How Community-Based Research Sites Are Revolutionizing the Patient/Physician Relationship - Courtney Alexander

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HANNAH LIPPITT: Hello and welcome to the Totally Clinical podcast, brought to you by Teckro. Totally Clinical is a deep dive into the freshest trends, big-time challenges, and most excellent triumphs of clinical trials. I'm Hannah, your host. Join me as I chat with industry experts, trailblazers, thought leaders, and most importantly, the people benefiting from clinical research. So, tune in, settle back, and don't touch that dial. It's time to get Totally Clinical.

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HANNAH LIPPITT: Today, I'd like to welcome Courtney Alexander to the podcast. Courtney is Site Supervisor, Contract and Budget Manager at Centricity Research, the largest consolidated Research Network in North America. Centricity takes an integrated approach to clinical trials, helping physicians adapt quickly to the environment by pairing them with subject matter experts.

During this podcast, we discuss the type of trials best suited to this community-based approach, the key role coordinators play with patients, and points of friction for physicians having to adapt to their new surroundings. I thought to start by exploring Centricity’s rather revolutionary approach of running clinical trials that has proved very successful. Could you start by explaining more about this as well as how your role works?

COURTNEY ALEXANDER: Centricity believes that the main focus is on finding the right candidates for each trial that we have. That being said, it takes a lot of coordinator time and dedication to achieve those promised goals for enrollment, as well as following each individual protocol a site has at any given time.

Centricity has been able to successfully align job descriptions, positions, departments, all of that to allow for a more patient-focused approach from the clinical operations team, which is our coordinators and our research assistants, as well as our recruitment team, providing the appropriate support, including individual start-up teams, regulatory finance, and others. That frees up coordinators to do just that, to coordinate their protocols and enroll patients into clinical trials.

Where my role comes into play is that I supervise those coordinators. So, I have a site in both our Savannah, Georgia and Columbus offices. One is a pulmonary research site, as well as an oncology research site. Both of those are community-based offices. They are integrated within practices so that we have the best options and best availability to our patients for those clinical trials, for those indications. I also help those sites to meet their measurable goals; so sometimes it would be meeting their enrollment goals or their revenue.

The majority of the time, internally, it would be the quality and metrics in which we put in our contract and budgets. So when those sites are doing well, and we're working well with our physicians, that's great, and my job is minimal at best. But whenever things are difficult and we have physicians and such that are maybe not happy or want different protocols or need more studies, that's where I come into play as well. So I help continue to keep the physicians engaged in research and wanting to enroll into the trials that they currently have and keeping those in the forefront, as well as helping to contact other community-based physicians with our CMO and finding additional options for research.

HANNAH LIPPITT: One subject that we've mentioned here before at Teckro is that research shows that when a physician has taken part in a trial, over 50% of them don't want to do so again because they found it such a shock in comparison to their normal roles. How do you work with physicians in this integrated way to ensure they get up to speed successfully?

COURTNEY ALEXANDER: So we have found at Centricity that when we put a subject matter expert, so that's generally the site supervisor or an experienced coordinator, with an inexperienced physician or a sub investigator, any type of physician who is getting interested in research, we've found that that's hugely successful in continuing clinical research with that physician after that first study has been done. We are integrated within their practice, we work alongside the physicians, their office staff, so we're bringing our company culture into their office space. So working alongside of them as if we are their office staff, but technically we are not.

So working together as one and a very cohesive relationship with the physician, and guiding them through the clinical trial process and how we work and how research is actually done as opposed to standard medicine. Because ultimately, they are subject matter experts in the specific specialties that they work in, whereas we are subject matter experts in research.

HANNAH LIPPITT: So I imagine that can be points of friction because physicians have to adapt so quickly. How do you approach the situation when problems arise?

COURTNEY ALEXANDER: Because of the way that our company is structured in different departments that conduct the different parts of the protocol; so we have the recruitment team, we have our finance team, we have the coordinators which is what we call clinical operations, and then we also have contracts and budgets and everything like that. So once we divvy up all that time to different departments, that frees up the coordinator to work through all the growing pains with that physician, as well as the site supervisor and the CMO.

As growing pains occur and friction does sometimes happen, whether it be regards to a patient on a protocol or just the way that the dynamics are working within this new relationship, we invest in our relationship with that PI by allowing that coordinator to continue working in that space and trying to work through the logistics of troubleshooting that new relationship and finding out what works for both parties to ensure the best outcomes.

HANNAH LIPPITT: And can you give any examples of any particularly difficult situations and how you overcame them?

COURTNEY ALEXANDER: I think with most newer sites that we've had in the past, research is just different. You know, knowing what medications you can and cannot give on a protocol, remembering how many protocols you have at any given time, remembering what patients are currently on a protocol whenever you're treating them in your standard of care office settings so that you don't give them a prohibited medication or you do document this adverse event properly, I think that is one of the bigger growing pains that we've found.

But again, housing that coordinator on site and then working alongside with the physicians and following the patients closely and creating that relationship not only with the patient but the physician, to say, “Hey, your patient's coming in today for a sick visit. I need to talk to them before they leave.” I think that that's been an integral part in the successes of our relationships previously and forthcoming.

HANNAH LIPPITT: So what's been the response by investigators and physicians when it comes to this new model of community-based sites?

COURTNEY ALEXANDER: We have had more success with this model, I believe, than we have in our standalone sites. So, we do have some sites that are not integrated into a physician-based practice or community-based location, they just have their own office and then we contract investigators to come in and see patients. So, we've had... we have both models and we've noticed that with this model, the community-based approach, it is extremely more successful being integrated with that clinic and that physician in their office, not necessarily being in their “clinic” clinic, but having space within their facility and having real time access to a coordinator versus referring them out for a research protocol.

HANNAH LIPPITT: And what kind of trials do you think are best suited to this model?

COURTNEY ALEXANDER: The majority of your trials that will be best suited to this type of trial are going to be your chronic indications, your specialty indications, your COPD trials being integrated in a COPD office like we are in our Savannah, Georgia, office has been a huge factor in the success of that site, same as being integrated into an oncology facility and having oncology trials for the community there has been a huge part of its success instead of having to refer them to Emory or the cancer centers of America and such for different protocols.

HANNAH LIPPITT: So, it's interesting you talk about oncology trials as they can be so complex. So, I imagine having site staff closer to patients must be much easier.

COURTNEY ALEXANDER: Absolutely. We found that being integrated into the center as contractors essentially and being able to access the EMR and pre-screened charts for the physicians and then take those charts to the physician and say, “Hey, we think this is a great trial candidate, we've looked at the inclusion exclusion criteria, we think that they would be perfect for this study, what are your thoughts, here’s some basic information on the study, here are the medications that they need to have taken,” or “Here's what they have to had previously in order to qualify,” and then that physician will let us know whether or not we can approach that patient based on his interactions with that patient or their outlook on what's going on with their care and things like that.

So, it is a hugely beneficial relationship to be in that facility, integrated with that staff and integrated with those physicians to offer these opportunities to these subjects.

HANNAH LIPPITT: What more do you think could be done to help investigators adapt quickly to clinical trial settings?

COURTNEY ALEXANDER: Protocols are very cumbersome, right? So they're multiple, multiple pages of so much information and being able to access that information easily and repeatedly and to be able to look at that information in real time. Since, like I said, the protocols are so cumbersome and large and difficult to keep when you have 30 or 40 different protocols running at one site, such as an oncology center, you can't have all that information with you at all times to know if you have a study for colorectal cancer, or breast cancer, or lung cancer, or multiple myeloma. It's just very difficult to navigate these days. So that would be the biggest thing that I can say is a hindrance for engagement with the physicians is carrying so many protocols at one time and then trying to get them to recruit or refer or to know exactly what they're referring into at any given moment.

HANNAH LIPPITT: So if we think about the future, how do you see the community-based model developing and what other key changes do you think will happen when it comes to increasing accessibility for patients?

COURTNEY ALEXANDER: I think the more community involvement we have as far as patients having access to advertising materials, such as Facebook and Instagram and mass production of emails and things like that, the more we can get things out there to these patients to make them aware of what opportunities and options they do have for their care is a huge part of enrolling patients. And not only that, but empowering physicians to have the patients ask about clinical research as an option for their care. I think that research is one of those, for lack of better terms, “dirty words” people just don't talk about in standard clinic for some reason – it's got such a negative connotation with it – when in fact it is a huge, huge asset to any physician to offer.

When you think about physicians and the amount of patients they have to see now because of COVID and insurance changes, the care you get in clinical research is hugely different than what you would get in a standard practice – not to add a slight to standard practice, obviously – because physicians are doing exactly as they're mandated to do, they're caring for their patients. But a research coordinator sees a far less amount of patients per day than a physician does, allowing them to have a better standard of care with that patient, better bedside manner, more time to allocate to that patient's care and their needs to get what they need from us.

That being said, physicians are still doing a good bit of the work for those visits, but it's the coordinators who are the face of that trial for that patient, and when you put that into retrospect, the majority of patients keep coming to their visits and keep going into additional trials further because of that coordinator and their experience with that coordinator, not even necessarily because of the five, ten, 15 minutes they get with that physician at each visit.

HANNAH LIPPITT: It's so interesting to hear you talk about the important role that coordinators play. Sometimes their role doesn't get as much attention in comparison to, say, investigators.

COURTNEY ALEXANDER: Coordinators are the stepping stone, in my opinion, for a lot of clinical trials. They're the main point of contact for any issues a patient has. They're the main point of contact when the patient is sick on the protocol. They're the ones who are getting calls at all hours of the night when the diary doesn't work, or they're having issues with the device for the study or the medication bottle broke or multiple different things that happen within a protocol that are unforeseen circumstances, they're that contact, they're the ones who walk the patient through the informed consent majority of the time, at least in our standard practice.

Coordinators consent the patients, they're the ones letting them know, like “This is how many visits you're going to have, this is how you're going to contact me at 24 hours a day if you need to, things like that. They're the ones that they go to and you build a rapport with that patient over clinical trial enrollment and retention. They or someone you see on a routine basis normally, and you have scheduled visits and you get to know them, you don't just sit there and do your assessments and they go home. You're getting to know them, they're telling you about their grandchildren or, “Hey, I got a new dog,” and they're showing you pictures of their children or whatever the case may be. You have that additional time with that patient where they get to be heard and seen and feel like they made a connection with somebody, and that's the big part of what Centricity does, we have these great coordinators who have this great bedside manner, and they allow these patients to really build a relationship with them.

HANNAH LIPPITT: And if we turn our attention back to physicians now, if you had a physician in front of you, what would you say to try to explain how community-based trials can help them do their roles more effectively?

COURTNEY ALEXANDER: So, one thing that we kind of encourage in physicians is that when in doubt, lean on your coordinator. They are research experience, they are the knowledge base for your research in experience, whereas you're their knowledge base for whatever that different indication is, whether it's COPD or cardiac or rheumatoid or neurological, you guys are going to rely on one another to make sure this protocol runs smoothly and you guys are going to be a team. So where you are faulting, you're not necessarily as strong, your coordinator will pick up that slack and vice versa. So we just encourage that the physicians communicate effectively with us and with our coordinators and with our other staff so that we can ensure that they have a pleasant experience being our PI or investigator or whatever role they're going to play on that protocol so that they continue to do research because research is an extremely intricate part to the community and making sure patients get the best care possible.

HANNAH LIPPITT: And do you have any final thoughts to share with the listeners on the benefits they should know about when it comes to community-based trials?

COURTNEY ALEXANDER: I think it's extremely pertinent to note that everybody should have access to clinical trials. Everybody. And when you're in a community-based center, a physician's office, a community oncology site, even a standalone site that really has a lot of outreach and has a lot of physicians that refer to it. Your patients – everybody's patients – should know that clinical research is not a last effort or a last option. It's definitely an opportunity for them to find the next up and coming medicine that could impact their lives in such a dramatic or strategic way to where their quality of life is impacted in a positive manner.

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HANNAH LIPPITT: And that's your dose of Totally Clinical. For all the listeners out there, you can follow Teckro on Twitter – the handle is @TeckroOfficial – LinkedIn, and Facebook, and subscribe to our YouTube channel. And of course, download the Totally Clinical podcast on Apple, Spotify and Google. See you on your next visit and remember to bring your friends. Thanks for listening. Goodbye!

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