[HN Gopher] The case for clinical trial abundance
       ___________________________________________________________________
        
       The case for clinical trial abundance
        
       Author : apsec112
       Score  : 24 points
       Date   : 2024-12-19 16:16 UTC (3 days ago)
        
 (HTM) web link (ifp.org)
 (TXT) w3m dump (ifp.org)
        
       | CharlieDigital wrote:
       | I worked in this space for ~10 years and learned a lot.
       | 
       | In 2011, the bootstrapped startup I was at built the first COTS
       | trial site electronic document exchange portal. Up until then,
       | trial teams would use a mish mash of shipping paper, fax, FTP,
       | E-mail, etc.
       | 
       | Our product was a finalist for the Transcelerate Shared
       | Investigator Portal (SIP) project to unify this process on one
       | platform.
       | 
       | I saw the internal workings of IT teams in many large pharmas and
       | fought to modernize the internal workings of our own team.
       | 
       | I say all this as preface. The industry as a whole is highly
       | political, incredibly conservative when it comes to tech, and has
       | high barriers to innovation.
       | 
       | I use this term "political" broadly to cover an array of issues I
       | observed. One of which is that there a lot of jostling for
       | influence because that's how consultants and vendors make money.
       | A lot of folks with influence are long-time industry veterans
       | with domain expertise, but no technical prowess paired with it.
       | 
       | In the end of the Transcelerate SIP selection process, Veeva
       | submitted a non-existent product (at the time) and ultimately
       | Cognizant (the consultancy running the selection) built their own
       | because of course! Millions of dollars in recurring revenue were
       | on the line!
       | 
       | Lots of good ideas have come and gone because the entrenched
       | interests in this space extract rent from the friction. One
       | working group I was a part of was iterating a spec as a
       | spreadsheet instead of a technical format like a standard API...
       | 
       | One point I particularly disagree with the OP is CT.gov. It is
       | fine, IMO, because it is meant for industry and not laypersons.
       | It has an excellent API[0] and there are plenty of third parties
       | that build consumer-facing apps for trial matching. For example,
       | I built a really basic one using LLMs to match natural language
       | criteria to clinical trials and emails you when a matching trial
       | pops up in the change feed[1]. The main problem with CT.gov right
       | now is that it lacks a bit in data quality standards. There's a
       | lot of variation in completeness of data dependent on country of
       | origin and even between companies.
       | 
       | The lack of technical standards in the industry really hurts
       | innovation. For example, clinical trial protocols should arguably
       | be a standard technical template. The FDA has done some work in
       | this area[2], but industry has largely not adopted it. You can
       | find public protocols attached to some trials on CT.gov, but
       | every company has a different structure. Yet it is this document
       | that underpins the design and execution of the trial (on top of
       | being hard for trial sites to adapt between different sponsors).
       | 
       | [0] https://clinicaltrials.gov/data-api/api#extapi
       | 
       | [1] https://zeeq.ai
       | 
       | [2] https://osp.od.nih.gov/policies/clinical-research#tab1/
        
       ___________________________________________________________________
       (page generated 2024-12-22 23:00 UTC)