Miranda Schmalfuhs is an Associate Editor for Applied Clinical Trials. She can be reached at 

Miranda Schmalfuhs

Left to right: Robert Dougherty, Miranda Schmalfuhs, Dr. Dillard Elmore, and Evan Johnson

I recently had the pleasure of speaking on a panel at the recent Talk Health event in Philadelphia, PA at Le Méridien on September 11th, 2023. The panel, moderated by Evan Johnson, chief of staff at Watzan, and focused on what success looks like in audio from a publisher, vendor, and HCP perspectives. Speaking on the panel with me was Dr. Dillard Elmore, a practicing physician, and Robert Dougherty, president of Dougherty Media.

As members of the panel, we all use audio in professional and personal capacities. Outside of producing the 

, my leisure listening includes a few different podcasts hosted by some of my favorite comedians. Dougherty also uses audio often. “It's a lot easier for me to when I'm on the road to listen as opposed to read through certain things. But we as a company have found it's a different form of media consumption in a way to get your thought leaders information out quickly in a different format.” They do so typically in one-to-three-minute audio segments, which Doherty describes as ‘definitely very engaging’ seeing ‘much more engagement’ than the newsletters they’re currently producing.

Dr. Elmore shared that for him, the beauty of audio is that it's not selfish. “If you watch TV, you have to focus all of these senses. If you're studying through a textbook, you need all of your senses again. Whereas with audio, some of my fondest memories are spending time with family and friends, but listening to music. If I'm listening to an audiobook or medical podcasts, I can be mowing the lawn, do all my laundry, I can be cooking…You can have a conversation and still do other things.”

One of the biggest hurdles for getting started with audio is capturing quality audio. Some subjects won’t have headphones to plug into their laptops, let alone a professional microphone. Some basic practices to ensure usable audio would be to ideally have at least headphones with a microphone, but if not, to be in a quiet room that doesn’t provide an echo or have thin walls.

Beyond the quality of audio, making sure the subject is comfortable being interviewed is a key component to success. Typically for our podcast, we will have a pre-call with the guest where we speak about the topic and discuss the questions and direction the episode will take. Scheduling can also be a concern because the higher up in the c-suite the KOL is, the busier their schedule is and the harder it is it access them. A big concern is not wanting to be misquoted or misrepresented, having the questions ahead of time allows for the guest to be fully prepared when it comes time to record the episodes — and in turn, can help cut down on the editing process. Another tip here, encourage using bullet points versus drafting full responses to keep answers conversational and engaging.

The editing process for audio depends on the guest(s), and typically takes from one-to-three minutes per minute of audio. Certainly, a subject or host could go minutes without saying any filler words or making an error that requires edits. More tedious episodes with a less experienced subject, could take up to a few hours. It’s beneficial to create a standard procedure for editing to ensure you keep to a set schedule of posting content. For example, the 

 podcast has been posting biweekly, on Thursday mornings, at 9am EST, since its inception in 2018. Our listeners know exactly when and where they can find out content, and trust it will be there when they look to listen to it.

Between the preparation for the episode and the availability of the KOL, the process could take a couple of months or happen in two weeks, every episode will be different.

Dougherty said getting audio into e-newsletters and emails wasn't ‘too bad’ for his company and that the process is ‘pretty efficient.’ They interview physicians for a short time segment and after being combined with static banner advertisements, the e-newsletter goes out. Recipients then click to listen to the audio clip and end up on a dedicated landing page that also have those same static advertisements.

“They did really well, we saw a high engagement rate of 18-27% and 3-5% click through rates. They also act almost like a resource library…great KOLs people could go back to.” He explained that in some instances audio content that initially had 60 downloads/plays, would later reach 200+ plus while in the archive. Dougherty added that while their delivery rates for emails have always been strong, adding audio to their emails improved both their open and engagement rates significantly.

“It’s a different type of media. We’re using thought leaders to get information out about the message/brand, that you really couldn’t put in a banner advertisement.”

Dr. Elmore’s audio use begins soon after he wakes up. “I do the audio Bible for about 15 minutes, and while getting ready, I go through a swath of podcasts.” He shared that the typical podcast he’s looking for is less than 30 minutes, citing that even shorter listening times would be great. “I want to get to the point. I don't want my time to be monopolized by one thing. I would like to get a nice broad objective view of what's happening. Then when I'm having a conversation with say, a neurosurgeon, about my patient, I feel that I know [what they’re talking about] and there’s the ability to go deeper.” Other important qualities to grab this doctor’s attention: an engaging host presenting interesting content. “They could just make something that's basic, seem intriguing, and make you want to go down that rabbit hole. That's beautiful.”

In total, Dr. Elmore spends about two and a half hours each day, including his commute, consuming audio content. Admittedly, not all of Elmore’s audio is business, his leisure listening is reserved for sci-fi audiobooks during his commute. He added that his use of audio, that he says has been ‘like a renaissance’, has become such a large part of his life — it has decreased the amount of television that he watches.

“I just see [audio] being used more often across the board. I see a lot of pharma websites where you have the option to listen to a press release now,” explained Dougherty. Right now, a natural human voice or one of a recognized thought leader are still the best options, because you have all of the control. “Sophisticated areas of translation may be a little more difficult for artificial intelligence (AI) such as some of the generic terms and brand names…It’ll be interesting to see what AI does for that — I think it'll be commonplace in the very near future if it isn’t already.”

With AI programs getting better every day, some now even with your choice of accent, the wave of audio is going to be tough to beat.

Articles

Panel at recent Talk Health event at Le Méridien, in Philadelphia, PA, on September 11th, 2023, focused on what success looks like in audio from a publisher, vendor, and HCP perspectives.

Audio Success in Pharma

Matt Smith — Vice President Research Site Development at Slope, a provider of a clinical trial execution platform focusing on clinical inventory and sample management — discusses the competition companies and sponsors face when trying to become a sponsor of choice, challenges new technologies like artificial intelligence present, how to foster collaboritive relationships, and much more in this Q&A. 

Matt Smith, Vice President Research Site Development, Slope

: What kind of competition do pharmaceutical companies and trial sponsors face when trying to become a sponsor of choice? Is there more competition for those who are conducting research for oncology trials, rare diseases, and other high-demand areas?

Pharmaceutical companies face fierce competition when vying to become the sponsor of choice for research sites. Every sponsor wants to have the first pick of the best sites and access to site KOLs. With numerous established sponsors and a steady influx of new companies, the market is saturated with potential sponsors for research sites to collaborate with. Additionally, most studies are conducted by the same small percentage of sites, intensifying the competition for these top sites. Sponsors that specialize in specific therapeutic areas create niche competition for research sites focused on partnering with sponsors with expertise in particular fields.

Another significant aspect of the competition is the emphasis on reputation and credibility. A sponsor's history of developing groundbreaking medications and getting them to market can make a difference in a research site's decision-making process. Sponsors that have experienced controversies or issues with previous studies, especially in the site's target indication, may see reluctance from potential research partners, thinking about what’s best for their patients. Competition can also increase for sponsors on trials in certain indications with a smaller patient population, or one where there are several competing trials looking to reach the same patients, and with existing treatment options.

The good news is that, while there is competition for sites, it’s fairly easy to stand out to sites, earn their trust, and receive your figurative gold star as a sponsor of choice. Even better is that this process is largely free. Sites simply want to be valued for their work, not be seen as a commodity, [be] paid fairly and on time, and know that their voices are heard. If you’re willing to listen, be open, and have these relationships directly, you can quickly set yourself apart from others and be seen as a preferred sponsor.

: What are the most common obstacles faced by trial sites? What challenges do new technologies, like AI, present in trial execution?

New technology is largely seen as an opportunity to improve our industry. However, we must not only focus on the outcome, but also how the tech is being implemented and used in the trial, who is responsible for the work, and the data that’s necessary for those amazing outcomes we’re all promised.

AI technology holds significant potential, but it's crucial to bear in mind that we are still in the early stages where additional oversight is a necessity. When we’re looking at the promises of any technology, we need to ask a critical question: Who are the people that will be responsible for its success? It is likely that the sites responsible for entering the data or integrating it with existing platforms and processes will take on this role. That’s why it’s important that sponsors support sites with the adoption and integration of new technology to ensure its success.

The importance of technology support also extends to new tools adopted by patients. For example, we often see technology that allows a patient to journal and report their status, which could help to improve trial data and provide insight into the patient’s trial experience.

What’s typically not discussed, though, is the tech support necessary for those patients who may struggle with using the technology. When the tech isn’t working for the patient, it usually requires the site staff to act as IT support. I’ve heard accounts from several sites of technology issues relating to patient apps that required the site coordinators to spend hours on the phone with tech support to get it working for their patients. All of this time is not billable by the site, and may even turn off patients from participating in clinical research.

: What kind of strategies should/do sponsors and companies use to foster collaborative relationships?

It’s fairly simple, actually, especially as sites are eager to collaborate with sponsors and to work on trials that help their patients. First and foremost, find a few advisory sites within your target therapeutic area. This work can’t be outsourced. Sponsors really need to foster and maintain these direct relationships. Sites are more than willing to help provide feedback, which ultimately benefits patients and the industry, and helps to achieve quicker outcomes with less cost and risk.

Furthermore, provide these two to three advisory sites with the draft protocol, and any specific questions or concerns. Set up a review call to discuss their thoughts and questions; it can’t be an email. To really understand their thoughts, you need to have a call or meeting with each site.

Usually, the sponsors that maintain these relationships with sites have been able to work with these sites on past trials, or have met them at industry events and formed a relationship through common goals. The thing that most of these sponsors have in common is that they manage or are heavily involved in the site selection process, which includes pre- and post-feasibility work, where they’re engaged and asking for feedback from the sites.

: How much does the patient burden impact a site's decision in choosing a sponsor? What can companies do to put patient support at the top of the list?

One of the areas that sites and sponsors agree on is that the patient experience is a vital consideration of any trial. What’s interesting, though, is that while there is a lot of attention given to the patient experience, as an industry, we seem to forget that the site is primarily responsible for that patient experience.

In competitive indications, and especially those with a decent functioning treatment option, the patient burden can weigh heavily on a site’s decision to work on a trial or not. I recall a promising trial for an indication where the current treatment was effective, while the new trial drug was looking like it would far exceed the status quo. While PIs were excited about the drug candidate, they were turning it down in high numbers. Talking with the PIs directly revealed that their issue was with the protocol design that required the patients to wash out and stop using the current treatment for a few months before starting the trial. While the PIs were excited about the initial data of the trial drug, they couldn’t justify having patients go off treatment.

: Trust is a big theme we’ve been hearing about lately. How can sponsors ensure that sites, and their patients, will be able to rely on them?

 If you want to be a sponsor of choice, simply talk to the sites, see what they need, and how you can help, and pay them what you have committed so they can pay their staff and treat patients. Sites realize you can’t change everything, but your willingness to listen and talk it through will mean everything, especially if you’re able to help streamline a few things going forward. To earn trust, you have to give trust. Having an open dialog where you can listen and talk freely is the easiest way to do that.

: How else can sponsors enhance their trial outcomes and establish themselves as preferred partners?

 Talk to the sites. Don’t be afraid of the hard questions or the awkward answers; you don’t have to fix everything overnight. Utilize the feedback and if you’re not able to make a suggested adjustment, let the sites providing the input know why you didn’t. Also, realize that it’s a process, and engaging sites for feedback is most valuable when done over the course of the trial.

Solicit site engagement during all phases of the trial. This starts with study design, pre-study analysis for enrollment, and soliciting site feedback proactively. During the trial, engage sites to get a live view into patient enrollment status. What trends are they seeing? What issues are leading to screening fails or patients declining to participate? Finally, after the study is complete, talk to a few sites to get a well-rounded perspective. Speaking with sites that had high potential during startup but ended up falling short will likely yield your most valuable feedback.

In this Q&A, Matt Smith, Vice President Research Site Development, Slope discusses the competition pharma companies and trial sponsors face when trying to become a sponsor of choice and build trust with sites and patients.

How to Become a Sponsor of Choice

 team's journey capturing interviews with thought leaders and session recaps—plus some team fun along the way—from DIA 2023 in Boston, MA! 

Find more DIA 2023 coverage, including video interviews and session recaps 

Follow Group Social Media Editor, Miranda Schmalfuhs, as she and the rest of the team attend the DIA 2023 conference in Boston, MA.

DIA 2023 VLOG

This DIA 2023 session, moderated by Victoria DiBiaso, Global Head, Patient Informed Development and Health Value Translation, Sanofi, opened by expressing how imperative it is to establish research priorities and make development decisions that ensure that the medicines that are developed with the patient data they have. As well as answer the questions that individuals with those conditions and their caregivers and their HCPs are all seeking the answers to. The presentation included live polling of the audience that showed 68% of attendees’ companies are currently engaging patients systematically across their development programs, yet nearly two-thirds of that percentage aren’t measuring the impact. Meanwhile, attendees found that embedding patient feedback into their development processes has the most impact in study design, enrollment, and transparency.

DIA 2023 Session: Measuring Impact of Patient Engagement Across Research and Development 

Measuring Impact of Patient Engagement Across Research and Development

, were Jennifer Kim, PhD, Research Assistant Professor, Tufts Center for the Study of Drug Development; Ellyn Getz, Director, R&D Partnerships, CSL Behring; Douglas Noland, Head of Patient Partnerships, Executive Director, Astellas; and Heather Pin, Head of Patient Centric Operational Effectiveness, Sanofi.

Kim shared the latest phase of a multi-phase, multi-year plan between Tufts CSDD and the DIA, working group comprised of sponsor companies, CROs, patient advocates, vendors, and consultants to map what patient engagement look like across the industry. The group formed a 36-item, multiple choice survey comprised of three different buckets. The first bucket was logistical support, the second gathering input from patients and stakeholders, and finally, feeding that information back to patients. The survey was distributed to eight sponsor organizations of varied sizes, over the course of three months. Some of the most notable findings included a significant difference in perception amongst the senior leaders of their organization. Their companies were providing patients with transparent informed consent process as well as travel and compensation for their time, yet questions pertaining to bridging the patient/scientist gap and feeding information back to patients, scored low. Another low scoring area wasgathering input for KPIs from underrepresented patients.

Getz revealed that patient focus being a core value of their company has driven CSL to use plain language summaries company-wide for all studies. The CSL patient partnerships team embeds their activities in clinical development and operations processes. She said the survey helped them lay out that framework to improve areas such as diversity, patient satisfaction, and site activation engagement. Where they are having the most success right now is in their early study design and planning phase process. Aiming to build on the Tufts/DIA survey, CSL is actively going out to their study teams after conducting patient advisory boards to see if any modifications were made to the design or new activities added to offer further support for participants. They found that around 60% of each of the study teams that offered patient advisory boards (Phase II and III) changed the procedures that they were offering in some way. In 2022, 50%, had changes their type of study visits, offering even more flexible options for participants—30% gave patients the flexibility to decide when they wanted to come into the site, or even have that procedure at their home.

Not all has been smooth sailing, however, some advisors have expressed not wanting to participate in a study that’s too involved because it would be too burdensome for their sites. Getz says the conversations can be hard but that it is necessary to think more creatively about how to bring in crucial patient insights and feedback in conducting the study moving forward. She continued that the modifications that are being shared help validate movement in the right direction.

Another audience poll exposed the biggest challenges when engaging patients in development programs as trust, timelines, education, resources, and management buy in.

Nolan shared an anecdote of Astellas’ patient centricity journey from the bottom 10% to the top 10%. About seven years ago, Astellas had the Chief People Officer of the Cleveland Clinic, evaluates their level of patient centricity, and received a 50-page report with his opinion that they actually weren’t patient centric at all. In actuality, the company was science and marketing centered, as was the industry. Despite having an offering of 62 unique 800 numbers, five tech platforms, and various different systems—what was lacking was training in fundamental areas such as empathy, microaggressions, customer service, and even colorblindness. Having brought that information to their CEO, Nolan boasts that with stronger systems and processes in place, the company’s highest metric on their annual employee engagement survey, is patient centered.

Last to share insights was Heather Pin. Pin shared some metrics from a list of 80 that Sanofi has compiled from speaking with companies throughout the past three years. The objective is to measure the impact of patient insights on product development. She spoke of their corporate and social responsibility to make an impression on patient advisors that they've listened to them, hear what they say, and show them they’ve actually listened and acted upon those insights. “We want to be able to take this information, all this data, and be able to make better recommendations, better decisions. We want to lessen the complexity for the patients, whether it's to make their treatment easier, or to join a clinical trial.”

The process is slow and steady though, Pin put an emphasis on asking the right questions. “The first year, it is the hardest because that's when you're creating the baseline.” A big tip to accomplish this, she said, is to use examples. “Make sure you pass them by several people and roles, different people in those roles to make sure they're crystal clear.” It’s very common to edit these questions as priorities, trends, and company goals change. Pin recommends entering and looking at the data on a regular basis.

DiBiaso built upon Pin’s point adding that the patient relevant information and data is available to be on the label, and that compared to last year, they’re showing 95%, increase in the number of programs that have a strategy in place to try to achieve that. Another company claim, 83% of programs have a clinical outcome assessment strategy in place before starting Phase II. Their few years of tracking also show a 31% reduction of procedures this year compared to last, a significant reduction of burden.

Also mentioned in the session was PALADIN, a consortium dedicated to accelerating new medicines development through optimizing patient advocacy group and industry collaboration. Learn more about PALADIN 

The session concluded with an insightful period of Q&A including questions about your compensation policies and practices, using social determinants of health data to inform study design, and how to marry that data with the patient feedback.

Measuring Impact of Patient Engagement Across Research and Development June 27, 2023. DIA 2023, Boston.

DIA 2023 session focuses on taking patient feedback, how to implement them into trials, and measuring the impact they have on processes.

DIA 2023: Measuring Impact of Patient Engagement Across Research and Development

On October 15, the second day of Veeva R&D and Quality Summit Connect, four industry executives shared insights during the Media and Analyst Roundtable: Digital Trials Speed Path to New Therapies moderated by Veeva’s Vice President, Vault R&D, Jim Reilly. Participants from AbbVie, Labcorp, and GSK discuss the opportunities and challenges digital trials bring to the industry, and the importance of addressing them before fully embracing digital solutions.

Reilly: Digital trials have the potential to bring therapies to patients faster and in a more cost-effective way. Where do you see opportunities for improvement in how trials are run today?

Lorena Gomez, senior director of global study start-up, PRO management, and digital implementation, AbbVie:

 Every company had started to dip their toes into the digital world, but COVID-19 pushed us all into the proverbial pool. We had to come up with solutions really quickly to keep our studies afloat, now it’s forcing us to be a little bit more forward thinking.

We are asking questions like: ‘How can we make our trials more accommodating for our sites and our subjects?’ That’s where I see the biggest opportunity. With that comes the challenge of making our protocols simpler and easier to execute, while also thinking about studies in a way that facilitates digital approaches. To effectively do that, a strategic, enterprise-level plan is needed.

Mark Morais, president, clinical operations and commercial solutions, Labcorp Drug Development:

 What we need to think about now is a robust communication platform where we can start to share these learnings. We rushed into the digital space, and we are in danger of increasing complexity in trials. If we don’t understand the challenges, we cannot draw out consistency. That complexity is going to trickle down to manifest itself in terms of site burden. We need to think about the impact to sites, protocol design, and patients—especially in terms of what we’re capturing and how. We have to let digital drive simplicity as we potentially increase all of the disparate data sources.

It’s going to be important that we collaborate as an industry to understand how that patient journey and site relationship is going to change. Historically as partners, we’ve always brought trials to sites. Now, we’re going to find a way to bring patients to trials. This is going to open a new area for therapy of treatment. It’s going to allow us to look at diversity and inclusion in terms of the patients we’re recruiting and the sites that we’re using.

Digital is going to greatly broaden, not only the therapeutic potential, but the opportunities to reach new patients in a more cost-effective way. But if we’re not careful, complexity will derail the opportunity and that will hurt the industry.

 To that end, there are still many unknowns. It’s the wild west in the digital space and even regulators aren’t necessarily aligned on things such as whether devices need to be labeled or not. There are many different moving parts and a lot of work ahead to pave the path to digital.

Mayank Anand, vice president, and global head, data strategy and management,

 There are two components to this. Data and technology, the latter which is going to play a very pivotal role in this entire strategy. The problem is, we don’t have products that are fully mature. There are good solutions where some parts of it are matured, but not entirely. Every organization is looking for multiple solutions to plug in, increasing risk and creating an even more complex environment.

Now imagine you’re going to increase your data by 10-times or 20-times using decentralized technologies like sensors, are we ready for that instant data cleaning? The industry is already struggling with the data we get from trials today. This adds another level of complexity to it.

Data is going to explode in the next couple of years. Instant data cleaning will become a bigger challenge because the expectation will be that if data ingestion is faster, the output has to be faster too. Thinking about data ingestion, in the present world, there are barriers to getting external data. The sharing of data itself is a challenge. Every study brings its own complexity because you have 10 to 15 different external data providers, and everyone uses a different way to inject data. Now just imagine you are making the leap to maybe 20 or 30 different data sources, how would you standardize that?

With technology and data, we must address how we plug in to bring simplicity and a connected architecture. Otherwise, in the next five years we’ll be doing another transformation to address these issues.

Reilly: What can organizations do to advance to a more holistic way that drives a better trial outcome?

 One thing, which is a requirement, is the clinical hub. This concept has been around for some time, but with the creation of more integrations and data in different silos, there is a need for a better approach. I think the future lies in having a single source of ingestion and aggregation. This is difficult to accomplish because at present, we are not able to standardize. It’s very important that standardization is at the core among all of this if we really want to simplify trials.

As an industry, companies should stop customizing tools according to protocols. Don’t customize because you have some specific requirements—adopt and adapt the tool the way it is. I think that will be a more efficient way to bring simplicity to trials. This will not only help you, but I can guarantee investigators and patients will benefit because they actually face the complexity of these customized systems.

 I think the customization of systems creates a big drain in terms of how sites are utilizing the tools. This opens itself up for future issues in how we aggregate data, and the quality of the data itself. I think the one thing we need is not an entirely consistent strategy, but alignment as an industry on an end-to-end strategy for platform management and data aggregation, and the governance around that.

If we’re not careful, too much standardization will stifle innovation. Innovation is allowing us to transform the way that we work right now, but it’s also adding complexity.

We have to find that delicate balance between standardization, while still driving innovation and change. We’ve seen it in the post-COVID world as we all rush to create new strategies of how we were going to drive trial continuity and patient monitoring. We all created bespoke solutions, most of which are working great right now, but you’re starting to see those inconsistencies.

We’re also creating a great amount of learning. We need to take those learnings and share it as part of that end-to-end strategy and allow it to influence what we do next.

Reilly: When you look at regional guidelines and country-specific concerns, could you share your perspectives on how, as an industry, we can help overcome that

There are two pieces to this. First, there’s the upfront strategy around how the digital pieces of your program fit together from a data perspective. Companies need to assess these tools to ensure they can gather the needed information and bring all the data together to use it.

Then there’s how to operationalize and implement the tool. Can this even be done in the countries that you’re going to? Having that intelligence, a well-defined infrastructure, an overarching strategy–both from a data perspective and operational implementation perspective–are of critical importance to drive success.

Even regulators are still working on figuring out this space. I don’t know that it’s possible right now to guarantee success, but as an industry we have to continue communicating with one another. As several of our speakers have underscored already, sharing best practices and setting standards as an industry to eliminate all these obstacles will be critical.

As we start to collect more information and going direct to patients through wearables and real-time access, data privacy practices and regulations have not caught up yet. What we’re going to find is, the digital space is innovating and transforming faster than digital patient’s rights are. We’ll need to understand how that’s going to influence our ability to collect the data—what data we can collect, the timing of that data, and how it’s utilized.

 EU data protection doesn’t allow ease in using data centers outside the EU in relation to EU data protection law. This sometimes creates a bottleneck for organizations adopting technology that don’t have data storage within the EU.

As an industry, we must change our mindset. One side is changing and evolving versus the other side still wearing the old hat. One recent example is where we did some sessions for the FDA to understand how artificial intelligence and machine learning works into the clinical space, the uses, the advantage, and how they can improve their own ways of inspecting data. I think that’s the bigger problem, regulation.



is an Assistant Editor for Applied Clinical Trials. She can be reached at