diff --git a/Latex/Paper/outline2.txt b/Latex/Paper/outline2.txt index 9f9f6e7..562df84 100644 --- a/Latex/Paper/outline2.txt +++ b/Latex/Paper/outline2.txt @@ -1,12 +1,17 @@ -In 19xx the United States Food and Drug administration was created to "QUOTE". -Since XXXX they have . +In 19xx the United States Food and Drug Administration (FDA) was created to "QUOTE". +As of Sept 2022 \todo{Check Date} they have approved 6,602 currently-marketed compounds with Structured Product Labels (SPL) +and 10,983 previously-marketed SPLs. +%from nsde table. Get number of unique application_nubmers_or_citations with most recent end date as null. In 2007, they began requiring that drug developers register and publish clinical trials on \url{https://clinicaltrials.gov}. This provides a public mechanism where clinical trial sponsors are responsible to explain what they are trying to acheive and how it will be measured, as well as provide the public the ability to search and find trials that they might enroll in. -%this has become part of multiple datasets (cortellis) used to evaluate what drugs might be entering the market soon. +Data such as this has become part of multiple datasets +(e.g. the Cortellis Investigational Drugs dataset or the AACT dataset from the Clinical Trials Transformation Intiative) +used to evaluate what drugs might be entering the market soon. This brings up a question: can we use this public data on clinical trials to describe what effects their success or failure? -In this work, I use updates to records on \url{https://ClinicalTrials.gov} to separate the effect of +In this work, I use updates to records on \url{https://ClinicalTrials.gov} to disentangle +the effect of participant enrollment and drugs on the market affect the success or failure of clinical trials. %Describe how clinical trials fit into the drug development landscape and how they proceed Clinical trials are a required part of drug development. @@ -27,8 +32,17 @@ When registering these clinical trials % Introduce my work -At least in the world of drug development, these trials take place in a wider framework of Phases -% Now talk about phases, begin introducing work by Chris Adams +In the world of drug development, these trials are classified into different phases of development. +Pre-clinical studies may include +Phase I trials are the first attempt to evaluate safety and efficacy in humans, and usually \todo{Describe trial phases, get citation} +Phase II trials typically \todo{} +A Phase III trial is the final trial befor approval by the FDA +Phase IV trials are used after approval to ensure safety and efficacy in the general populace .... + +In the economics literature, most of the focus has been on evaluating how drug candidates transition between +different phases and then on to approval. + +% Now begin introducing work by Chris Adams % Lead into lit review diff --git a/Latex/Paper/sql used to pull data to answer various questions.sql b/Latex/Paper/sql used to pull data to answer various questions.sql new file mode 100644 index 0000000..98e7058 --- /dev/null +++ b/Latex/Paper/sql used to pull data to answer various questions.sql @@ -0,0 +1,54 @@ +--get a list of the most recent activations that exist for a given application. +create temp table nsde_activations as +select + application_number_or_citation, + count(distinct package_ndc) as package_count, + max(marketing_start_date) as most_recent_start, + max(marketing_end_date) as most_recent_end, + max(inactivation_date) as most_recent_inactivation, + max(reactivation_date) as most_recent_reactivation +from spl.nsde +group by application_number_or_citation +; + +select count(*) from nsde_activations +where most_recent_end is null +; +/* +count +----- + 6602 +*/ + + +select count(*) from nsde_activations +where most_recent_end is NOT null +; +/* +count +----- + 10983 +*/ + +/* +So, the current number of marketed compounds is how many NDA or ANDA (ANADA?) compounds there are. + +*/ + +-- get count of drugs that you can select by first 3 letters +select + left(application_number_or_citation, 3) as first_3, + count(*) as row_count +from nsde_activations +group by first_3 +; + + + +select + left(application_number_or_citation, 3) as first_3, + count(*) as row_count +from nsde_activations +where first_3 in () +group by first_3 +;