AIDS vaccine (Medestea)

Pharmaceutical companies can spend 10 to 15 years and more than $2.3 billion to bring new drugs to market. Despite these significant investments in drug development, 90% of clinical trials fail.For a greater chance of success, pharmaceutical companies must emphasize clinical trial validity to ensure that the outcomes are relevant and applicable to patients in real-world clinical settings and that the results can withstand increased scrutiny from the Food and Drug Administration (FDA).By saying your clinical trial is valid, youre saying that the results are meaningful and interpretable, explains Paul Williams, Psy.D., senior pharma account manager for Pearson Assessments. To make this claim, every aspect of the study must be held to very high standards.However, failure to demonstrate efficacy, safety concerns, issues with inclusion and exclusion criteria, and patient recruitment are among the most common reasons clinical trials fail. Intensifying scrutiny from the FDA has also led to dramatic increases in the number of warning letters issued to drug manufacturers that threaten the commercialization of new therapeutics.Following these five steps can increase the odds of clinical trial success.Choosing the best study design.In 2022, 14.5% of interventional clinical trials were terminated before completion. Optimizing the design of a clinical trial can have a significant impact on its success and provides the foundation for better outcomes. In contrast, a flawed study design can affect whether a clinical trial demonstrates efficacy.Successful clinical trials consider inclusion/exclusion criteria and site selection as well as patient recruitment, retention and burden to improve outcomes. With proper oversight, artificial intelligence can be used to conduct literature reviews, assess the suitability of eligibility criteria, predict patient dropout rates and compare statistical methods with successful outcomes to help researchers choose the best study design.Selecting the right endpointsSelecting endpoints is complex, and making the wrong choice can jeopardize the trial. In 2021, a high-profile clinical trial for an HIV vaccine failed to meet the endpoint of reducing HIV transmission by 50% compared to placebo, leading to the discontinuation of the trial.In drug development, clinical trials often contain multiple endpoints. While increasing the number of endpoints allows researchers to better assess the impact of the drug on multiple characteristics of a disease, it also increases the odds of making false conclusions about those endpoints.Using valid clinical assessments to measure outcomes can ensure the validity of clinical findings.Establishing reliability is essential to ensure that changes over time in a patients performance are the result of disease progression and not poor test items or administration and scoring errors, says Lynsey Psimas, Ph.D., Pearsons director of sales, pharma services.Deploying the right assessment toolsValid assessments are an integral part of clinical trial success. Research showed that 61% of the measurement tools used in trials had no evidence for measurement properties. The reliability and the remaining tools were rated sufficient for validity.Choosing clinical outcome assessments (COAs) to generate outcomes that are meaningful to patients is essential, Williams says.To help ensure your trial is valid, its necessary to choose valid and reliable instruments, he says. Shortcuts lead to reducing validity in ways that are not obvious or totally understood resulting in messy data and faulty conclusions.Developing COAs for a clinical trial isnt just time-consuming; its expensive and requires expertise. It also has the potential to affect the outcomes. Most Pearson COAs can be adapted for electronic administration, which helps with patient compliance, virtual data collection, and reduced errors in administration and scoring while streamlining efficiencies and saving time.Recruiting study participantsOne-third of NIH-registered clinical trials in the U.S. failed to meet patient recruitment goals. Poor patient recruitment is among the top reasons clinical trials are discontinued.Recruitment failure can be linked to a host of issues from mistrust in research and lack of logistical support to unrealistic estimates and lack of patient engagement in trial design.Technology can aid in clinical trial recruitment. Using AI to analyze medical records and social media content to identify suitable participants cuts down on the time and resources required to meet recruitment goals.Ensuring data quality and validityThe success of a clinical trial relies on collecting high-quality data. Not all studies follow guidelines to ensure data integrity, which affects the generalizability of research findings.The quality of data directly impacts the usefulness of the data in human clinical trials, Psimas says. Using tools developed in a psychometrically sound way and demonstrating reliability and validity is critical to making sound medical decisions about new therapies as these therapies are dependent upon reliable data from clinical trials.Providing education to promote standardized practices, monitoring data quality, establishing a data management plan and prioritizing real-time data collection helps improve data quality and reduce the volume of missing data.The term clinical means you are dealing with the health and wellbeing of others, Williams says. Those involved at every level of clinical trial research must adhere to the highest standards possible.For more information about how Pearson Assessments Pharma Research Services division helps to ensure clinical trial data is reliable, valid and can withstand rigorous FDA scrutiny, contact Pearson Assessments Pharma Research Services for a consultation. '

Dive Brief:Sanofi has agreed to work with Johnson & Johnson on what could be the first vaccine against a deadly strain of E. coli.J&J developed the vaccine, now in Phase 3 testing, to fight extraintestinal pathogenic E. coli, a leading cause of sepsis. The bacteria causes about 10 million cases of invasive ExPEC disease each year and is particularly dangerous for older adults.Per deal terms announced Tuesday, Sanofi will give J&J $175 million upfront and could make further payments based on reaching certain developmental and commercial milestones. The two companies will share research and development costs and profits in the U.S., France, Germany, Italy and Spain. For the rest of the world, J&J will receive tiered royalties and milestones.Dive Insight:J&J brought in Sanofi as it moves away from infectious disease work. In March, the company abandoned a high-profile attempt to develop a vaccine for respiratory syncytial virus. That followed Januarys announcement of disappointing results for an HIV vaccine.The New Jersey-based drugmaker has described the changes as a prioritization of research and development funds, with specific program exits in infectious disease and vaccines. Essentially, J&J is shutting down all work in the area outside of the E. coli vaccine and providing continuing access to HIV medicines already on the market, Fierce Pharma reported in August.J&Js Janssen unit began the Phase 3 trial of the E. coli vaccine in 2021 and is still enrolling patients. Researchers are testing the vaccine against a placebo in more than 18,500 patients, with an estimated primary completion date in May 2025.Although most people think of foodborne illness when hearing about E. coli, the vaccine targets a strain thats responsible for most urinary tract infections and can also cause meningitis, pneumonia and infections after surgery. The need for an inoculation has grown with rising antibiotic resistance, scientists say.Sanofi, one of the largest vaccine makers in the world, is a natural partner for J&J. The Paris-based company sells billions of dollars worth of shots for conditions including the flu and childhood diseases. The company also has a wide array of vaccines in development. '