Addex Therapeutics announced it is canceling its Phase IIb/III study evaluating its drug dipraglurant due to patient recruiting, staffing and pandemic-related issues.
Switzerland-based Addex Therapeutics announced it is canceling its Phase IIb/III study evaluating its drug dipraglurant as a potential treatment for dyskinesia associated with Parkinson’s disease due to the slow recruitment of patients.
Addex, a clinical-stage pharmaceutical company focusing on allosteric modulation-based drug discovery and development, emphasized that the recruiting problem had nothing to do with the drug, but rather with staffing and pandemic issues.
“This has been attributed to the consequences of COVID-19 related patient concerns about participation in clinical studies as well as staffing shortages and turnover within study sites,” Addex’s press release read.
Although it’s rough news for Addex, the company is not alone. Patient recruitment for clinical trials is a problem that has become increasingly more common across the life sciences industry since the COVID-19 pandemic.
According to WebMD, 80% of clinical trials do not meet enrolment deadlines.
In 2021, in the publication Trials, a group of researchers published an article compiling their findings on the most common challenges companies face when enrolling patients for clinical trials. Some of the top reasons included:
- Overoptimistic recruitment estimates
- Too narrow eligibility criteria
- Lack of engagement of recruiters
- Lack of competence/training/experience of recruiters
- Insufficient initial funding
- High burden for trial participants
The pandemic has made these enrollment struggles worse. Nature reported clinical trials waned during the pandemic because patients were nervous to go to hospitals and interact with other people for fear of getting sick. Additionally, facilities frequently furloughed staff or reassigned employees to other areas to help with urgent COVID-related patient care, leaving little staff to help with clinical trials.
The cancellation or delay of clinical trials has hit the treatment of neurological conditions, in particular. Between 2020 and 2021, about 2.2% of all trials that concluded had to end prematurely due to pandemic-related issues. However, for cerebrovascular disorder trials, the rate was 5.2%, and for neurocognitive disorder clinical trials, the rate was 4.5%. This effect may also explain why Addex’s trial for Parkinson’s, a neurodegenerative disorder, was struggling to recruit patients.
To help solve the patient recruitment problem, some companies are coming up with innovative solutions. Parexel, a global clinical research organization, launched the Community Alliance Network to increase access to new patient populations by integrating clinical research into the community healthcare setting. The goal of the program is to better serve patients, create further opportunities for increased diversity in clinical trial support, and support trial delivery for Parexel’s biopharmaceutical customers.
Over the last 10 years, Parexel has built up its this network with 500 of the top clinical research institutions and 21,000 principal investigators across 20+ countries with diverse site staff and patient populations across all therapeutic areas.
“By joining the Community Alliance Network, we can continue to bring healthcare solutions to consumers within the communities where they live and work,” said Tony Clapsis, senior vice president and general manager of CVS Health’s Clinical Trial Services. “With our community presence across the U.S., we’re able to accelerate access to clinical trials, and at the same time help to address longstanding issues with recruitment and diversity.”
Prometheus Biosciences also created its own solution to its clinical trial enrollment struggles with its Enroll360 platform. With Enroll360, Prometheus is building a global network of trial-ready sites where over 2,500 patients have already been genetically profiled and clinically characterized to determine their eligibility for Prometheus’ current and future clinical trials.
The platform seems to have worked. In June 2022, using the platform as a recruiting tool, Prometheus completed enrollment ahead of schedule for its APOLLO-CD Phase IIa study of PRA023 in Crohn’s disease patients, providing a potential model for other companies struggling with patient enrollment.
