All right on. Our next presenter will be discussing insights from TOUGH Center for the Study of Drug Development into evolving trial partnerships models. Please join me in welcoming the amazing Joane Chambers.
So what a.
Great attendance for this inaugural summit. And it's very nice to see so many familiar and friendly faces and to also meet some new people. So good afternoon. Hopefully everyone is still awake, you're not coming off that sugar high. But I just want to say thank you for the opportunity to share insights on the evolving global investigative site landscape at the Partnerships with Site Summit. I will be referencing my notes just to ensure that I stay on time.
I have fifteen minutes.
I have a lot of great information to share, insights and some data. A copy of the slides will be available after the summit, so if you want to take pictures of the slides, you're more than happy, but there will be a copy sent to everyone. As I prepared for this presentation, I reflected on the goal of this event to discuss, share and learn how pharma, biotech and CROs can be better partners with investigative sites, and this has been a longstanding challenge in our industry and remains
just as relevant today. So far, in my opinion and hopefully you agree, we've heard some really excellent presentations and panels on strengthening biopharma cro site partnerships, bridging the gaps, improving and streamlining communications. A common theme that we heard navigating consolidations and industry disruptions, leveraging technology to boost patient
recruitment and retention, and improving study conduct and management. And so when I stepped back and when I heard a lot of these common things teams this morning, my talk today will focus on the trends and insights shaping the site landscape, including investment interest and the importance of close collaboration between sponsors, CROs and sites to make clinical trials more accessible and convenient for patients. We all know and
we heard this just recently. One approach doesn't fit every single study, and at the same time, we must rethink how we conduct and manage trials across the industry, always keeping the patients safety front and center. So with this introduction, oh where's the clicker?
Oh?
So with this introduction, I'd like to just do a really brief.
Introduction to the TOUGH Center for the Study of Drug Development. Next year, TOUGH CSDD will celebrate fifty years as an independent academic group at the Tufts University School of Medicine based in Boston, Massachusetts. Over this time, the team has conducted data driven research that supports drug development and provides clinical provides critical insights for stakeholders across government, industry, and academia.
This afternoon, I will cover industry insights or perspective on the global investigative site landscape with new clinical trial execution models emerging and through these new models, creating a roadmap for increased consolidation, centralization and accessibility for clinical trial participation, for the participants and for the communities.
A few key areas of focus.
I'd like to highlight on this slide because I know that there's a lot of information that really reinforces the theme of this summit clinical trial success hinges on patient recruitment and retention. Only two to five percent of US patients are enrolling in trials and just twenty seven percent of screen participants meet the eligibility criteria. Patients are central
to clinical trials. We are hearing this theme throughout today investigative sites have the direct contact with patients and are known as the trusted partner, and yet all industry stakeholders are faced with the key patient participation burdens. Today, there's a growing demand for clinical trials that are more accessible, convenient, and flexible for participants, and while this is true for
some studies, it's not universal. In response, new site execution models have emerged, including site staff embedded in clinical care settings, home health services, and many more, as you can see on this slide. At the same time, site networks and academic institutions have grown to meet this demand. Larger private site networks are attracting investment and capital markets are backing roll up strategies and new models, and this is leading companies to rethink site use as well as study execution.
How is the site landscape shifting with these new execution models and where is where is the investment flowing. This section that i'll next present explores how clinical trial insights, growing capital interest, and new technologies like DCT solutions are
driving centralization, efficiency and accessibility. In order to keep pace, we must really rethink how trials are being conducted, something very different from thirty years ago, and again we heard that kind of common theme from this morning through this afternoon. From nineteen eighty to twenty ten, the clinical trial landscape was relatively straightforward, with six primary site execution models really
shaping trial management and patient outreach. This chart shows how a site distribution has changed over time from two thousand to twenty twelve, the six primary site execution models really dominate it as we saw on the previous slide. Between twenty twelve and twenty twenty four we see a more diverse mix of models, with a slight uptick increase in sites in Asia, increasing and expanding global access to clinical trials. We all know the site landscape is shifting. More sites
are handling multiple filings across different trial settings. This growth, especially among AMCs and hospitals and your dedicated sites, opens the doors for organizations to scale run trials more efficiently and diversify their portfolios. And these trends could reshape trial management and expand the site capacity to meet the growing demand.
Today.
Sorry Today, various site execution models aim to improve patient accessibility and operational efficiency in clinical trials. So again, back in the nineteen eighties we had six. Now we have a wide array of different site execution models, but again not one size fits all solution. And additionally, with these different types of models, what will each relationship look like? With biopharma and CROs. Over the past decade, protocol designs
have become even more customized. Endpoints, procedures, and planned visits have all increased across phases one, two, and three. In Phase three especially, the burden on patients and sites has grown. Patients face more visits and procedures while sites are managing more tasks. Additionally, expanding into more countries and having sites add to this level of complexity, so the impact is
really clear. Trials run longer, they face more amendments, and see higher dropout rates, all signs of the rising burden on the patients.
As we move forward.
Let's take a look at overall trial duration by phase from twenty eighteen to twenty twenty one. Phase one trials averaged one year and eight months, while phases two and three each took more than three years from protocol approval to actual databaselock. There's a high coefficient, a variation that reflects difficulty in predicting timelines and more protocol deviations. And then when we look at phase one. The high variance stems from the mix of complex diseases and trials and
more traditional studies. Key reasons, as we're probably all very much aware, but nicely to be reinforced. Key reasons that pay choose not to participate based on informed consent reviews include the burden of participant, the burden of participation, scientific or study related insufficient information and privacy or confidentially concerns participant feedback, and adds other challenges regarding the uncertainty about
receiving the investigational treatment. What's key here is the research center location and long study visits and large site networks in site management organizations help reduce patient burden by making studies more accessible and convenient. They streamline the operations, They improve the scheduling. They strengthen the communication to address the concerns about the research location, about the timing, and the procedures. This approach may also ease the anxiety about risks and
the treatment. Transparency. Transparency another word that we've heard today supporting stronger engagement and smoother participation. Since twenty twenty one, sponsors and CROs have increasingly relied on SMOs for their later stage trials. While Phase three studies have actually doubled by twenty twenty three and Phase two usage more than doubling, highlighting the smo's growing role in managing larger, more complex studies.
Since twenty sixteen, investors including private equity, venture capital, and corporations, have been building multi site research networks, and these networks benefit from technology standardization and centralized operations areas where investors can.
Add the real value.
Investor support has also grown steadily in Sponsors are increasingly evaluating the quality of sites that are receiving this type of backing. As as institutional interest in clinical research grows, financial investors are increasingly driving site consolidation. This trend is evident in this chart that we see here. In twenty twenty three, thirty four financial investors acted as a majority or a lead investor in site networks, compared with just
three in twenty fifteen. This year, the Tought Center launched a study on the changing global investigative site landscape. We looked at how organizations are working with different site models and how clinical child networks are growing and evolving. We had a working group of pharma companies biotech companies in one cro provide funding for this study. When we met it was very challenging for the entire group to really
identify all the different site types and the definitions. So based on this study, we came up with these three in order for the sites to self identify themselves.
One are you an.
Academic medical center or a health system? Two are you community based for profit site?
Network?
And three independent community based for profit site but you are not affiliated with a network. So the next few slides just really show highlights of this study. We're still also in the midst of analyzing some of the data, so from the survey that we sent out to global sites, we asked how the sites are funded and owned. As expected, we see that for profit networks rely on private equity
and investors. But what caught our attention in the study and the data was what sites across the three segments listed their funding as either individual or not individually or corporate. Looking at it from a study conduct phase, we see that across these across the site execution models, the study conduct phase was relatively consistent. Our working group wanted to understand where patients live in relation to the study site.
This slide shows that similar percentages of patients participate in trials within a one to ten mile or eleven to fifty mile from home. We added kilometers because some of our global sponsors of the working group were based internationally, and then we also saw that some other patients were in other comparable distant areas. Additionally, we wanted to take a look at public transportation, so public transportation from participants' homes to the site was actually limited, according to the
several research centers that replied to the survey. Again looking at that accessibility, the flexibility and the convenience for participants to join a clinical trial. Each site model uses DCT elements to make childs more accessible and flexible from the information. ECOA conducted at the patient's home is common in community based for profit sites, while your site networks and AMCs affiliated centers deploy a broader mix across apps, telehealth, wearables, and web portals others that are.
Backed by funding.
The views on expected use of technology was generally consistent across AMC's and affiliated centers and the site networks in the area that technology will improve data quality and integrity. Other areas showing strong alignment across the models, including providing faster enrollment recruitment and lead to greater trial efficiency. This slide shows how alternative visit locations are used across different
sites types. The beige areas that you see highlight. It represent the percentage of trials using these types of different locations and the actual providers whether it was a mix of a sponsor, ro or site or combination, and the slide actually reveals how the adoption varies across a different landscape. It was insightful to see how each group ranked the
top five challenges in clinical research. This is my last slide for these challenges which we heard this morning in the panel discussions communication protocol complexity, patient access, and staff turnover. The fifth profit pressure primarily affects privately backed site networks. I do have closing remarks. I'm just going to make this one comment. Strong partnerships today are what will shape the trials of tomorrow.
Thank you very much,