Speaker 1: All right on. Our next presenter will be discussing insights
Speaker 1: from TOUGH Center for the Study of Drug Development into
Speaker 1: evolving trial partnerships models. Please join me in welcoming the
Speaker 1: amazing Joane Chambers.
Speaker 3: So what a.
Speaker 2: Great attendance for this inaugural summit. And it's very nice
Speaker 2: to see so many familiar and friendly faces and to
Speaker 2: also meet some new people. So good afternoon. Hopefully everyone
Speaker 2: is still awake, you're not coming off that sugar high.
Speaker 2: But I just want to say thank you for the
Speaker 2: opportunity to share insights on the evolving global investigative site
Speaker 2: landscape at the Partnerships with Site Summit. I will be
Speaker 2: referencing my notes just to ensure that I stay on time.
Speaker 3: I have fifteen minutes.
Speaker 2: I have a lot of great information to share, insights
Speaker 2: and some data. A copy of the slides will be
Speaker 2: available after the summit, so if you want to take
Speaker 2: pictures of the slides, you're more than happy, but there
Speaker 2: will be a copy sent to everyone. As I prepared
Speaker 2: for this presentation, I reflected on the goal of this
Speaker 2: event to discuss, share and learn how pharma, biotech and
Speaker 2: CROs can be better partners with investigative sites, and this
Speaker 2: has been a longstanding challenge in our industry and remains
Speaker 2: just as relevant today. So far, in my opinion and
Speaker 2: hopefully you agree, we've heard some really excellent presentations and
Speaker 2: panels on strengthening biopharma cro site partnerships, bridging the gaps,
Speaker 2: improving and streamlining communications. A common theme that we heard
Speaker 2: navigating consolidations and industry disruptions, leveraging technology to boost patient
Speaker 2: recruitment and retention, and improving study conduct and management. And
Speaker 2: so when I stepped back and when I heard a
Speaker 2: lot of these common things teams this morning, my talk
Speaker 2: today will focus on the trends and insights shaping the
Speaker 2: site landscape, including investment interest and the importance of close
Speaker 2: collaboration between sponsors, CROs and sites to make clinical trials
Speaker 2: more accessible and convenient for patients. We all know and
Speaker 2: we heard this just recently. One approach doesn't fit every
Speaker 2: single study, and at the same time, we must rethink
Speaker 2: how we conduct and manage trials across the industry, always
Speaker 2: keeping the patients safety front and center. So with this introduction,
Speaker 2: oh where's the clicker?
Speaker 1: Oh?
Speaker 3: So with this introduction, I'd like to just do a
Speaker 3: really brief.
Speaker 2: Introduction to the TOUGH Center for the Study of Drug Development.
Speaker 2: Next year, TOUGH CSDD will celebrate fifty years as an
Speaker 2: independent academic group at the Tufts University School of Medicine
Speaker 2: based in Boston, Massachusetts. Over this time, the team has
Speaker 2: conducted data driven research that supports drug development and provides
Speaker 2: clinical provides critical insights for stakeholders across government, industry, and academia.
Speaker 2: This afternoon, I will cover industry insights or perspective on
Speaker 2: the global investigative site landscape with new clinical trial execution
Speaker 2: models emerging and through these new models, creating a roadmap
Speaker 2: for increased consolidation, centralization and accessibility for clinical trial participation,
Speaker 2: for the participants and for the communities.
Speaker 3: A few key areas of focus.
Speaker 2: I'd like to highlight on this slide because I know
Speaker 2: that there's a lot of information that really reinforces the
Speaker 2: theme of this summit clinical trial success hinges on patient
Speaker 2: recruitment and retention. Only two to five percent of US
Speaker 2: patients are enrolling in trials and just twenty seven percent
Speaker 2: of screen participants meet the eligibility criteria. Patients are central
Speaker 2: to clinical trials. We are hearing this theme throughout today
Speaker 2: investigative sites have the direct contact with patients and are
Speaker 2: known as the trusted partner, and yet all industry stakeholders
Speaker 2: are faced with the key patient participation burdens. Today, there's
Speaker 2: a growing demand for clinical trials that are more accessible, convenient,
Speaker 2: and flexible for participants, and while this is true for
Speaker 2: some studies, it's not universal. In response, new site execution
Speaker 2: models have emerged, including site staff embedded in clinical care settings,
Speaker 2: home health services, and many more, as you can see
Speaker 2: on this slide. At the same time, site networks and
Speaker 2: academic institutions have grown to meet this demand. Larger private
Speaker 2: site networks are attracting investment and capital markets are backing
Speaker 2: roll up strategies and new models, and this is leading
Speaker 2: companies to rethink site use as well as study execution.
Speaker 2: How is the site landscape shifting with these new execution
Speaker 2: models and where is where is the investment flowing. This
Speaker 2: section that i'll next present explores how clinical trial insights,
Speaker 2: growing capital interest, and new technologies like DCT solutions are
Speaker 2: driving centralization, efficiency and accessibility. In order to keep pace,
Speaker 2: we must really rethink how trials are being conducted, something
Speaker 2: very different from thirty years ago, and again we heard
Speaker 2: that kind of common theme from this morning through this afternoon.
Speaker 2: From nineteen eighty to twenty ten, the clinical trial landscape
Speaker 2: was relatively straightforward, with six primary site execution models really
Speaker 2: shaping trial management and patient outreach. This chart shows how
Speaker 2: a site distribution has changed over time from two thousand
Speaker 2: to twenty twelve, the six primary site execution models really
Speaker 2: dominate it as we saw on the previous slide. Between
Speaker 2: twenty twelve and twenty twenty four we see a more
Speaker 2: diverse mix of models, with a slight uptick increase in
Speaker 2: sites in Asia, increasing and expanding global access to clinical trials.
Speaker 2: We all know the site landscape is shifting. More sites
Speaker 2: are handling multiple filings across different trial settings. This growth,
Speaker 2: especially among AMCs and hospitals and your dedicated sites, opens
Speaker 2: the doors for organizations to scale run trials more efficiently
Speaker 2: and diversify their portfolios. And these trends could reshape trial
Speaker 2: management and expand the site capacity to meet the growing demand.
Speaker 3: Today.
Speaker 2: Sorry Today, various site execution models aim to improve patient
Speaker 2: accessibility and operational efficiency in clinical trials. So again, back
Speaker 2: in the nineteen eighties we had six. Now we have
Speaker 2: a wide array of different site execution models, but again
Speaker 2: not one size fits all solution. And additionally, with these
Speaker 2: different types of models, what will each relationship look like?
Speaker 2: With biopharma and CROs. Over the past decade, protocol designs
Speaker 2: have become even more customized. Endpoints, procedures, and planned visits
Speaker 2: have all increased across phases one, two, and three. In
Speaker 2: Phase three especially, the burden on patients and sites has grown.
Speaker 2: Patients face more visits and procedures while sites are managing
Speaker 2: more tasks. Additionally, expanding into more countries and having sites
Speaker 2: add to this level of complexity, so the impact is
Speaker 2: really clear. Trials run longer, they face more amendments, and
Speaker 2: see higher dropout rates, all signs of the rising burden
Speaker 2: on the patients.
Speaker 3: As we move forward.
Speaker 2: Let's take a look at overall trial duration by phase
Speaker 2: from twenty eighteen to twenty twenty one. Phase one trials
Speaker 2: averaged one year and eight months, while phases two and
Speaker 2: three each took more than three years from protocol approval
Speaker 2: to actual databaselock. There's a high coefficient, a variation that
Speaker 2: reflects difficulty in predicting timelines and more protocol deviations. And
Speaker 2: then when we look at phase one. The high variance
Speaker 2: stems from the mix of complex diseases and trials and
Speaker 2: more traditional studies. Key reasons, as we're probably all very
Speaker 2: much aware, but nicely to be reinforced. Key reasons that
Speaker 2: pay choose not to participate based on informed consent reviews
Speaker 2: include the burden of participant, the burden of participation, scientific
Speaker 2: or study related insufficient information and privacy or confidentially concerns
Speaker 2: participant feedback, and adds other challenges regarding the uncertainty about
Speaker 2: receiving the investigational treatment. What's key here is the research
Speaker 2: center location and long study visits and large site networks
Speaker 2: in site management organizations help reduce patient burden by making
Speaker 2: studies more accessible and convenient. They streamline the operations, They
Speaker 2: improve the scheduling. They strengthen the communication to address the
Speaker 2: concerns about the research location, about the timing, and the procedures.
Speaker 2: This approach may also ease the anxiety about risks and
Speaker 2: the treatment. Transparency. Transparency another word that we've heard today
Speaker 2: supporting stronger engagement and smoother participation. Since twenty twenty one,
Speaker 2: sponsors and CROs have increasingly relied on SMOs for their
Speaker 2: later stage trials. While Phase three studies have actually doubled
Speaker 2: by twenty twenty three and Phase two usage more than doubling,
Speaker 2: highlighting the smo's growing role in managing larger, more complex studies.
Speaker 2: Since twenty sixteen, investors including private equity, venture capital, and corporations,
Speaker 2: have been building multi site research networks, and these networks
Speaker 2: benefit from technology standardization and centralized operations areas where investors can.
Speaker 3: Add the real value.
Speaker 2: Investor support has also grown steadily in Sponsors are increasingly
Speaker 2: evaluating the quality of sites that are receiving this type
Speaker 2: of backing. As as institutional interest in clinical research grows,
Speaker 2: financial investors are increasingly driving site consolidation. This trend is
Speaker 2: evident in this chart that we see here. In twenty
Speaker 2: twenty three, thirty four financial investors acted as a majority
Speaker 2: or a lead investor in site networks, compared with just
Speaker 2: three in twenty fifteen. This year, the Tought Center launched
Speaker 2: a study on the changing global investigative site landscape. We
Speaker 2: looked at how organizations are working with different site models
Speaker 2: and how clinical child networks are growing and evolving. We
Speaker 2: had a working group of pharma companies biotech companies in
Speaker 2: one cro provide funding for this study. When we met
Speaker 2: it was very challenging for the entire group to really
Speaker 2: identify all the different site types and the definitions. So
Speaker 2: based on this study, we came up with these three
Speaker 2: in order for the sites to self identify themselves.
Speaker 3: One are you an.
Speaker 2: Academic medical center or a health system? Two are you
Speaker 2: community based for profit site?
Speaker 3: Network?
Speaker 2: And three independent community based for profit site but you
Speaker 2: are not affiliated with a network. So the next few
Speaker 2: slides just really show highlights of this study. We're still
Speaker 2: also in the midst of analyzing some of the data,
Speaker 2: so from the survey that we sent out to global sites,
Speaker 2: we asked how the sites are funded and owned. As expected,
Speaker 2: we see that for profit networks rely on private equity
Speaker 2: and investors. But what caught our attention in the study
Speaker 2: and the data was what sites across the three segments
Speaker 2: listed their funding as either individual or not individually or corporate.
Speaker 2: Looking at it from a study conduct phase, we see
Speaker 2: that across these across the site execution models, the study
Speaker 2: conduct phase was relatively consistent. Our working group wanted to
Speaker 2: understand where patients live in relation to the study site.
Speaker 2: This slide shows that similar percentages of patients participate in
Speaker 2: trials within a one to ten mile or eleven to
Speaker 2: fifty mile from home. We added kilometers because some of
Speaker 2: our global sponsors of the working group were based internationally,
Speaker 2: and then we also saw that some other patients were
Speaker 2: in other comparable distant areas. Additionally, we wanted to take
Speaker 2: a look at public transportation, so public transportation from participants'
Speaker 2: homes to the site was actually limited, according to the
Speaker 2: several research centers that replied to the survey. Again looking
Speaker 2: at that accessibility, the flexibility and the convenience for participants
Speaker 2: to join a clinical trial. Each site model uses DCT
Speaker 2: elements to make childs more accessible and flexible from the information.
Speaker 2: ECOA conducted at the patient's home is common in community
Speaker 2: based for profit sites, while your site networks and AMCs
Speaker 2: affiliated centers deploy a broader mix across apps, telehealth, wearables,
Speaker 2: and web portals others that are.
Speaker 3: Backed by funding.
Speaker 2: The views on expected use of technology was generally consistent
Speaker 2: across AMC's and affiliated centers and the site networks in
Speaker 2: the area that technology will improve data quality and integrity.
Speaker 2: Other areas showing strong alignment across the models, including providing
Speaker 2: faster enrollment recruitment and lead to greater trial efficiency. This
Speaker 2: slide shows how alternative visit locations are used across different
Speaker 2: sites types. The beige areas that you see highlight. It
Speaker 2: represent the percentage of trials using these types of different
Speaker 2: locations and the actual providers whether it was a mix
Speaker 2: of a sponsor, ro or site or combination, and the
Speaker 2: slide actually reveals how the adoption varies across a different landscape.
Speaker 2: It was insightful to see how each group ranked the
Speaker 2: top five challenges in clinical research. This is my last
Speaker 2: slide for these challenges which we heard this morning in
Speaker 2: the panel discussions communication protocol complexity, patient access, and staff turnover.
Speaker 2: The fifth profit pressure primarily affects privately backed site networks.
Speaker 2: I do have closing remarks. I'm just going to make
Speaker 2: this one comment. Strong partnerships today are what will shape
Speaker 2: the trials of tomorrow.
Speaker 3: Thank you very much,