4 Time Variables that a Medical Device Company Must Evaluate to Start a First-In-Human Medical Device Clinical Trial in Colombia
The time it takes to approve a clinical research study in Colombia has four main variables. The first is the search for the principal investigator (PI) and his/her associated hospital where he/she practices and has the right patient population (aka IPS in Colombia). The second is the approval time of the ethics committee associated with the IPS. The third is the approval time in the regulatory agency (INVIMA), and the fourth is the approval time of the import permit of the devices under investigation (VUCE). In this blog post, we will explain the reason that makes the selection of the principal investigator the critical success factor in a medical device early stage, early feasibility or first-in-human/first-in-man clinical trial in Colombia.
Approval time = PI selection + ethics committee + INVIMA + VUCE
Selection of the principal investigator (PI): As soon as one to three PIs are identified, you must evaluate their capacity to recruit patients and compare them. This variable is absolutely crucial to the success of the study. The goal here is to determine a) how many patients the IPS has in its own database who meet the inclusion and exclusion criteria of the study, and b) how long will it take for the PI and the IPS to recruit them. It is useless for a foreign manufacturer to choose a first-in-human destination country just based on the advertised record regulatory approval time at its Ministry of Health (MoH) or regulatory agency if the chosen PI and the hospital/research center does not have the ability to quickly recruit patients. It is well known in the clinical research industry that most trials fail because of the PI's inability to recruit patients.
Ethics Committee (EC): This time can be predicted with some accuracy because ethics committees have periodic meetings approximately every 15-30 days and if documents are submitted before each meeting, it could be known with certain accuracy when approval will be obtained. Each IPS in Colombia must be affiliated to a particular EC.
Regulatory Agency: The INVIMA medical device committee has periodic meetings approximately every 30 days and if documents are submitted before the publicly posted deadlines, you will know with certain accuracy when your study will be evaluated and hopefully approved if all documents are in order.
Import Permit (MinCIT/VUCE): Colombia's Ministry of Commerce, Industry and Tourism (MinCIT)/VUCE office generally approves an import registration in about 10 days. You will be able to import your investigational devices as soon as MinCIT/VUCE approves this import permit. You will be able to ship your investigational devices right when you submit your import permit application and will be able to properly nationalize them in about one week.
Conclusion
The selection of the PI is the critical success factor in a medical device clinical trial. It is also the time variable that you as a clinical trial sponsor can somewhat control. Sponsors sometimes compare different countries based on variables 2 to 4 listed in this blog entry, but forget that variable 1 can destroy its plans in a country. Usually, the excitement of having a first-in-human medical device clinical trial quickly approved in a country wanes quickly after a sponsor finds out that the chosen PI is not able to satisfactorily recruit patients for a trial.
About the author
Julio G. Martinez-Clark is CEO of bioaccess.™ ( www.bioaccessla.com ); a contract research organization (CRO) that helps foreign medical device manufacturers conduct first-in-human clinical research studies in Colombia.