Enrollment in clinical trials in which potential participants actively responded to online ads and underwent extensive pre-screening by patient recruitment and retention firm MediciGlobal were less likely to drop out before trial completion than those recruited by investigative sites.
Those who actively pursued trial participation through the company’s online recruitment model had a 38% lower risk of dropping out, based on analysis of four trials, compared to those trial participants who sites found and recruited.
“The difference also is in the greater efficiencies and lower costs in a clinical trial in which a rigorous pre-screening at the beginning can lead to higher retention rates downstream,” said Liz Moench, CEO of King of Prussia, Pa.-based MediciGlobal, which also specializes in clinical marketing strategies.
In a white paper summarizing MediciGlobal’s findings, the primary outcome showed that the route of entry to clinical trial participation has an effect on dropout probability. A secondary outcome showed retention rates across all trial visits to determine divergence patterns between the two groups. The objective of the analysis was to quantify the end-of-study difference in attrition levels between randomized patients who actively sought clinical research participation versus those who were approached and recruited by sites.
“Patients not actively seeking clinical trial participation may differ in their motivation to join a clinical trial, compared to patients who proactively seek inclusion,” Moench said.
The populations of the four trials—in Alzheimer’s disease, gout, interstitial cystitis and Ménière’s disease—were divided into distinct patient groups, said Moench, as the analysis did not identify the disease indications of the two groups of patients. Patients in Group A entered the trial through MediciGlobal’s recruitment model of online advertising coupled with intensive pre-screening for study inclusion/exclusion criteria, with phone follow up by a nurse for secondary pre-screening prior to being referred to a site.
Group B participants were recruited by medical professionals at sites, many offered participation through referrals by healthcare professionals or contacted as a result of a dataset review. Except for a small portion of Group B members who responded to a site’s advertising, the majority of Group B patients played no active role in initiating the recruitment process, according to MediciGlobal.
In total, early termination data from 2,849 subjects was assessed for a minimum of seven months across four trials.
All four trials displayed a lower relative risk of dropout by the end of data collection for patients who played an active role in seeking out trial inclusion compared to those in the passive recruitment group. Across the four trials analyzed, the average dropout rate was 15% for the actively recruited Group A, versus 24% for the passively recruited Group B. From that analysis, MediciGlobal has inferred that overall, patients who actively seek trial participation are, on average, 38% less likely to drop out of a trial than patients more passively recruited by investigative sites.
“Patients act in three ways: they search, seek and socialize for clinical trial entry,” said Moench. “They—those with advanced disease and others who are newly diagnosed—go out to collect online data about their disease and review the available clinical studies. They seek specific content about their disease, including easy-to-read science stories, and then they socialize, often through up to 40 patient communities, in which we advertise trials.”
MediciGlobal said there are multiple factors contributing to differences in retention, such as the motivation of the patients in each group or study-specific reasons.
“Factors could include the process of vetting candidates, differences in access to healthcare between the two groups, personalities of people proactively researching their options or financial motivations,” MediciGlobal said. “Further research in this area is needed to better understand the motivations of subjects entering research through various channels.”
Moench said since many sites don’t pre-screen candidates as rigorously as MediciGlobal’s multi-step online and nurse pre-screening process, due to time and resource constraints, sites will go through more patients and, ultimately, have a higher dropout rate.
“We can speed up enrollment rates by spending more time pre-screening at the outset and providing fewer patients of higher quality who have been thoroughly screened and meet the criteria for the study, compared to a site that will go through many patients but might not have as high a likelihood of finding a similar number of qualified trial participants,” said Moench.
But not everyone agrees with those findings.
“To say, in this digital age, that sites can’t pre-screen to find the best patients for their sites is ludicrous,” said Mark Lacy, co-founder and CEO of Benchmark Research, which operates six sites in California, Texas and Louisiana.
“My experience is that patient recruitment agencies are dismal,” said Lacy. “Sure there are exceptions, in which specific patients are hard to find, and sites may look to patient recruitment firms to help out, but the bulk of the major diseases are very well handled by sites.”
He added that most patients still rely on their physicians for advice about participating in clinical trials.
“If you are presuming,” said Lacy, “that a patient recruitment agency through its pre-screening has the inside track to a study, more than a doctor involved in clinical research who has a patient with a particular disease, I find that preposterous.”
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