Clinical Research

A Legacy of Innovation: Artemis Clinical Research Department 

“Clinical Research is not only a win over disease but a victory for our future Mankind”

Founded in 2007, the Artemis Clinical Research Department was born from the visionary dream of Mr. Onkar Kanwar, Chairman of Apollo Tyres Ltd and Artemis Medicare Services Limited. Driven by a passion for improving patient care through groundbreaking research, he envisioned a world-class center equipped with cutting-edge technology, advanced infrastructure, and renowned scientific minds. Under the leadership of Dr. Devlina Chakravarty, Managing Director of Artemis Medicare Services Limited, Artemis Hospitals are committed to excellence, innovation, and compassionate care, consistently achieving new heights of success each year.

 Clinical research is a method of determining a drug's safety and efficacy by observing its effects on a large group of people. The regulatory (DCGI/FDA/EMA) approves the pharmaceuticals after the trials are done, and only then do pharmaceutical companies produce or market the drugs. The economical and diversified patient pool allows global corporations to set up research facilities in India.

We are a leading center for Phase I-IV clinical trials across diverse therapeutic areas, including Oncology, Cardiology, and more. Currently, we are actively conducting 42 trials, demonstrating exceptional recruitment success in numerous high-profile studies, such as Keynote-593, Alirocumab, Acute lymphocytic leukemia(ALL) and Inotuzumab (where we were the highest recruiter in the Asia-Pacific region).

Key milestones include the successful implementation of T-DXD for HER2-positive breast cancer, resulting in a remarkable recovery success rate. These achievements underscore our commitment to delivering high-quality research outcomes that advance medical knowledge and improve patient care.

Ethical approval is paramount to our clinical research. Our DHR- the Department of Health Research  and NABH- National Accreditation Board for Hospitals & Healthcare Providers, accredited Ethics Committee provides rigorous oversight, ensuring that all trials comply with national and international regulations. This multidisciplinary team of experts safeguards participant rights and welfare, making ethical approval a mandatory step before any trial commences.

 1. What is clinical research/ clinical trial?

Clinical trials are a type of research that studies and establish the safety and efficacy of any new drug/device/treatment regimen in human population (healthy or sick people). Clinical trials are carefully designed, conducted, documented and reported to ensure the rights, safety and well being of the trial subjects. Clinical Trials are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment.

2. What are the phases of clinical trial?

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

There are 4 phases of clinical trials:

Phase I studies (Human Pharmacology) usually test new drugs for the first time in a small group of healthy volunteer except HIV & Cancer studies (20 to 100) to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a drug.

Phase II studies (Therapeutic Exploratory) test treatments that have been found to be safe in phase I but now need a larger group of human subjects to monitor for therapeutic index and adverse/side effects.

Phase III studies (Therapeutic Confirmatory )are conducted on larger populations and in different regions and countries, and are often the step right before a new treatment is approved for marketing.

Phase IV studies (Post Marketing) take place after country approval and there is a need for further testing in a wide population over a longer time frame.

3. What are the possible advantages and risk of participating in a clinical trial?

Possible Advantages of participating in Clinical Trial: 

·       Long term societal gains through better health outcomes and improving treatment options.

·       Gain access to new research treatments before they are widely available. 

·       Obtain expert medical care at leading healthcare facilities during the trial.

·       Facilitates medical knowledge dissemination and innovation.

Possible risk of participating in Clinical Trial:

·       The new treatment may cause side effects or be uncomfortable.

·       The new treatment may not work, or it may not be better than the standard treatment.

·       Patients can have more frequent visits for trial related procedures.

FAQ

1. Can a participant leave a clinical trial after it has begun?

Yes. Participating in clinical trial is always voluntary. A participant can leave a clinical trial, at any time without any penalty and without compromising on treatment outside the trial.

2. Will I be treated as a guinea pig?

No, you will not be treated as a guinea pig. There would be some extra activities or certain additional tests which you may have to undergo during your participation in the clinical trials. All this would be performed under excellent care providers while you are in the study. All trial participants are treated honestly and ethically. There are strict guidelines which are being followed to ensure participant’s rights, safety and well-being.

3. How will Safety and Privacy Be Protected?

The trial follows a carefully controlled protocol approved by regulatory authority (DCGI) and ethics committee experts and all personal information is protected in compliance with relevant laws.

4. What is an informed consent?

Informed Consent Form (ICF): A process by which a Subject voluntarily confirms his or her willingness to participate in a specific trial, after being informed of all aspects of the trial that are relevant to the Subject's decision to participate, including the right to withdraw at any time without any reason. The ICF clearly mentions the contact details of the study investigator (treating doctor), ethics Committee, and research team whom participants can contact if they have concerns about their health.

5. What is a placebo?

The placebo usually looks like the drug or other treatment being studied, but it has no active ingredients. Placebo means an inactive substance visually identical in appearance to a drug being tested in a clinical trial.

6. Who regulates Clinical Trials in India?

The Drugs Controller General of India (DCGI), the head of the Central Drugs Standard Control Organization (CDSCO), is the ultimate regulatory authority for the approval of clinical trials in India. All clinical trials must comply with the New Drugs and Clinical Trials Rules 2019.

8. How much is the cost of participating in a clinical trial?

Participating in clinical trial will not cost you anything.

9. Do I need to pay the cost of treatment during participation?

Every clinical trial is different. You need not have to pay for all study related medicines/procedures/investigations performed; however for non-study related procedures/investigations you have to pay the cost. Some studies reimburse associated travel costs as well.

10. What happens if I am harmed or injured during the study?

As per NDCT rule 2019(chapter VI-Seventh Schedule- Rules 39, 40& 42) there is provision for determine the quantum of compensation in cases of clinical trial related injury or death.

For more details about ongoing trials at Artemis Hospital refer mentioned link: https://ctri.nic.in/Clinicaltrials/login.php

Our Clinical Trials Accomplishment 

Our Clinical Research experience in many therapeutic areas 

Course & Training- “Industry-Academia Association”

An investment in KNOWLEDGE Always pays the best INTEREST

Artemis Hospital is pioneering innovative initiatives in nursing, paramedical education, and allied training. Since 2009, we have successfully launched DNB, PGDCC, and paramedical certification courses. Building on this momentum, we are introducing a certification course in clinical research from 2023 onwards to establish an academic portfolio to narrowing the gap between the academic training & clinical research industry needs & demand and to shape applicant’s future with planned career guidance.

Key Feature

Orientation (1st Day )

Instructional Period (class room teaching & self reading modules)

Assignment

Evaluation

Course Overview – “Advanced Certificate Course in Clinical Research” (ACCCR)

The Advanced Certificate Course in Clinical Research (ACCCR) is a comprehensive one-year program designed to equip you with the theoretical knowledge and practical skills needed to excel in the healthcare field. With a strong focus on industry relevance, our program offers:

• Hands-On Experience: Gain invaluable practical exposure through clinical research activities at Artemis Hospital, applying learning in real-world settings.
• Expert Guidance: Learn from renowned professionals from Artemis Hospital and Industry expert’s who bring their expertise to the classroom.
• Comprehensive Curriculum: Cover essential topics such as research methodology, ethics, regulatory affairs, data management, latest technologies and clinical trial design etc.
• Dedicated Career Support: Benefit from our commitment to securing meaningful employment opportunities for all graduates.

Industry-Aligned Curriculum

Our certification course is carefully designed to meet the evolving needs of the clinical research industry. You'll develop the skills and knowledge necessary to become a highly skilled and informed clinical research professional.

Key Course Topics

• New Drug Development Process
• Essential Clinical Trial Documents
• Roles and Responsibilities of Key Players
• Clinical Trial Process Cycle
• Current Regulations and Guidelines
• Safety Reporting Process
• Case Studies-Based Training
• Electronic Submission (Screening, Randomization, IP Dispensing, etc.)

Progression: To progress through the program, applicants must thoroughly understand each module. A mandatory assignment must be completed after finishing each module.

A minimum score of 50% on the assignment is needed to move on to the subsequent module.

Admission Criteria

1. The course shall be open to a candidate who have passed MBBS / BDS / BAMS / BUMS / BVSc./B.Pharm/BSc-Nursing/MPT/ BPT/ BSc-Occupational therapy /BSc- speech therapy / BSc-Medical Lab Techniques/BSc with Biochemistry/ Biotechnology/ Microbiology/ Zoology/ Bioinstrumentation or any other life sciences/ allied health sciences or equivalent examination from a statutory Institution/University  with minimum 50 % marks.

2.A written entrance exam with a minimum passing score of 50% is required for admission to the Advanced Certificate Course in Clinical Research. The exam will cover basic science subjects including zoology, botany, and chemistry.

3.The minimum age for admission shall be 21 years on or before 31st Dec. of the year of admission.

4.Medium of instruction and examinations: English

ORDINANCE-

 Project Submission:  After finishing the course, applicants are required to submit their projects: one copy to Gurugram University and one copy to the Artemis Clinical Research Department.

Unique Feature of  “Advanced Certificate Course in Clinical Research”

The Advanced Certificate Course in Clinical Research at Artemis Hospital goes beyond traditional programs to prepare you for immediate success in the dynamic clinical research field. Here's what sets us apart:

1. Real-World Experience: Our program provides a plethora of live projects to give you hands-on experience. This live practical training simulates real-world scenarios, ensuring you're well-equipped for the demanding clinical research industry.

2. Industry Expert Mentorship: You'll gain invaluable insights from leading industry professionals. Our instructors are seasoned clinical research experts who will provide industry-specific training and guidance to help you navigate the complexities of the field.

In a nutshell:

• Expert-Led Instruction: Learn directly from industry professionals.
• Comprehensive Curriculum: Master key concepts and gain practical skills.
• Interactive Learning: Engage in hands-on activities and real-world projects.
• Career Support: Get the resources you need to land your dream job.

 This unique combination will enhance applicants resume, make them a standout candidate, and equip with the confidence to thrive in your clinical research career.

State-of-the-Art Facilities

Smart classroom and world-class NABL-accredited laboratory facilities, including Histopath Lab, Radiology Lab, Pathology Lab, and Research Lab, provide with access to the latest medical technology and esteemed scientists. This hands-on experience will deepen your understanding of clinical research practices.

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