Patient recruitment remains the leading cause of delay for getting new medical products to market. These delays increase clinical trial costs and can cost Sponsors millions per day in drug-patent protection loss. So how do we, as an industry, combat this?
One solution is through “patient-centricity,” which is defined as, “Putting the patient first, in an open and sustained engagement of the patient to respectfully and compassionately achieve the best experience and outcome for that person and their family.” (AstraZeneca Pharmaceuticlas, n.d.) This solution seems to resonate throughout the industry, and why shouldn’t it? It is a lofty and worthy cause to put all patients first, especially in the clinical trial arena. However, the industry might be misinterpreting this concept, and the consequences are concerning.
“Patient first” could have several interpretations, from ethical to operational. However, it does not mean “direct to patient.” Except in life threatening situations, patients do not want to be their own advocates. When confronted with an injury or illness, they want their trusted doctor to diagnose, explain, and prescribe a solution. The patient is rarely interested in how the molecule works; they just want to feel and live better. And, in the rare situation that the provider can’t help, a referral is made to a specialist, but referrals aren’t often made to clinical trials.
Data suggests that 75% of patients would be interested in participating in a clinical trial if it was recommended by their doctor, however only 9% are typically asked (Sing Yu Moorcraft, 2016). This is because the opportunity exists only in the serendipitous situation where the treating physician is also an investigator. So, if we know that patients WANT to participate, and we also know that patients don’t want to be their own advocates, wouldn’t that mean that a major component of “patient-centricity” is the treating physician?
This is not a new concept. “Clinical trials as a care option” has been an industry goal for a while. In fact, Craig Lipset, the ex-head of innovation for Pfizer, is quoted saying, “Enabling physicians to offer clinical trials as a care alternative is the holy grail of participant enrollment.” (Lipset, 2021) So how do we get there? How do we become more patient-centric by engaging treating physicians to offer clinical trials as a care option?
Right now, it seems impossible due to misaligned incentives between treating physicians and investigator teams. Fears of patient leakage, unknown clinical trial sites, lost revenue, and a loss of control of the patient relationship all keep the scales unbalanced. Ask any dedicated clinical trial site, “Is there a local specialist that should be referring patients, but isn’t?” The answer is a resounding, “YES!” This should frustrate all of us, because it’s obvious, we are failing to be “patient-centric.’
Fortunately, the answer is easier than we’re making it, and it’s right in front of us. Post COVID, new technologies like telemedicine and other decentralized tools have been accepted as normal practice. Former FDA Associate Office Director and eSource guidance co-author, Jonathan Helfgott says, “Sponsors tend to be overly conservative while the FDA is open to new technologies that make it easier for patients to participate in clinical research, whether it be from their home, a local clinic, or a provider’s office. Simply using technology to connect a patient from an alternate location to the PI’s site does not trigger any new clinical sites or clinical investigators.” (Helfgott, 2022)
This concept of facilitating clinical trial appointments at a trusted, local provider’s office opens a huge door for clinical trial sites to generate referrals from treating physicians. Further, by aligning the incentives between providers and investigator teams, it enables existing clinical trial sites to leverage their current relationships with local physicians to truly begin offering “clinical trials as a care option.”
In conclusion, while it is necessary for Sponsors to act conservatively, they could be missing a huge opportunity to stimulate referrals from treating physicians at the local level. We forget, most clinical trial candidates are not medical mysteries, they typically have an existing diagnosis and have a relationship with a trusted local provider. By enabling local providers to facilitate certain clinical trial appointments, it has the potential to fill clinical studies faster, balance diversity, and even save lives.
Bio of Author – Scott Stout
Scott Stout has been recognized as one of the top healthcare innovators of 2021. While working as a professional investor in high finance, Scott identified a large gap in the clinical trial marketplace. He seized the opportunity to build a team of healthcare, high tech, and venture capitalists to turn his concept of expanding clinical trials, “Beyond Clinical Trial Sites,” into a reality.
Bio of Craig Lipset
Craig Lipset designed and co-led the industry’s first fully virtual clinical trial, and continues to serve as a decentralized trials advisor to major pharmaceutical companies, as well as the Innovative Medicines Initiative in Europe. He is co-chair of the Decentralized Trials & Research Alliance, the largest non-profit collaboration advancing the global adoption of decentralized research, with more than 100 member organizations including FDA, pharma, tech, service providers, advocacy, and healthcare organizations.
Bio of Jonathan Helfgott
With almost 20 years of combined experience at FDA, academia, and private industry. Jonathan worked at the FDA from 2006-2015, most recently serving as the Associate Director for Risk Science within the Office of Scientific Investigations at the Center for Drug Evaluation & Research (CDER). He also served as a compliance officer and pre-market reviewer at the Center for Devices & Radiological Health (CDRH), specializing in Digital Health, Software as/in a Medical Device (SaMD/SiMD), and eClinical.
Source for 9%
https://hints.cancer.gov/docs/Briefs/HINTS_Brief_48.pdf