Abstract
Current Methodoloy
Clinical studies offer a unique opportunity to assess the frequency and severity of treatment-emergent adverse events (TEAEs) in a controlled and objective setting. Data from clinical studies is one of the most important pieces of information available to physicians and patients to determine the choice of treatment.
75% of outpatients desired to be told of every single possible TEAE associated with their medication. Clinically meaningful assessment of the tolerability is important, as it may have a negative impact compliance with treatment, and patient quality of life. However, detailed safety discussion may be frequently under-represented and the quality and quantity of safety reporting across a range of studies has been found to be inadequatey.
A substantial amount of detailed information on the incidence and presence of TEAEs is recorded clinical studies. TEAEs are classified into, common, serious, unexpected, of special interest and drug-related effects, As well as severity grades such as mild, moderate, severe, life threatening or mortality.
The focus is on the overall incidence of TEAEs (an absolute number) and safety data are reported as an absolute list or summary. It only reports the number of patients that report a specific adverse event. This does not optimally utilize the detailed information captured in a clinical study database.
Current methods provide a limited view of the patient experience The collective burden of therapy on the individual or treatment group is not evaluated. Therefore, these methods do not allow: The identification, or Differentiation of patients who experience more than one treatment-emergent adverse event (TEAE), Contemporaneously Consecutively. Combination of incidence and severity on each day of a clinical study.
However, analysing TEAEs from the patient perspective and taking into account all tolerability issues experienced by that patient on each day of the study, may more accurately represent the safety burden experienced by patients.
BOTh Approach
What are the effects on individual patients?
At present, safety data from clinical studies are reported as an absolute list or summary, which does not optimally utilize the detailed information captured in a clinical study database.
Current methods provide a limited view of the patient experience, where the safety burden of treatment is only assessed as an overall summary over the study period. The collective burden of therapy on the individual or treatment group is not evaluated.
Therefore, these methods do not allow the identification or differentiation of patients who experience more than one treatment-emergent adverse event (TEAE), either contemporaneously or consecutively.
The presence and severity of adverse events on each day of a clinical study is not analysed.
The Burden of Therapy© is clearly focussed on the patient.
Clinical studies offer a unique opportunity to assess the frequency and severity of treatment-emergent adverse events (TEAEs) in a controlled and objective setting. Data from clinical studies is one of the most important pieces of information available to physicians and patients to determine the choice of treatment.
75% of outpatients desired to be told of every single possible TEAE associated with their medication. Clinically meaningful assessment of the tolerability is important, as it may have a negative impact compliance with treatment, and patient quality of life. However, detailed safety discussion may be frequently under-represented and the quality and quantity of safety reporting across a range of studies has been found to be inadequatey.
A substantial amount of detailed information on the incidence and presence of TEAEs is recorded clinical studies. TEAEs are classified into, common, serious, unexpected, of special interest and drug-related effects, As well as severity grades such as mild, moderate, severe, life threatening or mortality.
Advantages
Benefits of Burden of Therapy©
Patient
BOTh© enables the patient to decide on which drug to take based on better understanding of their effects.
The BOTh© graphics shows the price the patients has to pay in their health for obtaining a therapeutic benefit.
Study Sponsor
BOTh© provides more relevant and accurate data on the therapeutic agents investigated in clinical studies. This allows for better strategic decisions and providing the health authorities and medical community with more detailed safety information.
Payers
BOTh© provides information that allows for more comprehensive analysis of health resource utilization related to therapeutic agents. This helps the payers in making better informed reimbursement decisions.
Physicians
BOTh© provides a better insight into the effects of various therapeutic agents as well as the naturel history of disease states. This helps physicians to make more informed clinical and therapeutic decisions.
