Metrics & Benchmarks

Updated data from the Phase III TALAPRO-2 trial show that the combination of Talzenna (talazoparib) and Xtandi (enzalutamide) significantly improves overall survival in patients with metastatic castration-resistant prostate cancer regardless of mutation status.

The Phase II eNRGy trial showed durable antitumor activity with zenocutuzumab (Bizengri) in patients with NRG1 fusion–positive cancers, particularly non-small cell lung cancer and pancreatic cancer.

Phase III EV-302/KEYNOTE-A39 trial confirms that the combination of Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) provides sustained and significant overall survival and progression-free survival benefits compared to chemotherapy in previously untreated patients with locally advanced or metastatic urothelial cancer.

Gazyva/Gazyvaro (obinutuzumab) was found to significantly improve complete renal response in lupus nephritis patients, reinforcing its potential as an effective treatment option while also allowing for a reduction in corticosteroid use.

In the ALEXANDRA/IMpassion030 trial, Tecentriq (atezolizumab) added to postoperative chemotherapy was not found to improve treatment outcomes for patients with high-risk early-stage triple-negative breast cancer.

Braftovi (encorafenib) plus Erbitux (cetuximab) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) improved progression-free survival and overall survival compared to chemotherapy in patients with metastatic colorectal cancer with a BRAF V600E mutation.

The 12-month open-label extension of the PACIFIC trial demonstrated that bexicaserin significantly reduced seizure frequency in patients with developmental and epileptic encephalopathies while maintaining a favorable safety and tolerability profile.

The Phase III HYPERION trial was stopped early after strong positive interim results from the ZENITH trial demonstrated the efficacy of Winrevair (sotatercept-csrk) in treating pulmonary arterial hypertension, making it unethical to continue.

Abelacimab was found to significantly lower factor XI levels and bleeding events compared to rivaroxaban (Xarelto) in patients with atrial fibrillation at moderate-to-high risk for stroke.

The Phase III INAVO120 trial found that a combination of Itovebi (inavolisib) with Ibrance (palbociclib) and Faslodex (fulvestrant) significantly improved overall survival and progression-free survival in patients with PIK3CA-mutated, HR-positive, HER2-negative, endocrine-resistant advanced or metastatic breast cancer.

Phase III CheckMate -8HW trial shows the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) significantly improved progression-free survival and overall response rates in patients with microsatellite-instability–high or mismatch-repair–deficient metastatic colorectal cancer.

Keytruda (pembrolizumab) plus Lenvima (lenvatinib) and chemotherapy improved progression-free survival but did not achieve statistical significance for overall survival in patients with advanced HER2-negative gastroesophageal adenocarcinoma.

Use of decentralized approach in a Phase 1 pharmacokinetic trial shows the ability to enable remote data collection and monitoring, which could improve patient access and enhance the efficiency of clinical research.

The drug development process, beginning with preclinical research up to when the product goes to market, requires time, risk, and high costs.

Pegloticase (Krystexxa; Amgen) is approved to treat chronic gout in adults who fail to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors.

Series Part 3—Methods for early detection of risk and summary.

Series Part 2—The process of defining QTLs.

Series Part 1—Introduction and the relationship between QTL and KRI.

With large shift to decentralized strategies, industry roles appear set for change.

The perfect storm of industry growth, opportunity, and demand is translating to solid salary and satisfaction levels among clinical trial professionals, according to new survey.

Reference tool is a Rosetta Stone for clinical research. A look at the updates and enhancements in latest version.

The Clinical Endpoints Adjudication Group and Ethical Clinical designed and implemented an industry survey to evaluate factors that drive the use of endpoint adjudication in clinical trials.

The standardization of trial metrics offers numerous benefits towards overseeing clinical trials, optimizing clinical operations and mitigating study risks. However, on a situational basis customized metrics may become necessary to address study-specific risks, uncover unknown issues and demonstrate results.

Due to mistakes by research professionals, clinical trials have been subject to delays or even cancellations. The National Board of Medical Examiners is working to reverse this trend by introducing an assessment to test the knowledge of clinical researchers.