Biostatistical Expert Witness

Credible Defense for Medical Device Claims: Evidence-Based Support and Comprehensive Evaluation

In the realm of medical device claims, manufacturers face the challenge of providing robust evidence to defend against allegations of patient injury resulting from device use. Our expert consultants understand the intricacies of this domain and offer a comprehensive approach to support your defense with compelling evidence.

  1. Expert Data Filtering and Analysis:

Navigating the vast landscape of clinical research literature and extraneous data can be overwhelming. Our experienced team of solicitors specializes in filtering through this information, identifying the most relevant and compelling evidence to support your case. By focusing on the key data points, we streamline the process and ensure that your defence is backed by credible and significant findings.

  1. Quantitative Scoping Reviews:

Our quantitative scoping reviews provide an objective assessment of the available evidence related to your medical device. We employ rigorous methodologies to gather and analyse data from a wide range of sources. Through this comprehensive review, we identify gaps and strengths in the existing evidence, enabling us to strategize a compelling defence tailored to your specific case.

  1. Biostatistical Estimates and Precise Modelling:

To further strengthen your defence, our biostatistical experts offer precise modelling and estimations based on the available clinical trial data and other suitable evidence. Using advanced statistical techniques, we assess the safety and efficacy of your medical device in real-world scenarios, providing valuable insights that can bolster your case.

  1. Increased Likelihood of a Successful Trial:

By combining clinical expertise with quantitative scoping reviews, biostatistical estimates, and precise modelling, our expert consultants bring clarity and data-driven insights to your defence. Our evidence-based approach significantly increases the likelihood of a successful trial outcome, supporting your claims and reinforcing the validity of your medical device.

  1. Assessing the Integrity of Your Clinical Evidence and Study Conduct:

In the face of medical device claims, the integrity of your clinical evidence is paramount in defending against allegations of patient injury. Our expert consultants not only provide evidence-based support but also conduct comprehensive evaluations to ensure that your clinical studies have been conducted properly and meet the highest standards of integrity.

  • Rigorous Evaluation of Clinical Evidence: Our experienced team meticulously examines the quality and reliability of your clinical evidence. We assess the study design, sample size, data collection methods, and statistical analysis to ensure that your evidence meets the necessary scientific standards. By conducting this rigorous evaluation, we can identify potential weaknesses or biases that may affect the credibility of your defence.
  • Compliance with Regulatory Requirements: Medical device manufacturers must adhere to specific regulatory requirements when conducting clinical trials. Our consultants have in-depth knowledge of these regulations and ensure that your studies have been carried out in full compliance. We verify that all necessary approvals, ethical considerations, and reporting guidelines have been followed, ensuring the validity of your evidence.
  • Identifying Data Gaps and Limitations: In some cases, medical device claims arise due to insufficient data or limitations in the study design. Our experts are adept at identifying data gaps and limitations that may impact the strength of your defence. We work with you to address these issues proactively, ensuring that your clinical evidence is robust and comprehensive.
  • Strengthening the Credibility of Your Defence: By evaluating the integrity of your clinical evidence and study conduct, our expert consultants strengthen the credibility of your defence. Our evidence-based approach, coupled with comprehensive assessments, allows us to build a solid foundation to support your case. We work tirelessly to ensure that your defence is backed by reliable, trustworthy, and transparent evidence.

Choosing our biostatistical services means partnering with a team of experts who offer both evidence-based support and a comprehensive evaluation of your clinical evidence and study conduct. By combining these approaches, we provide a credible defence for your medical device claims, increasing the likelihood of a successful trial outcome. Contact us today to discover how our expertise can be tailored to meet the unique needs of your medical device claims, bolstering your defence and reinforcing the validity of your medical device.

Initial Planning Stages:

At the outset, we conduct comprehensive scoping reviews, systematic reviews, and meta-analyses of existing medical and psychological literature related to medical device or pharmaceutical-related lawsuits. Scoping reviews enable us to identify key factors and characteristics relevant to the situation or diagnosis that may have been overlooked by clinicians. Systematic reviews allow us to collect and examine existing clinical evidence from peer-reviewed journal articles, addressing specific questions crucial to your case.

Statistical Estimates:

Following a systematic review, we perform meta-analysis of relevant medical literature to produce accurate statistical estimates regarding the likelihood of particular outcomes occurring given specific circumstances. For instance, we critically analyze numerous clinical research studies related to the medical device or pharmaceutical in question, offering a more powerful estimate than any single study can provide. Moreover, we incorporate additional features into the estimate that might not be available in the existing research, bolstering the validity of our findings.

Statistical Modeling Using Discriminative and Generative Models:

Leveraging available clinical data sources, including clinical datasets and other relevant sources, we develop sophisticated statistical models, such as regression models, to predict specific outcomes under defined circumstances. This includes the likelihood of injury or misadventure due to medical treatment, delayed, missed, or misdiagnosis, and the level of suffering, complications, or incapacity that can be expected to occur. In some cases, we employ innovative and cutting-edge approaches, such as neural network analysis and Bayesian generative models like dynamic causal models, to uncover intricate connections between variables relevant to your case.

Constant Exposure to and Evaluation of Latest Clinical Research:

Our advantage lies in our constant exposure to and design of a wide spectrum of the latest clinical research studies. This expertise ensures that our statistical evaluations are up-to-date, thorough, and applicable to the specific circumstances of your medical device or pharmaceutical-related lawsuit. By relying on our expertise, you can rest assured that your case is supported by the most current and reliable evidence available.

Why is a Biostatistics Expert such a valuable asset to your team?

In medical device or pharmaceutical-related lawsuits, evidence-based support and comprehensive statistical evaluations are critical to your defense. Our services offer scoping reviews, systematic reviews, and meta-analyses to uncover compelling evidence and generate accurate statistical estimates. Through sophisticated statistical modeling, we predict outcomes and establish connections between variables, providing a strong foundation for your case. With our constant exposure to the latest clinical research, you can trust that your defense is backed by the most relevant and up-to-date evidence. Contact us today to discover how our expertise can strengthen your medical device or pharmaceutical-related lawsuit defence and increase the likelihood of a successful outcome.

Assistance for patient plaintiffs: enhancing your case with biostatistical expertise

In a peer-reviewed research paper mentioned in a previous blog post, it was highlighted that a significant percentage (up to 78%) of peer-reviewed research studies in the medical field contain statistical errors. This finding raises concerns, considering that doctors rely on these published journal articles to stay updated on clinical knowledge and evaluate new treatment approaches. However, identifying these errors and critically evaluating the research findings requires specialised expertise in biostatistics. Relying solely on a medical expert witness may limit your case compared to a combination of both a clinician and a biostatistician. While clinical practitioners bring valuable first-hand experience in patient care, practice, and disease, biostatisticians offer the ability to mathematically and impartially synthesise this experience.

Recent research has highlighted the power of mathematical approaches in predicting outcomes. For example, a study demonstrated that when a machine learning algorithm was fed Electrocardiogram (EEG) data from patients deemed healthy by doctors, it accurately predicted death within one year due to cardiac problems with an impressive accuracy of 0.85, where 0.50 indicates chance. Interestingly, doctors reviewing the EEG readings of deceased patients post-prediction often struggled to identify patterns indicating the cause of death. This exemplifies the potential of mathematical analyses in outcome prediction and highlights the advantage of incorporating current methods alongside medical opinion.

At Anatomise Biostats, we understand the importance of combining medical expertise with biostatistical analysis to strengthen your case. We recognise that errors in statistical analysis can impact the credibility of research findings. Our expert team of biostatisticians collaborates closely with clinical practitioners to provide a comprehensive evaluation of clinical evidence for patient plaintiffs.

biostatistical expert witness service for medical malpractice
Our experienced statistician and epidemiologist expert witnesses can produce statistical models that may enhance your evidence.

Whether you are a solicitor, manufacturer or patient, ​​Contact us to discover how we can assist your case.