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1 Introduction
Pages 7-9

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From page 7... ... Assessing and managing the risks of modern medical products is a complex and nuanced scientific, political, and sociological challenge that includes not only the assessment of risks and benefits, but also how we communicate them and make healthcare decisions based on them. To explore these issues, the Forum on Drug Discovery, Development, and Translation conducted a public workshop entitled Understanding the Benefits and Risks of Pharmaceuticals, with the broad goals of gaining a better understanding of the current system for evaluating benefit and risk and of identifying opportunities for improvement. Read the entire page →
From page 8... ... It discusses how individuals acquire information and make judgments about benefits and risks, how decisions depend on subtle contextual factors, and ways to help patients make informed decisions. Section 5 discusses patient experience with drugs over time and the limitations of postmarketing surveillance. Read the entire page →
From page 9... ... Patient Experience Regulatory Healthcare Communication Over Time Assessment Decisions Trial Design Requirements Known Known Known Package Safety / Efficacy Safety / Efficacy Decision-Making Unit Safety / Efficacy Insert Data Data Data Unknown at Known at approval approval Drug A Efficacy Efficacy Safety Safety Physician Data Data Data Data Legal/Payor Other Drug B Patient Drug C Constraints preventing optimal Approval Decision Unknown Physician / Patient decision-making Unknown Unknown Drug D Safety / Efficacy Safety / Efficacy Safety / Efficacy Benefit–Risk Data Data Data Benefit _ Lack of physician understanding and information on risk/benefit _ Proliferation of direct-to-consumer advertising by industry Risk _ Legal concerns _ Payor cost / choice constraints _ Patient decision fitness Non-optimal feedback loop to physician/patient Non-optimal communication Regulatory process is complex, to physician/patient inconsistent and often risk-averse _ Rules for gaining drug approval not always clear _ Package insert too confusing for patients _ Package insert too confusing for patients _ Lack of standardized quantitative approaches _ Risks and benefits not put in meaningful context _ Risks and benefits not put in meaningful context to benefit–risk analysis _ Company-sponsored communications often biased _ Company-sponsored communications often biased _ Potential risk-aversion bias may result in preventing _ Failure to systematically collect postmarketing safety data _ Numerous and confusing unofficial sources of information potentially helpful drugs from reaching patients and overrules physician/patient decision-making Regulatory, Physician, Patient Feedback Loop FIGURE 1-1 Constraints and limitations of the four-part life cycle of the pharmaceutical drug benefit–risk assessment process. SOURCE: Adapted from Jeffrey Leiden's presentation. Read the entire page →

From page 7...

... Assessing and managing the risks of modern medical products is a complex and nuanced scientific, political, and sociological challenge that includes not only the assessment of risks and benefits, but also how we communicate them and make healthcare decisions based on them. To explore these issues, the Forum on Drug Discovery, Development, and Translation conducted a public workshop entitled Understanding the Benefits and Risks of Pharmaceuticals, with the broad goals of gaining a better understanding of the current system for evaluating benefit and risk and of identifying opportunities for improvement.

Read the entire page →

From page 8...

... It discusses how individuals acquire information and make judgments about benefits and risks, how decisions depend on subtle contextual factors, and ways to help patients make informed decisions. Section 5 discusses patient experience with drugs over time and the limitations of postmarketing surveillance.

Read the entire page →

From page 9...

... Patient Experience Regulatory Healthcare Communication Over Time Assessment Decisions Trial Design Requirements Known Known Known Package Safety / Efficacy Safety / Efficacy Decision-Making Unit Safety / Efficacy Insert Data Data Data Unknown at Known at approval approval Drug A Efficacy Efficacy Safety Safety Physician Data Data Data Data Legal/Payor Other Drug B Patient Drug C Constraints preventing optimal Approval Decision Unknown Physician / Patient decision-making Unknown Unknown Drug D Safety / Efficacy Safety / Efficacy Safety / Efficacy Benefit–Risk Data Data Data Benefit _ Lack of physician understanding and information on risk/benefit _ Proliferation of direct-to-consumer advertising by industry Risk _ Legal concerns _ Payor cost / choice constraints _ Patient decision fitness Non-optimal feedback loop to physician/patient Non-optimal communication Regulatory process is complex, to physician/patient inconsistent and often risk-averse _ Rules for gaining drug approval not always clear _ Package insert too confusing for patients _ Package insert too confusing for patients _ Lack of standardized quantitative approaches _ Risks and benefits not put in meaningful context _ Risks and benefits not put in meaningful context to benefit–risk analysis _ Company-sponsored communications often biased _ Company-sponsored communications often biased _ Potential risk-aversion bias may result in preventing _ Failure to systematically collect postmarketing safety data _ Numerous and confusing unofficial sources of information potentially helpful drugs from reaching patients and overrules physician/patient decision-making Regulatory, Physician, Patient Feedback Loop FIGURE 1-1 Constraints and limitations of the four-part life cycle of the pharmaceutical drug benefit–risk assessment process. SOURCE: Adapted from Jeffrey Leiden's presentation.

Read the entire page →

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1 Introduction Pages 7-9

1 Introduction
Pages 7-9