Clinical Research

ABOUT DEPARTMENT

OVERVIEW

Radiant Superspeciality Hospital (RSH)- Clinical Trail Research (CTR) has been constituted in the year 2018, under the able leadership of Executive Director Dr. Sikandar G. Adwani
The Research Mission of RSH-CTR is to undertake and promote excellence in clinical research and to foster and support patient care and treatment. At RSH-CTR, Pharma-sponsored, Investigator-initiated and Academic research projects provide the foundation for the research activities. These projects are complemented by large organizational projects, population-based epidemiologic studies, community-based intervention programs, multicenter controlled clinical trial, and research training programs.

Clinical Trial

SPECIAL FEATURES OF RSH- Clinical Trail Research:

  • Experienced and GCP trained Research Investigators assisted by a dedicated and full time GCP trained Research Team.
  • Spacious working area with facilities for storage, audit and archival of research related activities
  • Updated SOPs in accordance with national and international regulations.

Research activities includes but not limited to the following main areas of particular scientific and clinical interest:

  • Centre for Accident & Emergency
  • Centre for Children
  • Centre for Diabetes and Obesity
  • Centre for Neurosciences
  • Centre for Cardiac Sciences
  • Children’s Heart Centre
  • Critical Care
  • Centre for Mother & Child
  • Centre for Physical Medicine & Rehabilitation
  • Centre for Internal Medicine
  • Centre for Gastroenterology

The main objective of the department is to

  • Set directions, priorities and thrust areas for Research
  • Periodically review the progress of Scientific and Clinical Trial Research Projects.
  • Suggest and review Research Proposals within RSH and in collaborations with other National and International Organizations.
  • Review sponsored (Pharma Sponsored, Govt Sponsored etc.) Research Proposals for feasibility and conduct at the Institute.
  • Coordinate the functioning of committees for research and ethics in RSH

General Information

Clinical studies helps to bridge research and patient care by evaluating therapies, drugs and diagnostic tools to give way to discoveries that might be of benefit to the human patients in future.
Clinical trials are used to test the safety and effectiveness of drugs and devices. Usually, they are sponsored by pharmaceutical companies and are conducted by research teams that include doctors and other medical professionals. Clinical trials are typically conducted in four phases:

– Phase I is when generally healthy people are given the medication to test if the ingestion of the pill or treatment will have no adverse and/or toxicological effect and that it is absolutely safe to be used in human patients.
– Phases II and III involves deeper evaluation regarding the safety, effectiveness, and dosage of the medication. It’s after these stages that the country drug regulator would approve the drug or device.
– Phase IV examines and conducted to collect more information for previously approved treatments.
All of the phases in clinical trial is governed by strict protocols, and are overseen by many regulatory bodies, from the Drug Controller General of India to Institutional Ethics Committee (DCGI). DCGI are a group of independent medical experts, ethicists, as well as lay person. Researchers periodically report to the IEC regarding entire conduct of the study which includes the tests involved in the study, the results recorded and even the side effects reported. According to the recent regulations, IEC now needs to be accreditated with NABH. (National Accreditation Board for Hospitals)

INSTITUTIONAL ETHICS COMMITTEE (IEC)

Institutional Ethics Committee is an independent body constituted of medical, non-medical, scientific and non-scientific members whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in the trial by, among other things, reviewing, approving and providing continuing review of trial protocols and amendments.
Timely reviews and safeguarding of high ethical standards formed the basis of the IEC review process which are essential for clinical research including student research, investigator initiated research and multi-centric multinational research.

Our Ethics Committee :
No.NameQualificationsIEC Designation
1.Dr.Sanket PandeMBBS.MD.
(Pediatrics)
Chairman
2Dr.Madhuri AgrawalMBBS.DCH.DNB
(Pediatrics)
Member Of Secretary
3.Dr.Kishor BansodMBBS.MD. (Pharmacology)Basic Medical Scientist
4.Adv.Nilesh AhujaB.S.L. L.L.B.Leagal Expert
5.Dr.Amit AchliyaMBBS.MD.
(Medicine)
Clinician
6.Mrs.Anita PatilBA.MA.M.Lib. SETLay Person
7.Ms.Sushama KingaonkarB.sc. MSWSocial Scientist
8.Dr.Rewati DhawleMBBS.DGOClinician
9.Dr.Anuradha KakaniMBBS.MD.DGO (Obstetrician & Gynecology)Clinician
10.Dr.Ashish DagwarMBBS. MS.Scientific Member

RIGHTS AND RESPONSIBILITIES OF RESEARCH PARTICIPANT

– Right to voluntary participation in research study.

– Right to know about Institutional Ethics Committee and its responsibilities towards protecting patients rights, safety and well-being involved in a research project and to provide public assurance of that protection

– Right to information about Research Study in an understandable language.

– Right to informed consent and if necessary audio-video consenting before participation in any Research Study.

– Right to refusal of participation or withdrawal of participation at any point in the study without disclosing any reason.

– Right to receive quality healthcare in a safe, clean environment without discrimination because of race, age, color, religion, nationality, culture, ethnicity, language, disability, sex or manner of payment.

– Right to be treated with dignity, respect and courtesy in a non-judgmental and non-threatening manner.

– Right to information regarding investigational product, duration of study, treatment option available as per standard of care, anticipated expenditure, information on medical management of any injury and compensation in case of any study related injury or death or any compensation provided for participation in an understandable language.

– Right to be informed of the risks, benefits and alternatives of proposed treatment

– Right to privacy and confidentiality.

– Right to be informed on how to voice a complaint to express concerns, violation of your rights and/or grievance and seek redressal

– Right to participation in research and innovative therapies.

– Right to consent for diagnostic and therapeutic procedures.

– Right to access clinical records

– Right to get 24 hours emergency contact details of Research doctor

– Right to get contact details of Chairperson and Member Secretary of Institutional Ethics Committee.

Responsibilities & role of Research Participant

– To provide correct and complete demographic information including full name, age, address, telephone number and e-mail ID (if available)

– To be compliant with research protocol and procedures

– To ask question when he/she does not understand what the doctors, research study team, or other healthcare team members tells about diagnosis or treatment

– To inform your research study doctor and research study team, immediately in case of any injury or development of any new medical conditions

– Not to take any medications without the knowledge of research doctor and research study team

– To disclose to doctors and research study team if currently part of any other Clinical Trial or had participated in any other Clinical Trial in last one year

– Provide complete and accurate information about your health including your previous medical history, and all the medications that you are presently taking including alternative treatments like Ayurveda, Homoeopathy, Unani or herbal medications, all records of previous investigations and treatment and of allergic reactions, especially sensitivity to any drug

– Right to information regarding investigational product, duration of study, treatment option available as per standard of care, anticipated expenditure, information on medical management of any injury and compensation in case of any study related injury or death or any compensation provided for participation in an understandable language.

– To follow instructions, advice and restrictions regarding treatment plan and visit schedules

– To treat hospital staff and study team with courtesy

FIND CLINICAL TRAILS
No.InvestigatorSpecialityStudy NameCompany NamePhaseTypeStatus
1.Dr.Sikandar G. AdwaniNeurologyA Double Blind,Double-Dummy Randomized Prospective, Two Arm, Parallel, Multicenter Phase VI Clinical Trail To Evaluate and Safety Of Gabapain NT (Fixed-Dose Combinatation of Gabapain And Nortriptyline) In Comparison With Gabapain In Patients With Neuropathic Pain” NAME OF DRUG-Gabapain NTLAMBDA THERAPEUTIC RESEARCH LTDIVNationalCompleted
2.Dr.Anand B. KakaniNeurosurgeryA Prospective, Multi-Centric, Randomized, Double-Blind, Parallel, Phase-III Study To Assess Efficiency Of Pmz-2010 As A Resuscitative Agent For Hypovolemic Shock To Be Used As An Adjuvant To Standard Shock Treatment NAME OF DRUG- Lyophilized Centhaquin Citrate Injection (PMZ-2010)PHARMAZZ INDIA PRIVATE LIMITEDIIINationalCompleted
3.Dr.Sikandar G. AdwaniNeurologyA Prospective, Multi-Centric, Randomized, Double-Blind, Parallel, Phase-Iii Study To Assess Efficiency Of Pmz-1620 Along With Standard Treatment In Patients Of Acute Ischemic Stroke. NAME OF DRUG-IRL-1620 For Injection (PMZ-1620)PHARMAZZ INDIA PRIVATE LIMITEDIIINationalOngoing