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 and at the same time addresses the stakeholders who can make or break 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:

Phase lll 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.

The Development and Validation of Patient-Reported Outcome (PRO) and Observer-Reported Outcome (ObsRO) Measures


Patient-Reported Outcome Measures are increasingly a vital part of regulatory submissions for new pharmaceuticals as well as providing supportive data for product positioning and value added propositions. 

The BROD GROUP has over 25 years of experience developing PROs:

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

  • We conduct concept elicitation and validation studies of already existing measures, conducting cognitive debriefings and electronic platform usability testing.

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


Publication examples:

Brod M, Hammer M, Kragh N, Lessard S, Bushnell DM.
Development and validation of the Treatment Related Impact Measure of Weight (TRIM-Weight).
Health Qual Life Outcomes. 2010;8:19.

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.
Quality of Life Research, 15:117-129, 2006.

Brod M, Skovlund SE, Wittrup-Jensen KU.
Measuring the impact of diabetes through patient report of treatment satisfaction, productivity and symptom experience.
Qual Life Res. Apr 2006;15(3):481-491.


The Design, Protocol Development, 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 studies addressing the specific study objectives by working with internal and external stakeholders to incorporate the most relevant endpoints and outcome measures.

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

  • We can also assist in the process of choosing the right vendor for the study.


Health Outcomes Studies:

Throughout the Product Development Life Cycle: Health Outcomes studies 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 can design studies with Health Outcomes as the primary outcome or piggyback Health Outcomes studies for clinical trials in Phase ll through Phase IV.


Burden of Illness Studies:

Burden of Illness studies are instrumental in setting the stage for new treatments and poorly understood diseases.

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. 


Publication examples:

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.
Quality of Life Research. 2010;19(9):1285-1293.

Brod M, Perwein A, Adler L, Spencer T, Johnston J.
Conceptualization and Assessment of Quality of Life for Adults with Attention Deficit Disorder, Primary Psychiatry.

Colman SS, Brod M, Potter LP, Buesching DP, Rowland CR.
Cross-sectional 7-year follow-up of anxiety in primary care patients. Depress Anxiety.

Late Phase Studies: Registries, Comparator and Effectiveness Studies:

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 for multiple audiences including payer, 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.

Colman SS, Brod MI, Krishnamurthy A, Rowland CR, Jirgens KJ, Gomez-Mancilla B.
Treatment satisfaction, functional status and health related quality of life of patients with migraine randomly asssigned to Almotriptan or Sumatriptan.
Clinical Therapeutics. 2001;23 (1):127-145.

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 the new product, and provide data to support reimbursement.


Publication examples:

Brod M, Christensen T, Thomsen TL, Bushnell DM.
The impact of non-severe hypoglycemic events on work productivity and diabetes management. Value Health.
Jul-Aug 2011;14(5):665-671.


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 mail and web-based surveys, conducted regionally or internationally. 


Publication examples:

Brod, M., Wolden, M., Christensen, T., Bushnell D.M.
A nine country study of the burden of non-severe nocturnal hypoglycemic events on diabetes management and daily function.
Diabetes Obes Metab. 2013;15(6):546-57.

Brod M, Christensen T, Bushnell DM.
The impact of non-severe hypoglycemic events on daytime function and diabetes management among adults with type 1 and type 2 diabetes.
J Med Econ. 2012;15(5):869-877.

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;28(12):1933-1946.


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:

Brod M, Schmitt E, Goodwin M, Hodgkins P, Niebler G.
ADHD burden of illness in older adults: a life course perspective.
Qual Life Res. Jun 2012;21(5):795-799.

Brod M, Verhaak C, Wiebinga C, Gerris J, Hoomans E.
Improving clinical understanding of the effect of ovarian stimulation on women's lives.
Reproductive biomedicine online. 2009;18(3):391-400.

Novak A, Brod M, Elbers J.
Andropause and Quality of Life: Findings from Patient Focus Groups and Clinical Experts.
Maturatas. 2002;43(4):231-237.

Brod M, Pohlman B, Wolden M, Christensen T.
Non-severe nocturnal hypoglycemic events: experience and impacts on patient functioning and well-being.
Quality of Life Research. 2012:1-8.


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. Sep 27 2009.

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

Manuscripts and Data Dissemination

When you work with The BROD GROUP there is never a need to also hire an outside medical writer. The Brod Group consultants have written over 100 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 also prepare and submit abstracts, develop poster and podium presentation content and production as well as represent you at scientific venues to present study findings.