2.2 Treatment Options

Chapter 2.2
Additional Resources

Before any new solutions can be considered, an innovator must thoroughly understand the treatment landscape for existing and emerging therapies as described in Chapter 2.2.  The steps below have been excerpted from the chapter and are presented with active web links to assist innovators in getting started with treatment research.

Develop an Overview of Treatment Options
  1. What to Cover – Create comprehensive descriptions of all relevant treatments in the field.
  2. Where to Look
    • Medical References – Refer to Harrison’s Principles of Internal Medicine, Guyton’s Textbook of Medical Physiology, or Schwartz’s Principles of Surgery for credible information regarding established treatments.
    • PubMed – A database of the U.S. National Library of Medicine that includes more than 16 million citations from MEDLINE and other life science journals back to the 1950s. General reviews will be particularly helpful in understanding pathophysiology (locate “Reviews” by selecting this type of article under the “Limits” tab from the main page of the site before beginning a search).
    • eMedicine – Clinical knowledgebase with more than 10,000 physician authors and editors.
    • Up-To-Date – A database of evidence-based clinical information.

Evaluate Clinical Treatment Profiles
  1. What to Cover – For each treatment option, assess the clinical rationale for why and when each one is used, including the mechanism of action, indications, efficacy, and safety.
  2. Where to Look

Analyze Economic Treatment Profiles
  1. What to Cover – Consider the financial impact associated with each treatment, including the costs of providing the treatment and the potential cost savings for using one particular treatment versus another available treatment.
  2. Where to Look – 
    • PubMed (Reviews)
    • Medscape – Database of clinical information targeted to physicians.
    • MEPS Data – The Agency for Healthcare Research and Quality provides data on the health expenditures of 18,000 U.S. households via the Medical Expenditures Panel Survey (MEPS). This data is publicly available for primary analysis.
    • Reimbursement Analysis (read ahead to 4.3 Reimbursement).

Utilization Treatment Profiles
  1. What to Cover – Provide an overview of how each treatment is currently used in clinical practice. Be sure to capture when/why each treatment is advocated and the frequency of procedures performed.
  2. Where to Look

Investigate Emerging Treatment Profiles
  1. What to Cover – Understand emerging treatments that target the given disease state to identify what new areas are being focused on and how quickly new treatments will come to market.
  2. Where to Look
    • PubMed – In addition to searching for relevant reviews, watch for information about early trials (e.g., animal trials) and papers presented at conferences to stay current with the most recent developments in a given treatment area.
    • ClinicalTrials.gov – A government database that tracks clinical trials with medical technology.
    • Controlled-Trials.com – A site for Europe that is comparable to ClinicalTrials.gov in the U.S.
    • U.S. Patent Office – A government database that contains all issued and provisional patents and patent applications (see 4.1 Intellectual Property for more information, as well as other sources).
    • VentureXpert – Provides data on mergers and acquisitions, IPOs, and VC funding based on data from Securities Data Corporation. A useful source to get information on emerging companies,
    • Other – Additional venture capital firm websites.

Summarize the Treatment Landscape
  1. What to Cover – Synthesize all of the findings from the first five topics into a comprehensive framework that summarizes the treatment landscape. At a minimum, this should include a summary of treatment options, risks and benefits, and a gap analysis with respect to need criteria and patient indications. Validate the need criteria with respect to the outcomes of existing therapies.
  2. Where to Look – Synthesize the information from steps 1 to 5. Bring in information from 2.1 Disease State Fundamentals for the patient segment gap analysis and from 1.3 Need Statement Development for the need criteria.

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