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Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses:

Industry’s greatest challenges in reaching diverse patient populations

Podcasts

Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more. 

Reaching Diverse Patient Populations With Personalized Treatment Methods

With close collaboration between sponsors, CROs, and regulators, this emerging technology has the potential to greatly improve the lives of patients.

Clinical Strategies to Optimize Software as a Medical Device to treat Mental Health

The future of clinical trial design involves incorporating the patient experience into strategic asset planning.

Tapping the Patient Voice as a Strategic Differentiator

The clinical trial industry has a rare opportunity to redefine its role in public health conversations. 

The Gatekeepers Are Gone: What’s Next for Digital Patient Engagement?

Research collaboration between Tufts and the Society for Clinical Research Sites explores the prevalence of this belief in healthcare.

What Does Racial Color-Blindness Mean for Clinical Trial Participation?

Recent research is showing medical treatment for pregnant women often relies on clinical data from non-pregnant female patient populations.

Pregnant Women: An Underrepresented Group in Clinical Trials 

In this video interview, Derek Ansel, vice president, therapeutic strategy lead, rare disease, Worldwide Clinical Trials, highlights the Rally for Rare event and how it succeeded in providing the community a space for collaboration and innovation.

2025 Rally for Rare: Bringing the Rare Disease Community Together

, Derek Ansel, vice president, therapeutic strategy lead, rare disease, Worldwide Clinical Trials, discussed the unique challenges in rare disease R&D, including competing priorities among researchers, difficulty in diagnosing and treating patients, and defining endpoints due to varying symptoms. Ansel also touched on the potential of technology and artificial intelligence to address some of these challenges and improve rare disease research.

ACT: Could you tell our audience a bit about the Rally for Rare event and its importance in raising awareness around rare disease research?

Our Rally for Rare event was a last-minute event, I will say. We were very much looking forward to attending the combined NIH-FDA, Rare Disease Day event in Bethesda that was postponed, and that event is so important, one, because it is an avenue for both patients, caregivers, those affected in the rare disease community to collaborate directly with researchers and physicians at NIH, at FDA, and other various scientific consortium and it really sets the precedent for global engagement in rare disease research. It's quite a remarkable event, so the fact that the event was postponed, really represented a gap for that collaboration. The work that these institutions do for rare disease research is critical and having that platform to discuss all of the things that I've mentioned thus far, a commitment around global awareness and engagement, commitment on endpoints, and removing those barriers and removing the red tape to drive rare disease research is really the pinnacle of that event, so Rally for Rare was our response to continuing that conversation, allowing those who otherwise would have been at that event to come and share in that space the same platform discussion and innovation they would have had at that event. It was held on Rare Disease Day, February 28, and we welcomed everybody in the rare disease community, patients, caregivers, advocacy groups, researchers, those of us in the industry to again, to continue that conversation. We use the term “rally for rare” to again, represent just how important this day is, Rare Disease Day, but also just because the event was being postponed to a later date in the year, that it was still important to have that conversation on that day for all the various reasons that I've mentioned.

Videos

In this video interview, Derek Ansel, vice president, therapeutic strategy lead, rare disease, Worldwide Clinical Trials, talks collaboration and maximizing resources among the various stakeholders in rare disease research.

The Role of Collaboration in Advancing Rare Disease Research

ACT: Is there anything you would recommend to help advance rare disease research from a policy or strategic perspective?

Another great question. I think it's really about collaboration. Now more than ever, I think the rare disease community and its various stakeholders need to really join forces to support and maximize really every resource available to the community. As I mentioned earlier, if you think about finances, there’s only so much money to go around. For example, if rare disease advocacy organizations could join arms, link together, and share additional funding to support research initiatives or research projects or clinical trials or registries that overlap with other groups might warrant financial benefit to those groups. I think coming together also supports conversations with regulatory authorities. By having a unified front, by working together, there's greater strength in greater numbers, and I think that's particularly true for regulatory authorities. From data sharing infrastructures, I think it's important that even our biotech partners and pharmaceutical companies, who spend a lot of money, time and energy developing programs in are disease, have some sort of exit strategy, whether, if the drug is not as safe and efficacious as we thought it was, using that data and other venues, are there patient advocacy organizations who would ingest that data and can use it to support subsequent clinical trials, so that another biotech company who's looking to research in the same disease doesn't have to start from square one at the very beginning. I think the lens of true collaboration, at least in industry, could really benefit all communities, I think, for drug development, at least for the time being.

In this video interview, Thierry Escudier, portfolio lead, Pistoia Alliance, highlights the need for maintaining data privacy in a highly regulated clinical research industry.

Maintaining Regulatory Adherence with Clinical Technology

, Theirry Escudier, Portfolio Lead, Pistoia Alliance, discussed the alliance’s newest initiative to assess the carbon footprint of clinical trials. The initiative aims to answer whether decentralized clinical trials positively or negatively impact carbon footprints. Escudier also discussed how clinical research stakeholders are slowly beginning to adopt more sustainability practices, focusing on reducing waste and costs.

ACT: What would you say to stakeholders who are still unsure of implementing more clinical technology?

I think it's very much beyond, I would say, the technology itself because, as we can see we are able to speak to each other. I think we have, maybe the Atlantic Ocean between the two of us, and we are still able to interact as we were in the same room, so the technology is there. It's more the question of data privacy in particular, I would say, for patients in using those technologies, we have to ensure that the data privacy is respected. In particular, that for the pharmaceutical sponsor, they shouldn't know anything about the patient identity that should be disclosed and things like this, so there is some of the regulatory, ethics, also difference between, I would say, all countries. Even I would say we have the global ICH E6 that is defining the way clinical studies should be run, but each country may have this their own ethics, let's say mindset, as well as data privacy and therefore, of course, there is sometimes also that fear from the pharmaceutical sponsor side is that, if I'm doing something brand new, is it going to be accepted by the regulatory when I will submit my dossier? That's why, very often the technology is very much, I would say, on line, with the technology of daily life, like even you can look to your bank account, I would say, using the web and so on, and you can interact with friends, but then, as you know, clinical trials are so regulated for the sake of protecting the patient and also the quality of data, that sometimes pharma, I think, is a little bit anxious to move towards those technologies until there is maybe some new guidance. As everyone had to deal with the pandemic crisis, with COVID, of course, there was an increasing speed of trying to adopt some technology, because no one was able to travel anymore, even the patients, they were, I would say, less accepting to travel to the to the sites. The monitors were not able to go anymore to the to the sites to review the source documents, so there was some attempt to try to look to the source documents, but depending on the countries, it might be very difficult. Now that we are back in what I would call a normal situation, after, indeed the very high increase of using technology during the pandemic, there was almost not a shift, but okay, let's come back to what we know, what we master, and let's see how the regulatory will help us, so that's why some of the recent guidance, the one from the EMA and the FDA regarding decentralized components is helping very much the pharmaceutical industry, as well as the CRO service provider and the tech provider to be a little bit more comfortable in the way they can think on implementing those new technologies, but yes, clinical research is a specific word, with a lot of concern for protecting patient data and making sure that you have no deviation, that you have a harmony between standardization across all sides, and of course, depending on the country, it might be very different.

In this video interview, Thierry Escudier, portfolio lead, Pistoia Alliance, discusses how an emphasis on patient centricity can encourage more sustainable trial designs. 

Sustainability by Design

ACT: In terms of sustainability, how have clinical research stakeholders been responding to challenges such as operational costs?

 If you start to think differently and looking to what do I need, really, in my trial? Once again, it's also part of the overall new concept, but it's not anymore really in the EU now on the patient centricity and patient engagement is, if we think, in the place of the patient, what matters for them, and it's one of the reasons we have so much concern in terms of patient recruitment. It's also well known that in most of the trials there is difficulty to recruit patients and/or to keep them in a trial, because sometimes there is too much burden. If you start to think differently, thinking more on the on the patient side, then you also start to think on the way you can design your trial. Maybe you can reduce some of the visits. Do you really need to have all those patient visits in the flow chart? Like maybe we can keep the visit, but we could have, I would say, a phone call, instead of asking the patient to cross the city, to go to the hospital, all those things, and in particular, with the technology, because now you could even have those Zoom calls, Teams calls that you can even put in place. You could also have all those new tools that you can give to the patient on those apps that will remind what they have to do, when they have to come, what type of data they have to record, so there is maybe some new ways of thinking on designing your trial, so that's what we call now sustainability by design. Instead of doing what we have been doing forever, can we think differently in maybe designing the trial somewhat differently, of course, keeping the most important, that is to say, ensuring that the safety of the patient and being able to assess the efficacy, because that's the rationale of doing those clinical trials, but maybe if you do that a little bit differently, you could act on two sides, reducing the cost in a way, reducing the carbon footprint, and at the end, it's a win-win situation for everyone.

In this video interview, Thierry Escudier, portfolio lead, Pistoia Alliance, talks the current landscape of sustainability in clinical trials and how stakeholders are beginning to pay more attention to carbon footprint amid increasing protocol complexity. 

A New Era for Sustainability in Clinical Research

Except a few, let's say, front-edge companies, that have already looked to that domain for a couple of years, I guess most of the clinical leaders have never really considered the sustainability, because I think no one has really assessed in the past, in fact, the impact of the clinical trial implementation. Everyone is focused for decades about ethics, about safety, about regulatory compliance, keeping I would say those trials within the budget, within the timelines, make sure that patients will, I would say, accept to be part of those clinical trials, having good data, good quality, so all those things with an increasing complexity of the trials, this has been proven many times by those studies from Tufts, it's clear that the protocols are becoming more and more complex. There is more and more, I would say, demand on both the investigator side and on both the patient and everyone was focused on that, and it's only in the recent days that there was a new mindset that is appearing to say also, well, clinical trials are not equal to zero in terms of carbon footprint, and because this is an overall action and implementation, can we reduce that impact that now people are also looking and a couple of comments is, is not to oppose, I would say, the sustainability versus the cost, because, if you think also in a different manner, one of the other issues in clinical trials is the waste, waste of packaging, waste of blood samples that are not used and even they are sent to the site, some waste of the drugs even now with all the IRT system, you can really more control, I would say, the number of supplies you are sending, but still, there is a lot of waste and this waste is purely, I would say, carbon footprint, but also it's a waste of money.

In this video interview, Rachael Higgins, chief commercial officer, PicnicHealth, discusses industry’s next steps in being able to maximize the benefits of virtual models.

Executing with Clinical Technology

, Rachael Higgins, chief commercial officer, PicnicHealth, discussed the company’s recently released 

2025 Annual State of Observational Research Report

. She highlighted some of the key findings including the persistence of more traditional research methods as well as how patient retention and incomplete data are creating challenges for the industry.

ACT: Looking forward, what do you think are the next steps for industry in closing the gap between the need for technology innovation and actually being able to execute with it?

I think it all is going to come down to education and getting our customers comfortable with how new models actually work. It is embracing new technologies that are out there, perhaps it's doing a pilot or doing a softer launch of it, but that way to be able to see that. Number one, it's really not that scary. Number one, it's going to solve your data depth issue, it's going to solve your patient retention issue, it's going to solve your budget issues, just giving it a test trial, if you will. I think that that really is the only way that we're going to be able to do it. When I looked at the results of this report, I saw that 61% of them are already using some type of virtual model in AI, and to me, that's a huge opportunity, because, there's 40 something percent of them that haven't, but I think it's because they truly don't understand what they are, but being open to that, really understanding that there isn't just one way to do things, there are so many other ways to do that, to do what it is to get to your final outcome. Then also, I think, working with regulators, so that regulators become more and more comfortable with the ability to leverage AI and some of the other technologies to get to those endpoints as quickly as possible, to again bring medicines to patients, which is what we're looking to do.

In this video interview, Rachael Higgins, chief commercial officer, PicnicHealth, highlights how addressing these challenges can aid industry in moving more towards the future.

Addressing Data and Patient Retention Challenges

ACT: How can industry address some of the challenges holding it back from moving towards the future such as incomplete data and patient retention?

I think for companies, the life science partners that we do have, I think they truly need to not only say that they're open to things like virtual trials, but actually to be able to embrace them and actually take that leap to be able to do more of that, because that really is the only way to truly do things like getting access to the universal patient record by having patients consent directly, allowing you to get access to their medical record. It is a way that's no burden, or less burden to the patient, and then also give something back to the patient. Things like allowing patients to get access to their medical records and to be able to share their medical records, to be involved in the research, things like that are really going to certainly help them be able to scale up in the ways that they need to be able to do. When you think about all of our customers who are out there and the challenges that they have, I think they're all solvable. I think it's just getting them comfortable in the fact that the old way doesn't have to be the only way, right? There are certainly many ways to skin a cat, and I think these new ways certainly have proven to be effective. I think, again, it's just taking that leap. And then certainly, when you think about where the future is actually going to, the R&D costs are rising tremendously year over year. You see it in the news constantly with our life science partners having to make very significant cuts with not only their staff, thinking about their pipeline, what it is they're going to do, so they have to do more with less, and again, leveraging some of these types of models, virtual opportunities, leveraging direct connection to the patients, leveraging AI, that's going to be able to address their problems, which is going to allow them to scale in the future, which is really what everybody wants, which, again, at the end of the day, is going to be able to bring medicines to patients, which is really what we all want.

In this video interview, Rachael Higgins, chief commercial officer, PicnicHealth, discusses findings from the report and the identification of current challenges being faced by the industry.

Implementing Virtual Models in Clinical Trials: Results from PicnicHealth’s Annual State of Observational Research Report

ACT: Could you tell our audience a bit about the 

 and highlight some of its most noteworthy findings?

The research report that PicnicHealth ran basically shows that the industry is definitely at a turning point. The stats show that 80% of the leaders that we interviewed are either using or they're open to virtual models. I think the exact number was 78% and I think this is happening because they are number one, getting pressures from the regulators, payers, and patients for number one, real-world data. They also are leveraging AI and tech-enabled solutions to be able to deliver this in a more systematic, efficient way. If I look at all the stats that were out there, I think one of the major stats that came out is data completeness, and this is the industry's biggest hurdle, 64% of them said that incomplete data is their top challenge and if you think about traditional methods, like a site-based study or a traditional chart review, it just isn't able to deliver that data completeness or capture the entire patient record, if you will, which is why they're actually looking for other options for that. Another area, which again, is no surprise, is patient retention, the loss to follow up with any trial, is one of the biggest issues for life science partners, and they are looking for ways to actually solve that, so having a direct connection to the patient is one of the ways that can increase keeping patients engaged, which then, in turn, would, obviously, enhance the retention. Another thing that we highlighted was 60% of leaders actually flagged that long-term follow up studies was a top priority for 2025 and we know that there are so many pressures and demands on life sciences with all of the cost-cutting measures that are happening, so they're looking for innovative ways to do that. Then last, but certainly not least is AI. If you think about some of the releases from JP Morgan, if you think about some of the questions that folks had answers with our survey, they are having a lot of pressure to leverage AI, not because it's the fun thing to do, but really because it is an innovative, efficient way to really be able to hone in on what it is that you're looking for and then get those answers really quickly. I think 61% of them are either using it or open to actually being able to do that.

In this video interview, Rachael Higgins, chief commercial officer, PicnicHealth, discusses findings from the report and the industry's willingness to adopt technology.

In this video interview, Cameron Breze, product manager, Inovalon, highlights current trends with decentralization and how a dual approach can ensure flexibility across different therapeutic areas.

Determining the Effectiveness of Decentralization Across Different Trials 

, Cameron Breze, product manager, Inovalon, discussed challenges in patient recruitment for clinical trials. Traditional recruitment methods, such as manual outreach, are now less efficient due to accessibility issues. Breze highlighted technology as a way to address recruitment challenges, which can be leveraged to automate and streamline processes, reducing labor intensity and errors.

ACT: Is the incorporation of decentralized elements and more remote trials helping with enrollment? Why or why not?

The efforts towards decentralized trials and remote patient recruitment are something that has been birthed out of recent changes in technology, but also socially and culturally, with the COVID 19 pandemic in 2019 to 2020, we really reframed, okay, how can we move research forward within particular constraints? I think it's always going to be a matter of what's the best fit. There are certain trials where that remote or decentralized approach might be best suited. You can think of, say, cream or an ointment for a skin condition where you could take a picture of it with your cell phone. There's no risk to your health in the long term. It's just something that might be visually disturbing you or affecting you mentally. Same thing with a lot of mental health conditions, where you could have therapy that's conducted remotely, or some cognitive behavioral combination of the two, plus an intervention. With that said, there are still trials that will essentially never be remote. There are a lot of more complex biologics that are being released on the market, where they're required to be administered through an IV or some other complex administration method where you have to be at a physical research site. It's not as simple as just taking a pill and then they'll monitor you and maintain that clinical connection as you move through the trial. I think it's something that people have in mind, and I think the most forward thinking organizations have a dual minded approach, where there will always be trials that are optimized for that decentralized approach, and then there are trials that will be better suited for powerhouse academic research centers and everything in the middle, because it will be quite a spectrum, and that will continue to evolve as we get new disease indications that are now accessible to treat. I'm very excited with a lot of the computational chemistry and computational biology methods that are coming out, where we can match, more specifically, to a lot of mild to moderate, genetically inspired disease and treat that through something like a biologic. All of that to say, that dual approach is what I think most organizations will take going forward, and it will continue to bear fruit, and we'll pivot and adapt as the industry moves along with us.

In this video interview, Cameron Breze, product manager, Inovalon, discusses the need for accurate information in creating useful clinical data.

The Role of Quality Data in Utilizing Machine Learning Models

ACT: With so many data sources now in the mix in clinical research, how important is the role of quality data in identifying patient populations?

Quality data is something that is top of mind for everyone in the in the data technology space. Many people like to use the age-old adage of garbage in garbage out when it comes to machine learning models and a lot of the data modeling that's available where if you're feeding it with inaccurate information, you're going to get a result that really can't be transposed and moved and translated into anything that's really applicable and that ends up being a waste of institutional resources and not the best way to serve patients. I can share a little anecdote as well on that. I published a research paper with the MIMIC for critical care database, where we looked at resuscitation, so fluid and IV administration in the hospital with organ failure, and found out through lots of computational modeling that essentially, we had a great record of the fluids that were put in, but not a great record of the fluids put out, so the clinical staff were not recording that, not because they were missing it or they were making some error, but in the scheme of making that particular research impactful, if you don't have that information, you can't make designations on that person's fluid status, and seeing that in aggregate across hundreds of thousands of patients, you get to see what a potential impact that could have had, had that policy or procedure been updated or changed, so I think a lot of those decisions help inform the way that site staff are trained and data is collected over time. Beyond the basics of setting up a system that is going to collect quality data and allow the researchers to interact with it, there's a lot of data vetting that has to go through, so relying on subject matter experts and folks with experience in those particular areas, it's an interesting intersection, where sometimes the person who may be best able to speak to the quality of the data might come from a tech background or a healthcare background where you wouldn't expect that to be the case, typically, so combining interests and having that overlap and Venn diagram and cross pollination of ideas is something that inspires me to work every day and have that overlap and really collaborative effort with a lot of people that I work with and a lot of my other peers in the industry.

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