NewsWhat's your challenge?
All the latest news and information from Adelphi Values.
Adelphi Values has been invited to present at the DIA’s Advancing the Science of Study Endpoints meeting to be held in Washington DC on Dec 5 and 6. The purpose of the meeting is to assemble health outcomes experts to examine global strategies for selecting study endpoints and the impact of endpoints during the analysis of clinical evidence for various types of drug approval processes.
Alan Shields, PhD, Vice-president of our US Patient-Centered Outcomes practice, will be presenting in a session entitled, Meaningful Score Changes to Establish Endpoint Definitions.
Meet our team presenting and exhibiting at the 19th Annual European Congress at ISPOR, the International Society of Pharmacoeconomics and Outcomes Research, which takes place from 31st October to 2nd November 2016 in Vienna, Austria.
Our workshop this year is entitled ‘Measuring multiple medication adherence – which measure when?’ and will be held at 1:45-2:45pm in Hall F2 (L0). Bryan Bennett, Director in Patient-Centered Outcomes at Adelphi Values, will be presenting alongside three others. The workshop explores the various methods used to estimate adherence to multiple medications (AtMM), presenting the methods currently employed in the AtMM literature followed by a discussion of pros and cons of the methods and the calculations used to derive the measure of adherence.
In addition, we have a variety of scientific poster presentations which cover therapy areas including oncology, dermatology, the respiratory system and acute pain along with topics such as psychometric analyses of clinical outcome assessments (COAs) and clinical trials.
With thousands of attendees from around 80 countries, ISPOR is recognised as the leading scientific and educational organisation for outcomes research in healthcare decisions and hosts many of the foremost experts around the world. This year’s event is entitled ‘Managing Access to Medical Innovation: Strengthening the Methodology-Policy Nexus’ and provides a great platform for knowledge sharing.
Our exhibition booths are numbers 504/505, with our sister company Adelphi Real World alongside us at 503. Come and visit our team at our booth – we look forward to seeing you!
If you would like further information on our presentations at ISPOR or on any of our broader healthcare value consultancy or patient-centered research solutions, please contact us or alternatively email email@example.com
In October, our US team will be taking part in JDRF One Walk, to raise money for the Juvenile Diabetes Research Foundation (JDRF). Covering 5km around Boston, the JDRF flagship event aims to raise awareness of type1 diabetes (T1D), and funds toward achieving their mission, “to create a world without T1D”. 1.25 million Americans are currently living with T1D and the prevalence is increasing.
As our chosen US charity for 2016, we supported JDRF at the ISPOR conference in Washington DC earlier this year, and our team are looking forward to taking part in the walk and continuing our support of this worthy cause.
JDRF is the leading global organization funding T1D research and with a mission to “accelerate life-changing breakthroughs to cure, prevent and treat Type 1 Diabetes (T1D) and its complications”, and currently funding more than 50 human clinical trials.
For more information on JDRF or how to get involved, please visit the JDRF One Walk website.
The Institute of Pharmaceutical Medicine at the University of Basel invited Bryan Bennett from Adelphi Values to give a lecture to students of the post-graduate ‘European Course of Pharmaceutical Medicine’, a course which is typically undertaken by pharmaceutical industry professionals.
The lecture titled ‘Epidemiology and patient-reported outcome studies’ was part of the seminar ‘Continuing Education Series – Frontiers in Drug Development: Key Concepts in Clinical Trial Design’ and covered the value of using Patient-Reported Outcomes (PROs) throughout the drug development process. More specifically, the use of PROs in clinical trials, the regulatory considerations, the development of PROs, industry good practice standards and the application of PROs and stakeholder value were discussed
As a leading expert in patient-reported outcomes, Bryan delivered the lecture and said “I felt very privileged to have been asked to participate in the lecture series. The ECPM is a centre of excellence in pharmaceutical training and development so it was great to be part of the seminar and share my knowledge in this way.” Excellent feedback followed the completion of this lecture with students stating that it was “very clear and informative – extremely helpful”, that they enjoyed the presentation and learnt a lot from it.
The European Center of Pharmaceutical Medicine (ECPM) is a leading university institute for medicine and drug development in Europe, with over 1600 experts having successfully completed their postgraduate training courses over the last 22 years.
If you would like further information on this lecture, our available training workshops or on any of our broader patient-centered research solutions, please contact us or alternatively email us at firstname.lastname@example.org
Thanks to all our clients and colleagues who visited our exhibition stand at ISPOR US which took place in Washington DC. As a result of your support, we have donated $500 to JDRF this year’s chosen charity.
JDRF is a charitable organisation that supports sufferers and families living with type 1 diabetes – a chronic, life-threatening condition which has increased five-fold in the under-five age group in the last 20 years. JDRF funds research to cure, treat and prevent type 1 diabetes, with the long term goal of helping to eradicate this disease.
If you would like further information on our activities at ISPOR or on any of our broader healthcare value consultancy or patient-centred research solutions, please contact us or alternatively email email@example.com
Meet the team presenting and exhibiting at the 21st Annual International Meeting of ISPOR, the International Society of Pharmacoeconomics and Outcomes Research, taking place 23rd–25th May in Washington DC.
Building on the success of previous ISPOR conferences, this year we will be hosting two workshops and presenting a number of scientific posters. Our first workshop entitled ‘Exploring and leveraging known resources to support pediatric clinical outcomes assessment (COA) development’ provides practical tips for improving the qualitative research conducted with children and adolescents as part of COA instrument development, incorporating the perspectives of professionals from outside of the instrument development field who work with children every day.
The second workshop, entitled ‘Empowering patient populations with physical or cognitive limitations through electronic clinical outcome assessments (eCOAs), considers technical solutions to overcome COA challenges and present opportunities, the patient experience in terms of usability and feasibility, and considerations for implementation and in trial experiences.
In addition, our scientific posters span a range of topics and therapy areas, including patient-reported outcomes, budget impact, quality of life, clinical studies and ongoing challenges in disease areas including cardiovascular, respiratory, oncology, women’s health and rare diseases.
Attracting thousands of attendees from around 80 countries, ISPOR is recognised as the leading scientific and educational organisation for outcomes research in healthcare decisions and hosts many of the foremost experts around the world. This year’s event is entitled ‘Value, Affordability, and Patient Centeredness: Can We Have it All?’ and will be a great opportunity to share knowledge and to discuss new ideas.
Our stand is in the main poster hall, numbers 16/17 alongside our sister company Adelphi Real World. To set up a meeting in advance, email firstname.lastname@example.org or alternatively come and say hello to the team at our booth. We look forward to seeing you in Washington DC!
If you would like further information on our presentations at ISPOR or on any of our broader healthcare value consultancy or patient-centred research solutions, please contact us or alternatively email email@example.com
We are honoured to have been invited to present at the 7th Annual Critical Path Institute Patient-Reported Outcome (PRO) Consortium Workshop to be held in Silver Spring, Maryland on 27th-28th April 2016.
Rob Arbuckle, Managing Director of our UK Patient-Centered Outcomes practice, will be presenting two case studies as part of the paediatric session. As a leading paediatric PRO development expert, Rob will be presenting case studies reporting the development and testing of paediatric PROs in a manner that essentially means that the same questions can be used across a broad range of ages. Rob will be co-presenting two examples from the common paediatric indications of the common cold and functional constipation/irritable bowel syndrome with constipation.
In addition to this, we will also have a poster presentation on our Asthma working group, updates for additional working groups and a subsequent manuscript publication.
The PRO Consortium is a public-private partnership established by the Critical Path Institute (C-Path) in cooperation with the U.S. Food and Drug Administration (FDA) and the medical products industry. The PRO Consortium brings together scientists from C-Path, industry, academia and regulatory agencies in a pre-competitive environment for the purpose of developing, evaluating and qualifying PRO instruments for use as primary or secondary endpoint measures in clinical trials designed to evaluate treatment benefit.
Increasing numbers of rare diseases are being recognised and more medicines to treat them are being developed. There are several unique challenges for developing evidence packages in rare diseases such as the paucity of information on patient populations, disease progression and appropriate Clinical Outcome Assessments (COAs). As with all clinical development programs, disease-specific COAs are an important part of assessing signs and symptoms of rare diseases and treatment response.
On Tuesday 22nd March at 3:00pm GMT Adelphi Values, in association with PMGroup, will host a webinar to look at the importance of and challenges associated with the development of evidence such as suitable endpoints, COAs and comparators in rare diseases using real-world examples.
Throughout the webinar we will explore:
The webinar will be hosted by Nikki Bonner, Associate Director, Patient-Centered Outcomes and Louise Heron, Director, Value Insight & Communication at Adelphi Values. We have also partnered with Alexandra Bowden PhD, Senior Manager at Ultragenyx Pharmaceuticals Inc, Denise D’Alessio MBA, Manager, Patient Reported Outcomes and Global Market Access & Policy at Novartis Pharmaceuticals Corporation, and Anne Kilburg MSc, Principal Consultant at Wellmera AG.
This webinar will be useful to professionals working in the pharmaceutical industry, academia, and consultancy who are involved in clinical trials, outcomes research, regulatory, commercial aspects of the drug development process, especially within rare diseases. It will also be useful to those with an interest in these areas.
To attend the free webinar please register here – the webinar can either be watched on the day or later as a recorded version.
Oncology is an area that is notoriously hard to achieve patient-reported outcome label claims, but experts at Adelphi Values continue to evaluate ways to work with the FDA guidelines to ensure data are robust and stand up to the scrutiny of regulators. To demonstrate this, and in collaboration with Novartis, we have published an article in the journal Expert Review of Pharmacoeconomics & Outcomes Research, entitled, Patient-reported outcomes for US oncology labeling: review and discussion of score interpretation and analysis methods. This paper approaches the conceptual and practical challenges associated with interpreting the clinical meaning of scores produced by patient reported outcome (PRO) questionnaires used to inform efficacy decisions for regulatory approval.
According to Alan Shields, Vice President of Adelphi Values US and lead author of the manuscript, “the issue of ‘score interpretation’ poses a challenge to the industry and we wanted to provide an accessible and practical perspective for outcomes researchers. Though the paper has an oncology focus, we feel that the summary of the history of terms such as “Minimal Important Difference” or “MID”, the review of the FDA position on the topic along with a depiction of sponsor challenges and success, and the illustration of available data analytic techniques are relevant and applicable to all outcomes researchers independent of therapeutic area.”
Below is the full citation and here is the link to the abstract and article.
Shields AL, Coon C, Hao Y, Krohe M, Yaworsky, Mazar I, and Foley C (2015). Patient-reported outcomes for US oncology labeling: review and discussion of score interpretation and analysis methods. Expert Review of Pharmacoeconomics & Outcomes Research. 15(6), 951-959.
This week we are attending the 6th Annual World Orphan Drug Congress in Geneva, Switzerland. We are pleased to be presenting a poster entitled ‘Development of patient-centred outcomes in rare diseases’ which will focus on the need for the development of new treatments for rare diseases and indications with orphan designation along with the importance of ensuring that patients are at the heart of drug development programs. We will also outline some of the challenges associated with development of COAs for rare diseases and how patient involvement can overcome these challenges.
Bringing together a full range of stakeholders and influencers in the orphan drug and rare disease sector, the conference’s key aims are strategy, advocacy and partnering for the orphan drug industry and topics will include pricing and reimbursement, commercialisation, collaboration and research on new areas.
If you would like further information on this presentation or on any of our broader patient-centred research solutions, please contact us at firstname.lastname@example.org
Don’t be a stranger, you might have a simple enquiry or need our help. Whatever the reason, visit our contact page to find out who can help you.
Our practices page will help you better understand our expertise and how we can help.