The launch of the Center for Observational Research by Skipta and Continuum Clinical aims to create opportunities for physicians to participate in real-world studies. These are noninterventional, observational studies that do not take place at the academic centers and trial sites one usually associates with clinical trials. The intriguing aspect is that this center exists entirely online. It is a network designed to connect interested physicians with observational studies smoothly and efficiently, and to accelerate the pace of enrollment and data collection.
The incorporation of real-world data is not a new concept in the biopharmaceutical industry. Data on how medications function and their adverse events in the wider population have long been collected in phase IV trials and affect the marketing and reimbursement for these medications. These data are invaluable for determining how a medication or device fares with patients of different ages, sexes, ethnicities and with varying comorbidities that are not accounted for in the initial clinical trial phases.
Any study, regardless of type, is only as strong as its design and interpretation. True evidence-based medicine, touted as the holy grail of practice guidance, requires a careful review of data; it is not predicated on a randomized controlled structure. Jeff Trotter, president of Continuum Clinical, said, “Real-world studies are really important. Like any clinical trial, we want to ensure that these studies are as operationally efficient as possible and of interest to everyone that participates (physicians and patients). We all benefit from there being better information about how diseases are managed and how products perform under actual practice conditions.”
The new Center for Observational Research aims to make it easier for physicians to find and participate in observational studies, enhancing this aspect of evidence-based medicine. It is touted as the first endeavor to crowdsource the participants on behalf of research sponsors. To achieve this crowdsourcing, Continuum Clinical partnered with Skipta, an online networking site for physicians. Skipta has hundreds of thousands of members, including other healthcare professionals such as pharmacists. Member clinicians use the website to self-sort into different areas of medical practice and topics of interest. As participation in Skipta takes place online, the member clinicians are already “plugged in,” so to speak, to the platform necessary to use the digital environment of the new center. In fact, noted Dr. Theodore Search, CEO of Skipta, “The center is accessible directly within Skipta’s specialized online medical communities, without a separate website or login required, ensuring a seamless user experience members are already familiar with.”
Continuum Clinical has extensive experience with patient recruitment, retention, study design and implementation in a variety of observational and noninterventional studies. The center will facilitate matching Skipta physicians with appropriate studies designed and maintained by Continuum Clinical.
Trotter said, “We’re kicking it off with Continuum studies. We have around 20 different studies that we’re listing initially; these are all projects that Continuum is involved with at some level, whether we’re designing or implementing the study. But we do not want to limit it to just projects that we’re involved with.
“If a sponsor wants to have their observational study listed, or another CRO wants to have their study listed, we’re fine with that,” said Trotter. “For all intents and purposes, it will start out exclusively and then evolve primarily to projects that Continuum is involved with, but we’re certainly open to others being listed.”
So why was this joint venture deemed necessary in the first place? Trotter said, “More and more physicians are recognizing that the internet is the way to access information about research and day-to-day practice. … These physicians don’t get up in the morning wanting to do a clinical trial. They get excited about patient care. Still, their experience, their patients’ experiences and the outcomes associated with what happens in the real world are increasingly of interest to the life-sciences community. Let’s tap into these wired communities of physicians and make it as easy as possible for them to raise their hand and say, ‘I’d like to know more about that opportunity.’ Let’s make it easier for us and our clients to identify these real-world practitioners. It tends to be a pressure point for a lot of the studies—finding the doctors to enroll patients is critical to getting these observational studies done.”
Search added, “We know physicians are inundated with information on a daily basis and it’s difficult for study sponsors to effectively recruit physicians. Our verified physician members are regularly logging into Skipta communities for news and information related to their profession, making it an ideal place to digitally house available research opportunities in a place where we know physicians are already visiting and engaging. Ultimately, Skipta members can benefit from participating in research projects and generating data that can help them optimize patient outcomes.”
Trotter clarified, “The first step is getting physicians to look at the list and find studies that are of interest to them and their patients. Continuum then follows up to make sure they are qualified to participate in the study. They will then enroll patients from their own practice. At some point, we may use the center as a vehicle for getting patients directly involved, but right now the center is more physician-centered.”
This venture aims to complement and enhance the activities of the clinical trial industry. Search said, “The center will impact the clinical trial industry by matching real-world study investigators to available research opportunities faster, accelerating the recruitment process and ultimately ensuring research is completed efficiently. This acceleration results in faster research completion, evidence collection and opportunities for improving health outcomes.”
Trotter added, “There are a lot of investigator lists that CROs and pharma companies maintain, but there tend to not be as many organized and systematic processes for finding real-world physicians. The clinical trial industry recognizes that we all would benefit from greater efficiency in getting patients and physicians to participate in these studies.
“Our particular contribution is focused on one step toward maximizing the efficiency of getting these real-world physicians to participate in the increasing number of observational studies and registries that are being sponsored. It may not revolutionize the industry, but I think it’s very consistent with where the industry is going,” said Trotter. “If we can, in some way, contribute to improving study efficiency and more effectively linking physicians with research opportunities, then it’s one modest way of contributing toward the advancement of observational studies.”
This article was reprinted from Volume 21, Issue 26, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »