DIA's 8th Annual Conference - The New Clinical Research Environment in India

Join Prominent Professionals to Discuss the Changing Industry Join academia, industry, regulators and researchers to discuss the new environment for health care product development at DIA India’s 8th Annual Conference. The event, to be held in Bangalore from October 24 to 26, will provide a forum for professionals to hear how their peers are coping with the challenges of new regulations and how they are planning to realize the promise of emerging opportunities. More than 90 renowned experts will speak on key issues, including keynote presenters Prof. Ranjit Roychaudhuory, Chairman of the Task Force for Research at Appollo Hospitals Group, and Mukhtar Ahmed, Oracle HSGBU’s Vice President of Product Strategy. The conference will also feature 12 tracks with 48 sessions on the key themes of clinical research, IT, life sciences, medical writing, and biostatistics. Program highlights include: Direction, outlook and vision for health related research in India Review of recent changes in regulations and their implications Challenges to global development and commercialization ex-India New opportunities for India-centric global delivery solutions Global benchmarks in health care research regulations Patient-centric endeavors for awareness and ethics of research Exhibiting and Support Opportunities are available! Click here for more information. Overview View Program Register Now upcoming events THANK YOU TO OUR MEDIA PARTNERS Keynote Speakers Padmashree Ranjit Roy Chaudhury Apollo Hospitals Group Mukhtar Ahmed Oracle HSGBU Featured Topics Drug Discovery Development Manufacturing Commercialization Regulatory Ethical, Social, Legal, Technology & Standards Lean Strategy Outsourcing Strategy Pharmacovigilance Therapeutics Overview View Program Register Now

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PCORI To Launch Comparative-Effectiveness Research Network.

Taken from DIA Daily. This daily enewsletter features summaries of breaking news and information about the pharmaceutical, biotechnology, and medical device fields from thousands of global news sources. This easy-to-read enewsletter is delivered to your inbox every business morning. Subscribe to the DIA Daily.

The Washington Post (4/24, Kliff) "Wonkblog" reports a "new nonprofit is putting millions" of Federal healthcare reform money "towards an effort to turn routine doctor visits into a treasure trove of data on what medical treatments work best." The Patient Centered Research Outcomes Institute, which the Affordable Care Act created to "support comparative effectiveness research," announced Tuesday that it "would move forward on that mission" by spending "$68 million to fund a network of health-care systems that cover as many as 12 million patients."

        CQ (4/24, Adams, Subscription Publication) adds that the Food and Drug Administration's Center for Drug Evaluation and Research Director Janet Woodcock, MD, "noted that the FDA has been involved for decades in trying to support comparative effectiveness research and find out more about the products that the agency approves for use in the United States." According to Dr. Woodcock, "What the FDA needs and what the medical community needs is actionable information."

        According to Government Health IT (4/24, Sullivan), the "hybrid model will include patients, health systems, payers, physicians and researchers as active participants in the research. To that end, PCORI detailed two cooperative funding agreement opportunities to support the creation of Clinical Data Research Networks (CRDN) and Patient-Powered Research Networks (PPRNs)." For the CRDNs, PCORI "will award $56 million to as many as 8 existing or new networks, while the PPRNs funding total is $12 million, available to 18 networks," according to the statement the institute released yesterday.

        Modern Healthcare (4/24, Robeznieks, Subscription Publication) notes that PCORI Executive Director Dr. Joe Selby announced the funding during a roundtable discussion in the District of Columbia. "Putting patients' interests first in such an endeavor can make a difference and 'smooth the friction' between stakeholders," Selby "said of the project's patient-first focus." American Medical Association President-Elect Dr. Ardis Hoven, who was one of the roundtable participants, "called the effort 'an exciting opportunity,' and noted its potential for advancing the use of information gleaned from clinical registries into medicine." Organizations interested in participating in the network "must file a letter of intent by June 19 and must complete an application by Sept. 27."

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Building a National Data Infrastructure to Advance Patient-Centered Comparative Effectiveness Research

We hope you'll mark your calendar for an important PCORI roundtable discussion: Building a National Data Infrastructure to Advance Patient-Centered Comparative Effectiveness Research. When: Tuesday, April 23, 2013, 9:00-11:00 a.m. ET (Light breakfast available at 8:00 a.m.) Where: The National Press Club in Washington, D.C. RSVP: Friday, April 19, 2013, by 5:00 p.m. ET (If registration reaches the venue's capacity, registration will close before this time.)   Comparative clinical effectiveness research (CER) can play a significant role in improving the volume and quality of information available to patients, caregivers, clinicians and other healthcare stakeholders. A data-rich national infrastructure to support high-quality, efficient CER will benefit all Americans. The right infrastructure has the potential to transform research and foster a learning healthcare system that uses meaningful evidence drawn from clinical practice to improve patient outcomes. On Tuesday, April 23, PCORI will host a roundtable discussion on how to create a national data infrastructure to support high-quality patient-centered CER. The roundtable will bring together representatives from government, industry, payers, health systems, and the research and patient communities to discuss the challenges and opportunities in creating such a research infrastructure and where PCORI's investments can provide unique value. Audience members will be able to pose questions to roundtable participants toward the end of the event. A webcast will be available for those who can't attend in person. Individuals who wish to attend in person should register for the event through the PCORI website. The event agenda will be updated as roundtable participants are confirmed. ###

pcori subjects of our first targeted funding announcements

March 19, 2013

We're pleased at the interest researchers, patients and other stakeholders have shown so far in our efforts to identify key research questions in five topic areas we're considering as the subjects of our first targeted funding announcements. And we hope to see even more interest and input in coming weeks.   On March 1, we launched a series of ad hoc multi-stakeholder workgroups to help us refine questions for our initial set of targeted research topics. Three of the five workgroups have since convened, but there are still ways for you to get involved. You can:   Join one of our two remaining workgroups via webinar. Treatment Options for Back Pain on Thursday, March 21 Obesity Treatment Options in Diverse Populations on Tuesday, April 16   Watch archived webinars and submit your comments. We've posted the archived versions of the three workgroups held so far. You can view them using the links below: Treatment Options for Severe Asthma in African-Americans and Hispanics/Latinos  Treatment Options for Uterine Fibroids Preventing Injuries from Falls in the Elderly  You can also still submit a question or comment via our website, email, Twitter and telephone. We are accepting feedback on Preventing Injuries from Falls in the Elderly until March 26. Email us at falls@pcori.org. We hope you'll join us as this process continues. Your input will help us ensure that the final research questions we consider for funding effectively answer patients' questions and reflect the community's needs.   We also invite you to check out the archive of the webcast from our recent regional engagement workshop, The Power of Partnership in Research: Improving Healthcare Outcomes in Rural Settings. The event, held March 9-10 in Wichita, Kan., was a highly energized gathering of all members in the health care community, where we jumpstarted many new research partnerships.  Please share your comments about this event and any of our other engagement efforts by email at getinvolved@pcori.org.

PCORI needs your help: launching ad hoc workgroups on March 1 -seek input from the healthcare community

February 27, 2013

The Patient-Centered Outcomes Research Institute (PCORI) needs your help as we launch a series of ad hoc workgroups on March 1 to seek input from the healthcare community on refining our initial set of targeted research topics for funding. The workgroups, made up of researchers, patients, and other stakeholders, will meet one time each in March and April. They will provide input to our staff and Board of Governors on the critical research questions that should be answered within each of the five topics, which are: Treatment Options for Severe Asthma in African-Americans and Hispanics/Latinos - March 1 Treatment Options for Uterine Fibroids - March 5 Preventing Injuries from Falls in the Elderly - March 12 Treatment Options for Back Pain - March 21 Obesity Treatment Options in Diverse Populations - April 16 Each workgroup's proceedings will be open to the public via webinar/teleconference. We welcome your comments and suggested research questions via email (targetedPFAworkgroup@pcori.org) and Twitter (@PCORI). We also welcome comments, suggestions, and input from interested individuals for up to two weeks before and after each meeting through our website. You'll find a full list of workgroup meetings and information on how submit input and register for their associated webinars on our site's events page. Our Board approved the development of five targeted funding announcements at its November 2012 meeting. Three topics were identified at that time and two more were identified in January. This accelerated approach to the development of targeted funding announcements will jump-start our long-term strategy to generate and prioritize specific research topics, starting with questions solicited directly from patients and stakeholders. We hope you take the opportunity to participate in one of our workgroup meetings. Your input is critical to our mission to help people make informed health care decisions, and improve health outcomes.

PCORI Board of Governors Meeting (Feb 4) and Health Affairs Briefing (Feb 6)

February 1, 2013 We'd like to let you know about two exciting events next week and how you can participate. Board of Governors Meeting On Monday, the PCORI Board of Governors will hold a public meeting in San Francisco. The meeting will take place 8:00 a.m. to 5:00 p.m. PT and will include a 30-minute public comment period at 2:30 p.m. Click here to register to provide comments during the public comment period. A webcast will be available for participants who cannot attend in person. Click here to register for the webcast. Monday, February 4 8:00 a.m. - 5:00 p.m. PT At the meeting the Board will review our plans to develop funding announcements on a set of specific high-impact research topics. We have identified five such topics to consider for an initial round of Targeted PCORI Funding Announcements: treatment options for uterine fibroids; treatment options for severe asthma in African-Americans and Hispanics/Latinos; preventing injuries from falls among the elderly; treatment options for neck and back pain; and obesity treatment options in diverse populations. Additional Board business includes reports on: PCORI Advisory Panels. PCORI's strategic plan. An ongoing evaluation of PCORI's research funding application review process. PCORI's conflict of interest policy. For more information, including an agenda, presentations, a link to the workshop webcast, visit the PCORI website. Health Affairs Briefing On Wednesday, PCORI will join Health Affairs for a briefing to discuss its February 2013 issue, "New Era Of Patient Engagement."PCORI Executive Director Joe Selby, MD, MPH will speak at the briefing on how PCORI is engaging patients and stakeholders in shaping its research agenda. Wednesday, February 6 8:00 a.m. - 2:30 p.m. W Hotel Washington, 515 15th Street NW, Washington, DC Click here for more information Follow @PCORI and @HA_Events on Twitter for live coverage of the briefing.

Patient-Centered Outcomes Research Institute | 1828 L Street, NW | Suite 900 | Washington | DC | 20036

PCORI's Patient-Researcher Matching Challenge webinar Jan. 28

January 24, 2013

Would you like to help connect researchers and patients interested in partnering to design and conduct patient-centered comparativeness research studies? We at the Patient-Centered Outcomes Research Institute hope so. And we have a way for you to do just that.

Join us on Monday, January 28, at 12:00 pm - 1:00 pm for a webinar exploring PCORI's Patient-Researcher Matching Challenge. We announced this initiative in December with $50,000 in prize money for applicants who submit the best concept or prototype for a system connecting researchers and patient partners interested in pursuing rigorous patient-centered outcomes research. We are undertaking the challenge in collaboration with the San Francisco-based company Health 2.0. The webinar will provide an overview of the challenge and let potential applicants pose questions to me and to our Director of Communications, Bill Silberg. Our approach to research is neither traditional nor simple because it requires sustained and meaningful engagement with patients, caregivers and other stakeholders. We know many researchers are interested in adopting this approach and seek funding from us, but don't necessarily know the best or most effective way to proceed. Likewise, many patients are interested in working with researchers, but are unsure of how to make the connection that will allow them to participate. The PCORI Challenge offers an opportunity for innovators to help researchers and patients connect, and help PCORI fulfill our commitment to "research done differently" by bringing together in collaboration the many voices that represent our diverse healthcare community. Applicants may consider submitting a well-articulated conceptual model, adaptation of an existing matching protocol reimagined for the purpose outlined in this challenge, a prototype for an entirely new web-based service or app, some combination of these approaches, or something else entirely. Winners of the challenge will receive cash prizes and their work may be considered for additional PCORI support. We thank you for your continued interest in our work and encourage you to register for the webinar to learn more about this exciting approach to problem-solving.

Thank you. Sue Sheridan, MIM, MBA Director, Patient Engagement

A look back at PCORI's 2012 achievements

December 27, 2012

The holiday season is traditionally a time to look back at the year's achievements. So, as we approach the end of 2012, let me remind you of a few of PCORI's accomplishments and invite you to read more about them.    This has been a year of substantial progress for PCORI. We finalized our definition of patient-centered outcomes research (PCOR) and our National Priorities and Research Agenda, and adopted methodological standards for PCOR, all after soliciting and incorporating public comment. We made major strides in engaging a broad range of healthcare community stakeholders in our work. And we approved 75 research awards, 50 earlier this year through our Pilot Projects Program and 25 more on December 18 in our first round of primary research funding.    You can find out more about all of these efforts on our web site. But let me point you to a few recent PCORI Blog posts on developments you might find of particular interest.

Our First Set of Patient-Centered Comparative Effectiveness Awards In my most recent blog post, Round One: PCORI Gets Into the Business of Funding Patient-Centered CER, I outline how pleased we were with our first set of awards resulting from the PCORI Funding Announcements (PFAs) we released in May. I discuss the approach our selection committee used in picking the 25 projects, in 17 states, to which we've committed nearly $41 million in funding. And I tried to give you a sense of what we learned from this effort and how we might do a better job with our application guidelines and review process in the future.    Engaging the Stakeholder Community in Research Prioritization Earlier this month we hosted two back-to-back workshops in the ongoing effort to engage the healthcare community in our process for selecting and prioritizing the topics we hope to see researchers study.     The first of our most recent workshops, "What Should PCORI Study? A Call for Topics from Patients and Stakeholders," literally invited stakeholders to suggest topics we should fold into our funding process. Susan Hildebrandt, our Director of Stakeholder engagement, provides a closer look at the results of that workshop in her blog post, Harnessing the Expertise of the Healthcare Community to Guide Outcomes Research.    The second workshop, "PCORI Methodology Workshop for Prioritizing Specific Research Topics," brought together expert methodologists, researchers, patients and other stakeholders to help us refine our process for identifying the questions important to patients, caregivers and clinicians so they can be the subject of future funding calls. Senior Scientist Rachael Fleurence, PhD, shares more about this initiative in her post Workshop Advances PCORI's Process for Picking High-Priority Research Questions.   Engaging Patients in Building a Research Community Bringing patients into our work in a meaningful way has been a particular emphasis for us this year. In Maintaining Momentum, Implementing Patient Input, Sue Sheridan, our Director of Patient Engagement, provides a follow-up report on the Patient Engagement Workshop we held in October, sharing plans for implementing some of the suggestions that came out of the event. We're also very excited about the launch of our first challenge initiative, which seeks out innovators who will create a "matching system" to link patients and scientists as partners in conducting research.  In Matchmaker, Matchmaker, Sheridan and PCORI Deputy Executive Director Anne Beal, MD, MPH, provide background and details of this competition, another suggestion discussed at the Patient Engagement Workshop.

We look forward to continuing our work together to advance our program of "research done differently" as we seek to provide patients and those who care for them with information that will help them make better-informed health and health care decisions. We have big plans for doing that in 2013; I'll be reporting to you on some of those initiatives in early January.   Until then, best wishes for the New Year.     Joe Selby, MD, MPH Executive Director Patient-Centered Outcomes Research Institute

PCORI approves 25 awards, totaling $40.7 million over three years, to fund patient-centered CER

December 18, 2012

The Patient-Centered Outcomes Research Institute (PCORI) has approved its first primary research projects. PCORI today announced the approval of 25 awards, totaling $40.7 million over three years, to fund patient-centered comparative clinical effectiveness research projects under the first four areas of its National Priorities for Research and Research Agenda.

All proposals were approved by PCORI's Board of Governors pending a business and programmatic review by PCORI staff and completion of a formal award contract.   The approved research projects, based at institutions in 17 states, resulted from PCORI's first cycle of primary research funding announcements issued May 22. PCORI received nearly 500 applications. The approved projects were selected through a competitive, multi-stage review process that incorporated patients, caregivers and other stakeholders in the evaluation of proposals. Applications were evaluated on scientific merit, engagement of patients and other stakeholders, methodological rigor and fit within PCORI's research priorities and research agenda.   The projects approved for funding include those that will study ways to improve care for people with such health problems as bacterial and viral infections, cardiovascular disease and stroke, certain cancers, chronic kidney disease, chronic pain, depression and other serious mental illness, and pediatric diabetes, as well cross-cutting proposals investigating how to improve care for people with multiple conditions. Other projects seek ways to improve patient-clinician communication, reduce selected health disparities, and improve the way healthcare systems operate.   Information on all of today's awards, including the project name, primary investigator, and research institution, is provided on the PCORI website, www.pcori.org.   For more information about PCORI funding opportunities visit www.pcori.org/funding-opportunities.   #####

About PCORI The Patient-Centered Outcomes Research Institute (PCORI) is an independent, non-profit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed health care decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work.

PCORI Patient Engagement Workshop Blog Post and Archived Webcast

The Patient-Centered Outcomes Research Institute recently hosted its first patient engagement workshop, "Transforming Patient-Centered Research: Building Partnerships and Promising Models."It was the first in a series of workshops aimed at bringing PCORI's vision for patient and stakeholder engagement to life.   Workshop participants provided input to help PCORI establish procedures for identifying research questions, reviewing research proposals for funding, and ensuring patient participation throughout the research process. PCORI captured the conversations at each session and will compile them in a detailed report that will be released in about a month.   You can watch the archived webcast of workshop plenary sessions here.   PCORI's Director of Patient Engagement Sue Sheridan shared her experiences and reflections from the workshop in a new blog post on the PCORI website.     In her post Sheridan explains, "We heard a range of suggestions that we will explore further, including how to best capture research ideas from patients and other stakeholders, the concept of 'micro-grants' for building partnerships between patients and researchers, enhanced patient participation in funded proposals, tools for matching researchers with patient partners, and even the creation of a PCORI Ambassador initiative. And we were repeatedly challenged to 'listen,' be fully transparent, responsive and inclusive."   Read the complete blog post on the PCORI Blog.