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Health literacy is the degree to which individuals have the ability to find, understand, and use information and services to inform health-related actions for themselves and others¹. A 2015 report, commissioned by Public Health England, identified that up to 61% of...

In the hierarchy of evidence, randomized controlled trials are the gold standard. While seeking expert opinion will never compare in terms of scientific rigor, it can be a valuable option in cases of limited, insufficient, or conflicting information. This is, of...

In April 2022, Industry Standard Research conducted a survey on behalf of PPD (the clinical research business of Thermo Fisher Scientific) with 152 leaders of biotech and pharmaceutical organizations worldwide to gather their insights on industry trends. Not only did...

This blog is based on a webinar hosted by Vitaccess. For access to this webinar, and all webinars that we have hosted, please visit our dedicated webinars page.[sc_fs_multi_faq headline-0="h2" question-0="What is a “micro-moment”?" answer-0="During a clinician visit,...

This blog is based on a webinar hosted by Vitaccess in collaboration with Odelle Technology. Odelle Technology is an established consultancy dedicated to helping MedTech, BioTech, and diagnostic businesses navigate public and private healthcare sectors across Europe....

Analyzing datasets from our clients’ real-world studies can be complicated. The nature of these studies, and what sets them apart from randomized controlled trials (RCTs) – namely, the flexibility of digital data collection compared to the rigid experimental boundaries of trials – means that a data analysis question that seems simple at the outset could have different answers depending on the approach. The obstacles to overcome also vary, and how they are preempted or resolved can have a considerable impact on eventual success. We’ll be exploring two theoretical examples in this post.

People experience things in a unique way, using their own words and meanings to make sense of what is going on around them. In the case of a health condition or disease, the words and meanings that people use to describe their experiences may differ from those used by...

Scientific advisory boards (SABs) are an important part of the governance framework for digital real-world studies. These studies are conceptualized and designed with the purpose of collecting longitudinal data on the real-world experiences of patients, or caregivers...

The UK’s National Institute for Health and Care Excellence (NICE) has published an update to its methods and processes for health technology assessment. The update follows a year-long review and includes a number of significant changes to how innovative medicines will be evaluated for pricing and reimbursement in the UK.

Diagnosis “validation” is the part of the recruitment process for patient-/caregiver-reported studies where the eligibility of the prospective participant is verified.

The role of color in app design is a combination of art and science, and requires cross-team collaboration between design and localization. There are many factors to consider when determining which colors to choose – we cover a few of them in this post.

When we are designing our real-world studies, the collection of health-related quality of life data is an essential component. Measuring HRQoL means looking at the physical, mental, emotional, and social impact that health status and health status changes have on our study participants. The evidence generated from our studies is used to shape research and drug development: we need, therefore, to ensure that we select the most appropriate instrument for its measurement.

The use of digital tools means that longitudinal real-world evidence studies can be considered as adaptive registries, with a powerful range of both pre- and post-approval use cases.
Pre-approval use cases include granular understanding of burden of disease, healthcare resource utilization, and patient journey and treatment patterns for audiences such as regulators and health technology assessment.

Health economists generally agree that there’s no gold-standard approach to HRU data collection, with different methods suiting the needs of different analyses. Three of the most common sources of HRU data are:

1. clinician-reported data (e.g., health records, clinical trial investigator case report forms, and expert opinion),
2. secondary datasets (e.g., medico-administrative and health-record databases), and
3. patient- or caregiver-reported data (e.g., surveys and diaries).

When deciding on the value of a certain treatment for cancer, the current “value paradigm” considers factors such as improvements in clinical outcomes, side effects, and quality of life (QoL). One factor that is not taken into account – as discussed in an opinion article recently published by JAMA Oncology – is the impact of treatment on patients’ time.

It is critical to make sure the app is free of any defects that could impact its function once it has been launched. The role of QA analysts is to test it in as many ways as possible, to detect any faults that need ironing out during the development process.

Health economists generally agree that there’s no gold-standard approach to HRU data collection, with different methods suiting the needs of different analyses. Three of the most common sources of HRU data are:

1. clinician-reported data (e.g., health records, clinical trial investigator case report forms, and expert opinion),
2. secondary datasets (e.g., medico-administrative and health-record databases), and
3. patient- or caregiver-reported data (e.g., surveys and diaries).

Cognitive debriefing is a step within the linguistic validation process to validate a questionnaire called a patient-reported outcome (PRO) – PROs are used in clinical research, such as trials or studies. This step is usually carried out via face-to-face interviews with participants in the target country. The aim of the interview is to evaluate (the “debrief” part) the translated questionnaire, ensuring that everything is fully understood (the “cognitive” element) in the target language. It’s an opportunity to make sure the patient voice is represented in the translated version .

The Digital Healthcare Act (Digitale-Versorgung-Gesetz, DVG) of December 2019 has enabled physicians and physiotherapists to issue prescriptions for digital applications in Germany. These apps are available to the 73 million Germans that receive statutory health insurance.

The process kicks off with a scoping exercise exploring some fundamentals: What condition are we looking at? Why will real-world evidence be meaningful in the study of this condition? Which features will address the target audience’s needs?

Adverse events (AEs), particularly with drug therapies, remain a challenge in modern healthcare. The increasing complexity of cancer therapeutics, an ageing population, and rising multimorbidity all continue to contribute to and complicate safety issues for patients. However, while our understanding of AEs should be evolving, and our AE storytelling for patients should be more engaging, reporting of AEs really has not changed. Indeed, AE narratives remain directed at clinicians and regulators, rather than to patients. We believe there is value in being able to tell patients an AE narrative.

Adverse events (AEs), particularly with drug therapies, remain a challenge in modern healthcare. The increasing complexity of cancer therapeutics, an ageing population, and rising multimorbidity all continue to contribute to and complicate safety issues for patients. However, while our understanding of AEs should be evolving, and our AE storytelling for patients should be more engaging, reporting of AEs really has not changed. Indeed, AE narratives remain directed at clinicians and regulators, rather than to patients. We believe there is value in being able to tell patients an AE narrative.

Health literacy is the degree to which individuals have the ability to find, understand, and use information and services to inform health-related actions for themselves and others¹. A 2015 report, commissioned by Public Health England, identified that up to 61% of...

In the hierarchy of evidence, randomized controlled trials are the gold standard. While seeking expert opinion will never compare in terms of scientific rigor, it can be a valuable option in cases of limited, insufficient, or conflicting information. This is, of...

In April 2022, Industry Standard Research conducted a survey on behalf of PPD (the clinical research business of Thermo Fisher Scientific) with 152 leaders of biotech and pharmaceutical organizations worldwide to gather their insights on industry trends. Not only did...

This blog is based on a webinar hosted by Vitaccess. For access to this webinar, and all webinars that we have hosted, please visit our dedicated webinars page.[sc_fs_multi_faq headline-0="h2" question-0="What is a “micro-moment”?" answer-0="During a clinician visit,...

This blog is based on a webinar hosted by Vitaccess in collaboration with Odelle Technology. Odelle Technology is an established consultancy dedicated to helping MedTech, BioTech, and diagnostic businesses navigate public and private healthcare sectors across Europe....

Analyzing datasets from our clients’ real-world studies can be complicated. The nature of these studies, and what sets them apart from randomized controlled trials (RCTs) – namely, the flexibility of digital data collection compared to the rigid experimental boundaries of trials – means that a data analysis question that seems simple at the outset could have different answers depending on the approach. The obstacles to overcome also vary, and how they are preempted or resolved can have a considerable impact on eventual success. We’ll be exploring two theoretical examples in this post.

People experience things in a unique way, using their own words and meanings to make sense of what is going on around them. In the case of a health condition or disease, the words and meanings that people use to describe their experiences may differ from those used by...

Scientific advisory boards (SABs) are an important part of the governance framework for digital real-world studies. These studies are conceptualized and designed with the purpose of collecting longitudinal data on the real-world experiences of patients, or caregivers...

The UK’s National Institute for Health and Care Excellence (NICE) has published an update to its methods and processes for health technology assessment. The update follows a year-long review and includes a number of significant changes to how innovative medicines will be evaluated for pricing and reimbursement in the UK.

Diagnosis “validation” is the part of the recruitment process for patient-/caregiver-reported studies where the eligibility of the prospective participant is verified.

The role of color in app design is a combination of art and science, and requires cross-team collaboration between design and localization. There are many factors to consider when determining which colors to choose – we cover a few of them in this post.

When we are designing our real-world studies, the collection of health-related quality of life data is an essential component. Measuring HRQoL means looking at the physical, mental, emotional, and social impact that health status and health status changes have on our study participants. The evidence generated from our studies is used to shape research and drug development: we need, therefore, to ensure that we select the most appropriate instrument for its measurement.

The use of digital tools means that longitudinal real-world evidence studies can be considered as adaptive registries, with a powerful range of both pre- and post-approval use cases.
Pre-approval use cases include granular understanding of burden of disease, healthcare resource utilization, and patient journey and treatment patterns for audiences such as regulators and health technology assessment.

Health economists generally agree that there’s no gold-standard approach to HRU data collection, with different methods suiting the needs of different analyses. Three of the most common sources of HRU data are:

1. clinician-reported data (e.g., health records, clinical trial investigator case report forms, and expert opinion),
2. secondary datasets (e.g., medico-administrative and health-record databases), and
3. patient- or caregiver-reported data (e.g., surveys and diaries).

When deciding on the value of a certain treatment for cancer, the current “value paradigm” considers factors such as improvements in clinical outcomes, side effects, and quality of life (QoL). One factor that is not taken into account – as discussed in an opinion article recently published by JAMA Oncology – is the impact of treatment on patients’ time.

It is critical to make sure the app is free of any defects that could impact its function once it has been launched. The role of QA analysts is to test it in as many ways as possible, to detect any faults that need ironing out during the development process.

Health economists generally agree that there’s no gold-standard approach to HRU data collection, with different methods suiting the needs of different analyses. Three of the most common sources of HRU data are:

1. clinician-reported data (e.g., health records, clinical trial investigator case report forms, and expert opinion),
2. secondary datasets (e.g., medico-administrative and health-record databases), and
3. patient- or caregiver-reported data (e.g., surveys and diaries).

Cognitive debriefing is a step within the linguistic validation process to validate a questionnaire called a patient-reported outcome (PRO) – PROs are used in clinical research, such as trials or studies. This step is usually carried out via face-to-face interviews with participants in the target country. The aim of the interview is to evaluate (the “debrief” part) the translated questionnaire, ensuring that everything is fully understood (the “cognitive” element) in the target language. It’s an opportunity to make sure the patient voice is represented in the translated version .

The Digital Healthcare Act (Digitale-Versorgung-Gesetz, DVG) of December 2019 has enabled physicians and physiotherapists to issue prescriptions for digital applications in Germany. These apps are available to the 73 million Germans that receive statutory health insurance.

The process kicks off with a scoping exercise exploring some fundamentals: What condition are we looking at? Why will real-world evidence be meaningful in the study of this condition? Which features will address the target audience’s needs?

Adverse events (AEs), particularly with drug therapies, remain a challenge in modern healthcare. The increasing complexity of cancer therapeutics, an ageing population, and rising multimorbidity all continue to contribute to and complicate safety issues for patients. However, while our understanding of AEs should be evolving, and our AE storytelling for patients should be more engaging, reporting of AEs really has not changed. Indeed, AE narratives remain directed at clinicians and regulators, rather than to patients. We believe there is value in being able to tell patients an AE narrative.

Adverse events (AEs), particularly with drug therapies, remain a challenge in modern healthcare. The increasing complexity of cancer therapeutics, an ageing population, and rising multimorbidity all continue to contribute to and complicate safety issues for patients. However, while our understanding of AEs should be evolving, and our AE storytelling for patients should be more engaging, reporting of AEs really has not changed. Indeed, AE narratives remain directed at clinicians and regulators, rather than to patients. We believe there is value in being able to tell patients an AE narrative.