciting phenomenon, but we have to watch it carefully. To your point, there have been a number of global public opinion polls that have looked at a variety of sectors throughout our economy. The pharmaceutical industry being one of them, and it has enjoyed a bump in positive ratings. It is one of the only sectors where public opinion has maintained this positive bump throughout the pandemic. We think a lot of it has to do with the drug development enterprise being at center stage with a tremendous amount of public visibility. It hasn’t necessarily influenced public trust because awareness around activity rarely translates into behavior.

This confidence in clinical research might be rising, but we know the industry still needs to put in the work to repair and rebuild its relationship with the minority population.

I think it is widely known now that COVID-19 incidents and severity is much higher in minority communities. This is all part of broader awareness for the critical need of diversity and awareness in clinical research. If you look at a minority or a Caucasian community what you see are very high levels of awareness of clinical research. They will self report that they know what clinical research is, however, there is a significant disconnect between awareness about research and personal involvement in clinical research. Some of it has to do with distrust in clinical research and the drug development process.

 

Really good points, Ken, and I can share some of my personal interactions in my circles. Even in the minority population there is a difference of opinion in terms of if they should take the vaccine or not. If you look at healthcare workers in the minority population they feel as though they need to take the vaccine for their own safety, but for those not in the healthcare settings they will say things such as, “I am skeptical”, or “I don’t see the need to take it because of this distrust.” So yes, there is even a difference of opinion in the minority population about how safe these vaccines are.

That is such a great point! There is kind of an insular community when you’re in the healthcare environment. We forget as clinical research professionals the vast majority of the public has no real exposure to healthcare unless they’re facing the burden of disease.

 

There are obviously a lot of complexities that come into play. I don’t want to ignore the positives we have seen because despite all that, we were able to develop multiple vaccines much quicker than anyone anticipated. How did the industry work together to make that happen?

There is just so much that has happened. Clinical research is heavily regimented and methodical activity. Historically, we not only deviate from it, but we treat the way we operate in a very rigid way. The pandemic forced everyone to become much more accommodating and flexible. There was a recognition that we all need to step in together to protect patient safety. We need to conduct our research activity while helping each other succeed in this environment of high uncertainty with such a huge public health crisis. With that very accommodating and collaborative style, we saw pivoting and adaptation to embrace remote and virtual approaches where we could minimize infection to emphasize patient convenience in these approaches.

 

It is clear that the industry definitely rose to the challenge and collaborated around this common cause. How much of this is going to last beyond the pandemic and do you have any last recommendations around how we can continue to build trust in the industry?

As an observer looking in, we often watched how the research enterprise adopts changes in the way we operate and that adoption is incredibly slow. While there is a lot of hope that we will embrace some of the many ways that we have contributed to this accelerated development activity that has yielded some very exciting treatments. I think that we may end up looking at a lot of these adaptations as one time occurrences. Long-term, if we are unable to address the additional complexity that has been introduced through virtual and hybrid trial designs, we may be looking at companies that start to re-think which of the adaptations really deserve full focus and investment.


Transcript:

Ken Getz:
There’s a kind of an insular community when you’re in the healthcare environment. And that we forget as clinical research professionals, that the vast majority of the public, has no real exposure to healthcare unless they’re facing the burden of a disease.

Announcer:
Welcome back to the Trial Better Podcast. On today’s episode, we’re excited to welcome Ken Getz, Founder and Chairman of CISCRP and a professor at Tufts University School of Medicine. Ken will share his thoughts and how the pharmaceutical development industry can seize the momentum of its COVID-19 response, to improve public perception in the long run. Listen now as Trial Better host Otis Johnson discusses with Ken, the importance of taking advantage of this opportunity to increase global trust and
clinical research.

Otis Johnson:
Hi everybody and welcome to the Trial Better Podcast. I’m your host, Otis Johnson, ERT’s Vice President of Trial Oversight and Chief Diversity Officer. Today, I’m looking forward to a very interesting discussion on public perception of the pharmaceutical industry with Ken Getz, Founder and Chairman of CISCRP and a professor at the Tufts University School of Medicine. Ken, thanks for joining us.

Ken Getz:
Thank you so much for the invitation Otis. It’s my pleasure to be here.

Otis Johnson:
Great, great. Well, to start off, why don’t you tell us a little bit about your experience in the clinical research field and a little bit about yourself as well?

Ken Getz:
Well, thank you. I have about 30 years of experience really as an observer of the clinical research enterprise. First through my involvement in management consulting, and then I started a publishing company called Center Watch that captured a lot of data and observation about the research enterprise and clinical trials activity and published that information. After I sold Center Watch to Thomson Reuters, I moved into academia and the nonprofit world, and I’ve been there for about 20 years. So I’ve always been an outsider looking in, no shortage of things to think about and write about and data to gather about behavior of research professionals, conducting and involved with clinical research.

Otis Johnson:
Great, great. Ken, I know you are quite the advocate for building clinical research awareness and you have certainly been a reliable source of data and insightful metrics on the clinical research industry. Why do you think the general public have such a lack of trust in the pharmaceutical industry and in pharmaceutical development in general?

Ken Getz:
Yeah, it’s such a critical issue and it’s one that is one of the perennial problems that we see in this industry. It has been around for quite a long time, and it really speaks to a long history that we’ve had as an industry of questionable practices, both in R&D, as well as on the commercial side, when we look at the pharmaceutical pricing and profit taking, for example, and some of the unethical practices that have received a lot of visibility, particularly among minority community involvement in government funded and industry funded research. So, that’s certainly been a part of it. I would say the other part is that as an industry, we’ve generally not done a good job of educating patients and the public. In fact, most often, research professionals are advised not to respond to the immediate inquiry or a complaint from a patient group.

Ken Getz:
And so as a result, often we saw a lack of response and even misalignment in the messages that come from industry and the pharmaceutical and clinical research enterprise in general. Often what we talk about as an industry, or when we’re interacting with the public, are our therapies that we’ve developed and how well they’re working and how exciting they are, and if they represent a particular breakthrough in the way that we’re treating a given disease. Whereas, often the biggest visibility and concern that the public may have really relates more to errors and a lapse in judgment on the part of professionals managing research activity. So that’s been a part of it as well.

Ken Getz:
And one other thing I was just going to mention Otis, which is sort of fascinating, is if you look at the way clinical research is depicted in mass media and in popular culture, think about movies like Dead Pool, for example, a fairly recent Marvel movie or The Fugitive. These are usually about clinical research that has gone horribly wrong, where there might be some dark or sinister practice, dishonest and unethical practice, and that’s often the kind of lesson that the public gets when they learn about clinical research.

Otis Johnson:
Wow, indeed. One can certainly understand how these practices you described and the perceptions can lead to such negative sentiments towards the industry. Throughout the pandemic from February to July 2020, the percentage of the US population who gave the pharmaceutical research industry positive ratings increased by 22%. some even referred to the industry as cool, which is welcome, but surprising to hear. Why are we seeing such an uptick in confidence now?

Ken Getz:
Yeah, this is an exciting phenomenon, but it’s one that we really have to watch carefully because it’s very nuanced. To your point, there’ve been a number of global public opinion polls looking at a variety of different sectors throughout our economy, the pharmaceutical industry, being one of them. And it’s really enjoying such a bump in positive ratings, as you mentioned, almost like a renaissance. And it’s one of the only sectors where public opinion has stayed elevated since we entered this pandemic period. Other sectors in the global economy took a bump at first, and then they’ve settled back down.

Ken Getz:
So we think a lot of it has to do with the fact that the drug development enterprise and the pharmaceutical industry, is sort of center stage right now. It’s getting a tremendous amount of public visibility, and even more than that, there’s so much hope and faith in the abilities and the talents of the many professionals, the scientific and operating professionals in our industry, to all get together with regulatory agencies and health authorities, to address this incredibly critical global health crisis and global health need. And that’s, I think, really played a huge part in elevating public awareness. It hasn’t necessarily influenced public trust though. And that’s something that we really need to think about in part, because awareness about activity that’s going on, rarely translates into behavior, and we’re seeing that now as well.

Otis Johnson:
Yes, indeed. So this confidence in clinical research might be rising, but as you said, we know that the industry still needs to put in the work to rebuild and repair its relationship with the minority population in particular. Can you talk a little bit about that?

Ken Getz:
Yeah, I think it’s widely known now that COVID-19 incidents and severity of the disease or the infection, is much higher in minority communities. And so this is all part of a broader awareness of the critical need for diversity and inclusion in clinical research, and it’s even more pronounced as we look at the inequities in terms of COVID treatments and in terms of the severity of the illness and its incidence, so, that’s a big part of it. And this really relates to what I was just describing. If you look at any given community, a minority community, or an underrepresented community, or a Caucasian community, what you are seeing are very high levels of awareness about clinical research. If you ask people, “Do you know what a clinical trial is?” They’ll self-report that they do, and it’s at an even higher level now then it’s been in the past. But when you dig beneath it, you start to see that there’s a disconnect between awareness about research and about personal involvement in clinical research.

Ken Getz:
And some of it has to do with that distrust that you and I were talking about. Some of the distrust is even born from awareness of the speed with which vaccines have been developed. And there’s a concern that maybe the drug development community has cut corners. How else could they possibly have achieved a 75%, 80% speed reduction? So here are just some examples. While the awareness of clinical research is really high among minority communities, nearly 40% perceive the clinical trials in general is unsafe right now, much higher than they used to. And nearly 60% have said that they’re unwilling to participate in a trial right now, and that compares to single digit numbers that we used to see before the pandemic.

Ken Getz:
And as for COVID vaccines and treatments specifically, about 50% of part of respondents to our survey from minority communities, said that they were concerned about the drug development process, and about a third were telling us that they’re unlikely to participate in this round of vaccination activity. So there’s that disconnect between high visibility and high awareness about clinical research activity, and internalizing and recognizing that every one of us has a personal part to play in addressing the pandemic.

Otis Johnson:
Yeah, really good points Ken and I can share some of my personal interactions in my circles where even in the minority population, there is a difference of opinion in terms of whether they should take the vaccine or not. If you look at the healthcare workers within the minority population, they feel like they need to take the vaccine for their own safety. But for those that are not in the healthcare settings, they will say, “I’m skeptical. I don’t see the need to take it because of this distrust.” So yes, there is even a difference of opinion within the minority population about how safe these vaccines are.

Ken Getz:
Yeah. That is such a great point. And it’s something we’ve seen in other studies we’ve done as well. There’s a kind of, an insular community when you’re in the healthcare environment. And that we forget as clinical research professionals, that the vast majority of the public has no real exposure to healthcare, unless they’re facing the burden of a disease, right? And so there’s that real disconnect and that’s the
group that we really need to reach.

Otis Johnson:
Yes, indeed. So there’s obviously a lot of complexities at play here, but I don’t want to ignore the positive that we’ve seen, because despite all that, we were able to develop multiple vaccines quicker than anyone anticipated. How did the industry work together to make that happen?

Ken Getz:
I wish we had like a five hour podcast to really tease this apart. There’s just so much that has happened. As you know, and I imagine as so many listening to this podcast know, clinical research is a heavily regimented and methodical activity. And historically we often, not only do we not deviate from it, but we sort of treat the way we operate within this environment in a very rigid, some would even say, immutable way and what the pandemic did, is it forced everyone to become more accommodating and more flexible. There was this recognition that we all need to sort of step in together and protect patient safety, but we need to continue to conduct our research activity while adapting and adjusting and while helping each other succeed in this environment of high uncertainty, with such a huge public health crisis, where all of us can really do something important and address this incredible global hope that is now being placed in us as an enterprise.

Ken Getz:
So with that very accommodating and more collaborative style, we saw regulatory agencies, the oversight mechanisms, including ethical review, industry, the investigative site community, patient communities, technology providers, all different stakeholders, I think really approach this in a far more accommodating and flexible way. And we saw, as I know you know well, so much pivoting and adaptation, really embracing remote and virtual approaches where we could minimize the risk of spreading infection, for example, to really emphasize patient convenience in clinical research through these approaches that might bring the trial to the patient’s home. Data could be collected remotely. We saw heavier usage of data access during interim periods where we could make different adjustments, not only in the science and the design of the trial, but we could adapt the way we were executing our studies.

Ken Getz:
And of course, we also saw incredible public interest and patient interest. And I would even say patient advocacy group commitment to helping the research enterprise here. And that played a big part, especially in the Operation Warp Speed trials, where some of the studies were able to enroll 40, 50,000 people in record time. So all of this really contributed to a hyper-accelerated time period. And one last thing Otis, we don’t want to forget that Operation Warp Speed also freed up a lot of dollars in order to invest in the approaches that were necessary to support this flexibility and this speed.

Otis Johnson:
Yeah. So it is clear that the industry definitely rose to the challenge in this respect and pivoted well and collaborated around this common cause. How much of this is going to last after the pandemic, and do you have any last recommendations around how we can continue to build trust in the industry?

Ken Getz:
Yeah. This is the question that everybody’s asking now. And as I mentioned, right at the beginning of our discussion as an observer looking in, we’ve often watched how the research enterprise adopts changes in the way we operate and that adoption is incredibly slow and in many respects, it can be highly dysfunctional. So while there’s a lot of hope and faith that will embrace many of the approaches that have contributed to this accelerated development activity that has really yielded some very exciting treatments for COVID-19. I think that we may end up looking at a lot of these adaptations as one-time occurrences, as almost like a pilot or a proof of concept that was, that unfolded as facilitated by a public health crisis. But unless we address some of the fundamental characteristics of our development activity, the fact that our protocols are so hyper-complex today, and as a result, very, very inefficient.

Ken Getz:
We have a tremendous level of customization in our studies. We collect a remarkably high volume of data coming from diverse sources and all of these things add to larger and growing costs to conduct our studies, longer cycle times, higher levels of unpredictability and inefficiency. Long-term, if we’re unable to address the additional complexity that’s been introduced now, we may be looking at companies that start to retrench and rethink which of the adaptations or some of the newer areas really deserve full focus and investment. And a lot of it, the decision to embrace something long-term comes with a real understanding of the return on the investment that’s been made. And we don’t have that insight right now. We’re doing these changes out of necessity, but we don’t have a business imperative to continue to support them.

Otis Johnson:
Great, great. So lots of useful nuggets in there, Ken. It appears that it’s not just the speed of developing the vaccine and security and regulatory approval that is driving confidence in the industry, it’s also a genuine display of interest in getting the vaccine to people and the recognition that the work of clinical research doesn’t end when a drug or vaccine is approved. And as an industry, we need to stay involved in delivering the ultimate value. That is how we build trust in our industry.

Otis Johnson:
So with that, Ken, I want to thank you again for joining us on this episode of the Trial Better Podcast. I think we learned a lot about the amazing opportunity we have right now as an industry to build trust and improve the way people perceive clinical research. Please remember to comment, rate or review Trial Better on Apple podcasts or your favorite podcast channel. You can also reach out to us at trialbetter@ert.com with any questions or suggestions. Thanks for tuning in for this episode of Trial Better.

Announcer:
That’s a wrap on this episode of Trial Better. Thanks to Ken for the great discussion on public trust and clinical research and how COVID-19 has presented the industry with a unique opportunity to change its relationship with the public. To stay up to date on all of the latest content from Trial Better, subscribe to Trial Better on your favorite streaming platform. Questions or comments, email trialbetter@ert.com. Until next time, thanks for listening to Trial Better.


FEATURED GUEST:


Ken Getz

Ken Getz, Founder and Chairman of CISCRP

Ken Getz is the Director and a professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise. A well-known speaker at conferences, symposia, universities, investor meetings and corporations, Ken also holds a number of board appointments in the private and public sectors. He received an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University.


ADDITIONAL RESOURCES:


Visit the CISCRP website

Visit the Tufts CSDD website


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