During a panel discussion held at DIA Global 2024, industry experts discussed how AI and real-world data (RWD) are accelerating drug development.
LEARN MORE about how curated clinical trial datasets can be used by AI to transform medicine
We are pleased to announce the launch of a new CorEvitas clinical registry in Adolescent Alopecia Areata (AA). This registry, which is open to enrollment, addresses
LEARN MORE about how curated clinical trial datasets can be used by AI to transform medicine
This cutting-edge platform provides secure access to anonymized, local-level data encompassing diagnosis, treatment, demographics, and more across England. By utilizing this platform, healthcare stakeholders can make informed strategic decisions, optimize resource allocation, enhance treatment strategies, and improve care coordination and outcomes.
The first Real-World Data (RWD) platform offering primary care activity data, Vantage utilizes a panel dataset sourced from EMIS, SystmOne, and Vision, covering England. With more than 15.6 million patients added to the primary care panel dataset since 2019, it is currently the fastest-growing GP-provided source.
For more information on Primary Care Activity Data and to request a demo of CorEvitas’ Vantage platform, click here
Our groundbreaking research is referenced by the World Health Organization (WHO) and the International Society of Pharmacovigilance (ISoP) Drug Safety Journal.
The WHO publication titled “Pregnancy Exposure Registries in Low- and Middle-Income Countries (LMICs)*” sheds light on the vital role of pregnancy exposure registries in LMICs. According to the WHO publication, pregnancy registries play a pivotal role in monitoring the safety and outcomes of medications, vaccines, and other exposures during pregnancy, especially in regions where such data are scarce. The research conducted by CorEvitas’ pregnancy registry has significantly contributed to filling this critical gap in knowledge.
Findings from our pregnancy registry studies have been acknowledged in the Drug Safety Journal by the International Society of Pharmacovigilance (ISoP). The manuscript titled “The COVID-19 International Drug Pregnancy Registry (COVID-PR): Protocol Considerations,” published in the journal, assesses the relative risk of obstetric, neonatal, and infant outcomes associated with the use of drugs specifically indicated for the treatment of COVID-19 compared with other drug treatment strategies. These data provide valuable insights about COVID-19 treatment during pregnancy for healthcare professionals, policymakers, and researchers.
The acknowledgement of these data in prestigious publications reaffirms the importance of pregnancy registry studies in facilitating evidence-based decision-making to improve maternal and fetal health outcomes worldwide.
For more information about CorEvitas’ pregnancy registries, click here
Read the abstract: The COVID-19 International Drug Pregnancy Registry (COVID-PR): Protocol Considerations
Download the WHO publication: Pregnancy Exposure Registries in Low- and Middle-Income Countries (LMICs)*
*Landscape analysis of pregnancy exposure registries in low- and middle-income countries. Geneva: World Health Organization; 2023. Licence: CC BY-NC-SA 3.0 (https://creativecommons.org/licenses/by-nc-sa/3.0/igo/).”
We are pleased to announce the launch of a new CorEvitas syndicated clinical registry in generalized pustular psoriasis (GPP). This registry, which is open to enrollment, is CorEvitas’ 10th syndicated disease registry and addresses an unmet need for real-world evidence (RWE) related to the clinical and patient-reported outcomes of patients with GPP.
The new registry will prospectively collect detailed patient-level data enabling assessment of the natural history of the disease and treatment patterns, along with the prevalence and incidence of comorbidities in patients with the disease.
Read the press release, here.
To find out more about the GPP registry, including some information on some of the variables we collect, visit corevitas.com/gpp-generalized-pustular-psoriasis-registry/
September 6, 2022
The following highlight example use cases for clinical registry data as a source for real-world evidence (RWE):
For use cases where it’s critical to have access to consistent, reliable diagnostic detail, biopharmaceutical companies can leverage clinical registry data. These data have several advantages over other real-world data sources:
Clinical registry data is especially fit-for-purpose when answering research questions that require large volumes of detailed information collected across a broad network of sites. Highly structured clinical registry data lends itself well to both simple and sophisticated statistical analyses.
“We engage a large number of physicians working in specialty areas that align to the diseases we cover in our registries,” says Christine Barr, Vice President, Drug Safety and Pharmacovigilance at CorEvitas. “In our registry studies, physicians and patients complete questionnaires on a set schedule. This allows us to collect accurate information about drug use and dosages, adverse events that may be experienced, disease activity and disease characteristics over time. We also collect targeted source documentation that supports adjudication by expert physician panels. Our registries include broader patient populations that may not be well represented in clinical trials. This helps address uncertainties about long-term use of therapeutics in real-world populations.”
Across Phase II and Phase III clinical trials, clinical registry data can be leveraged in several different manners. With a single-arm comparator study model, RWE is collected in lieu of a control group. This dramatically reduces patient enrollment targets. Using registry data can also simplify recruitment where the targeted disease is severe, and fewer treatments are available.
Once a drug has received regulatory approval, clinical registry data are also utilized. By design, clinical trials are relatively short in duration and examine only a limited number of patients. Many subgroups or vulnerable populations are rarely, if ever, represented in clinical trials, including pregnant women, people with background comorbid conditions (for example, cancer or heart disease) and patients who have already been exposed to or failed treatment in the same class of drugs.
“Once a drug has passed through clinical trials, it has demonstrated efficacy and relative safety in a cohort of patients over a limited observation period,” Barr explains. “But many questions remain that can and should be answered. Clinical registries are frequently used in the post-approval space to help answer these questions. These data provide missing information to contextualize what was seen in the trial, filling in the blanks that inevitably appear because clinical trials can never have enough time, enough patients or enough patient diversity to accurately mirror real-world conditions.”
Clinical registry data are especially valuable for use in formal post-authorization safety studies that pharmaceutical companies can employ to demonstrate to regulators that they are applying an appropriate level of rigor to answer questions about effectiveness and safety. Regulators may choose to require these sorts of studies, but pharmaceutical companies may also perform them voluntarily. These voluntary studies may be part of a risk management plan and strategy, to show regulators they are making a good-faith effort to assure the safe use of the product in the real world, complementing the insights derived from their clinical trials.
October 20, 2022
KEY LEARNING OBJECTIVES
December 7, 2016
“I’m very passionate about rheumatology because we have the ability to care for patients over the long term. We really are partners in their care, we walk the journey with them,” Leslie Harrold, MD says. “Some patients we can heal, some we can’t, but we’re always there to work with them and try to give them the best care and the best quality of life. I think we really are trying to be partners with them and work collaboratively so they can have the best care and the best outcomes possible.”
At the 2016 American College of Rheumatology Annual Meeting in Washington, DC, Harrold was on hand to present findings from the Corrona RA Registry, the largest prospective rheumatoid arthritis (RA) study in the world, with over 40,000 patients enrolled. The ever-growing registry was first launched in 2001, and serves as the basis of countless research efforts on the prevalence and treatment of the painful rheumatic condition. Harrold is a Senior Medical Director of Pharmacoepidemiology and Outcomes Research for the Corrona Registry.
Dr. Harrold’s team displayed a number of posters at the Meeting. A pair of them examined challenges and outcomes for RA patients with poor prognosis factors. “There hasn’t been a lot of work on poor prognosis,” she told MD Magazine in an interview, “What we chose to use were the poor prognosis characteristics that were included in the 2008 RA treatment recommendations put out by the American College of Rheumatology. They suggested you alter your treatment based on these characteristics.”
The poor prognosis factors her team examined were functional status, or how well an RA patient can function in daily life; seropositivity; x-rays that showed erosive disease; and extra-articular manifestations, such as RA lung disease/nodules or Sjögren’s syndrome.
One of the two examined if the presence of such factors in patients had an impact on their physicians’ treatment decisions. Out of a cohort of 3,621 patients with RA who were biologic naïve, they found that 42.9% had 0 or 1 poor prognosis factors, meaning the majority in the study had multiple. 34.9% displayed 2 factors, while 22.2% showed 3 or more. One outcome in they examined was the initiation of treatment with any disease-modifying antirheumatic drug (DMARD) and change in disease activity based on clinical disease activity index (CDAI)
“In 2008 the ACR did tell rheumatologists they need to consider poor prognostic factors when discussing patients’ treatment regimens. In the subsequent ACR treatment guidelines, they took that out,” she says, “So we did analysis to see if physicians are using poor prognosis factors to determine whether they initiate a biologic or change any therapy to accelerate care.”
When adjusting for baseline CDAI scores and disease factors, there was no significant relationship between poor prognosis and new DMARD use.
“We found that, no, physicians aren’t taking into account poor prognoses when making treatment decisions. We also looked at one-year outcomes in those who had poor prognoses and found that they did worse, they had diminished change in disease activity scores,” Harrold explains.
Another poster detailed a preliminary work that used the same patient group to examine how their prognosis factors impacted their work status. Those with 0 or 1 poor prognosis factors were the most likely to be employed, whether full or part-time, and were at the 1-year follow-up point, though rates for all three categories dropped over the course of that year.
“It really suggests that we should focus in on those with poor prognosis and see if we can do things to prevent them from being unemployed, or unable to work,” says Harrold of this examination. “This is a subset of the RA population that we should probably give intensive treatment to, to prevent those adverse sequelae. Not only clinical adverse sequelae, but also in their social environment, like being able to work or function.”
For Dr. Harrold, these findings underscore a need for increasingly close and collaborative treatment of patients, with an emphasis on the individual characteristics that make each RA case uniquely challenging.
November 17, 2016
Since its inception in 2001, the CorEvitas RA Registry has grown to become the largest prospective rheumatoid arthritis (RA) study in the world, with over 40,000 patients enrolled. It is used as the foundation of countless research efforts on the prevalence and treatment of the painful rheumatic condition. At the 2016 American College of Rheumatology Annual Meeting in Washington, DC, Leslie Harrold, MD, was on hand to present the findings of a few of these new studies. Harrold is a Senior Medical Director of Pharmacoepidemiology and Outcomes Research for the CorEvitas Registry.
Dr. Harrold’s team displayed a number of posters at the Meeting. A pair of them examined challenges and outcomes for RA patients with poor prognosis factors. “There hasn’t been a lot of work on poor prognosis,” she told MD Magazine in an interview, “What we chose to use were the poor prognosis characteristics that were included in the 2008 RA treatment recommendations put out by the American College of Rheumatology. They suggested you alter your treatment based on these characteristics.”
The poor prognosis factors her team examined were functional status, or how well an RA patient can function in daily life; seropositivity; x-rays that showed erosive disease; and extra-articular manifestations, such as RA lung disease/nodules or Sjögren’s syndrome.
One of the two examined if the presence of such factors in patients had an impact on their physicians’ treatment decisions. Out of a cohort of 3,621 patients with RA who were biologic naïve, they found that 42.9% had 0 or 1 poor prognosis factors, meaning the majority in the study had multiple. 34.9% displayed 2 factors, while 22.2% showed 3 or more. One outcome in they examined was the initiation of treatment with any disease-modifying antirheumatic drug (DMARD) and change in disease activity based on clinical disease activity index (CDAI)
“In 2008 the ACR did tell rheumatologists they need to consider poor prognostic factors when discussing patients’ treatment regimens. In the subsequent ACR treatment guidelines, they took that out,” she says, “So we did analysis to see if physicians are using poor prognosis factors to determine whether they initiate a biologic or change any therapy to accelerate care.”
When adjusting for baseline CDAI scores and disease factors, there was no significant relationship between poor prognosis and new DMARD use.
“We found that, no, physicians aren’t taking into account poor prognoses when making treatment decisions. We also looked at one-year outcomes in those who had poor prognoses and found that they did worse, they had diminished change in disease activity scores,” Harrold explains.
Another poster detailed a preliminary work that used the same patient group to examine how their prognosis factors impacted their work status. Those with 0 or 1 poor prognosis factors were the most likely to be employed, whether full or part-time, and were at the 1-year follow-up point, though rates for all three categories dropped over the course of that year.
“It really suggests that we should focus in on those with poor prognosis and see if we can do things to prevent them from being unemployed, or unable to work,” says Harrold of this examination. “This is a subset of the RA population that we should probably give intensive treatment to, to prevent those adverse sequelae. Not only clinical adverse sequelae, but also in their social environment, like being able to work or function.”
For Dr. Harrold, these findings underscore a need for increasingly close and collaborative treatment of patients, with an emphasis on the individual characteristics that make each RA case uniquely challenging.
“I’m very passionate about rheumatology because we have the ability to care for patients over the long term. We really are partners in their care, we walk the journey with them,” she says. “Some patients we can heal, some we can’t, but we’re always there to work with them and try to give them the best care and the best quality of life. I think we really are trying to be partners with them and work collaboratively so they can have the best care and the best outcomes possible.”