Christina Brennan, MD, MBA, FACRP, is senior vice president of clinical research at The Feinstein Institutes for Medical Research at Northwell Health.

Richard D. Carvajal, MD, is physician-in-chief and director of medical oncology at the Northwell Health Cancer Institute, and leads all hematology and medical oncology programs across Northwell’s cancer network.

In this episode of OncChats: A Close Look at Clinical Trials in Oncology and Beyond, Drs Brennan and Carvajal highlight the increasing push to simplify cancer trial eligibility criteria and improve diversity in participant enrollment, stressing the importance of making clinical research more accessible and inclusive—especially for underrepresented populations.

A Close Look at Clinical Trials in Oncology and Beyond: Recruitment and Inclusion

 OncChats: A Close Look at Clinical Trials in Oncology and Beyond

, Christina Brennan, MD, MBA, FACRP, and Richard D. Carvajal, MD, of Northwell Health and Northwell’s Feinstein Institutes for Medical Research,  highlight the increasing push to simplify cancer trial eligibility criteria and improve diversity in participant enrollment, stressing the importance of making clinical research more accessible and inclusive—especially for underrepresented populations.

Yeah, and given the complexity of these protocols, are you finding it harder to find eligible patients who meet the criteria?

 I think the good news is that there is a clear recognition across the field in the industry that these therapies have to be made more accessible. And so, [when it comes to determining] what inclusion and exclusion criteria are really important, we will verbally state that we have to keep it as lenient as possible. There’s a major effort in the cancer field. You mentioned ASCO. So ASCO [and] Friends of Cancer Research, they’ve published a big position paper stating that things have to be simpler, but the FDA is doing the same thing. Why are we excluding patients with brain metastases? Why does it matter if they had some relatively slow-growing cancer 3 years ago? Why are those patients excluded? Honestly, they shouldn’t be.

Yeah, and if you look at that, why did it take until 1993 to have conversations to make sure we were including women after the Revitalization Act? Why did it take until 1993 [for that change to happen]? It’s crazy. Women and men behave differently [with regard to] their bodies, and not everything can be approved for one sex.

Yeah, and that brings up the need for racial/ethnic and socioeconomic diversity [when it comes to trial] enrollment. I’m so excited that this has at least become top of mind for everyone; [there’s an acknowledgment that] this is critical.

I agree. The FDA is focusing on this; there are separate offices in the FDA that are focused on diversity, equity, and inclusion. We have to continue to talk about it and to ensure that these patients are included, and that we’re doing a good job, as well.

Videos

In this episode, experts highlight the increasing push to simplify cancer trial eligibility criteria and improve diversity in participant enrollment.

In this episode of OncChats: A Close Look at Clinical Trials in Oncology and Beyond, Dr Carvajal discusses the progress made in cancer clinical trials, with nearly 20,000 trials worldwide and over 80 FDA-approved cancer drugs since 2015, while also noting the challenges posed by the increasing complexity of therapies and trial protocols.

A Close Look at Clinical Trials in Oncology and Beyond: State of Affairs and Industry Progress

, Richard D. Carvajal, MD, of Northwell Health and Northwell’s Feinstein Institutes for Medical Research, discusses the progress made in cancer clinical trials, with nearly 20,000 trials worldwide and over 80 FDA-approved cancer drugs since 2015, while also noting the challenges posed by the increasing complexity of therapies and trial protocols.

 Speaking of cancer, I know you attended the ASCO Annual Meeting, which is a very largely attended conference in the oncology space, what do you think is the current state of cancer trials? I know that’s a loaded question.

 Dr Brennan, I am so excited about what we're doing in the cancer space. I can’t even tell you. If you look globally, there are nearly 20,000 cancer trials ongoing. When you look at what the FDA has done, since 2015, almost one-quarter of the drugs that have been approved have been cancer drugs; so that’s more than 80 drugs. All of this progress has led to improvements in outcome; we’ve decreased the death rate of cancer by one-third since 1991. In part, it’s because of what we’re doing [with these trials]. I think [when it comes to] the state of clinical research in cancer, we’re making a lot of progress. As in every other field, though, it is becoming harder and harder to do these trials and deliver these sorts of therapies to patients, in part because the therapies are getting more complex.

We’ve gone from chemotherapy trials to targeted therapy/precision medicine trials, to checkpoint blockade. Now, we’re launching all these cell therapy trials with all the complexity associated there; [there are also] theranostics trials. All of this requires a tremendous amount of institutional resource and time to make it all happen. If you look at our protocols, and I’m sure this is the case for all of them, but now, they’re routinely 300 pages. I guess I’m a little bit old now, but when I started doing this in [the early 2000s], a reasonable protocol could be 50 pages. I think that just shows the complexity.

In this episode, experts discuss progress in cancer clinical trials and the challenges posed by the increasing complexity of therapies and protocols.

In this episode of OncChats: A Close Look at Clinical Trials in Oncology and Beyond, Drs Brennan and Carvajal emphasize the importance of providing flexible trial options, such as satellite sites and remote follow-ups, to enhance recruitment and retention, while underscoring the importance of patient choice and lessons learned from the shift toward decentralized trials during the COVID-19 pandemic.

A Close Look at Clinical Trials in Oncology and Beyond: Boosting Accessibility

, Christina Brennan, MD, MBA, FACRP, and Richard D. Carvajal, MD, of Northwell Health and Northwell’s Feinstein Institutes for Medical Research, emphasize the importance of providing flexible trial options, such as satellite sites and remote follow-ups, to enhance recruitment and retention, while underscoring the importance of patient choice and lessons learned from the shift toward decentralized trials during the COVID-19 pandemic.

 Yeah, I agree. First, looking at Northwell, as large as Northwell is [with] 21 hospitals and over 900 ambulatory sites, maybe not every center can participate in research, but at least they could be perhaps a satellite site where some follow-ups can take place. This way, it gives patients options, because patients often complain about traveling, even to academic medical centers, where some of these trials are taking place. They just can’t keep getting there, which [leads to poor] compliance for follow-up. I feel if we give patients options, whether it’s going to one location for the initial enrollment [and then] perhaps some of the follow-ups and treatment can be [given] at a different center, this [would] improve a lot of the recruitment and retention. [This would] increase the pool of investigators, as well. Like you said, they can have some participation; it doesn’t mean that it’s the same [level] as maybe [what we would see at] the primary location.

When we think about that, this is what comes to mind to me, but you can tell me what you think. We’ve heard a lot in the industry, especially during [the] COVID-19 [pandemic about] DCTs, decentralized clinical trials, and I didn’t particularly like the term, [but] it was something that the FDA really redefined and kept moving forward with. We had to pivot during [the pandemic] to a lot of remote environments and [we needed to] continue to make sure patients were receiving treatment and being followed. Now, moving forward, just as we’re saying coming to the study location for one aspect of the trial but giving the patient the option [of going to a center that is more convenient, we raise the question], can some of those follow-ups be done at the patients’ homes? We’ve done this at Northwell, and I think that would also go a long way in the clinical trial space [with regard to] patient satisfaction.

[However,] not everyone wants a visit at home. I remember something funny. We did a survey on [female] patients having visits at their homes for part of their clinical trials. Believe it or not, some of the women said, “I don’t want people coming to my home. I felt I had to clean before I could have a visit.” That could be true [for some]; it added another layer of stress or burden on the patient because they felt they had to have their house in order. As such, I keep saying patient choice, patient centricity [is key]; I don’t think clinical [trial] protocols can be so black and white. I think [there needs] to be options for our patients.

Northwell [was] such a leader in that COVID-19 [pandemic] space [with regard to determining] how to actually do these sorts of trials in that environment. [For example,] the famotidine trial; it was pretty amazing that you were able to design and pull that off as quickly as you did.

 Yeah, that is a great example. Just to give the audience some perspective, this was a trial that we did during [the pandemic and explored] famotidine, which is the active ingredient in Pepcid, which many of us know is an over-the-counter, gastrointestinal type of drug. We were originally going to have this as an outpatient trial, recognizing then that the last thing a patient wanted to do when they had COVID-19 and were feeling pretty sick was to keep coming back and forth to the hospital or the clinic. As such, we completely pivoted the trial to a fully remote trial, and we were able to utilize Northwell’s resources. We recognized our laboratory groups were already going to the patients’ homes, so that was an easy win. We worked with pharmacy [to ensure] drug delivery to the patients’ homes, so that was [another] win. And then, we were able to provide the patients with electronic tablets so that they could provide patient-reported outcomes to us in real time. We really did a good job in showing that [a trial] was [able] to be fully remote. Once we really measured our data, we found that we reached patients in zip codes who never participated in clinical trials with us at all.

What an amazing lesson. In the cancer space, when the pandemic hit, even our most challenging or complex trials, these phase 1 trials, we figured out how to make them happen so that patients didn’t have to come in as frequently. In a way, it forced us to look at what’s really necessary in these trials to actually answer the question.

In this episode, experts emphasize the importance of providing flexible clinical trial options, such as satellite sites and remote follow-ups.

In this episode of OncChats: A Close Look at Clinical Trials in Oncology and Beyond, Drs Brennan and Carvajal discuss the challenges of increasing awareness and participation in clinical trials, underscoring the need for education and support for community physicians, as well as making clinical trials more accessible and less burdensome for busy providers.

A Close Look at Clinical Trials in Oncology and Beyond: Barriers to Participation

, Christina Brennan, MD,MBA, FACRP, and Richard D. Carvajal, MD, of Northwell Health and Northwell’s Feinstein Institutes for Medical Research, discuss the challenges of increasing awareness and participation in clinical trials, underscoring the need for education and support for community physicians, as well as making clinical trials more accessible and less burdensome for busy providers.

Patients trust their providers the most, but yet we have challenges still when providers don’t bring up clinical trials as an option. How do you think that we can move the needle more for community physicians and others to really bring up clinical trials as part of their conversations? Do you think it’s education awareness? I’m still trying to figure out why we’re not doing a better job with this.

I wish I had that magic bullet answer for you. But part of this is examining, what are the barriers [to doing this,] right? We know there are many, many barriers that providers and patients have [with regard to] clinical trial participation, etc. Part of this is just awareness on both sides.

But how do our physicians know what the appropriate trial portfolio is for each clinical scenario? And again, our general practitioners, for instance, in internal medicine, are not going to know all the hypertension and diabetes and cholesterol trials that are ongoing, whereas our cardiologists, who focus on hypertension would. So, how do we make sure our generalists have access to the expertise and knowledge that the subspecialists might have?

I agree. When you say the word “awareness,” it became clear to me and others a few years ago that even our own employees and faculty were not aware of the breadth of clinical trials that Northwell was participating in. If we don’t have our own employees as our ambassadors to [ensure] patients themselves or in the communities [are] having these discussions, we’re not going to be able to do a good job for [them]. We [must] have our own awareness [first]. When I walk through the halls of the cancer Institute, I love to see the banners that are [placed] high up [and spread from] the ceiling down [that tell us that] clinical trials are happening there. You want that to become a part of the practice and the discussions.

One thing that I think about for these community providers—and not everyone can be an investigator on a trial, we know that—[is that] a lot of them are not having the opportunity to participate. When you mention some of the basic trials on hypertension, cardiac prevention around lipids, etc. [some are] not getting an opportunity to participate, and there is still that resistance of referral, because they feel sometimes that they will lose their patients to that clinical trial list. I would look at this as an opportunity in the industry. Although we want to go back to our key opinion leaders on a lot of these trials, we have to give opportunities to new investigators, young and growing investigators, to be able to reach them, as well. I don’t know, what are your thoughts on that?

 That is so critical. What would the ideal state be for clinical trials? A potential ideal state is that every healthcare organization is a trial site, and every clinician is an investigator, right? Within the cancer institute, what we’ve done is try to move in that direction, where 8 of our 10 cancer centers are actually clinical trial sites and all our cancer institute members are investigators.

 Right? Now, just because someone’s an investigator and we can do trials at a site still does not mean it’s going to happen, because of all the work that’s involved to do this. As such, another important piece is, that we have to take all the complexities—which are increasing, of course—that are involved with these trials and make it simple for the clinicians to actually participate. So, within cancer, within our Cancer Clinical Trials Office, we have an enormous staff of research nurses, healthcare professionals, coordinators, and so forth, who are able to really lift that burden of identifying consenting patients and take the documentation from the physicians who are very busy. Even if [those busy physicians] want to participate, it’s just very challenging [for them so] let’s take as much of the burden as possible off of them and make it easier for them to enroll their patients so their patients get the benefit from that study.

In this episode, experts discuss the challenges of increasing awareness and participation in clinical trials.

In this episode of OncChats: A Close Look at Clinical Trials in Oncology and Beyond, Drs Brennan and Carvajal discuss the importance of integrating clinical trials as a standard of care, emphasizing education for healthcare providers and patients to view them as a viable treatment option rather than a last resort, particularly in the realm of oncology.

A Close Look at Clinical Trials in Oncology and Beyond:Incorporating Into Standard Care

, Christina Brennan, MD, MBA, FACRP; and Richard D. Carvajal, MD, of Northwell Health and Northwell’s Feinstein Institutes for Medical Research, discuss the importance of integrating clinical trials as a standard of care, emphasizing education for healthcare providers and patients to view them as a viable treatment option rather than a last resort, particularly in the realm of oncology.

Good afternoon, Dr Carvajal. I’m glad that the two of us are getting together today to talk about clinical trials—not only clinical trials at Northwell, but the state of clinical trials across our industry. Just so the audience is aware, why don’t you introduce yourself, as you’re fairly new still to Northwell.

 Thank you, Dr Brennan, and I’m thrilled to be speaking about this topic. My name is Richard Carvajal; I’m a medical oncologist. I have the role of deputy physician-in-chief, here, at the Northwell Health Cancer Institute, so I oversee hematology and oncology. A large part of why I came here was because of what we are able to deliver to our patients across Northwell and beyond in terms of novel therapies on clinical trials. Something that I always say is—and this is true for all of medicine, but I think particularly true for cancer—clinical trials, although we consider this research, is really part of standard of care. Access to these new treatments is what we have to provide all our patients with cancer until we’re curing everybody. We have to do this and push the envelope.

Agreed. And my name is Dr Christina Brennan. I have been at Northwell for 24 years. I’m the senior vice president for our Clinical Research Program. [I oversee] general research, and then, as you mentioned, yourself and our vice president Erica Love, oversee the oncology side. I think we’ll get right into it. I like that you brought up looking at clinical research more as standard of care. I’m not sure if you’ve heard throughout the industry, but there’s been a movement called CRAACO, or clinical research as a care option. I want to talk about that for a moment, because I think it’s so important. I still see [this with] many of our providers, and then patients [also] believe this, that clinical trials become almost thought of as a last resort. How do you think that we can really incorporate more clinical trials within clinical care?

 Yeah, so that’s a wonderful question. Obviously, you would need a multipronged approach to really do this. I think the foundation of solving that issue is really a matter of education. This is education for our faculty, our team members, and the patients and family, that this is really an expectation. Again, I’ll just bring it back to the cancer space. What I always tell my patients is that the clinical trial options, or “investigational” options, should be a part of every single decision-making discussion. That is, you want to know what is standard of care or currently available today, and what are the questions that we’re trying to answer on clinical trials? In the best of all worlds, what we’d be able to do is treat our patients today with the treatments of the future, which presumably are going to be better.

Check back for the next episode, which will air tomorrow at 1 pm.

In this episode, experts discuss the importance of integrating clinical trials as a standard of care, particularly in the realm of oncology.

Christina Brennan, MD, MBA, FACRP

Articles

A Close Look at Clinical Trials in Oncology and Beyond: Recruitment and Inclusion

A Close Look at Clinical Trials in Oncology and Beyond: State of Affairs and Industry Progress

A Close Look at Clinical Trials in Oncology and Beyond: Boosting Accessibility

A Close Look at Clinical Trials in Oncology and Beyond: Barriers to Participation

A Close Look at Clinical Trials in Oncology and Beyond: Incorporating Into Standard Care