North America: Clinical Trial Sites & Investigators In USA, Canada & Mexico
Aside from being one of the most preferred regions to conduct clinical trials, North America is also the location of 45% of global clinical trials, which is why researchers prefer this region. The increasing prevalence of cancer, heart disease, infectious diseases, and tropical diseases has generated multiple unmet requirements for the research of new drugs.
The increasing diversity of the population profile in North America is expected to enhance clinical trials for new or rare diseases.
Clinical Research in North America
Globally sponsors and CROs prefer to conduct clinical research in North American regions due to many reasons. These include
- The clear and established regulatory scenario.
- The easy and smooth approval process.
- The agile and robust ethical review process.
- Awareness of clinical research among the population and patients
- Stringent and well-defined clinical conducting regulations and patient insurance policies.
- Availability of qualified investigators and sites.
- Fewer timelines for the initiation, conducting, and completion of trials.
- More available oncology, and rare disease sites.
Clinical trial statistics
Clinicaltrials.gov shows that a total of 161,332 trials were registered from all over the world, with 34,112 trials still ongoing.
The major therapeutic areas of the currently ongoing trial are
- Oncology trials
- Immune trials
- Psychotic disorders
- Digestive disorders & gastrointestinal disorders
- CNS & Respiratory tract diseases
Statistics of clinical research Worldwide
A total of 352,349 clinical trials are registered on clinicaltrials.gov worldwide of which 161,061 are from North America. This is about 42% of trials worldwide.
Oncology clinical trials in North America
Statistics of Oncology Trials in North America
Total oncology trials registered on clinicaltrials.gov were 77,017 of which 39,717 were from North America. This is about 51.06% of global trials. This proves the domination of the North American regions for clinical research.
The total number of oncology trials registered on clinicaltrials.gov worldwide is 77,017 of which 39,717 trials are from the North American region. This is about 51.56% percent of total oncology trials.
In North America, the United States is the leading region for oncology trials followed by Canada and Mexico. Other countries located in North America are gaining prominence for trials. In this article, we will be focusing on these 3 regions. Let’s discuss the main advantages of North American clinical trial sites.
Why you should conduct oncology trials with sites in North America
There are several advantages to conducting clinical research with sites in North America such as time, patient recruitment, sites, and investigators’ availability
Clinical research site timelines
- The main hindering and time-consuming factors that may come across for any clinical trials are
- obtaining regulatory approvals,
- patient recruitment, and
- When the clinical development process is well defined strategically, it is obvious that our process moves quickly with less or no hindrance.
- In the United States, most of the regulatory pathways are clear and established, and this helps in the timely conduction and completion of clinical trials.
- Another main hindering factor for any clinical trial is patient recruitment and retention but due to
- the high prevalence of cancer in the united states,
- readily available patient data from many disease organizations, and
- the availability of various resources for recruitment makes the recruitment possible within the determined time and avoids delays.
Patients recruitment at sites
- The available patient population, cancer prevalence, and clinical research knowledge exposure among the patient populations are some of the overwhelming factors for conducting clinical trials with sites in North America.
- Clinical trial sites in these regions utilize various platforms for patient recruitment. Support from Clinical Research Networks (CRN)’s has developed to pool resources and expertise in conducting clinical research.
- They include clinical sites and investigators usually organized around a specific disease area and can be accessed by many different research stakeholders for the conduct of clinical research.
- They help in providing a patient database for oncology trials and any other trials.
- The Clinical trial sites in the United States have various patient recruitment resources, applications, and websites, and in some instances, patients voluntarily search for clinical trials to participate.
Sites and investigator’s availability
- Many hospitals and clinics are clinical trial sites in North American regions and have plenty of oncology sites that are working on many clinical research trials.
- Most of the sites have qualified and GCP-trained staff that handles clinical trials more efficiently.
- Sites from North America have experienced and qualified clinical investigators.
- Credevo has a huge database of investigators and sites from North America. Conduct feasibility to contact these sites or contact Credevo for more details by completing the form at the end of this article.
- Compared with other regions, expenses for conducting clinical trials are high or maybe equal, but when evaluating the time versus the cost, the overall cost almost remains the same.
- Considering all factors such as
- recruitment timelines,
- site initiation,
- site activation timelines, and
- overall conduction timelines, along with the potentially rapid regulatory process, the overall cost of clinical trials remains the same in the USA.
- Furthermore, clinical trial data generated in the USA is acceptable globally.
Now let’s understand the advantages and challenges of each region in North America
Clinical trials, sites, and clinical investigators in the USA
The United States was the top location for global clinical trials taking up 35% of the total number of geographies in 2018.
Moreover, the dominant causes of death remain the same for both sexes, which include
- heart disease,
- chronic Lower respiratory disease,
- Alzheimer’s disease, and
- unintentional injuries.
Regulatory in the USA
The United States Food and Drug Administration, commonly referred to as the FDA, regulates foods, drugs, cosmetics, and medical devices for both humans and animals in the USA. Only after a review of the FDA and Institutional Review Boards (IRBs), the sponsor can initiate clinical trials in humans.
- To initiate a clinical trial, a sponsor should submit an Investigational New Drug (IND) Application with the content specified in the Code of Federal Regulations (CFR) 21, section 312, to the FDA and should wait 30 days before the trial initiation.
- The FDA has an opportunity to review the documents and authorize the trial.
- A company can typically submit a new drug application once the drug successfully passes all three phases of clinical trials.
Click here to explore the regulatory process for conducting clinical trials in the United States
Clinical Trial Sites & clinical investigators in the USA
The accessibility to oncology clinical trial sites and clinical investigators is very lucrative due to the exposure of clinical trials among medical professionals, clinical investigators, and patient populations.
The advantages of choosing clinical trials sites from the USA are
- Most oncology clinical trial sites have a well-established infrastructure, with the necessary devices, treatment equipment, and infrastructure required for conducting clinical trials.
- Availability of experienced clinical investigators and GCP-trained staff.
- Good patient recruitment rate in oncology trials due to wide exposure to clinical research among the population and many available resources for recruitment.
- Availability of multiple oncology diseases and subtypes that could help in any type of oncology trials recruitment
- Voluntary organizations support providing the patient database to connect and recruit.
- The USA has more sites available for conducting clinical trials than any other region in the world which provides a great choice to choose from.
- Less site activation, recruitment, and clinical trial conducting timelines compared globally.
“Credevo has a great experience with clinical trial sites and clinical investigators from North America. While performing feasibility studies, response from sites was quick, and have qualified clinical trial investigators with good experience.”
Challenges with clinical trials sites & investigators in the USA
Planning to conduct clinical trials in the USA comes with several advantages, but there are also some challenges that must be overcome.
- The high financial cost involved in conducting clinical trials with the sites in the USA.
- Availability of sites for conducting first-in-human trials to phase IV trials along with proof-of-concept trials.
- Need a clear drug development strategy well planned before you even initiate any clinical development process or else may lead to regulatory, ethical, or other delays that may increase the financial burden of conducting clinical trials.
- The delays associated with navigating the many regulatory and ethical requirements of studies involving human subjects.
- Though stringent regulatory may create clear and well-established pathways may also hinder in timely completion of clinical trials.
- Conducting multiple sites clinical trials may also be challenging due to clinical shipment challenges as the clinical trial sites may be far apart or scattered across the region.
- Need a well-scientific feasibility study to explore great oncology sites and clinical investigators to avoid clinical trial failures.
Clinical Trial Sites in Canada
Canada has a favorable environment for conducting clinical trials and provides sophisticated sites and qualified investigators to perform oncology clinical trials.
Advantages of conducting clinical trials with sites in Canada
- Studies are non-IND, and there is no requirement to publicly list the trial.
- Companies can use studies conducted in Canada to obtain novel claims in Canada and to substantiate claims in the US.
- Cross-referencing clinical trial applications to Health Canada with other submissions for the same product can reduce the burden.
Regulatory in Canada
- Health Canada will usually review a well-compiled clinical trial application approximately 3 to 6 weeks after the time of filing.
- Once Health Canada provides initial feedback, obtaining ethics approval can be done to ensure that both Health Canada authorization and ethics approval are received at the same time.
- To speed up recruitment, potential candidates can be identified through electronic medical record review before obtaining ethics approval.
- Conducting natural health product clinical trials in Canada allows the Sponsor to investigate populations and endpoints which, in the U.S., could trigger the need to file an Investigational New Drug (IND) Application.
Click here for a detailed regulatory process for conducting clinical trials in Canada
Clinical trial sites in Mexico
Mexico is quickly becoming a major player in the pharmaceutical and medical device industries. The conduct of clinical trials in developing countries has received increased attention recently. Mexico has also made many regulatory amendments to ease the conduct of clinical trials.
Regulatory Process in Mexico
Any research on human beings which includes testing new medicinal products and new uses, as well as dosages and administration routes for already approved medicinal products are approved by the Federal Commission for Protection Against Sanitary Risk (COFEPRIS – Comisión Federal para la Protección contra Riesgos Sanitarios).
The type of approval is Sequential, where the Sponsor or applicant should first obtain approval from Ethics before getting approval from COFEPRIS.
Click here to explore the regulatory process for clinical trials in Mexico
Clinical trial sites in Mexico
- Clinical trial sites of government-backed hospitals and public institutions conduct more than 70% of clinical trials in Mexico.
- Placebo-controlled trials, necessary for accurately determining drug efficacy and safety, are routine in Mexico.
- Consejo Nacional de Ciencia y Tecnologia (Conacyt) finances most of the medical research in Mexico through grants, while international pharmaceutical companies support a smaller portion.
- Most sites in Mexico offer good infrastructure for conducting clinical trials.
- The site infrastructure in Mexico continues to improve, which encourages CROs and sponsors to conduct clinical trials in the country.
- As Mexico is a developing country and most sites are government-owned, the cost of conducting clinical trials is reasonably comparable to that of the USA and Canada.
Disadvantages of conducting clinical trials with sites and clinical investigators in Mexico
- The uneven distribution of specialists and specialized infrastructure in the country.
- Centers in less-urbanized regions may lack the proper human and material infrastructure to meet the requirements of some trials.
- Require collaboration between the host institutions and pharmaceutical companies to develop the necessary infrastructure to support the trial.
Contact clinical trial sites & investigators in this region
Would you like to contact sites & investigators from North America and assess the feasibility with them for your clinical trial?
Now, it’s very easy to do so. Just provide your email and requirements details below and you can connect with our team for support.
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