What Does it Take? | First in Human Clinical Trials
Does the CRO you’re working with have what it takes to successfully conduct First-in-Human (FIH) clinical research?
What are FIH trials?It’s important to define what we’re talking about here when we say FIH, because not all FIH trials are alike. Most people who know a thing or two about clinical research are familiar with the FDA standard Phase I FIH study, which is used for investigational new drugs (INDs). FIH trials are typically conducted with 20-80 study volunteers. The objective, according to an article in the American Journal of Therapeutics, is to find “the metabolism and pharmacologic action of [a single] drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.”
So, when you boil all that down, what we’re really saying is that those FIH studies give researchers a baseline for understanding the safety of the drug and may also show the mechanism of action in humans.
Cookie Cutters vs. Snowflakes
Because nothing is ever easy, there are Phase I studies that deviate from the FIH Phase I cookie-cutter norm, such as:
- Clinical trials in which volunteers receive one of the following types of investigational new drugs:
- A new compound in a new drug class
- A new compound in a drug class that’s already been through human testing with a different IND
- A new drug/approved drug combo
- An approved drug with a new formulation or dose
- Clinical trials requiring a special population (e.g. pediatrics, adolescents, elderly)
- Clinical trials for which the drug is intended to be therapeutic (e.g. patients with gout, diabetes, pain, etc.)
Each FIH trial must be evaluated on an individual basis because the objectives and risk factors vary (a.k.a. the snowflake factor). The preclinical data, trial design (traditional vs. adaptive design), proposed population, and safety measures should be assessed for every FIH trial.
What part does the CRO play?
If a sponsor is outsourcing their FIH trial, the CRO will play a very vital role.
Consider it like building a house. Are you going to ask your electrician what’s best for the plumbing? No, you ask the expert. That’s what a truly qualified CRO can offer a sponsor. They are there to offer their expertise to ensure the successful completion of the trial.
CROs experienced in the conduct of FIH studies are knowledgeable and equipped to guide sponsors through the process of building the best protocol possible. They conduct studies all day long, Monday to Sunday. They’re going to be able to tell you about recruitment, if your blood draw times are feasible, and if your timelines are realistic.
A team with general or late phase clinical research expertise isn’t enough.
It is essential that the Physician Investigator and study team have a lot of experience conducting FIH trials and possess the qualifications to ensure your trials go smoothly. The clinical team is vital to ensuring that the protocol is optimal with little room for amendments or deviation, while also making sure recruitment goals can be met, even with the most stringent inclusion/exclusion criteria. Whether it’s a simple Single Ascending Dose (SAD) trial or a complex, adaptive design, the team conducting the study is a pivotal factor to success.
When it’s time to outsource a clinical trial to a CRO, it’s best to find out how involved the principal investigator (PI) and sub-investigators will be. Additionally, the experience of project managers, study coordinators, lab personnel, data managers, and medical writers are equally important. The PI is responsible for overseeing staff; however, problems can arise when a PI is either A) inexperienced or uninformed in conducting FIH trials or B) puts too much responsibility on his/her staff to perform tasks he/she should be overseeing.
Overall, an experienced CRO can minimize the risk of recruitment and retention issues, safety concerns, bad data and a whole myriad of other issues that could slow down your FIH clinical trial.
Does your CRO have what it takes?
Contact our team today to discuss how we can help with your upcoming Phase I/II clinical trial at email@example.com.