In this post, I’ll share our experiences at flaskdata.io with early stage drug and device vendors doing their first Phase 1 safety study. You’ll see a common thread of speed and data quality.
I’ll tear down the challenges for early stage life science companies into 10 parts.
Early stage drug and device clinical trials are often challenged by tight budgets and an inadequate Phase 1 protocol design. The tight budget is a reality, but the inadequate protocol is not. The best use of funds for your Phase 1 study is to retain a consultant. You want someone experienced in data model design and clinical conduct. Even if you think you can do it yourself, don’t. Get someone else to work with you. It is common for 1 person to design the CRF and another person to design the clinical protocol.
Phase 1 clinical trials are moving to electronic informed consent and other decentralized trial functionality like video visits. For electronic informed consent and a small number of patients – the most cost effective solution for you may be to use a tool like SignRequest. Print out a PDF of the ICF and put it into a digital signature loop.
Phase 1 clinical trials are usually short, so speed of everything is important. This means that you need to be able to build the study very quickly using a visual forms designer like Flask Forms. Customers using Flask Forms can build a complete eCRF system in 5 working days.
Phase 1 medical devices trials are often performed in-house with help from a regulatory consultant and contract CRA. Phase 1 drug studies are often outsourced to CROs. No matter who runs the process – you need to have a clear understanding that the ownership of the data and the data quality sits firmly on your shoulders – the shoulders of life science sponsor.
Many Phase 1 studies are still paper. This is gross mistake as paper is in fact much more expensive (and slower and less secure) than a digital data management system like Flaskdata. I’ve written essays here, here and here why you should not use paper source documents in clinical trials.
Phase 1 clinical trials may collect data from external sources like ECG and labs, but the predominant source of data will still be DDC – direct data capture. Consider carefully the cost-benefit of using medical IoT – it may be worth using medical IoT devices for BP measurements and hooking them directly up to the cloud clinical data management system.
Multiple design options are on the table: PK, SAD/MAD, PK/PD, BA/ABE, DDI, TQT, device, bio-similar, food effect etc.
Phase 1 clinical trials are often conducted at bedside with the PI/CRC going from patient-to-patient for patient assessments. During COVID-19 – this became even more challenging as you could not bring mobile devices into the department. Nonetheless – in direct to bedside visit – the ability to perform DDC on a table becomes a cost-effective feature for the site coordinator and PI.
You need same-day visibility to missing outcomes, adverse events and mis-dosing in early stage studies. You don’t have the time to do it the big-pharma, big-CRO way of sending you and SDTM file once/month. You need to decide to proceed or kill clinical development as soon as possible. If you are using a CRO, make it clear that the CRO team needs to be working on the same clinical data management system as you with full data transparency and data portability
In summary, for early stage drug and device projects – speed, speed, speed; but not at the expense of a faulty protocol. And if I had to give you one piece of advice – KISS: Keep it simple stupid.