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治験担当医師のFMV(適性市場価値)と報酬基準:契約の構造化および医師ミーティングのプランニング

Clinical Investigator FMV and Compensation Benchmarks: Structuring Contracts and Planning Investigator Meetings

発行 Cutting Edge Information 商品コード 89844
出版日 ページ情報 英文 102 Pages
納期: 即日から翌営業日
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治験担当医師のFMV(適性市場価値)と報酬基準:契約の構造化および医師ミーティングのプランニング Clinical Investigator FMV and Compensation Benchmarks: Structuring Contracts and Planning Investigator Meetings
出版日: 2014年08月31日 ページ情報: 英文 102 Pages
概要

当レポートでは、治験責任医師のFMV(適性市場価値)と報酬基準について分析し、FMVの計算・報酬決定の際のベンチマークを示しており、業界データ、報酬データなどを提供しています。

第1章 治験担当医師のFMV(適性市場価値)の計算

  • FMVの計算・医師報酬を決定する際に考慮する最も重要な要因に関する基準(ベンチマーク)
  • 8つの一般的な治療領域におけるプライマリーインベスティゲーター・サポートインベスティゲーターの報酬上限・平均給与
    • 心血管
    • 中枢神経系(CNS)・神経科
    • 糖尿病
    • 消化器科
    • 内分泌科
    • 感染症
    • 泌尿器科
  • 各種データ
    • ライフサイエンス企業のFMVの計算方法
    • FMV構築プロセス図
    • 主要な治験領域における治験ベンチマーク、ほか

第2章 治験担当医師の契約の構造化およびパススルーコスト

  • 治験担当医師報酬関連の給与構造・プロセス
  • 一般的な目標達成報奨金・治験担当医師への支払い回数・源泉徴収率
  • 直接経費の幅・平均
  • 各種データ
    • 直接経費(製品ライフサイクルフェーズ別)
      • 施設内治験審査委員会(IRB)
      • 採用
      • 設備
      • 薬局セットアップ
      • 試験手順・ラボ
      • 書類保管
      • オフィスサプライ、ほか

第3章 医師ミーティングのプランニングおよび予算作成

  • 医師ミーティング予算:治験フェーズ・医療費償還プロセス別
  • 予算設定・医療費償還プロセス簡素化の方法を示すエグゼクティブへのインタビュー
  • 各種データ
    • 医師ミーティングの平均参加者数(企業・フェーズ別)
    • 医師ミーティングの平均全体予算(企業・フェーズ別)
    • 参加者1人あたりの平均コスト(企業・フェーズ別)、ほか

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目次
Product Code: PH202

REPORT KEY FINDINGS

  • Leverage multiple sources to calculate true, accurate fair-market value.
  • Consider compensating investigators monthly on a per-patient visit basis.
  • Weigh clinical trial details heavily to determine principal investigator payments.
  • Prepare for direct costs to keep quarterly budgets intact.
  • Build precise investigator meeting budgets with itemized cost per attendee calculations.

WHY CLIENTS NEED THIS REPORT

  • Build comprehensive trial budgets
  • Build FMV calculation to fend off regulators
  • Structure investigator contracts
  • Plan for likely pass-through/direct costs from trial sites
  • Prepare for an upcoming investigator meeting

REPORT FEATURES

This report's three (3) chapters showcase benchmarks and best practices for developing a formal process to build fair-market value calculation, prepare comprehensive trial budgets, structure investigator contracts, track trial progress through payment schedules, and conduct successful investigator meetings.

Highlights include:

  • Metrics showing factors contributing to investigator compensation, as well as companies' detailed assessments of their individual FMV processes.
  • Criteria and strategic pointers for choosing the right principal investigators & support staff, vetting sites and ensuring accountability for trial tasks.
  • Data detailing average compensation for principal and supporting investigators for trials in nine (9) major therapeutic areas.
  • Charts showing prevalence of specific payment structures and milestones used to compensate investigators.
  • Average costs and ranges for key direct costs, including IRB fees, recruitment costs, and pharmacy set-up fees.
  • Expert recommendations on driving investigator meeting attendance and increasing attendees' levels of engagement.
  • Detailed benchmarks showing investigator meeting attendance and costs - critical components to building precise budgets.

Data are split, where relevant:

  • Geography:
    • US
    • Europe
    • Asia
    • Rest-of-World (ROW)
  • Therapeutic areas:
    • Arthritis
    • Cardiovascular
    • CNS and neurology
    • Diabetes
    • Endocrinology and Metabolic Diseases
    • Gastroenterology
    • Infectious Disease
    • Oncology
    • Urology

PRIMARY AUDIENCE

  • Clinical teams
  • Medical affairs teams
  • Legal, Regulatory and Compliance teams
  • Association of Clinical Research Professionals
  • Purchasers/downloaders of:
    • PH126: Managing Investigator Compensation
    • PH152: Clinical Operations
    • PH192: Clinical Development and Trial Operations
    • PH180: Oncology Clinical Trials
    • PH173: Phase I Clinical Trials

REPORT DEFINITIONS

  • Principal Investigator: These physicians assume ultimate responsibility for a clinical trial at the designated investigator site. In addition to performing and overseeing the medical interventions detailed within the trial protocol, principal investigators' responsibilities include, but are not limited to, patient inclusion/exclusion assessments, adverse event reviews and serious adverse event reporting.
  • Supporting Investigator: These physicians operate under the supervision of the principal investigator at each trial site. Supporting investigators may perform any, or all, of the medical interventions detailed within the trial protocol.
  • Compensation Limit: A self-imposed, annual limit placed on the amount of money that a sponsor can compensate a physician or investigator

KEY QUESTIONS THIS REPORT ANSWERS

Promote Transparency by Building an Accurate Investigator FMV Calculation

  • How do life science companies calculate FMV despite lack of formal regulatory guidance?
  • While every trial's calculation process is unique, what are the three common elements that will lead to true, accurate investigator FMV and compensation?
  • Which factors do most surveyed companies consider when determining investigator compensation, and why?
  • What criteria do companies use to select the right investigators and sites? How should they balance investigators' professional credentials and clinical experience in the decision-making process?
  • How can companies clearly outline trial responsibilities and increase accountability within trial teams?
  • How can companies prepare for trial delays when using academic institutions?
  • During the feasibility stage, what questions should sponsors ask sites to ensure that they receive an accurate picture of site capabilities?

Establish an Investigator Payment Schedule and Keep Trials on Track

  • How much are principal investigators and supporting investigators paid per visit, on average? How do these rates change depending on therapeutic area?
  • What are the benefits of a payment structure and milestone payments?
  • Which payment schedule is optimal for sponsors and investigators?
  • How much should companies expect to budget for direct costs throughout product development? (e.g., IRB fees, patient recruitment, testing and lab fees, pharmacy set-up)?

Organize a Successful Investigator Meeting Within Budget

  • What are companies' primary goals for an investigator meeting?
  • What key factors should companies consider to organize a successful investigator meeting?
  • How can companies balance online technologies and traditional approaches to boost investigator meeting attendance and involvement?
  • What strategies can companies use to accurately budget for investigator meetings and avoid surprises?
  • How should companies effectively allocate their investigator meeting budgets to cover specific costs (e.g., food, lodging and transportation)?

Table of Contents

CHAPTER BENEFITS AND METRICS BREAKDOWN

Chapter 1: Calculating Clinical Investigator Fair-Market Value (Author: Ryan)

The exact formula a company uses to calculate investigator FMV is not as important as establishing a process in the first place. This chapter offers benchmarks on the most critical factors to consider while calculating FMV calculation and determining investigator compensation. This chapter also shows benchmarks for compensation limits and average payments for principal investigators and supporting investigators in eight common therapeutic areas: cardiovascular, CNS and neurology, diabetes, gastroenterology, endocrinology, infectious disease, oncology and urology.

Chapter Benefits

  • Establish a process to calculate FMV that fits company needs.
  • Consider subscription services to fill in budget estimates.
  • Document historic physician payments to build a cost database.
  • Consult Medicare procedure reimbursement rates, then add overhead costs.
  • Customize physician payments based on individual office visits.
  • Weigh investigator experience and certifications when assessing capabilities.
  • Plan adequately for delays when using academic institutions.
  • Establish clear accountability by outlining PI and staff responsibilities.

Chapter Data

17 charts detailing how life science companies calculate investigator fair-market value (FMV). The chapter contains process diagrams for establishing an FMV process, as well as benchmarks for clinical trials across a number of key therapeutic areas.

  • Diagram showing elements of a standard investigator FMV calculation
  • Percentage of companies considering specific factors to determine investigator compensation (US, Europe, Asia)
  • Infographic showing how to customize trial budgets using cost benchmarks
  • Diagram showing FMV calculation process at a large medical device company
  • Average investigator compensation for trials in these nine therapeutic areas:
    • Arthritis
    • Cardiovascular
    • CNS and neurology
    • Diabetes
    • Endocrinology and metabolic disease
    • Gastroenterology
    • Infectious disease
    • Oncology
    • Urology
  • Annual compensation limits for principal investigators

Chapter 2: Structuring Clinical Investigator Contracts and Pass-Through Costs (Author: Ryan)

This chapter focuses on payment structures and processes surrounding clinical investigator compensation. It explores popular strategies and tactics used to pay investigators as well as the different ways companies contract with investigators. The chapter also examines common milestone payments, the number of payments made to clinical investigators and withholding rates. Finally, Chapter 2 provides ranges and averages of direct costs that investigators often pass through to sponsors.

Chapter Benefits

  • Pay per patient visit to capture the cost of procedures and physicians' time.
  • Establish compensation limits to ensure physicians are paid fair-market value.
  • Use milestone payments to track trial progress and manage expectations.
  • Build accurate budgets by planning for direct costs.

Chapter Data

17 charts detailing the various facets companies consider when building a plan for compensating clinical investigators.

  • Payment structures used to compensate investigators (US, rest-of-world)
  • Milestone payments in investigator contracts (US, rest of world)
  • Number of payments to investigator in standard payment schedule
  • Percentage of compensation withheld until trial completion
  • Direct costs (by product lifecycle phase)
    • Institutional Review Boards (IRB) fees
      • Initial protocol review
      • Continuing review
      • Amendments
      • Administrative termination
    • Recruitment costs
    • Equipment costs
    • Pharmacy set-up fees
    • Testing procedures and laboratory fees
    • Document storage fees
    • Office supplies

Chapter 3: Planning and Building Budgets for Investigator Meetings (Author: Natalie)

This chapter delves into the critical aspects necessary for focused and engaging investigator meetings. To guide companies through these recommendations, this chapter presents investigator meeting budgets by both trial phase and reimbursed items. Interviewed executives offer ways to build budgets and to simplify reimbursement processes. These meetings are an opportunity for companies to train and engage physicians before a clinical trial begins. To avoid regulatory censure, companies should ensure that accommodations for these meetings are modest, and the meetings themselves driven by scientific discussions. To prepare, event planners should build itemized budgets by calculating the cost per attendee. As a result, the number of participants will largely influence meeting budgets.

Chapter Benefits

  • Use cost per attendee metrics to build precise budgets.
  • Review key factors - geography, timing and culture - to drive attendance.
  • Project phase impact of attendance on travel, lodging and food budgets.
  • Prioritize meeting convenience for attendees.
  • Weigh pros and cons of online meetings.

Chapter Data

21 charts detailing investigator meeting costs and budgets.

  • Average number of investigator meeting attendees (by company and by phase)
  • Percentage of companies reimbursing investigators for meeting costs, by item
  • Average total budget for investigator meetings (by phase and by company)
  • Average investigator meeting cost per attendee (by phase and by company)
  • Investigator meeting budget allocation (by percentage), by cost item
  • Average cost per item, by phase
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