Setting the Groundwork for Patient-Centric 1st in Human Clinical Trial Funding Opportunities
From Michael Kaplan, MRA President & CEO: There is a reason the word “Alliance” is in our name! The Melanoma Research Alliance (MRA) knows that to achieve our mission of ending suffering and death due to melanoma, broad partnerships and collaborations are required. In this spirit, MRA entered its first partnership with the Rising Tide Foundation for Clinical Cancer Research (RTFCCR) in 2017, partnered again in 2019, and is now setting the groundwork for a 3rd partnership anticipated to launch in the fall of 2021.
RTFCCR, based in Switzerland, was founded in 2010 and operates with the goal of helping patients improve their quality of life and win the fight against cancer! In 2017, MRA and RTFCCR joined forces to fund a European-led Team Science Award (TSA). In 2019, the two organizations co-funded a TSA focused on melanoma metastasis. For 2021, both organizations are working together to invite applications for two new team science awards through the MRA 2021 RFP.
In early August 2021, MRA will issue its annual RFP; and as with past years, a 2nd release will be issued in early September. Within that second release, RTFCCR and MRA plan to include a special opportunity to fund up to two awards for patient-centric research to advance new treatment approaches to first in human melanoma patient trials.
Funding is anticipated to support up to $1.5 million for each of the two awards, over a five-year period. Critical to these opportunities will be a patient-centric approach, where patients are engaged early on, and throughout the project in designing/refining/and guiding of such research efforts to ensure patient needs and preferences are front and center.
Toward that end, we share this pre-alert and the following blog to encourage potential applicants to begin thinking now about potential research efforts that meet both the patient-centric frame for this opportunity and advances new compounds/treatments to human trials for melanoma. To further thinking on this topic, we are excited to share the following blog authored by Alexandre Alencar, MD and Valerie Behan, PhD (RTFCCR Senior Scientific Program Managers); and T.J. Sharpe (melanoma survivor, blogger & cancer advocate).
A Seat at the Table: A New Approach to Research
There is significant value in integrating patient involvement throughout the clinical development process. From improved trial design, higher and quicker enrollment, better adherence to trial protocols, and potentially quicker time to market – important goals for all stakeholders (and if you are reading this – that’s you). It also can make the study a better experience for patients, have more relevant and patient-focused measures and endpoints, and identify areas of unnecessary burden that can help streamline the research process.
In the last decade, designing patient-centric trials has evolved the way clinical research is conducted. A good example is some of the early anti-PD-1 trials; one of the companies developing an anti-PD-1 therapy recognized how transformative they could be, and with the help of patient/patient advocacy group input, modified the traditional trial design to include a compassionate crossover; if you were randomized to the standard of care chemotherapy and your disease progressed, you would be stopped on your chemotherapy and given the study drug. This meant the endpoint needed to change from overall survival to progression-free survival. That trial enrolled quicker and helped lead to a faster approval than another competing therapy, giving the sponsor a huge boost in the market, but also getting a game-changing treatment to patients earlier than would have been possible had it followed the more traditional route of its competitor. That value was measured not in time to market or revenue generated, but patients treated and lives saved.
Unfortunately, patients are too often NOT involved in medical research. The Rising Tide Foundation decided to see what we – as a funder – can do to make sure that patients have a seat at the table.
Rising Tide Foundation’s Journey
At Rising Tide Foundation, we embrace the pivotal role that patients play in developing approaches for the diagnosis and management of cancer and its effect on everyday life. We want to involve patients by putting their experiences to use, helping to shape research so that it is carried out with patients, rather than to or for them.
Last year, we began to work with consultancy group Patvocates to better understand the role of funders in advancing greater patient involvement in clinical research through the grants they provide.
Through this process, we created a guidance document that outlines ways in which researchers can better involve patients in the research process.
A New Direction for Future Grant Awards
Rising Tide Foundation defines patient engagement as meaningful engagement of patients in the development of therapeutic, detection or prevention approaches to cancer care. It encompasses the active and collaborative interaction between patients and researchers across all stages of the research process, where research decision making is guided by patients’ contributions as partners, recognizing their specific experiences, values, and expertise.
To demonstrate our commitment to patient engagement, RTFCCR has updated our funding guidelines. One important change is the requirement for a Patient Engagement Plan as part of every application. Such plans will describe Patient Engagement processes during the generation of the project application as well as during the implementation of the project. In this way, we at RTFCCR are helping to ensure our funded projects involve patients across the entire research lifecycle.
We at the Rising Tide Foundation are excited to also be working on our third collaboration with MRA, which will be announced this fall as part of MRA’s 2021 RFP. Previously, we’ve partnered to fund Team Science Awards based in Europe and one focused on melanoma metastasis. In 2021 – RTFCCR and MRA will come together to support first in human melanoma trials focusing on reducing side effects and improving quality of life through two $1.5 million Team Awards over five years.
The most exciting thing for us is that MRA has fully embraced our new efforts to give patients a seat at the table in clinical research for awards funded through this partnership. We expect with this to receive exciting applications which include the co-design of endpoints with patients. We will be soon announcing this funding opportunity at MRA’s website.
“MRA applauds the Rising Tide Foundation for giving patients a more active role in research projects that directly affect them,” says Kristen Mueller, MRA Senior Director, Scientific Program. “After two fruitful past partnerships, we are looking forward to partnering with Rising Tide for a third time to advance new therapies that affect melanoma patient needs, such as improved disease control, reduced side effects, and improved quality of life, while giving patients a voice in the research process.”
Giving Patients a Seat at the Table
A patient-centric design that involved patients as stakeholders and co-creators increases the likelihood of success for everyone – the patient receiving the treatment, the site administering the trial, the sponsor developing the therapeutic, and any funder helping to finance it. Each of these groups have a vested interest in the trial being successful, but too often, one of their voices is absent from the input process. As shown above, involving the patients in part of this process provides value for each of the stakeholders in clinical research.