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How can you ensure the reliability and accuracy of your clinical evidence?

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As a medical sales professional, you know how important it is to provide credible and compelling clinical evidence to support your product's value proposition and differentiate it from the competition. But how can you ensure that your clinical evidence is reliable and accurate, and that it meets the expectations and standards of your target audience? In this article, we will discuss some best practices and tips to help you achieve this goal.

本文章的要点总结

Understand your audience:

Tailor your clinical evidence to meet the specific needs of different stakeholders. Customize the data presentation to resonate with physicians, payers, and regulators for maximum impact.### *Adhere to guidelines:Follow regulatory and ethical standards like FDA, EMA, or ISO for consistent and credible evidence. This ensures your clinical research minimizes bias and meets professional benchmarks.

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1 Know your audience

The first step to ensuring the reliability and accuracy of your clinical evidence is to understand who your audience is and what they are looking for. Different stakeholders, such as physicians, payers, patients, and regulators, may have different criteria and preferences for evaluating clinical evidence, such as the type, level, and quality of data, the relevance and applicability of the outcomes, and the transparency and validity of the methods. Therefore, you need to tailor your clinical evidence to the specific needs and expectations of your audience, and use the appropriate language, format, and channels to communicate it.

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Joy Frestedt, PhD

CEO, Frestedt Inc - we do Clinical, Regulatory and Quality Support so you don’t have to! Let us be your first call for help | Author | Speaker | Trainer | expanding new roles to accelerate patient care.
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No. Clinical Data Reliability and accuracy are independent of the audience. The data are the data. Pay attention to clinical data relevance and quality.

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Maria Bodian

MBA | MD | Supervision and Management of Site Performance
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Clinical evidence is meticulously gathered by individuals who conduct clinical trials — those who directly interact with patients, listen to their concerns, and address their needs. Statement that “you need to tailor your clinical evidence to…” is a first step to deception. Succumbing to external expectations marks a second step towards dishonesty. Proposing the notion of tailoring evidence to specific agendas is a gateway to a big lie. To uphold integrity in clinical trials, understanding your sites, investigators, coordinators, and nurses is crucial—comprehending their moral compass, cooperation skills, and adaptability. I firmly advocate for transparent communication as the paramount approach to establish this understanding.

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Sanjay Bhatia

CEO of Iksana Consulting & Partner at NextPlan
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True Clinical data generated for a brand has to be relevant to the target audience. A clinical trial on Otitis Media for an antibiotic brand is not going to cut much ice with a Surgeon

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2 Follow the guidelines

The second step to ensuring the reliability and accuracy of your clinical evidence is to follow the guidelines and standards that govern the design, conduct, analysis, and reporting of clinical research. Depending on the nature and scope of your product and the market you are targeting, you may need to comply with different regulatory and ethical requirements, such as the FDA, EMA, or ISO, as well as the best practices and recommendations of professional associations, such as the CONSORT, PRISMA, or STROBE. By adhering to these guidelines, you can ensure that your clinical evidence is consistent, credible, and transparent, and that it minimizes the risk of bias, error, or misinterpretation.

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Sanjay Bhatia

CEO of Iksana Consulting & Partner at NextPlan
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Clinical data is always generated as per guidelines set and the protocol and proforma are validated by an ethics committee. The conclusions or findings is an area where a lot of attention needs to be given

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3 Use multiple sources

The third step to ensuring the reliability and accuracy of your clinical evidence is to use multiple sources and types of data to support your claims and demonstrate your product's value. Depending on your product's stage of development and the level of evidence required, you may need to use a combination of preclinical, clinical, and real-world data, such as laboratory tests, animal studies, randomized controlled trials, observational studies, registries, surveys, or patient-reported outcomes. By using multiple sources of data, you can increase the robustness, completeness, and generalizability of your clinical evidence, and address potential gaps or limitations in your data.

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Sharoni Billik, MBA, MBS

Your KOL Engagement Partner | Clinical Development & Medical Affairs Professional Services | Founder & Principal, SBHC
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Using clinically-validated and established data sources are vital to ensure reliability and accuracy of data. These must be established (ie as part of the guidelines) and accepted by leading experts as the finite and ultimate ways to measure and classify data

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4 Validate your data

The fourth step to ensuring the reliability and accuracy of your clinical evidence is to validate your data and methods before presenting or publishing them. This means that you need to check and verify that your data are accurate, complete, and consistent, and that your methods are appropriate, sound, and reproducible. You can do this by using various techniques, such as data cleaning, quality control, peer review, or independent verification. By validating your data and methods, you can enhance the credibility, reliability, and accuracy of your clinical evidence, and avoid potential errors, inconsistencies, or discrepancies in your data.

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5 Update your evidence

The fifth step to ensuring the reliability and accuracy of your clinical evidence is to update your evidence regularly and incorporate new findings and developments in your field. Clinical research is a dynamic and evolving field, and new data, methods, and standards may emerge over time that may affect the validity, relevance, or applicability of your existing evidence. Therefore, you need to keep track of the latest trends and innovations in your field, and update your evidence accordingly. By updating your evidence, you can ensure that your clinical evidence reflects the current state of the art and the best available knowledge in your field.

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6 Seek feedback

The sixth and final step to ensuring the reliability and accuracy of your clinical evidence is to seek feedback from your audience and other experts in your field. Feedback can help you identify the strengths and weaknesses of your clinical evidence, as well as the opportunities and challenges for improvement. You can seek feedback from various sources, such as your customers, colleagues, mentors, peers, reviewers, or editors, and use different methods, such as surveys, interviews, focus groups, or comments. By seeking feedback, you can enhance the quality, relevance, and impact of your clinical evidence, and address any questions, concerns, or suggestions from your audience.

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7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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How can you ensure the reliability and accuracy of your clinical evidence?

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1 Know your audience

2 Follow the guidelines

3 Use multiple sources

4 Validate your data

5 Update your evidence

6 Seek feedback

7 Here’s what else to consider

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