Trials
We need to add filtering options.
In the table I would like to see Disease, Clinical trial number + Title, Geography (a specific country or international), Phase, Status, Enrollment, Primary Completion Date.
Trials
We need to add filtering options.
In the table I would like to see Disease, Clinical trial number + Title, Geography (a specific country or international), Phase, Status, Enrollment, Primary Completion Date.
Overview
I would like to add additional sections: 1. Sales (wee what we have in the current US) 2. Clinical Evidence 3. Technology Features - we are collecting additional features for certain technologies. These features are technology dependent.
Target
Add Technology/Modality (like Antibody Drug Conjugate) somewhere prominently, eg. next to target
Indications
Indication is a specific language used for approved indications. it is okay if we use Indication also where the drug is studied but not yet approved. For the approved indications we need more details: Exact Indication Language - Structured Indication - Date of Approval - FDA (US) /EMA (EU) /PMDA (JP) or NMPA (China). Keep in mind that a drug like Keytruda has 30+ indication in the US alone.<br /> Each of these indication is supported by clinical evidence (clinical trial data) which could be also linked to the indication.
For indication, which are not yet approved we could simple list the disease, disease stage and line of therapy (keep in mind the same drug might be studies in the same disease but a different line of therapy).
I would change "Failed" to "Discontinued"
Ownership
I don't think we need this. Unless we want to track previous ownerships. Which is a big task by why not. In this case I would change it to "Ownership history"
Targets
I don't think we need this
Chemistry
We don't have this but if we can getb this from PubChem then why not.
Recent milestonesdata: confirmed
I don't think we have this but maybe it is easy to recreate it with existing data.
KRAS G12C
We separated targets and mutations. In this specific case KRAS would be the target and KRAS G12C the mutation.
We also have categories like Action type(s): covalent, irreversible, non-covalent, reversible Target - Action Specificity: Mutation Specific, HLA-restricted Binding Site - allosteric site, active site HLA Allele - a bunch of HLA subtypes as values
Additionally we also capture if a drug is brain penetrant.
Top targets
Top Targets as a section doesn't go well with Drugs because most have only 1-2 targets. I would remove this.
Indication
I am not sure we need this here. Some drugs has 30+ indications and they wouldn't fit here.
Owner
Change Owner to Organization and add Geography next to the Organization with values like Worldwide, US, Ex-US, Europe, Japan, China, Greater China A lot of drugs have multiple organizations in different geographies. We also need to add a "Partner" between Organization and Geography. For example Company A partner with Company B in US and Company C sells it Ex-US.
Sotorasib
We need a "Development Status" somewhere in a prominent place to show if the drug is: In Development Discontinued Unknown
Development phase
Change Development Phase to Highest Development Phase
Change Phases to: Pre-Clinical, Phase 1, Phase 2, Phase 3, Approved There is also some drugs which are "Withdrawn"
Additionally we could also add: IND Submission - which happens between Pre-clinical and Phase 1 NDA Submission - between Phase 3 and Approved I just don't know if we have this data consistently
Sotorasib in KRAS G12C–Mutated Advanced Solid Tumors
I am wondering if we could introduce a box somewhere on the top which shows the study outcome as positive, negative, not available?
Could we also show here the Number of Publications?
Overview
Could we add after publications a new section called "Trial History". We run this for few trials and maybe we could do for a selected number of trials. See an example in the data lake. <br /> https://datalake.bioloupe.com/admin/clinical_trials/36511#history-timeline
Structured criteria
I would add Diseases, Disease Stage, Line of therapy, Biomarker and Value A trial might have multiple diseases with each has their own Disease Stage, Line of therapy, Biomarker and Value therefore we need to structure this box to accommodate this.
NCT03425643
Sometimes the trial has additional Other Study ID Numbers, which could be listed here.
Brief summary
I can't highlight and annotate "Overview" therefore I leave comments here. We need the following under Overview: Official Title, Brief Summary, Detailed Description, Conditions, Interventions , Sponsors
Status
I would like to see here: Study Start Date (Actual or Estimated) Primary Completion Date (Actual or Estimated) Study Completion Date (Actual or Estimated)
First posted
I think this is too prominent here. It could be somewhere else with smaller text size
Completed
We show Phase II, Completed, 2 sponsors on the top of the page. Do we need those? They don't bother me but it is a duplication.
Development phase
The Phases should be: Early Phase 1, Phase 1, Phase 2, Phase 3, Phase 4.
Sometimes the trials is Phase 1/Phase 2 or Phase 2/Phase 3, in these cases we should highlight both.
estimated_loss_of_exclusivity
"estimated_loss_of_exclusivity" can be a fact but not going to come from drug approval. For example some companies in their annual report show these date by region. When this data is not available from the annual report then we could also look at the US patent database (we haven't tried it because it is complicate) or use a standard timeline.
drug_approval_organisations
drug_approval_organization is NOT necessarily the same as drug ownership. When one company buys another the marketing authorization owner often stays the original even the ownership of the drug changes.
breakthrough_therapy
"breakthrough_therapy", "fast_track", "orphan_drug", "prime_eu" and "rmat" can happen independently of drug approval. These regulatory designations are give during development and not at approval.
drug_target_actionsSection titled “drug_target_actions”
There are additional values are missing here "Mutation(s)" (FK), "HLA Allele" (FK), "Action Type" (FK), "Target - Action Specificity" (FK), "Binding Site Specificity" (FK)
discontinuation_reason
We also need "discontinuation date" and more free text describing the reasons beyond the categorical values.
cell_therapy_metadatajsonbCell source, cell type, genetic modification, target antigen (cell/gene therapies only)
For each "technology_id" we would need to develop a "technology_metadata". Currently we have this for few eg. ADCs or Cell Therapies but I would like to revise the existing ones and create it for those technologies where it doesn't exists.
drug_type
Isn't "drug_type" the same as "technology_id"?
When to add a new matview
Should we have a matview for all UI tables?
Alternative considered: Compute status from drug_approvals (approved = marketed, no approval = in_development). Rejected because it loses curated knowledge that cannot be recovered from structured sources.
In this specific examples we should make changes in the "Drug Approvals" facts and "drug status" should be a computed uneditable data. Simply we should plug in more data sources: - for example we could extract the China approval from press release - we could get additional EU approvals from other data sources
scraped
Could we avoid using the word "scrape"? These authoritative resources are ofte APIs. We could use "Ingest".