Do you know according to clinicaltrials.gov a total of 354,130 clinical trials were registered worldwide with 71,256 ongoing trials as recorded on Oct-2020? The number of trials being conducted is increasing year by year from 56.16k in 2017 to 60.69k in 2018. In the US more than 2.3+ million people participate in approximately 80,000+ clinical trials every year throughout the US.

Chronic diseases such as heart disease, stroke, cancer, respiratory diseases, and diabetes are the leading causes of mortality in the world and represent 63% of all deaths. It is projected that chronic diseases will account for seven out of the top 10 causes of death in the world by 2030. the sites and investigators working in these therapeutic segments are available widely all over the globe.

The statistics show that number of new cancer cases around the world is also expected to increase from 12.7 million in 2008 to 21 million by 2030. About 350 million to 400 million people worldwide have a rare disease, with 25 million to 30 million affected people in the US, while over 45 million people may be suffering from a rare condition in Asia, with 20 million in China alone.

Now, most of the research and pharma companies are focusing on innovative cancer treatment and treatments for rare diseases. The demand for sites and investigators is increasing by folds globally.

World clinical trials statistics

From a total of 354,130 trials registered globally, the major part of trials was registered in North America (150,680), Europe (101,302), the Middle East (15,596), South America (11,184), and other parts of the world (102,148).

Leading therapeutic areas

The sites and investigators from the above regions are busy in conducting clinical trials in the following therapeutic areas.

Therapeutic area Trials (in numbers)
Communicable & Infectious Disease31,921
Carcinomas50142
Immune Diseases30,266
Digestive System Diseases29,798
Vascular Diseases29,649
Respiratory Tract Diseases29,029
Mental Disorders27,246
Central Nervous System Diseases22,888
Metabolic Diseases22,741

What are the most retarding factors for clinical trials globally

Globally most of the clinical trials fail in completing the study by time and the following is the scenario of most of the studies irrespective of regions.

  • 45% of clinical trials are delayed
  • 70 % of clinical trials face study start-up delays
  • 80-90% of clinical trials fail in the recruitment of patients

Patient recruitment is a nightmare for many researchers and is the leading cause of study delays. The main reason for recruitment delays are due to

  • Inability to select perfect sites.
  • Uncertainties in estimation of the number of patients from sites- 
  • Improper estimation of time required for patient enrollment.
  • The protocol design.
  • The competitive landscape.

These issues can be answered to a major extent by choosing the right site for your clinical trials hence becomes a critical part of clinical trials and this can be achieved by performing clinical trial feasibility.

How can you choose the best sites for your clinical trials?

There are many ways for finding the right sites for your clinical trials but the most modern and efficient way of identifying the clinical trial sites in conducting feasibility. It may just take a few hours to days based on the type of feasibility and outcome you are looking for. 

The basic steps involved in choosing the right site includes

  • Establish the study requirements you’re looking for
  • Conduct feasibility to explore the sites and investigators
  • Evaluate and finalize the most promising sites that match your study requirements.

Clinical trial sites and investigators in North America

Most of the clinical trials in the world are happening in North America due to its regulatory structure, clinical trial awareness, patient recruitment rates, faster study timelines, and a huge number of research sites,  scattered across the geography.

Clinical research sites in North American regions such as the USA, Canada are considered to have the most advanced sites in the world, with many sites having the infrastructure and resources necessary for conducting clinical research.

Advantages of sites and investigators from North America

  • Have a wide range of sites right from academic clinical research facilities to physicians clinics.
  • Experienced investigators in wide therapeutic and sub-therapeutic areas
  • Good patients recruitment and retention rates and availability of various resources and mediums for recruiting.
  • Availability of many rare diseases and oncology sites.
  • Most sites have faster trial initiation, recruitment timelines, and almost reach the predetermined study completion timelines.
  • The majority of sites are “good sites”
  • Great importance to the protection of intellectual property (IP) rights,

Disadvantages

  • Costs associated with sites in conducting clinical trials is high compared to the developing countries.
  • Stringent regulatory process and formalities.
  • Timeframe delays in a few cases of clinical trials
  • Trial sites require to follow not only federal laws but also states and regional policies and this may be even worse in multi-regional trials.

The other regions in North America are improving the scenarios of performing clinical trials and are coming into the limelight in recent years.

Clinical trial sites and investigators in Europe

In the EEA (European Economic Area), approximately 4,000 clinical trials are authorized each year. This equals roughly 8,000 clinical-trial applications, with each trial involving two Member States on average. From this, approximately 61% of clinical trials are sponsored by the pharmaceutical industry and 39% are initiated by non-commercial sponsors, like academia.

Europe’s top five countries for healthcare markets include Germany, France, Italy, the UK, and Spain, with Germany being a potential market for clinical trials. It is ranked second in the world and first in Europe for the number of active clinical trial sites, with over 22,000 active clinical trial sites.

Europe has presented continuous competitiveness to the top regions like North America and Asian countries for conducting clinical trials.

Advantages of clinical trial sites in Europe 

  • The primary reason for conducting trials with clinical trials sites in Europe is the shorter study protocol approval time and the European sites are likely to be finished before the U.S. sites begin
  • Considering the study costs which fall into three categories monitoring and contract research organization (CRO) costs, investigative site costs, and ethics committee costs. The monitoring and CRO costs are generally less than those with costs in the United States,
  • There are countries in Europe where sites and investigators are more eager to participate in a study compared to other regions, and it is obviously wise to choose a region where investigators and sites are generally enthusiastic to take part in the clinical research.
  • Most of the sites in the European countries have fewer start-up timelines and good recruitment speed
  • Support regulatory environment

An example of costs involved in Europe

Monitoring for a 20-subject study was bid at $133,000 by a U.S. CRO; the same study was bid at $45,000 by a Dutch CRO. The Ethics committee costs run about the same as U.S. IRB costs, approximately $2000 per study. 

Clinical trials sites and investigators in the Asia Pacific and other regions

A study shows that clinical trial recruitment has been increased in the Asian-Pacific countries over other regions like Europe, and North America in the last decade.

The study also shows that major annual increases in clinical trials were seen in the Asian countries like Iran, China, and India. Asian countries have a large patient population naive and this makes these regions preferable for performing clinical research with other additional advantages like costs.

Asia-Pacific has a growing number of experienced investigators.  As of 2019, there are over 43,000 active principal investigators (PIs) across Asia-Pacific markets, which is comparable to North America.

However, this increase was not seen in the pediatric population and this was thought to be the parent reluctance for their children participating in the clinical trials, lack of clinical trial awareness, restrictive regulatory oversight, and ethical factors.

The rise in interest for Asian countries are attributed due to the following reasons

  • Presence of heterogeneous population groups 
  • Availability of a large number of treatment naïve patients
  • High incidence of some diseases in Asian and other regions other than Europe and North America
  • Low cost associated with conducting clinical trials in regions like Asia, Africa, etc.
  • Low-density clinical trials performed providing a less competitive environment for sites and principal investigators

Examples of choosing countries

Most of the pharma companies would prefer to carry out drug trials for the treatment of liver cancer or gastroesophageal cancer in Korea or China, as these countries provide a large pool of patients naive for conducting clinical trials in these diseases.

Advantages of sites and investigators from the rest of the world

  • Fewer costs associated with trial conduction, site costs, and costs per patient. The major cost drivers include staff and admin, clinical procedures, site monitoring, and site retention which are attributable to be low in Asian-Pacific countries and other regions.
  • Improving clinical research site in fractures and following international standards to manage large clinical trials. 
  • Diverse ethnic population for patient recruitment
  • Improving regulatory approval timelines for example  China, where regulatory timelines have decreased by 16 months since 2016
  • Asia-Pacific countries are also becoming more diligent in developing regulatory regimes that protect intellectual property (IP) rights and stringent policies at research sites, 
  • Countries from regions like Asia-Pacific demonstrate clinical trial compliance levels equivalent to Europe and North America.

Disadvantages

  • The uncertain regulatory environment and ethical challenges  
  • Infrastructural challenges with the site of few countries
  • Diverse language barriers and requirements of information to be presented in regional scripts at the site.
  • Not well-structured patient recruitment policies implemented at sites.

COVID and clinical trials sites

Due to the COVID pandemic, the pharma industry inclining towards the COVID and infectious related research, and more Covid-19 clinical trials are being planned and initiated, while a large number of clinical trials for non-Covid-19 indications are suffering delays.

Many regulators such as EMA, FDA, TGA are offering accelerated approval for Covid-19 therapeutics and vaccines and this made the sponsor shifting their focus towards COVID and COVID-related trials. However strategically some of the pharmaceutical companies have announced disruptions in planning and ongoing trials, postponing trial start dates, and halting subject enrolment.


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References

  1. https://www.clinicaltrials.gov/
  2. https://www.appliedclinicaltrialsonline.com/view/selecting-study-appropriate-clinical-sites-3-steps
  3. https://www.clinicaltrialsarena.com/comment/us-clinical-trials-covid-19/
  4. http://frost-apac.com/BDS/whitepaper/Asia-Pacific%20Clinical%20Trials%20-%20White%20Paper%20-%20Frost%20&%20Sullivan.pdf