Published - Fri, 20 Jan 2023

Scope of Clinical Research

Scope of Clinical Research

I. Introduction

Clinical research is the scientific study of the safety and efficacy of interventions in human subjects, using a systematic and rigorous process to evaluate the potential benefits and risks of new treatments, drugs, medical devices, and diagnostic techniques. It involves the use of human subjects to test the safety and efficacy of new treatments and interventions and to understand the underlying mechanisms of disease. Clinical research is conducted in a variety of settings, including academic medical centers, hospitals, research institutes, and private industry, and is governed by strict ethical guidelines to protect the rights and welfare of human subjects. The goal of clinical research is to improve human health by developing new treatments, drugs, and medical devices, and by advancing our understanding of the underlying mechanisms of disease.

Importance of Clinical Research

Clinical research is of great importance because it plays a crucial role in the development of new treatments, drugs, and medical devices that improve human health and saves lives. It allows us to understand the underlying mechanisms of disease, identify new risk factors and biomarkers, and develop new diagnostic and therapeutic strategies.

Clinical research helps to generate new knowledge about the safety and efficacy of interventions in human subjects and provides the evidence needed to inform clinical practice and public health policy. It also allows for the identification and testing of new treatments for diseases that are currently untreatable or for which current treatments are inadequate.

Clinical research also plays a vital role in the advancement of personalized medicine, where treatments are tailored to the specific characteristics of an individual patient. This approach increases the chances of treatment success and reduces the risk of adverse reactions.

Moreover, clinical research is also important for the pharmaceutical and medical device industry by providing the data and evidence needed to support the development and approval of new products.

Overall, clinical research is essential for the development of new and effective treatments, the advancement of personalized medicine, and the improvement of human health. It is a vital component of the healthcare system, which helps to improve patient care and promote public health.

Current state of the Clinical Research Industry

The current state of the clinical research industry is characterized by several trends and developments.

One trend is the increasing globalization of clinical research, with more studies being conducted in emerging markets and countries with diverse patient populations. This allows for greater access to diverse patient populations and also reduces the costs of conducting research.

Another trend is the increasing use of technology and data science in clinical research. Electronic data capture, remote monitoring, and wearable devices are being used to collect data in real time and improve the efficiency of clinical trials.

The implementation of the new EU clinical trial regulation (EU No 536/2014) and the 21st-century cures act (Public Law 114-255) in the US have also led to changes in the clinical research industry. These regulations are aimed at streamlining the clinical trial process, making it more efficient and reducing the regulatory burden on researchers.

Additionally, there is a growing emphasis on patient-centric and patient-centered research, with more focus on involving patients in the design, conduct, and dissemination of research. This approach helps to ensure that research is relevant and responsive to patient needs and priorities.

Finally, the COVID-19 pandemic has brought significant changes to the clinical research industry. The pandemic has accelerated the adoption of remote monitoring, telemedicine, and other digital technologies, and has led to an increased focus on the development of vaccines and treatments for COVID-19.

Overall, the clinical research industry is in a state of constant evolution, with new technologies, regulations, and trends shaping the way research is conducted, and with the ongoing COVID-19 pandemic having a significant impact on the industry.

II. Types of Clinical Research

Clinical research is the comprehensive study of the safety and effectiveness of new medical interventions, such as drugs, devices, or therapies. It is a type of medical research that involves human volunteers and is conducted according to a plan, called a protocol. There are several types of clinical research, including treatment research, prevention research, observational studies, and clinical trials. Treatment research usually tests an intervention such as medication, psychotherapy, new devices, or new approaches. Prevention research looks for better ways to prevent disorders from developing or returning. Observational studies observe people in normal settings and gather information, group volunteers according to broad characteristics, and compare changes over time. Clinical trials, on the other hand, are studies to test new drugs, already approved drugs, devices, or other forms of treatments. They look at new ways to prevent, detect, or treat diseases and are conducted according to a specific plan, which describes what the researchers hope to learn from the study. The goal of clinical trials is to determine if a new test or treatment works and is safe. The team members involved in a clinical research study may include a principal investigator, research coordinators, study monitors, and institutional review boards.

Phase I-IV Clinical Trials

Phase I-IV Clinical Trials are the four phases of clinical research that are used to evaluate the safety and efficacy of new treatments, drugs, and medical devices in human subjects.

Phase I trials are the first step in testing a new treatment in humans. They typically involve a small number of healthy volunteers and are designed to assess the safety of the treatment, determine a safe dose range, and identify any potential side effects.

Phase II trials are conducted in a larger group of patients and are designed to assess the effectiveness of the treatment and to identify any potential side effects. These trials typically last several months and may involve hundreds of patients.

Phase III trials are conducted in an even larger group of patients and are designed to confirm the effectiveness of the treatment, to monitor side effects, and to compare the treatment to standard treatments. These trials may last several years and may involve thousands of patients.

Phase IV trials are also known as post-marketing trials. These are conducted after the treatment has been approved and marketed, to monitor its long-term safety and effectiveness, and to gather additional information about its use in the general population.

These four phases of clinical research are a progressive process that allows researchers to gradually build a body of evidence about the safety and efficacy of a new treatment, and to identify any potential risks and benefits before it is made widely available to patients.

Observational Studies

Observational clinical studies are a type of research that involve collecting data on individuals without administering any interventions or treatments as part of the study. This type of research is used to investigate treatment outcomes, understand the tolerability profile of marketed medicines, and study large, heterogeneous patient populations with complex, chronic diseases. The NIDCR provides tools and templates to help investigators conduct observational clinical studies. These studies are distinct from interventional studies, also known as clinical trials, in which a drug, device, or procedure is administered to research participants as part of a research protocol. Registries, a type of observational study, are also used in clinical research, but the definition and regulatory framework for observational studies vary across countries and regions. Guidelines such as the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement have been developed to help investigators report the results of observational studies.

Real-World Evidence Studies

Real-world data (RWD) refers to data relating to patient health status and/or the delivery of healthcare that is routinely collected from various sources. Real-world evidence (RWE) is the clinical evidence derived from the analysis and/or synthesis of RWD. RWD is often collected in a non-randomized controlled trial (RCT) setting and can come from various sources such as electronic health records, claims data, and patient-generated data. RWE is thought to complement evidence on the efficacy of medications from RCTs and can be used to inform healthcare decisions, drug development, and regulatory approval. The use of RWE in clinical research is increasing and is expected to change how studies are run. Advancements in technology such as artificial intelligence and big data analytics have made it possible to collect and utilize large amounts of RWD. However, there is still a lack of consensus on the definition of RWD and challenges such as data quality and privacy need to be addressed.

III. Key Players in the Clinical Research Industry

The clinical research industry is a multi-billion dollar, multi-disciplinary sector that involves various stakeholders and players. These include pharmaceutical companies, government agencies, regulatory authorities, clinical research organizations (CROs), clinical trial site management organizations (SMOs), ethics committees, investigators, clinical research coordinators, and human volunteers or subjects.

One of the major players in the industry are CROs, which provide a range of services for the drug development process, including trial design, protocol development, regulatory compliance, data management, and monitoring. Another important role in the industry is that of the Clinical Research Associate (CRA), who oversees and reviews site activities for clinical trials via on-site monitoring visits and in-house assessments according to the trial-specific monitoring plan.

Clinical Research Managers also play a significant role in the industry, they are responsible for drafting and supervising study designs, generating case reports and informed consent forms, mentoring clinical research staff, approving budgets, and regulatory documents.

The industry is constantly evolving and embracing new innovations, such as the use of novel solutions and technology to take a hybrid approach to clinical trial design, providing a more flexible system that is better tailored to suit clinical trial subject needs.

The global clinical trials market is expected to grow from $19.84 billion in 2022 to $28.92 billion by 2027, at a CAGR of 7.83%. The high number of clinical trials in Phase III is driving the growth of the market segment.

Overall, the clinical research industry is a complex and dynamic field that requires a wide range of skilled professionals to conduct safe and effective studies to promote the safety and efficacy of new products such as vaccines, drugs, and dietary supplements.

Pharmaceutical and Biotechnology Companies

The biotechnology industry is a rapidly growing field that encompasses a wide range of careers, including biomedical engineering, clinical technology, microbiology, biomanufacturing, epidemiology, and genetic counseling. The industry is expected to see significant growth in the coming years, with the market for biotechnology and pharmaceutical services outsourcing projected to expand at a compound annual growth rate of 5.5% from 2022 to 2030. Many biotechnology companies are focused on developing new therapies and treatments for various diseases, and often rely on partnerships and collaborations with other companies, such as clinical research organizations (CROs), to advance their research and development efforts. The top CROs in the industry include IQVIA, Parexel, Syneos Health, Covance, Icon, PRA Health Sciences, PPD, Chiltern, Fisher Clinical Services, and Medpace. The largest companies in the biotechnology industry are primarily located in the US, China, Japan, India, Australia, and various European countries.

Contract Research Organizations (CROs)

Contract Research Organizations (CROs) are essential players in the clinical research industry. They provide a range of services to support the drug development process, including study design, patient recruitment, data management, and analysis. CROs also have access to specialized equipment and expertise that may not be available in-house at pharmaceutical or biotech companies. By outsourcing these services to CROs, companies can save time and resources while ensuring that studies are conducted to the highest standards. Additionally, CROs can also provide access to a larger patient population for clinical trials, which can accelerate the drug development process. Overall, CROs play a critical role in advancing medical research and bringing new treatments to market.

Academic Medical Centers and Research Institutions

Academic Medical Centers (AMCs) and Research Institutions are key players in the clinical research industry. These organizations have a long-standing tradition of conducting cutting-edge research in various medical fields, and often have access to the latest technologies, equipment and facilities. Furthermore, AMCs and Research Institutions have highly qualified and experienced researchers and physicians who are experts in their fields. These organizations are responsible for many of the groundbreaking discoveries and innovations in the medical field. Additionally, they often have access to large patient populations, which makes them ideal sites for clinical trials and observational studies. The knowledge and expertise of the researchers and physicians at these institutions, along with the resources they have, makes them invaluable partners in the drug development process. Overall, AMCs and Research Institutions play a vital role in advancing medical research and bringing new treatments to market.

Regulatory Agencies

Regulatory Agencies are key players in the clinical research industry, responsible for ensuring the safety and efficacy of drugs, medical devices, and other treatments. These agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), review and approve clinical trial protocols, inspect research sites and monitor ongoing studies to ensure compliance with good clinical practices. They also review and evaluate data from clinical trials to determine whether a new treatment is safe and effective for its intended use. The approval of these agencies is crucial for the commercialization of new treatments, as drugs and medical devices must receive regulatory approval before they can be marketed to the public.

Regulatory Agencies also play a role in providing guidance to industry, academic, and research organizations on how to conduct clinical trials and how to submit their data for review. Additionally, they continuously monitor the safety of products once they are approved and available on the market.

Overall, Regulatory Agencies play a critical role in protecting public health by ensuring that new treatments are safe and effective, as well as providing guidance and oversight to the clinical research industry.

IV. Current Challenges and Opportunities in Clinical Research

Advances in Technology and Data Science

The use of technology and data science in clinical research is rapidly growing, with opportunities to improve efficiency and accuracy in data collection, management and analysis. However, there is also a need to ensure that these technologies are being used ethically and that patient data is being protected.

Patient Recruitment and Retention

Recruiting and retaining patients for clinical trials can be a significant challenge, particularly for studies of rare diseases or conditions. Opportunities exist to improve patient engagement and education to increase participation in clinical trials.

Changes in Regulatory Environment

The regulatory environment for clinical research is constantly evolving, with new guidelines and regulations being introduced. Keeping up with these changes and ensuring compliance can be challenging, but it also presents opportunities for innovation and improved patient safety.

Ethical Considerations

Ethical considerations are a crucial aspect of clinical research, including issues related to informed consent, patient privacy, and protection of vulnerable populations. Opportunities exist to improve ethical standards and ensure that clinical research is conducted in a responsible and ethical manner.

Personalized Medicine and Precision Medicine

Advances in genomics and precision medicine are providing new opportunities for more targeted and personalized treatments. However, there are also challenges in ensuring that these treatments are accessible and affordable for all patients

Emerging Markets and Globalization

The increasing globalization of clinical research presents opportunities to access new patient populations and expand the reach of clinical trials. However, there are also challenges in ensuring compliance with different cultural and regulatory requirements in different countries.

Overall, while there are challenges in the clinical research field, there are also many opportunities for innovation, improved patient outcomes, and advancements in medicine.

V. Conclusion

Future of Clinical Research Industry

The future of the clinical research industry is likely to be shaped by a number of factors, including advances in technology, changes in regulatory environment, and shifting patient demographics.

  1. Advances in technology: The use of technology in clinical research is expected to continue to grow, with increasing use of electronic health records, remote monitoring, and artificial intelligence to streamline the clinical trial process and improve data accuracy and security.

  2. Increased use of real-world data: Real-world data (RWD) and real-world evidence (RWE) is becoming increasingly important in the decision-making process for drug and device development, approval, and reimbursement. This will bring more diverse patient population to the clinical trials and make the trial results more generalizable.

  3. Personalized medicine and precision medicine: Advances in genomics and precision medicine are expected to lead to more targeted and personalized treatments for patients.

  4. Globalization: The clinical research industry is becoming more globalized, with an increasing number of clinical trials being conducted in emerging markets. This presents opportunities to access new patient populations, but also raises challenges in terms of cultural and regulatory differences.

  5. Virtual and remote trials: With the growth of technology and the need to limit physical interactions due to the COVID-19 pandemic, there is an increasing interest in conducting virtual and remote clinical trials. This will allow more patients to participate in trials without the need to travel to a physical location, making it more convenient and cost-effective.

  6. Increased patient engagement: Patients are becoming more involved in the clinical trial process and it is expected that patient engagement will continue to increase in the future, leading to more successful recruitment and increased patient engagement.

Overall, the clinical research industry is facing a number of challenges and opportunities, but it is expected to continue to grow and evolve in response to advances in technology, changes in the regulatory environment, and shifting patient demographics.

Importance of Collaboration and Innovation

Collaboration and innovation are critical for the advancement of the clinical research industry.

  1. Collaboration: Collaboration among different stakeholders such as pharmaceutical companies, academic institutions, regulatory agencies, and patient groups can lead to more efficient and effective clinical research. Collaboration allows for the sharing of resources, expertise and knowledge, which can result in more rapid progress and better outcomes.

  2. Innovation: The clinical research industry is constantly evolving, and innovation is essential for keeping pace with new discoveries and advances in technology. This can include the development of new drugs, medical devices, and diagnostic tools, as well as new trial designs and methodologies.

  3. Partnership: Collaboration and innovation often go hand in hand, and partnerships between different organizations can lead to the development of new treatments and technologies that would not be possible through individual efforts.

  4. Speed up drug development process: Collaboration and innovation can speed up the drug development process and make it more efficient. This can lead to new treatments being made available to patients more quickly, which can have a significant impact on public health.

  5. Cost-effective: Collaboration and innovation can also lead to cost-effective solutions, as shared resources and expertise can reduce the overall cost of research and development.

Overall, collaboration and innovation are vital for the advancement of the clinical research industry and for improving patient outcomes. They are necessary for the development of new treatments, technologies and methodologies that can help speed up the drug development process, reduce costs and improve public health.

Impact on Patient Care and Public Health.

The clinical research industry has a significant impact on patient care and public health.

  1. New treatments: Clinical research is responsible for the development of new treatments and therapies for a wide range of diseases and conditions. This can lead to better patient outcomes and improved quality of life for individuals suffering from these conditions.

  2. Access to cutting-edge care: Clinical research also allows patients to access cutting-edge care and treatments that may not be available through standard medical practice.

  3. Advancements in medical knowledge: Clinical research leads to advancements in medical knowledge and understanding of disease, which can improve diagnosis and treatment for patients.

  4. Public health benefit: Clinical research also has a significant impact on public health, as new treatments and therapies can lead to improved health outcomes for large populations.

  5. Cost-effective: Clinical research can also lead to cost-effective solutions, as new treatments and therapies can reduce the overall cost of healthcare by reducing the need for hospitalization, rehabilitation, and long-term care.

  6. Global health: With the globalization of the clinical research industry, patients in emerging markets also have access to new treatments and therapies which can improve their health outcomes.

Overall, the clinical research industry has a significant impact on patient care and public health. New treatments and therapies developed through clinical research can lead to better patient outcomes, improved quality of life, and cost-effective solutions. This, in turn, can have a positive impact on public health, both locally and globally.

Comments (1)

Anuj Kumar Tripathi
Anuj Kumar Tripathi
Superb Article!
Sat, 28 Jan 2023
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The Importance of Clinical Trial Feedback
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It proposes that: “All medical research subjects should be given the option of being informed about the general outcome and results of the study.”[ii]Writing in the BMJ, clinical research participant Cynthia Chauhan describes the importance of engaging and informing participants: “Including patients’ voices from inception through to the completion of trials, as well as focusing on the emotional, social, and financial aspects of trial participation for patients, can make participation easier for more of us.”[iii]The majority of those involved in clinical trials appear to agree, with 75% of clinical trial participants surveyed in one study agreeing that ‘patients should be informed of trial results’. [iv]So, the question is: what’s the best way to engage and inform those who take part in clinical trials?Effective communicationsFor the inquisitive participant, the results of the majority of clinical trials conducted in Europe and the USA are published and freely available on international databases. 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The EU expects that those running trials will do more than simply post a summary, encouraging them to provide: “direct feedback to patients who have taken part in their trials including an acknowledgement of their contribution and an expression of thanks for their time.” Simply publishing a summary online isn’t enough.[ix]Every clinical trial should be accompanied with a communications plan that identifies your key audiences, stakeholders and communications methods. The Communications Handbook for Clinical Trials proposes that communication with participants should be considered a key priority, and one of the first – and most important – actions in this plan.[x]Within the accompanying plan, those running trials should use various methods to engage participants, including newsletters, websites, social media and direct communication. 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Available from: [Last accessed: 18.12.2017][x] Communications Handbook for Clinical Trials: Strategies, Tips, and Tools to Manage Controversy, Convey Your Message, and Disseminate Results. Online. Available from: [Last accessed: 18.12.2017][xi]

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The Rise of Home Diagnostics in Clinical Trials
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The field of home diagnostics has seen significant innovation and advancement in the past few decades – and in the wake of the COVID-19 pandemic, the growing use of home testing has allowed important clinical research to continue remotely.The advantages of embracing remote trial protocols are substantial, suggesting that the adaptations made in response to COVID-19 are part of a broader move towards decentralizing trials and clinical research. 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In addition, highly customized home collection kits allow patients to collect and submit their own biological samples directly for laboratory testing, removing the need for clinicians to manage the preparation, packaging, and shipping of samples. As clinical research adopts remote testing and patient monitoring as standard protocol, the clinical trial landscape will need to adjust to help see trials and research to successful outcomes. The advantages of home diagnosticsFor clinicians and health care practitioners (HCPs) alike, home diagnostics offers a host of benefits:Easing strain on healthcare systems – as at-home testing and monitoring becomes more affordable, faster, and more accurate, this can ease pressure on HCPs managing heavy workloads – particularly when it comes to routine testing and patient monitoring.Improving and increasing telemedicine – many medical appointments are now conducted over phone or video chat, and home diagnostics lets HCPs request tests remotely, reducing the need for patients to visit clinics and hospitals.Personalizing patient care – home diagnostics improves clinicians’ ability to offer faster and better-targeted medical care and gives patients a more accessible and personalized approach to managing their own individual healthcare.Improved patient experience in clinical trials – home testing can eliminate the need for time-consuming site visits, reducing the burden on patients who may be either too busy to miss work for appointments, or too unwell to leave home for travel.Better patient enrollment and retention in clinical trials – making the trial process easier on participants increases patient enrollment and retention, reducing the commercial impact associated with patients dropping out of trials.Cost reduction in clinical trials – with fewer and smaller clinical sites required, it becomes easier and less costly for trials to scale up studies for larger regions and bigger patient pools. Logistical challenges for clinical researchersThe logistics of implementing at-home testing involve a number of key considerations for clinicians and trial service providers alike, including:Getting the right kits to the right patients at the right time – at-home testing necessitates careful logistics management, particularly for large-scale studies, that clinicians may lack the expertise to undertake. Working with experienced providers capable of managing quick turnarounds and accelerated timelines will help clinicians deal with these emerging logistical challenges.Participant coaching – patients need to be guided in how to administer tests and study drugs at home. Clinicians may need to provide in-person or video training, and clear at-home kit and testing design is needed to make the process as simple as possible for trial participants.Tracking and tracing of clinical samples – to preserve the integrity of clinical materials, trial sample kits must be properly labeled and assembled, with clear instructions for use and automated tracking to mitigate the risk of human error.Inventory tracking – in order to manage the supply and distribution of testing and drug administration kits, inventory must be carefully monitored. Use of an external system, such as PASSPORT™ from Avantor Clinical Services, can greatly reduce the logistical burden that at-home testing places on clinicians.Preservation of sample integrity through the shipping process – kits must be properly assembled to make sure samples are securely packaged for their return, including the option of refrigerated shipping to keep samples at optimal temperature during the journey from home to lab.Data and privacy concerns – to guarantee patient privacy and data security, labeling and indexing must be carefully managed throughout the shipment, collection, and storage of all patient samples and data, to accurately record the source of such samples, where appropriate, or to anonymize or blind samples in other cases. What home diagnostics means for clinical trialsThe field of home diagnostics has the potential to ease the transition from traditional on-site clinical research models into a remote approach that takes advantage of improved health technologies. Combined with the increased use of mHealth tools such as wearables and smartphone apps, and the adoption of telemedicine, home diagnostics will play a vital role in enabling trial protocols to shift towards a decentralized approach. With significant clinical advantages to be gained by using home diagnostics – particularly as COVID-19 necessitates a remote approach to clinical research – it’s important that clinical trial managers and clinical service providers work together to manage the fast-changing needs of the trial landscape. At Avantor Clinical Services, we have been able to move quickly to help identify the resources needed for at-home testing and expedite the provision of kits for collecting at-home patient samples in a COVID-19-related study. These kinds of interventions will be crucial in adapting home testing to the meet the changing needs of clinical trials in future. SummaryAs the field of clinical research responds to changing circumstances in light of global health concerns, home diagnostics is one tool among many that will facilitate remote clinical research, but it is an essential one. Decreasing or eliminating the need for on-site visits will improve patient enrollment and retention and reduce the cost of research studies – enabling trials to progress quickly and efficiently, and ultimately get important treatments to market faster.  This article has been produced by Avantor Clinical Services as part of our ongoing commitment to creating a better world through the delivery of mission-critical products and services. To learn more, contact us today ReferencesErin Blakemore. This Is What the First Home Pregnancy Test Looked Like. June 2015. Accessed May 2020.Mobolaji Ibitoye, Timothy Frasca, Rebecca Giguere, and Alex Carballo-Diéguez. Home Testing Past, Present and Future: Lessons Learned and Implications for HIV Home Tests (A Review). May 2014. Accessed June 2020.Global Home Diagnostics Market is Expected to Reach USD 6.53 Billion by 2025: Fior Markets. August 2019. Accessed May 2020.The Medical Futurist. Digital Skin Care: Top 8 Dermatology Apps. June 2019. Accessed June 2020.

Tue, 24 Jan 2023

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