In This Week’s Issue:
1. PIPC: Hepatitis Roundtable Summary and Recommendations, click here to view the paper.
2. Applied Clinical Trials Online: Congress, FDA Look to Improve Clinical Trial Practices & Policies, click here for the full article.
3. Medscape: Lessons From WHI, Part 4: The Trial That Keeps on Giving, click here to view the interview (free registration required).
4. PCORI: Two New Advisory Panels Set Initial Priorities, click here for the post.
5. BJM: Campaign Is Launched to Make Patients the Focus of Evidence Based Medicine, click here for the article.
6. New Health Affairs July Issue: The Impact Of Big Data On Health Care, click here for the full post.
7. Deloitte: Building Trust In The Collection And Use Of Real World Health Data, click here for the article.
8. BioCentury: CER Guidance for Late-Stage Diabetes Studies, click here for the article (subscription required).
1. PIPC: Hepatitis Roundtable Summary and Recommendations, click here to view the paper.
2. Applied Clinical Trials Online: Congress, FDA Look to Improve Clinical Trial Practices & Policies, click here for the full article.
3. Medscape: Lessons From WHI, Part 4: The Trial That Keeps on Giving, click here to view the interview (free registration required).
4. PCORI: Two New Advisory Panels Set Initial Priorities, click here for the post.
5. BJM: Campaign Is Launched to Make Patients the Focus of Evidence Based Medicine, click here for the article.
6. New Health Affairs July Issue: The Impact Of Big Data On Health Care, click here for the full post.
7. Deloitte: Building Trust In The Collection And Use Of Real World Health Data, click here for the article.
8. BioCentury: CER Guidance for Late-Stage Diabetes Studies, click here for the article (subscription required).
1. PIPC: Hepatitis Roundtable Summary and Recommendations
On May 8, 2014, the Partnership to Improve Patient Care (PIPC) convened a Roundtable of experts in the diagnosis, treatment, and care of patients with hepatitis B (HBV) and C (HCV): i.e., patient advocates, health care providers (nurse practitioners, physician specialists including family physicians, gastroenterology, infectious disease, and oncology), representatives from the Department of Health and Human Services (HHS), and the Patient-Centered Outcomes Research Institute (PCORI), all of whom participated individually and/or on behalf of their representative organizations, to discuss current challenges to and potential solutions for the appropriate dissemination and implementation of clinical evidence. Additionally, this group focused on the value and clinical benefits of ensuring patients and providers have access to reliable, relevant, current data and information.
Building on an earlier PIPC Roundtable focused on gastrointestinal disorders, expert stakeholders, including patients and providers, identified hepatitis as a clinical area with significant opportunities to improve patient care through appropriate communication and implementation of evidence-based research. Therefore, by focusing on recent advances in screening and treatment for HBV and HCV, this Roundtable hoped to accomplish two goals:
Present PCORI with creative approaches and options to inform PCORI’s development of a Dissemination and Implementation Action Plan;
Highlight broader practice and policy issues related to clinical and societal value in providing patients and their providers with access to useful clinical and health care information and messages that will help them make informed health care decisions leading to better patient health outcomes. Click here to view the paper.
2. Applied Clinical Trials Online: Congress, FDA Look to Improve Clinical Trial Practices & Policies
Writing for Applied Clinical Trials Online, Jill Wechsler reported on recent efforts by both the Administration and Congress to promote CER. “PCORI recently established an advisory panel on clinical trials to update research standards in this area and to help the Institute review clinical trials in its research portfolio, particularly those designed to directly compare different treatments. The panel will work with PCORI's Methodology Committee to examine cross-cutting research issues such as ensuring patient-centeredness, dealing with missing data, examining heterogeneity of treatment effects, and devising standards for data registries.” Click here for the full article.
3. Medscape: Lessons From WHI, Part 4: The Trial That Keeps on Giving
Last week, Henry R. Black's fourth part of his interview with Rebecca D. Jackson ran in Medscape. In it, the two discuss the benefit of person-centered clinical trials. “[Rebecca D. Jackson, MD: The Women's Health Initiative], with that real commitment to risk and benefit, was a person-centered study rather than a disease-centered study. That's probably the way we should design all clinical trials because we don't do that in effectiveness trials. That's what PCORI and others are starting to ask now, that we should think about this as a person-centered and maybe as a society-centered intervention.” Click here to view the interview (free registration required).
4. PCORI: Two New Advisory Panels Set Initial Priorities
Earlier this month, Emma Djabali, and Bryan Luce wrote a blog for PCORI commenting on previous advisory panel discussions. “On May 1, 2014, our Advisory Panel on Clinical Trials met for the first time, to provide counsel on PCORI's strategies for supporting clinical trials. […] ‘I care about whether a study answers the question it's purporting to answer,’ said Elizabeth Stuart, PhD, AM, who was recently named the panel's first chair. ‘Is the question important? Is the design the best to get at it?’ she added.” Click here for the post.
5. BJM: Campaign Is Launched to Make Patients the Focus of Evidence Based Medicine
Zosia Kmietowicz of BMJ reported on the status of evidence based medicine stating that, “[c]linical care has become ‘medicalised and bureaucratised,’ said Trish Greenhalgh at the launch of the Campaign for Real EBM...At the campaign launch Greenhalgh said, ‘If patients knew how much of their consultation was driven by box ticking they would be hopping mad. We need more research about how to make the doctor listen to the patient.’” Click here for the article.
6. New Health Affairs July Issue: The Impact Of Big Data On Health Care
Writing for the Health Affairs Blog, Chris Fleming gave a synopsis of the publication’s July article noting the focus on Big Data. “Health Affairs explores the promise of big data in improving health care effectiveness and efficiency in its July issue. Many articles examine the potential of approaches such as predictive analytics and address the unavoidable privacy implications of collecting, storing, and interpreting massive amounts of health information. [...] A series of papers focus on comparative effectiveness and predictive analysis.” Click here for the full post.
7. Deloitte: Building Trust In The Collection And Use Of Real World Health Data
Last week, Karen Taylor of Deloitte also commented on the potential for Big Data’s analytical power when there is quality data available. “The value of real world evidence is strongly linked to the pool of data available for analysis and the quality of this data. By ensuring quality, broadening sample sizes and increasing linkage to other relevant sources of data, we can drive unique insight that is reflective of the population as a whole.” Click here for the article.
8. BioCentury: CER Guidance for Late-Stage Diabetes Studies
BioCentury recently reported on policies surrounding patient reported outcomes data. “The not-for-profit Center for Medical Technology Policy called for increased collection of patient-reported outcomes data and greater representation of certain subgroups in comparative effectiveness research studies in Type II diabetes. [...] According to CMTP, most large systematic reviews of diabetes drugs find that evidence is insufficient due to lack of representation of these subgroups, failure to report patient-reported outcomes and issues with comparability.” Click here for the article (subscription required).
On May 8, 2014, the Partnership to Improve Patient Care (PIPC) convened a Roundtable of experts in the diagnosis, treatment, and care of patients with hepatitis B (HBV) and C (HCV): i.e., patient advocates, health care providers (nurse practitioners, physician specialists including family physicians, gastroenterology, infectious disease, and oncology), representatives from the Department of Health and Human Services (HHS), and the Patient-Centered Outcomes Research Institute (PCORI), all of whom participated individually and/or on behalf of their representative organizations, to discuss current challenges to and potential solutions for the appropriate dissemination and implementation of clinical evidence. Additionally, this group focused on the value and clinical benefits of ensuring patients and providers have access to reliable, relevant, current data and information.
Building on an earlier PIPC Roundtable focused on gastrointestinal disorders, expert stakeholders, including patients and providers, identified hepatitis as a clinical area with significant opportunities to improve patient care through appropriate communication and implementation of evidence-based research. Therefore, by focusing on recent advances in screening and treatment for HBV and HCV, this Roundtable hoped to accomplish two goals:
Present PCORI with creative approaches and options to inform PCORI’s development of a Dissemination and Implementation Action Plan;
Highlight broader practice and policy issues related to clinical and societal value in providing patients and their providers with access to useful clinical and health care information and messages that will help them make informed health care decisions leading to better patient health outcomes. Click here to view the paper.
2. Applied Clinical Trials Online: Congress, FDA Look to Improve Clinical Trial Practices & Policies
Writing for Applied Clinical Trials Online, Jill Wechsler reported on recent efforts by both the Administration and Congress to promote CER. “PCORI recently established an advisory panel on clinical trials to update research standards in this area and to help the Institute review clinical trials in its research portfolio, particularly those designed to directly compare different treatments. The panel will work with PCORI's Methodology Committee to examine cross-cutting research issues such as ensuring patient-centeredness, dealing with missing data, examining heterogeneity of treatment effects, and devising standards for data registries.” Click here for the full article.
3. Medscape: Lessons From WHI, Part 4: The Trial That Keeps on Giving
Last week, Henry R. Black's fourth part of his interview with Rebecca D. Jackson ran in Medscape. In it, the two discuss the benefit of person-centered clinical trials. “[Rebecca D. Jackson, MD: The Women's Health Initiative], with that real commitment to risk and benefit, was a person-centered study rather than a disease-centered study. That's probably the way we should design all clinical trials because we don't do that in effectiveness trials. That's what PCORI and others are starting to ask now, that we should think about this as a person-centered and maybe as a society-centered intervention.” Click here to view the interview (free registration required).
4. PCORI: Two New Advisory Panels Set Initial Priorities
Earlier this month, Emma Djabali, and Bryan Luce wrote a blog for PCORI commenting on previous advisory panel discussions. “On May 1, 2014, our Advisory Panel on Clinical Trials met for the first time, to provide counsel on PCORI's strategies for supporting clinical trials. […] ‘I care about whether a study answers the question it's purporting to answer,’ said Elizabeth Stuart, PhD, AM, who was recently named the panel's first chair. ‘Is the question important? Is the design the best to get at it?’ she added.” Click here for the post.
5. BJM: Campaign Is Launched to Make Patients the Focus of Evidence Based Medicine
Zosia Kmietowicz of BMJ reported on the status of evidence based medicine stating that, “[c]linical care has become ‘medicalised and bureaucratised,’ said Trish Greenhalgh at the launch of the Campaign for Real EBM...At the campaign launch Greenhalgh said, ‘If patients knew how much of their consultation was driven by box ticking they would be hopping mad. We need more research about how to make the doctor listen to the patient.’” Click here for the article.
6. New Health Affairs July Issue: The Impact Of Big Data On Health Care
Writing for the Health Affairs Blog, Chris Fleming gave a synopsis of the publication’s July article noting the focus on Big Data. “Health Affairs explores the promise of big data in improving health care effectiveness and efficiency in its July issue. Many articles examine the potential of approaches such as predictive analytics and address the unavoidable privacy implications of collecting, storing, and interpreting massive amounts of health information. [...] A series of papers focus on comparative effectiveness and predictive analysis.” Click here for the full post.
7. Deloitte: Building Trust In The Collection And Use Of Real World Health Data
Last week, Karen Taylor of Deloitte also commented on the potential for Big Data’s analytical power when there is quality data available. “The value of real world evidence is strongly linked to the pool of data available for analysis and the quality of this data. By ensuring quality, broadening sample sizes and increasing linkage to other relevant sources of data, we can drive unique insight that is reflective of the population as a whole.” Click here for the article.
8. BioCentury: CER Guidance for Late-Stage Diabetes Studies
BioCentury recently reported on policies surrounding patient reported outcomes data. “The not-for-profit Center for Medical Technology Policy called for increased collection of patient-reported outcomes data and greater representation of certain subgroups in comparative effectiveness research studies in Type II diabetes. [...] According to CMTP, most large systematic reviews of diabetes drugs find that evidence is insufficient due to lack of representation of these subgroups, failure to report patient-reported outcomes and issues with comparability.” Click here for the article (subscription required).