Transparency, Oversight, and Opt-in Consent Makes Patients More Open to Sharing Data
A newly published paper in JAMA Network Open found that patients are more likely to participate in patient data sharing programs if certain conditions are met. Survey data from 3,500 hundred patients showed that patients valued transparency, opt-in informed consent, oversight mechanisms, and privacy.
Using Real-world Data to Take Better Baseline Patient Measurements
After recruitment and on-boarding, patients in clinical trials undergo a battery of baseline measurements. However, measurements can vary significantly from moment to moment and “normal” ranges are often wide. Therefore, an approach that uses multiple measurements could help reduce this uncertainty and improve clinical trials.
Improving Health Equity Through More Representative Clinical Trials
Patients from marginalized or rural populations often have less access to clinical trials or distrust based on a long-standing history of medical exploitation. However, this disparity in patient populations is detrimental to health equity efforts, biasing research by skewing heavily toward primarily white, upper-middle class, urban participant populations.
EMA Committee Recommends Regeneron’s Libtayo + Chemotherapy Combo for Lung Cancer
Regeneron’s Libtayo (cemplimab-rwlc) has received a recommendation from the European Medicine’s Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) for use in forms of non-small-cell lung cancer (NSCLC) as a combination therapy with a traditional chemotherapy agent. The recommendation comes as the company releases promising phase III clinical trial data.
FDA Pumps the Brakes on Fulcrum Sickle Cell Drug Trial
The US Food and Drug Administration (FDA) has put a damper on Fulcrum Therapeutics’ ambitions by placing a full hold on a clinical trial for the company’s new therapeutic, FTX-6058. The company says the FDA made the decision based on preclinical data, although the specific reason for the hold has yet to be reported.
Clinical Trials Must Include Diversity Plan in FDA Applications
Many patients from rural areas and marginalized backgrounds are severely underrepresented in many clinical trials. To address this problem, the US Food and Drug Administration (FDA) has announced that in the near future, all clinical trials registered through the agency must contain a plan to ensure diversity in the participant population. The plan will take time, however, as the agency must issue a final guidance and wait for public input.
US Govt Accountability Office Recommends FDA and HHS Improve IRB Inspection Oversight
The US Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) received a rebuff from the Government Accountability Office (GAO) over their oversight over institutional review boards (IRBs) for clinical trials. IRBs, which help oversee ethics in research on the local level, are supposed to be overseen by the agencies, but in practice this rarely happens.
Labcorp Reveals Name for New CRO – Fortrea
Labcorp has announced that its upcoming clinical development spin-off will be named Fortrea. Fortrea will be independent and publicly traded, providing drug and health tech development and commercialization services to pharma and biotechs. Once spun off, Fortrea will begin with a workforce of 19,000 employees.
BSQ’s Abecma CAR-T Multiple Myeloma Therapy Cuts Progression or Death in Half
Bristol Myers Squibb has released positive new data from its KarMMa-3 trial for Abecma, its CAR-T therapy for multiple myeloma. The results show that patients taking Abecma instead of the current standard of care have 51% reduced risk of death or disease progression. Data also indicates that patients in the Abecma group had a median time without disease progression of 13.3 months.
Boehringer Ingelheim Reveals Positive Trial Results for Rare Psoriasis Therapeutic
Boehringer Ingelheim revealed new results from its Phase IIb EFFIOSAYIL 2 trial that shows its new antibody-based therapeutic Spevigo can prevent flare-ups in a rare and severe form of psoriasis, generalized postular psoriasis (GPP). The drug is the first treatment to be approved for the disabling and sometimes life-threatening condition.
Bristol Myers Reveals Positive Phase II Data for Leukemia CAR-T Cell Therapy Breyanzi
Bristol Myers Squibb has announced new clinical trial data for its leukemia CAR-T cell therapy Breyanzi. The data shows that the therapy has met its primary endpoint in the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL), beating standard care in complete response rate. Bristol Meyer intends to present the data at an upcoming conference.
J&J and Legend’s CAR-T Therapy Better Than Standard Care in Phase III Trial
J&J and Legend Biotech have announced new results from their CARTITUDE-4 trial that shows their new CAR-T therapy Carvykti is more effective at treating multiple myeloma than standard care. The companies say that the therapy, which many predict to be an upcoming blockbuster, has achieved the trials primary endpoint of progression-free survival.
Verana Health Publishes Real-World Data Ophthalmology Study Replicating Phase III Trials
Verana Health has announced the publication of its research in Ophthalmic Surgery, Lasers and Imaging (OSLI) Retina. The study used de-identified real-world data (RWD) and replicated two phase III trials for the use of Regeneron in wet age-related macular degeneration, making it the first of its kind in the field.
Nature Medicine Perspective: Next-Gen Evidence-Based Medicine
The recent wave of digital health solutions, data analytics, and artificial intelligence (AI) is driving the newest generation of evidence-based medicine, according to a Nature Medicine perspective by Vivek Subbiah. These technologies are empowering novel clinical trials that utilize real-world evidence (RWE) and patient-centric approaches in a wide range of fields and disease contexts.
Improving Recruiting of Black and Rural Patients
In the US, Black and rural residents are often significantly underrepresented in clinical trials. This negatively impacts these populations and decreases the clinical potential of new therapeutics. In a recent Clinical Leader article, Chief Editor Ed Miseta discusses the underlying causes of clinical trial under-representation and insights from two studies on how to address it.
GAO Report Finds Certain Demographics Underrepresented in Cancer Drug Trials
A newly released report from the US Government Accountability Office finds that, despite years of health equity efforts, several key demographics are routinely underrepresented in clinical trials for new cancer therapeutics. This includes people with lower-incomes, rural residents, teens, older adults, and women. In addition, people from certain ethnic and racial backgrounds are also underrepresented.
Making Clinical Trials Populations Better Represent Patients
Clinical trial participants are often not representative of the patient populations. People from marginalized backgrounds are often overlooked, leaving lingering safety and efficacy questions remaining for those already facing barriers to access. In a new PM Live, article, Paul Chew of Phesi discusses diversity in clinical trials and why it is critical in improving health equity efforts.
Researchers Propose Novel Real-World Evidence Observational Study Design to Investigate Surgical Transfusion Complications
Observational evidence suggests that surgical transfusions are associated with increased complication risk, but randomized clinical trials (RCTs) have yet to identify such a phenomenon. In a newly published study in BMC Medical Research Methodology, researchers introduce an observational study design that uses real-world evidence to achieve results that mirror those found in parallel RCTs.
Eisai and Biogen’s Alzheimer’s Drug Surrounded by Cost and Safety Worries
As Eisai and Biogen’s novel Alzheimer's drug lecanemab inches closer to the finish line, many worry that the high price of the antibody-based therapeutic may lower patient access. A primary concern is whether payers will cover lecanemab, especially after the aduhelm controversy over the past few years. In addition, recent adverse events, including a second patient death, have engendered worry for many.
FACILITATE Patient-Centered Framework Will Boost Repurposing of Clinical Trial Data
The Framework for Clinical Trial Participants’ Data Reutilization for a Fully Transparent and Ethical Ecosystem (FACILITATE) is a project supported by a coalition of EU and Non-EU nations to help support the re-use of clinical trial data. This will allow increased access to existing pools of real-world evidence (RWE) that is often out of researchers’ reach. In addition, it will provide participants with access to their trial data.
Norstella and Citeline Announce Complete Merger
Norstella, a biotech that provides end-to-end services for therapeutic development has merged with Citeline, a leader in pharma intelligence. The acquisition brings the value of Norstella up to $5 billion, ranking among the largest in the industry. Norstella will use Citeline’s range of services and assets to help improve the company’s drug development support services.
Clinical Leader Live: Are Decentralized Clinical Trials Cutting Costs at Clinical Sites?
The logistics of the COVID-19 pandemic directly impacted the ability of many pharma and biotech companies to perform research at traditional clinical trial sites. As a result, the use of decentralized clinical trials (DCTs) and hybrid format trials boomed. An episode from earlier this year covers how this has impacted traditional clinical sites and their staff.
FDA Issues Final Guidance on Clinical Trials with Multiple Endpoints
Last week, the US Food and Drug Administration (FDA) released its final guidance on multiple endpoints in clinical trials. The goal of the guidance is to provide standardized strategies for clinical trials with multiple endpoints to avoid ambiguity in study findings that might have bearing on the regulatory approval process and patient outcomes.
CVS Health Enters the Clinical Trial Space
Researchers are increasingly eyeing pharmacies as recruitment sites for clinical trials due to their proximity to a wide range of patients. To capitalize on this growing opportunity, CVS Health will begin to host clinical trial recruitment at its numerous sites across the US. In a new article on Applied Clinical Trials, Moe Alsumidaie sits down with Jill Pellegrino, VP of recruitment and real-world evidence (RWE) at CVS Health Clinical Trial Services to talk about the move.
FDA Opens Applications for PDUFA VII Real-World Evidence Programs
The US Food and Drug Administration (FDA) will start accepting applications for two programs that are part of the Prescription Drug User Fee Act (PDUFA VII). These programs are intended to help improve the use of real-world evidence (RWE) in approvals for new therapeutics. In addition, the program is set to promote novel clinical trial designs.