Foreign Clinical Trials (FCTs) for Life Science Startups

A guide by Interventional Concepts, Inc.

Did you know 40-65% of all clinical trials involving FDA-regulated products are being conducted overseas?

Source: Blake Wilson, Clinical Studies Conducted Outside of the United States and their Role in the Food and Drug Administration’s Drug Marketing Approval Process, 34 J. Int'l L. 641 (2013). Available at: http://scholarship.law.upenn.edu/jil/vol34/iss3/5

Time! Innovators can't afford to wait for a lengthy FDA trial approval in the US.(also drastically reduced costs and easier subject recruitment)

Source: Blake Wilson, Clinical Studies Conducted Outside of the United States and their Role in the Food and Drug Administration’s Drug Marketing Approval Process, 34 J. Int'l L. 641 (2013). Available at: http://scholarship.law.upenn.edu/jil/vol34/iss3/5

You will learn how to

select a site overseas that will save you time, money and quickly recruit patients for your early-stage trial.

Crisis in life science innovation

Key contributors to the crisisFactors cited as having the highest impact on decisions to move medical device investment outside of U.S.

Source: National Venture Association/Medical Innovation & Competitiveness Coalition survey of 259 NVCA member firms investing in the healthcare sectors; 60% (156 firms responding), October 2011.

Medical Device Development Pathway

The medical device development pathway from discovery and ideation to product launch and post market monitoring is shown. The regulatory process affects a significant portion of the device development pathway and should accommodate the iterative, cyclical nature of device design and development.

Source: Center for Devices and Radiological Health, U.S. Food and Drug Administration (FDA)

Current landscape of medical device development

FDA knowledges real or perceived problems

● Initial clinical testing of novel devices has moved to non-US sites

● Device innovation may follow overseas

● Devices are being exclusively developed for non-US markets

● FDA’s requirements can be an impediment to early clinical testing of new devices

● Growing concern regarding the time lag in the availability of beneficial medical devices for US patients

Source: Innovation Pathway Program at FDA, January 8, 2014

Meet Dr. John B. Simpson Phd Md (founder & CEO, Avinger, Inc.).

He and his team traveled to Colombia to conduct an early-feasibility clinical trial.

Avinger developed the first ever image-guided directional atherectomy device by using clinical data from Colombia in preparation for FDA approval.

A true innovator!

Dr. John Simpson has revolutionized the field of medicine through innovations that have fundamentally altered how physicians treat cardiovascular disease.

"I can only say good things about our experience in Colombia." John B. Simpson, PhD MDWatch a video about Dr. Simpson's experience in Colombia here

It’s no surprise that Dr. Simpson chose a cost-effective, ethical and quality site overseas.

There are 120 officially certified sites in Colombia.Source: INVIMA official list of GCP-certified clinical research sites. Available at https://www.invima.gov.co/images/pdf/inspecion_y_vigilancia/buenas-practicas-clinicas/listado-documentos/30-09-2016/BPC_1_IPS_Certificadas_Septiembre_2016.pdf. Blake Wilson, Clinical Studies Conducted Outside of the United States and their Role in the Food and Drug Administration’s Drug Marketing Approval Process, 34 J. Int'l L. 641 (2013). Available at: http://scholarship.law.upenn.edu/jil/vol34/iss3/5

Fast approval. Cost savings. Easier recruitment.

Colombia's MoH can approve a clinical trial in 30-60 days.

Trial costs are over 50% lower overseas.

Subject recruitment may be faster overseas.

What people are saying

When it comes to launching early clinical trials for medical devices, the three leading Latin American countries are Colombia, Paraguay and Chile...Colombia also is relatively close to the East Coast with short flights, has a stable government and is the only country trying to attract startups and small companies for phase I. It is harder and more costly to do early stage trials in the U.S., and Colombia hospitals and some doctors have close relationships with the University of Miami Medical School, a teaching hospital.

Jonathan Rourke, CEO & co-founder, Mitraspan, Inc., CenterWatch Weekly, April 6, 2015

Download the CenterWatch Weekly (April 6, 2015) article here

What people are saying

MRCTs [multi-regional clinical trials| can expedite global clinical development and facilitate registration in all regions across the globe. The ultimate goal of MRCT is to bring new medicines to patients globally as fast as scientifically possible and reduce the drug lag. MRCT also helps in expansion of clinical research into developing countries bringing medical care options to subjects who otherwise may not have access to them. Investment in drug development increases potential benefits to local scientific and medical and paramedical professionals. It provides access to more advanced technologies and helps in the development of technical expertise. MRCT provides the sponsors access to otherwise untapped pools of patients, as well as early patient access to new medications.

Premnath Shenoy, Multi-regional clinical trials and global drug development, Perspect Clin Res. 2016 Apr-Jun; 7(2): 62–67.

Download the paper here

Useful tools for site pre-selection

There are thousand of clinical research sites overseas, and it may be difficult to select one.

● Contract research organizations (CROs)

● Word of mouth● Literature search

Activities in a clinical trial

Adherence to the principles of good clinical practices (GCPs), including adequate human subject protection

(HSP) is universally recognized as a critical requirement to the conduct of research involving human subjects. Many

countries have adopted GCP principles as laws and/or regulations. The Food and Drug Administration’s (FDA’s)

regulations for the conduct of clinical trials, which have been in effect since the 1970s, address both GCP and HSP.

● Study design● Site selection● Trial set-up● Regulatory submission (IRB and

national regulatory agency)● Investigational product

importation and logistics● Project/study management● Data management● Study monitoring● Statistical analysis● Medical writing

See Acceptance of Foreign Clinical Studies - Information Sheet - FDA

Selecting the site

It would be wise (and a good practice) to use some objective criteria to compare and rank the sites so the process is more rationally and less emotionally driven.

One way to do that is to use a weighted Pugh Matrix. The technique is simple and uses a quantitative approach to rank different options (sites) based on multidimensional criteria (aspects that matter to you).

Download the Pugh Matrix here

Need help with a foreign clinical trial?

Contact Julio Martinez-Clark to find a site overseas.October 4, 2016 | Interventional Concepts, Inc. | Julio G. Martinez-Clark, President & CEO | jmclark@interventionalconcepts.net