diff --git a/Concept-paper-2022-02-09.md b/Concept-paper-2022-02-09.md index b8f78ed..9d74922 100644 --- a/Concept-paper-2022-02-09.md +++ b/Concept-paper-2022-02-09.md @@ -9,11 +9,15 @@ I think I can get two, maybe three, papers out of this: - How can one statistically describe the way drugs pass through the FDA development pipeline? - What is the effect of `policy` on phase completion and phase transition? + - What is the impact of surragate endpoints on phase transition completion? on phase transition? # Models ## Phase completion: Joint Probability Estimation (single paper?) +This is just following in the footsteps of [[AbrantesMetz-Adams-and-Metz]], but with a possibly different probability estimation approach. +Also, I think I can improve the richness of the terminal states. + Can probably use the data we have. This would include Plan Normalized duration, where we take the planned completion date and estimate the term: (Actual completion date - start date)/(Planned completion date - start date) @@ -42,8 +46,31 @@ It would also be straightforward to develop simulations from this approach, as t # Estimation Strategy Probably use a non-parametric bayesian approach to estimating the probability densities? +[AbrantesMetz-Adams-and-Metz] use a hazards model. + +## Phase Completion Probabilities: + +The goal is to estimate + +- P(completing phase 1 & duration phase 1 | Data) +- P(completing phase 2 & duration phase 2 | Data & transitioned to phase 2 & duration phase 1) +- P(completing phase 3 & duration phase 3 | Data & transitioned to phase 3 & durations phases 1,2) + +I may also include the combined phases + +- P(completing combined phase 1-2 & duration phase 1-2 | Data) +- P(completing combined phase 2-2 & duration phase 2-3 | Data & transitioned to phase 2 & duration phase 1) + +## Phase Transition Probabilities: + +The goal is to estimate + +- P(transitioning to phase 2 | completing phase 1 & duration phase 1 & Data & market data) +- P(transitioning to combined phases 2-3 | completing phase 1 & duration phase 1 & Data & market data) +- P(transitioning to phase 3 | completing phase 2 & durations phases 1,2 & Data & market data) +- P(transitioning to phase 3 | completing combined phase 1-2 & durations phase 1-2 & Data & market data) -## Identification Strategy +## Identification Strategies ### Descriptive identification