|
Bankers Clinical Research
|
|
|
|
What is Clinical Research?
|
|
Clinical Research is the study of new therapies and/or medical devices and better
ways of using current medicines which may improve treatment or prevention of a disease.
It is a branch of medical science that determines the safety and effectiveness of
medications, devices, diagnostic products and treatment regimens intended for human
use. These may be used for prevention, treatment, diagnosis or for relieving symptoms
of a disease. Studies performed in humans that are intended to increase knowledge
about how well a diagnostic test or treatment works in a particular patient population.
Participation by patients and physicians is essential for the development of new
drugs and medical devices. Several trials may take place over a period of time until
a new drug or device is approved and becomes available to our patients by prescription
|
|
Clinical trial is an experiment performed on human beings in order to evaluate the
comparative efficacy of two or more therapies. Clinical trials are research studies
used to find out if new treatments work better, the same, or worse than the standard
treatment for the same disease. Clinical trials are strictly monitored and carefully
evaluated on both national and local level.
|
|
Changing face of Clinical Research in India
|
|
The concept and understanding of clinical trials has undergone a drastic change
in recent times. Clinical trials were once thought to be a last resort for people
who had run out of treatment choices. Today many patients are choosing to receive
their first treatment in a clinical trial. Patients now understand that participation
in a study is a matter of choice and not compulsion. |
|
Clinical trials are divided into phases: |
|
Phase I:
|
|
In these studies, researchers look for the best way to present a new treatment and
to determine how the treatment can be given safely. These studies usually include
only a limited number of patients who would not be helped by other known treatments. |
|
Phase II:
|
|
Phase II trials focus on learning whether the new treatment has an effect on a particular
disease and researchers watch for any harmful side effects. As in Phase 1 trial,
only a small number of people take part because of the risks and unknowns involved.
|
|
Phase III:
|
|
These trials compare the results of people taking the new treatment with results
of people taking standard treatment. In most cases, studies move into Phase III
studies only after a treatment shows promise in Phases I and II. Phase III trials
may include hundreds of people around the country and is conducted on a larger scale. |
|
Phase IV:
|
|
Phase IV trials are used to further evaluate the long- term safety and effectiveness
of a treatment. Less common than phase I, II and III trials, phase IV trials take
place after the new treatment has been approved for standard use. |
|
Bankers Heart Institute's Initiative
|
|
Human life is at stake here. Hence, the entire complex process of Drug Development
focuses on a need to group the best of medical expertise, experience and infrastructure
to test a drug for efficacy and safety before it is introduced into the market.
New treatments and medications developed by researchers are carefully tested; safety
for each and every patient is our primary concern, and is guided by strict U.S.
Food and Drug. |
|
We, at Bankers Clinical Research are actively involved in various multi phase multinational
trials.
|
- We influence the future of drug availability and cost for our own and other patients
- We maintain the forefront of knowledge in our profession and specialty in order
to provide the best and most up-to-date treatment for our patients
- We enable patients and medical staff to gain firsthand knowledge of promising new
drugs and devices
- We make available to our patients otherwise unobtainable medications
- We make a contribution to medical progress and advancement
|
- High Level of Patient Care
An important benefit to participating in a Banker clinical trial is the high level
of patient care. Patients who participate in clinical trials are closely monitored
and guided through treatment by clinical trial staff in addition to your doctor
and his/her staff.
- Access to Promising New Treatments
Being in a clinical trial means you might receive a treatment that doctors's hope
will be better than the standard treatment. These treatments may not be available
outside of a clinical trial.
- Paving the Way for Better Treatments
Clinical trials are the only way we will ever ultimately find a cure for many diseases.
Fewer than 5% of adults with cardiac diseases are currently receiving treatment
as part of a clinical trial.
|
|
Rational for conducting Trials at Bankers Clinical Research
|
|
Association with Bankers Heart Institute, which is one of the most advanced cardiac
hospital in Gujarat with over 20 satellite centres across Gujarat, Madhya Pradesh
and Rajasthan. |
|
Why Bankers Clinical Research is the pioneer?
|
- Infrastructure facilities for the ethical conduct of clinical trial activities is
the topmost.
- Experience in handling the Industry standard of documentation and audit.
- Large pool of patients and disease of different specialties.
- Lower cost of approximately 50 ? 60 % less than other countries for conduction of
trials.
- Steady speed of target oriented patient recruitment with high retention.
- Dedicated research team
- Super specialty tertiary care hospital with high end equipments and advanced technology
- Multilingual communication skills, especially English
- GCP trained Investigators and clinical research staff
- State of the art diagnostic and therapeutic laboratories
- IT & Telecom infrastructure, especially on data base, data mining, Clinical Data
Management and integrated medical records management with Hospital Information System
- Easy archival with confidentiality maintenance
- Site Management to coordinate and facilitate the ethical conduct of clinical trial
activities , as per ICH - GCP & National guidelines.
|
|
Responsibilities of Bankers Clinical Research |
|
To the Sponsor: |
- Ensure timely conduct of the study and prepare the site for post trial audit
- Coordination for non disclosure agreement between PI and sponsor
- Feasibility questionnaire accomplishment
- EC application processing
- Documents collation and dispatch to sponsors as per Schedule Y ? ICMR / GCP / CFR
guidelines
- Cost Estimate and negotiation with sponsor
- Provision of Sub Investigators / Clinical Research Coordinators / Study Nurses.
etc
- Coordination, Monitoring and Drug Accountability maintenance
- Maintaining records on Clinical trials, finance and adverse events
- Filling of CRF (paper / e ? CRF)
- Reporting of SAE
- Coordination and follow up with the subject for the trial
- Coordination for meetings between PI and the Sponsor/CRO
|
|
To the Hospital |
- Increasing the scientific image
- Meet obligations of regulatory bodies, financial monitoring and patient rights
- Follow ICH-GCP guidelines and ICMR guidelines
- Bridge the gap between the Hospital, PI and the Sponsor
- Help PI to screen potential patients
- Selecting Study Coordinator / CRA / relevant study team members
- Assistance in completing feasibility questionnaire
- Assistance in EC application and EC approval process
- Drug accountability
- Filling CRF and diary maintenance
- Assistance in Patient counseling for Informed Consent.
- Coordination between the courier for collection and transportation of blood samples
to in-house lab/central lab
- Scheduling patient visits and follow up
- Assisting and maintaining the study file note
- Update patient tracking log to the sponsor company
|
|
To PI: |
- A bridge between Sponsor, Hospital, Patient and other team members
- Assistance to PI in coordinating and facilitating logistics and support services
for ethical conduct of Clinical Trials
- Patient recruitment & retention with GCP compliance at all Apollo Hospital sites
|
|
To Patients: |
- Reimbursement as per GCP
- Assistance in counselling on Informed Consent, patient information sheet, diary,
etc.
- Organizing patient visits
- Personal / telephonic follow up of patient visits with experienced Social Workers
- Drug disbursement and follow up with accountability maintenance
|
