Strategy Plans for Health Outcomes and Late-Phase Development

Health Outcomes Strategy Plans:

Developing a Health Outcomes strategy early in the drug development process provides critical information needed to address concerns of regulatory agencies, develops value-added statements, and addresses the stakeholder’s requirements which can make or break approval as well as the commercial effort to position a product. 

Including Health Outcomes can be a minimal investment with the potential for maximal return and allows for proactive planning for maximizing product positioning at launch. 

The BROD GROUP develops Health Outcomes Strategy plans, which include competitive product analysis, optimal outcomes, endpoints, and research designs targeted for your product, and will provide a blueprint for an optimal Health Outcomes research and dissemination plan throughout the drug development process.

Late-Phase Strategy Plans:

Early phase III is the optimal time to begin addressing Late-Phase research objectives that will bridge clinical and marketing needs in today’s market. The BROD GROUP will help you to position your pharmaceutical during peri-approval and post-launch to meet commercialization objectives while maintaining scientific integrity. Proactively planning a Late-Phase Strategy, which addresses the specific audiences, objectives, and regulatory requirements for your product, facilitates optimal product positioning.

Development and Validation of Clinical Outcome Assessment (COA) Measures

Clinical Outcome Assessment (COA) Measures are increasingly a vital part of regulatory submissions for new pharmaceuticals as well as providing supportive, real-world data (RWD) for product positioning and value-added propositions. 

The BROD GROUP has over 35 years of experience developing COAs:

  • We develop and psychometrically validate Patient-Reported Outcome (PRO) measures including: Symptom and Functioning, Health-Related Quality of Life (HRQOL), Impact of Treatment, Patient Satisfaction, Work/Life Productivity, and Well-being as well as Observer-Reported Outcome (ObsRO) and Caregiver Burden measures.

  • We conduct qualitative research to support COA measure development, which includes expertise in concept elicitation and cognitive debriefing, and administer trial experience interviews.

  • We design and oversee execution of validation studies of already existing measures, conduct cognitive debriefings, and electronic platform usability testing.

  • We develop and review regulatory COA dossiers and facilitate regulatory interactions regarding health outcomes labeling claims.

 

Publication examples:

Brod M, Højby Rasmussen M, Vad K, Alolga S, Bushnell DM, Bedoin J, Maniatis A.
Psychometric Validation of the Growth Hormone Deficiency-Child Impact Measure (GHD-CIM).
Pharmacoecon Open. 2021 Jan 12. doi: 10.1007/s41669-020-00252-5.

Brod M, Waldman LT, Smith A, Karpf D.
Living with Hypoparathyroidism: Development of the Hypoparathyroidism Patient Experience Scale-Impact (HPES-Impact).
Qual Life Res. 2021 Jan;30(1):277-291. doi: 10.1007/s11136-020-02607-1. 

Brod M, Højbjerre L, Pfeiffer KM, Sayner R, Meincke HH, Patrick DL.
Development of the Weight-Related Sign and Symptom Measure.
J Patient Rep Outcomes. 2017;2(1):17. doi: 10.1186/s41687-018-0042-9.

Brod M, Johnston J, Able S, Swindle R.
Validation of the Adult Attention Deficit Hyperactivity Disorder Quality-of-Life Scale (AAQOL):  A Disease-Specific Quality-of-Life Measure.
Qual Life Res. 2006 Feb;15(1):117-129. doi: 10.1007/s11136-005-8325-z.

Design, Protocol Development, Conduct, and Scientific Oversight of Real-World Studies

The BROD GROUP provides cutting edge consulting for the design, implementation, analysis, and dissemination of real-world studies. 

  • We design and conduct studies addressing the specific study objectives by working with patients, clinicians, advocacy groups, and internal and external stakeholders to collect real-world evidence (RWE) critical to our understanding of disease and treatment and central to the incorporation of the most relevant real-world endpoints and outcome measures into clinical trials.

  • These studies encompass health outcomes; burden of illness; patient-centered qualitative research; late-phase registries, comparator and effectiveness; market access; and patient and clinician surveys.

  • We provide scientific oversight for the life of the study as well as provide analytic and dissemination services as needed.

Health Outcomes Studies:

Throughout the Product Development Life Cycle: Health Outcomes studies, which examine symptoms, impacts, economic, and social aspects of disease and treatment, can be critical for ensuring regulatory approval, positioning products, and supporting value-added statements at launch, and maximizing commercialization objectives over the entire life cycle of a product.

The BROD GROUP designs studies with Health Outcomes as the primary outcome or piggyback Health Outcomes studies for clinical trials in Phase II through Phase IV.

 

Publication examples:

Brod M, Beck JF, Højbjerre L, Bushnell DM, Adalsteinsson JE, Wilkinson L, Rasmussen MH.
Assessing the Impact of Growth Hormone Deficiency (GHD) in Adults: Interpreting Change of the Treatment-Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD).
Pharmacoecon Open. 2019 Mar;3(1):71-80. doi: 10.1007/s41669-018-0082-3.

Brod M, Pohlman B, Lasser R, Hodgkins P.
Comparison of the Burden of Illness for Adults with ADHD across Seven Countries: A Qualitative Study.
Health Qual Life Outcomes. 2012 May 14;10:47. doi: 10.1186/1477-7525-10-47.

Burden of Illness Studies:

Burden of Illness studies are instrumental in setting the stage for new treatments and poorly understood diseases as well as informing a reimbursement strategy and identifying key endpoints for future studies.

The BROD GROUP has designed and conducted multiple burden of illness studies, based on both literature reviews and qualitative studies, to educate and inform both health care professionals and patients and inform future study design. 

 

Publication examples:

Waldman LT, Parthasarathy S, Villa KF, Bron M, Bujanover S, Brod M.
Understanding the Burden of Illness of Excessive Daytime Sleepiness Associated with Obstructive Sleep Apnea: A Qualitative Study.
Health Qual Life Outcomes. 2020 May 7;18(1):128. doi: 10.1186/s12955-020-01382-4.

Brod M, Alolga SL, Beck JF, Wilkinson L, Højbjerre L, Rasmussen MH.
Understanding Burden of Illness for Child Growth Hormone Deficiency.
Qual Life Res. 2017 Jul;26(7):1673-1686. doi: 10.1007/s11136-017-1529-1.

Brod M, Valensi P, Shaban JA, Bushnell DM, Christensen TL.
Patient Treatment Satisfaction After Switching to NovoMix® 30 (BIAsp 30) in the IMPROVE™ Study: An Analysis of the Influence of Prior and Current Treatment Factors.
Qual Life Res. 2010;19(9):1285-1293. doi: 10.1007/s11136-010-9699-0.

Patient-Centered Qualitative Research:

In-depth appreciation of the patient, payer, and clinician perspectives is critical for understanding burden of disease, identifying the most targeted endpoint and outcome measures, and designing studies which are optimal for assessing outcomes specific to a project’s objectives.

The BROD GROUP conducts individual telephone interviews and focus groups as well as convenes expert panels and advisory boards to meet this challenge.

These studies can be either a stand-alone qualitative study, such as for a Burden of Illness project, or as part of a larger study design.

We use the latest software to qualitatively analyze the information, synthesizing the data so that it is suitable for publication or for internal stakeholder purposes.

 

Publication examples:

Pfeiffer KM, Brod M, Smith A, Gianettoni J, Viuff D, Ota S, Charlton RW.
Assessing Physical Symptoms, Daily Functioning, and Well-Being in Children With Achondroplasia.
Am J Med Genet A. 2021 Jan;185(1):33-45. doi: 10.1002/ajmg.a.61903.

Brod M, Schmitt E, Goodwin M, Hodgkins P, Niebler G.
ADHD Burden of Illness in Older Adults: A Life Course Perspective.
Qual Life Res. 2012 Jun;21(5):795-799. doi: 10.1007/s11136-011-9981-9.

Brod M, Pohlman B, Wolden M, Christensen T.
Non-Severe Nocturnal Hypoglycemic Events: Experience and Impacts on Patient Functioning and Well-Being.
Qual Life Res. 2013 Jun;22(5):997-1004. doi: 10.1007/s11136-012-0234-3.

Brod M, Verhaak C, Wiebinga C, Gerris J, Hoomans E.
Improving Clinical Understanding of the Effect of Ovarian Stimulation on Women's Lives.
Reprod Biomed Online. 2009;18(3):391-400. doi: 10.1016/s1472-6483(10)60098-3.

Late-Phase Registries, Comparator and Effectiveness Trials:

Product and Disease Registries as well as Comparator and Effectiveness trials are crucial to understand the effectiveness of a pharmaceutical in the "real world" of clinical practice.

The BROD GROUP is experienced in designing these types of studies which further our understanding of a product while addressing both clinical and commercial objectives.

Our studies incorporate real-world data (RWD) for multiple audiences including payers, patients, clinicians, and regulatory agencies. 

 

Publication examples:

Rothermich EA, Brod MI, Schonfeld WH, Rowland CR, Gomez-Mancilla B.
Prospective Study Designs in Outcomes Research: The Case of Migraine. Pharmacoeconomics. 2002;20(11):715-725. doi: 10.2165/00019053-200220110-00001.

Colman SS, Brod MI, Krishnamurthy A, Rowland CR, Jirgens KJ, Gomez-Mancilla B.
Treatment Satisfaction, Functional Status, and Health-Related Quality of Life of Migraine Patients Treated With Almotriptan or Sumatriptan.
Clin Ther. 2001 Jan;23(1):127-145. doi: 10.1016/s0149-2918(01)80036-9.

Market Access Studies:  

It is vital to support product development with Market Access studies to enable an effective commercialization strategy.

The BROD GROUP designs studies that facilitate product positioning, aid patient acceptance of a new product, and provide data to support reimbursement.

 

Publication examples:

Brod M, Nikolajsen A, Weatherall J, Pfeiffer KM.
The Economic Burden of Post-Prandial Hyperglycemia (PPH) Among People with Type 1 and Type 2 Diabetes in Three Countries.
Diabetes Ther. 2016 Mar;7(1):75-90. doi: 10.1007/s13300-016-0154-2.

Brod M, Christensen T, Thomsen TL, Bushnell DM.
The Impact of Non-Severe Hypoglycemic Events on Work Productivity and Diabetes Management.
Value Health. 2011 Jul-Aug;14(5):665-671. doi: 10.1016/j.jval.2011.02.001.

Patient and Clinician Surveys:

Patient or clinician surveys are powerful tools for Market Access for:

  • Establishing burden of illness

  • Understanding the real-world impact of disease and treatment on patients and the healthcare system

  • Providing data on patient preferences, treatment and disease management behaviors, international comparisons, and the patient experience of the course of disease

The BROD GROUP has local as well as global experience in the design, implementation, data analysis, and dissemination of findings for both paper and pen/pencil surveys via mail and electronic surveys (e.g., web-based with electronic data capture (EDC)), conducted regionally or internationally. 

 

Publication examples:

Brod M, Basse A, Markert M, Pfeiffer KM.
Post-Basal Insulin Intensification and Healthcare Resource Use in Type 2 Diabetes: A Web-Based Physician Survey in the United States and United Kingdom.
Diabetes Ther. 2019 Aug;10(4):1323-1336. doi: 10.1007/s13300-019-0636-0.

Brod M, Wolden M, Christensen T, Bushnell DM.
A Nine Country Study of the Burden of Non-Severe Nocturnal Hypoglycemic Events on Diabetes Management and Daily Function.
Diabetes Obes Metab. 2013 Jun;15(6):546-557. doi: 10.1111/dom.12070.

Brod M, Rana A, Barnett AH.
Adherence Patterns in Patients With Type 2 Diabetes on Basal Insulin Analogues: Missed, Mistimed and Reduced Doses.
Curr Med Res Opin. 2012 Dec;28(12):1933-1946. doi: 10.1185/03007995.2012.743458.

Comprehensive Literature Reviews

Comprehensive Literature Reviews are an important tool for developing a thorough understanding of a disease and are necessary for product development strategies. Literature reviews reveal gaps in knowledge and may point to new directions for product development. They also assist in cultivating competitive intelligence, understanding the burden of disease as well as detailing the current state of a therapeutic area.

The BROD GROUP Medical Research Librarian systematically conducts comprehensive literature searches, synthesizes available information, and provides reports for your research needs.

 

Publication examples:

Brod M, Tesler LE, Christensen TL.
Qualitative Research and Content Validity: Developing Best Practices Based on Science and Experience.
Qual Life Res. 2009 Nov;18(9):1263-78. doi: 10.1007/s11136-009-9540-9.

Brod M, Kongso JH, Lessard S, Christensen TL.
Psychological insulin resistance: patient beliefs and implications for diabetes management.
Qual Life Res. 2009 Feb;18(1):23-32. doi: 10.1007/s11136-008-9419-1.

Writing and Presentation Services for Data Dissemination

When you partner with The BROD GROUP, there is never a need to also hire an outside medical writer. Our consultants have written over 150 peer-reviewed manuscripts and Scientific Congress publications. We have a 98% acceptance rate for manuscripts we prepare based on the studies we have developed, conducted, and/or provided scientific oversight for.

Additionally, The BROD GROUP can prepare and submit abstracts, develop poster and podium presentation content and production as well as represent you at scientific venues to present study findings.