Why Moving More Cancer Trials Into The Community Benefits Patients And Sponsors

A conversation with Amita Patnaik, MD, FRCPC, co-director of clinical research and co-founder, of START Center for Cancer Research

Location has long been a barrier to patient participation in clinical trials. While clinical trials had once been primarily conducted at academic medical centers (AMCs), more are increasingly hosted by community sites.

Case in point: The START Center for Cancer Research (“START”), which began treating patients in the community space in 2007. Amita Patnaik, MD, FRCPC, and fellow co-founder Kyriakos P. Papadopoulos, MD, opened the first START site in San Antonio, Texas, to provide more convenient access for cancer patients in need.

In this conversation, Dr. Patnaik recounts the growth and necessity of START’s locations and site network amid the perpetual need to bring clinical research, especially for cancer, closer to patients.

Clinical Leader: Tell us about the “start” of START in San Antonio. What was the goal of opening this community-based site?

Dr. Patnaik: About 80% of patients are cared for in a community practice setting, and yet the vast majority of clinical trials are housed, at least historically, within the framework of academic medical centers (AMCs). As you can imagine, this has left patients in the community with access to 20% or fewer clinical trial options.

We intended to create a streamlined Phase I clinical trials operation where we could have agency and autonomy while providing access in a setting where the vast majority of cancer care was being delivered. At the time of our inception, there were no other models of Phase 1 research programs housed within community practice settings. This was a very novel paradigm whereby patients could receive potentially lifesaving and innovative therapeutic approaches that they might not otherwise be able to obtain.

What are some of the benefits of moving out of an AMC and into a community location?

It created a very unique opportunity within a large community practice for patients and their treating physicians to have seamless access to a large arsenal of cutting-edge and breakthrough therapeutics. It also elevated the conversation within one of the largest practices in San Antonio about the availability of next-generation oncology drugs and propelled San Antonio into the national spotlight. The presence of a Phase I research program in a community practice allowed for demystifying the role of research studies in the care of cancer patients along with earlier education and discussion about the benefit of trial participation. One of the greatest benefits of moving to the community was that we were able to remove many of the key barriers to clinical trial participation which exist when patients have to leave their homes and their practices to seek these novel treatments at academic medical centers.

One of the most exciting outcomes of moving to the community was that we turned drug development on its head, where patients were not only coming to us, but we were going to the patients and meeting them in their own practice. As you can imagine, this was far less disruptive to patients as they had the benefit of remaining in their communities while continuing to receive all the multidisciplinary care which was a necessary part of their cancer treatment. It not only improved the delivery of care for patients in the community, it also brought great awareness of the role and impact of clinical trials and made it part of everyday conversation.

Moving into the community setting also helped to remove some of the key obstacles that can delay the opening of studies such as contracting, budgeting, and regulatory review as well as discussions surrounding intellectual property. All these factors can conspire to limit the opening of clinical trials at academic medical centers, sometimes imposing a delay of weeks to months, ultimately having a detrimental impact on the care of patients. As a site network, we eliminated key barriers to clinical trial participation and created a highly democratized process, which not only improved access to life-saving drugs but also brought a greater awareness about clinical trials within our community.

What should sponsors come to expect when working with a site network such as START?

One of the most important benefits is centralized coordination. When a protocol enters the START network, there is a broad-scale deployment that allows access to all of our sites. Unlike traditional models where information is often compartmentalized, our system allows the information to be rapidly and thoughtfully disseminated to all of our sites. Our sponsors have around-the-clock access to our centralized study acquisition team, which facilitates communication such that they only have to communicate with one individual, and thereby gain access to the entirety of our network.

Once a trial is launched at our site, our sponsors have access to highly dedicated and experienced teams of research staff led by seasoned principal investigators who have been working in the field of drug development for decades. Our infrastructure is built upon ensuring the safety of our patients also as well as high-quality and reproducible data. Sponsors can anticipate having not only speed but also efficiency of scale and a dedicated team that operates with a high level of uniformity, guided by standardized operating processes, safety, and data quality.

Speaking of partnering, tell us about START’s partnerships, including those with hospital systems. How did you get those up and running, and why are they so beneficial?

We initially partnered with a very large community practice in San Antonio, and that solidified the importance of offering innovative therapies to patients who are receiving cancer care in a community setting. We subsequently realized the importance of doing this work on a more national and international scale and that led to very strong partnerships with hospital systems and community practices across the globe.

After we opened our flagship center in San Antonio in 2007, we opened two START sites in Madrid. One was in a private hospital and the other was in a public setting. And we continue to grow from there. As of right now, we have eight global locations, of which five are housed in the EU and three in the U.S.

We also announced recently a partnership with Northwell Health, which is the largest provider of cancer care in New York and sees 19,000 patients per year with cancer diagnoses. Our first facility within Northwell Health System is going to be a START early phase trial site at the Zuckerberg Cancer Center, which opens in 2025 in Long Island, NY — arguably one of the most diverse populations in the world. One of the most powerful aspects of these partnerships is that we bring innovative therapies to patients who live and are cared for outside of AMCs and comprise a very diverse population.

Do you then have any advice for sponsors on how best to work with sites?

One of the most important pieces is communication and strong collaborative relationships so we can foster transparent communication and the timely provision of resources. We have multi-site meetings that we have been able to do through virtual platforms. The pandemic made us realize that we could do this as a global community within a virtual framework.

These conversations have allowed us to have a deeper understanding of the needs of our pharma biotech partners and vice versa. They have had a chance to understand at a more granular level not only the capabilities we have but also the things we might need to have more meaningful collaborations. That might involve having a pipeline discussion every six months to a year so that we can better deploy resources and have conversations about synergy and strategic positioning of trials at specific sites that best meet the needs of patients and sponsors.

We also think sponsors should be flexible and remain open to feedback to ensure their clinical trials are feasible, practical, and fulfill the needs of patients. Open dialogue and communication about development plans are important to ensure alignment of goals and help our sites to keep abreast of what is happening in the pharma biotech space. A regular cadence of such communication is now standard with many of our pharma partners— sometimes monthly, others quarterly, or biannually. These conversations often revolve around how to make processes more patient-centric while ensuring greater access and removal of barriers for patients to enroll in trials.

START is doing its part to alleviate patient burden, but what can sponsors do or what are they doing well that also can ensure accessibility for these patients?

There are a variety of barriers that patients encounter, with transportation and housing being two of the most frequent challenges. We are trying to structure our discussions with sponsors such that there is greater flexibility and consideration for patients as they navigate the process of seeking out clinical trials. For example, our flagship START site is located in San Antonio, Texas. While our patients within San Antonio and neighboring communities have easier access to clinical trials, many other areas in Texas do not offer clinical trials and thus patients must still travel to get to our center. Allowances that are as simple as travel and lodging help to decrease the patient’s financial burden.

We have also encouraged our sponsors, particularly through the pandemic, to have flexibility in scheduling. In the past, we were accustomed to seeing fairly rigid data collection timelines, but the pandemic taught us that building flexibility with windows of time to safely assess patients was not only pragmatic but also feasible with no detrimental impact on patient safety or data quality.

We have also seen allowances for new tools such as digital health assessments, virtual visits, and remote/off-site laboratory assessments. These considerations appear to be gaining traction within the phase I research space, and our pharma partners have been more understanding about their utility. We are all aligned on the need to ensure patient safety while alleviating the burden associated with clinical trial participation.

What is START's take on the future of these remote elements in trials?

Decentralized elements are going to play a critical role in making clinical research more accessible and available to patients. Virtual visits and at-home care — both are going to be indispensable in allowing patients to participate in trials. These elements will help improve patient adherence and data collection and also reduce the travel burden on patients.

We are also increasingly seeing the deployment of digital tools, including EKG monitoring and other wearables, digital drug diaries that enable around-the-clock oversight of safe drug administration, and digital quality-of-life tools that allow patients to report their symptoms.

These digital resources are giving us a new-found awareness of real-time data collection and the ability to aggregate data in a more pragmatic setting, which not only enhances patient accessibility and comfort but also gives us a more accurate picture of patient physiology in a more realistic setting. By implementing decentralized approaches, we can reach a more diverse patient population and enhance the generalizability of our trial results.

About The Expert:

Amita Patnaik, MD is an internationally recognized medical oncologist and co-founder of START based in San Antonio, Texas. She is the co-director of clinical research at START and director of the START fellowship program. Her clinical interests include Phase I drug development and malignancies of the breast and colorectum. Dr. Patnaik has pioneered the development of over 20 FDA-approved anticancer drugs over the past 20 years, including pembrolizumab, abemaciclib, and copanlisib. She is currently the principal investigator/co-investigator of over 60 early-phase clinical trials of novel anticancer agents for patients with advanced cancer.

Dr. Patnaik is a member of the American Society of Clinical Oncology and the American Association for Cancer Research. She serves as a preceptor and mentors medical, graduate, postgraduate students, and high school students.