Episode description

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, 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.