The Effect of Biomarkers on Clinical Trial Risk in Gastric Cancer.

Objectives: This study examined clinical trial success rates for new drug developments in gastric cancer since 1998. We also examined the clinical trial design features that may mitigate the risk of clinical trial failure.

Materials And Methods: Clinical trial data was obtained from clinicaltrials.

The Effect of Biomarker Use on the Speed and Duration of Clinical Trials for Cancer Drugs.

Background: The purpose of this study was to explore the effects biomarkers have on the duration and speed of clinical trials in oncology.

Materials And Methods: Clinical trial data was pooled from www.clinicaltrials.

Does biomarker use in oncology improve clinical trial failure risk? A large-scale analysis.

Purpose: To date there has not been an extensive analysis of the outcomes of biomarker use in oncology.

Methods: Data were pooled across four indications in oncology drawing upon trial outcomes from www.clinicaltrials.

Clinical trial risk in leukemia: Biomarkers and trial design.

This study analyzed the risk of clinical trial failure for leukemia drug development between January 1999 and January 2020. The specific leukemia subtypes of interest were acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), and chronic myeloid leukemia (CML). Drug development was investigated using data obtained from https://www.

Clinical Trial Risk in Hepatitis C: Endpoint Selection and Drug Action.

Background and Aims. This study analyzed the risk of clinical trial failure of new drugs for hepatitis C between January 1998 and January 2015. Methods.

Clinical Trial Risk in Chronic Obstructive Pulmonary Disease: The Effects of Drug Class and Inclusion Criteria.

Background: This study analyzed the risk of clinical trial failure in chronic obstructive pulmonary disease (COPD) drug development between 1998 and 2015. We investigated elements that influenced clinical trial risk and factors that could improve outcomes during development.

Objectives: This study aims to quantify clinical trial risk for drug development in COPD and factors that affect clinical trial risk.

Biomarker use is associated with reduced clinical trial failure risk in metastatic melanoma.

Given the high morbidity and mortality associated with metastatic melanoma, considerable attention has been paid to identifying potential therapies. Until recently, few therapies have been specifically approved for treating metastatic melanoma. In an attempt to increase clinical trial successes, many therapies are implementing biomarkers for patient stratification.

Clinical trial risk in type-2 diabetes: importance of patient history.

Purpose: To determine the risk of clinical trial failure for drugs developed for type-2 diabetes.

Methods: Drugs were investigated by reviewing phase I to phase III studies that were conducted between 1998 and February 2013. The clinical trial success rates were calculated and compared to the industry standard.

Biomarkers and receptor targeted therapies reduce clinical trial risk in non-small-cell lung cancer.

Introduction: This study analyzed the risk of clinical trial failure during non-small-cell lung cancer (NSCLC) drug development between 1998 and January 2012. We also looked for factors that impacted clinical trial risk in NSCLC.

Methods: NSCLC drug development was investigated using trial disclosures from http://www.

Impact of biomarkers on clinical trial risk.

The last decade has witnessed the cost of drug development rise dramatically; concurrently, the number of new drug approvals has declined. Clinical trial failure rates have contributed significantly to this 'innovation' crisis and are directly related to clinical trial risk. One strategy that is often touted to resolve this challenge depends on embracing a personalized medicine approach where treatment is tailored to a patient's unique genetic background.

Clinical trial risk in castration-resistant prostate cancer: immunotherapies show promise.

Objectives: To determine the risk of failure during drug development in castration-resistant prostate cancer (CRPC) and to identify factors that could improve outcomes.

Methods: We investigated CRPC by analysing compounds in phase I to phase III clinical trials between 1998 and April 2011. Drug development failures were classified as medical or commercial and were compared with industry expectations.

Impact of biomarkers on clinical trial risk in breast cancer.

We determined the success rate of new drug approval by the US FDA in two breast cancer indications, one of which used a biomarker. This allowed us to assess if biomarkers improved clinical trial risk in breast cancer. We performed a retrospective screening of industry-sponsored drug development programs registered on clinicaltrials.

Risk of failure of a clinical drug trial in patients with moderate to severe rheumatoid arthritis.

Objective: We conducted a systematic review to determine the risk of drug failure in clinical testing with patients with moderate to severe rheumatoid arthritis (RA).

Methods: Therapies for RA were investigated by reviewing phase I to phase III studies conducted from December 1998 to March 2011. Clinical trial success rates were calculated and compared to industry standards.

Clinical trial risk in Non-Hodgkin's lymphoma: endpoint and target selection.

Purpose: To quantify the clinical trial risk of new drug development in Non-Hodgkin's lymphoma (NHL). Risk estimates for this disease have not been reported before.

Methods: We undertook a retrospective review of clinical trials in (NHL) in four subtypes to compare the success rate with the industry average.

The success rate of new drug development in clinical trials: Crohn's disease.

Purpose: To determine the risk of drug failure during clinical trial testing in Crohn's disease and determine what steps can be taken to improve outcomes. This is the first study to quantify such risk for a single disease.

Methods: Moderate to severe Crohn's disease was investigated by reviewing press releases from 1998 to June 2008.