使用数据驱动解决方案优化癌症乳腺临床试验

Optimizing a BreastCancer Clinical Trial withData-Driven Solutions A global pharmaceutical company is preparing to conduct a clinical trial for anovel breast cancer treatment. The company uses a suite of Citeline solutionsto accelerate trial planning and study start-up to ensure a data-driven andefficient approach. These solutions provide instant recommendations on keytrial parameters — based on the gold standard in clinical trial data in Trialtroveand Sitetrove, which the pharmaceutical company has relied on for years forprotocol development and investigator and site selection. Use Case| Optimizing a Breast CancerClinical Trial with Data-Driven Solutions Step 1:Determining Primary Endpoints & I/E Criteria The company defines the type of breast cancer trial they need to runin Protocol SmartDesign, which provides recommendations for primaryendpoints. These suggestions are tailored to the specific subtype of breastcancer being targeted, such as HER2-positive, triple-negative, or hormonereceptor-positive breast cancer. Protocol SmartDesign also suggests inclusion/exclusion (I/E) criteria, whichfactor in key patient characteristics such as age, tumor stage, previoustreatments, and genetic markers. After reviewing the suggestions, thecompany modifies the I/E criteria slightly to align with their study’s focuson patients with a specific mutation. The platform updates the projectedstudy duration in real-time, ensuring the company is aware of how theseadjustments affect the trial timeline. Use Case| Optimizing a Breast CancerClinical Trial with Data-Driven Solutions Step 2:Forecasting Length of Study By refining the I/E criteria, the company immediately sees how their changes impact theforecasted enrollment duration. This dynamic feedback enables the team to balance thescientific rigor of the criteria with the practical considerations of recruiting breast cancerpatients who meet their specific trial parameters. Protocol SmartDesign ensures that thetrial is designed to meet both scientific and operational needs. Use Case| Optimizing a Breast CancerClinical Trial with Data-Driven Solutions Step 3:Selecting Countries and Investigators The company then moves to select the best countries and investigators to run the trial.Investigator SmartSelect generates a list of recommended investigators account with astrong history of success in breast cancer trials, considering factors such as investigatorexpertise in treating the specific subtype of breast cancer and their capacity to run a newstudy. The platform will also recommend countries and investigator allocation. Use Case| Optimizing a Breast CancerClinical Trial with Data-Driven Solutions The company can see forecasted enrollment rates, allowing them to fine-tune the selectionof countries and investigators until the trial’s timeline is optimal. Adjusting the mix ofcountries and investigators ensures they can hit enrollment targets within the desiredtimeframe. Use Case| Optimizing a Breast CancerClinical Trial with Data-Driven Solutions Step 4:Investigating Patient Populations andDiversity Goals Once the investigators are selected, the team leverages Sitetrove’s Global Patient Insightsto explore patient populations at the selected sites. Use Case| Optimizing a Breast CancerClinical Trial with Data-Driven Solutions This feature allows them to analyze whether there are enough eligible breast cancer patientsavailable in the targeted regions. Importantly, they also confirm that the selected sites canmeet all diversity goals, ensuring representation across race, ethnicity, and age groups,which is critical for breast cancer trials where specific populations may have higher risks orrespond differently to treatments. Use Case| Optimizing a Breast CancerClinical Trial with Data-Driven Solutions Step 5:Finalizing the Trial Plan With a breast cancer trial design that has been optimized for both patient recruitmentand trial timeline, the pharmaceutical company is ready to move forward confidently. Byleveraging real-time data and predictive analytics, they’ve created a trial that not onlymeets scientific objectives but also ensures a diverse and representative patient population,critical to the study of breast cancer treatment outcomes. Leveraging the power of Citeline SmartSolutions, Trialtrove, Sitetrove and Global PatientInsights, this company produced a protocol that had limited amendments, investigatorswho could successful run and recruit for the trial, allowing them to hit enrollment goals andcomplete the study on time and on budget. Learn how Citeline can help you optimize and accelerateclinical trial planning andsiteselection. About Citeline Citeline, a Norstella company, powers a full suite ofcomplementary business intelligence offerings to meet theevolving needs of life science professionals to accelerate theconnection of treatments to patients and patients to treatments.These patient-focused solutions and services deliver and analyzedata used to dri