Complex Drug Development Pushes Number of Clinical Trials Upward
Drug development (lab to shelf) is a long, complex, and highly regulated process with no guarantee of success 1 in 5000 drugs that enter in pre-clinical testing make it to the market, that is also with average timespan of 12 years in the US. Before a drug can reach a patient, it goes through rigorous testing to determine whether it is safe, and effective at treating the condition it was developed for, and to ascertain the correct dosage and appropriate administration route. Thus, the transition from pre-clinical research to clinical stages marks a critical turning point as it nears the new medicinal product to the market. The clinical trials market is thus slated for continued progress over the course of foreseeable future.
Pharmacovigilance Activities are Imperative in Drug Discovery
The efficacy, and safety of medicinal products are demonstrated by clinical trials. In modern medicine, the clinical trial is the gold standard and most dominant form of clinical research. Clinical trials are well controlled and function under a strict regulatory environment - heightened level of standardisation, scientific, and ethical compliance. Clinical trials are highly structured. Besides identifying the efficacy, they serve to determine side effects, interactions and long-term effects of pharma products being trialled. Clinical trials are to be conducted in a heterogeneous group. The US Food and Drug Administration (FDA) intends to ensure that people of different ages, races, ethnic groups, and genders are included in clinical trials. Volunteers who participate in the study must agree to the rules and terms outlined in the protocol, which makes sure that those who agree to participate are treated as safely as possible.
Meeting Compliance and Encountering Complexity Challenges
Clinical trials are conducted according to a protocol that describes the types of patients who may enter the study, the schedules of tests and procedures, the drugs involved, the dosages or amounts of drugs, the length of the study, and what the researchers are hoping to learn from the study. Similarly, stakeholders such as doctors, and other health professionals managing the clinical trials must follow strict rules set by the FDA. It involves extensive paper work - clinical trial filing packages for each study are several thousand pages long as every piece of the data and assessments are supposed to be reported. Moreover, over the years, it has become tougher for drug companies to keep pace with gruelling market demands. The costs of drug research, clinical trials, manufacturing, and compliance are reaching new highs and competition is pressurising the industry to adopt new technologies.
Power of Data Science in Drug Development and Ancillary Areas
Clinical trials have evolved with time. The drug commercialisation process is one of the most important and challenging steps in not only drug development but in ensuring the likelihood of success. Successful strategy rests on guidance provided by reliable data from multiple sources. Approximately 10-15 years to develop a new medicine means there is a vast amount of clinical and molecular data. Pharma majors are thus embracing data science, machine learning, neural networks, and statistical techniques.
Increasing Clinical Trials and Commercialisation of New Medicines
According to ClinicalTrials.gov, a total of 354,130 clinical trials was registered worldwide with 71,256 ongoing clinical trials as recorded on Oct-2020. The number of clinical trials is increasing year by year from 56.16 thousand in 2017 to 60.69 thousand in 2018. In the US, more than 2.3 Mn people participate in approximately 80,000+ clinical trials every year. The major number of clinical trials registered are from North America (150,680), Europe (101,302), the Middle East (15,596), and South America (11,184). Albeit significant gains, clinical trial costs have ballooned in recent years - a 13.52% increase in the past few decades (around US$2.6 Bn compared with US$179 Mn in the 1970s). Yet, the results speak - in the last 10 years, 293 medicines have been approved.
Rising Disease Prevalence Upholds Sustenance of Clinical Trials Market
Chronic disease prevalence is projected to account for seven out of the top 10 causes of death in the world by 2030. Statistics show that the number of new cancer cases around the world would touch 21 million by 2030. About 350-400 million people worldwide have a rare disease, which is why the most of CROs and pharma companies are focusing on innovative treatments for cancer and rare diseases. The demand for sites and investigators is multiplying globally, giving an impetus to the global clinical trials market.
Industry Deterrents Continue to Cause Delay in Clinical Studies
Clinical trials involve significant investments of time and money. Even so, sometimes clinical trials fail. The most retarding factors are most of the clinical trials fail in completing the study in time >45% of clinical trials are delayed, and 70% of clinical trials face study start-up delays. Moreover, 80-90% of clinical trials fail in the recruitment of patients; patient recruitment is a nightmare for many researchers and stands the leading cause of study delays. Attrition of key people involved in clinical research and budgetary constrains also remain among the major challenges facing companies. Big players influence trial results, whereas Big Pharma funds and runs most clinical trials – the scope for companies to focus on the benefits of a drug and downplay the risks (hide dangerous side effects to get their drug approved) for the sake of profit. This biased information could also influence doctors to prescribe a drug without knowing all the risks.
Due to the COVID pandemic, the pharma industry shifted focus towards the COVID-19, and overall infectious disease-related research. More COVID-19 clinical trials are being planned and initiated, side lining a number of non-COVID-19 clinical trials. As such other trials are suffering delays – many companies have announced disruptions in planning and ongoing trials, postponing trial start dates, and halting subject enrolment. Sponsors are shifting their focus towards the pandemic-related trials as regulators such as FDA, the European Medicines Agency (EMA), and the Therapeutic Goods Administration (TGA) are fast-tracking and offering accelerated approvals for COVID-19 therapeutics, and vaccines.
Competitive Landscape of Global Clinical Trials Landscape
Some of the key players in the global clinical trials market are Covance, IQVIA, Syneos Health, Pharmaceutical Product Development (PPD), PRA Health Sciences, Icon plc., Charles River Laboratories, Parexel International Corporation, WuXi Apptec, Medpace Holdings, Inc., KCR Pharmaceuticals Pvt. Ltd., and Pharmaceutical Solutions Industry Ltd. (PSI).