The document provides an overview of clinical trial statistics and regulatory updates from India. It discusses the increasing number of registered ethics committees in India and importance of quality and compliance. The newsletter also highlights key metrics sites should focus on to improve performance and notes recent Indian regulatory milestones related to clinical trials. Additionally, it briefly summarizes an FDA approval of a new drug and a platform aiming to improve patient recruitment for clinical trials.
A Pharma/CRO Partnership in the Design and Execution of Paperless Clinical Tr...Target Health, Inc.
DIA 2019 presentation by Dr. Jules Mitchel with Michelle Eli (Lilly) and Tom Haag (ex-Novartis) based on their experience with Lilly collaborating on Target Health's paperless clinical trial system.
A Pharma/CRO Partnership in the Design and Execution of Paperless Clinical Tr...Target Health, Inc.
DIA 2019 presentation by Dr. Jules Mitchel with Michelle Eli (Lilly) and Tom Haag (ex-Novartis) based on their experience with Lilly collaborating on Target Health's paperless clinical trial system.
Guidance for Industry Electronic Source Data in Clinical InvestigationsCRF Health
This guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations.2 In an effort to streamline and modernize clinical investigations this guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission.
Office of Inspector General Study on OCR's HIPAA audit programdata brackets
Office of Inspector General: OCR should strengthen its oversight of covered entities' compliance with the HIPAA privacy standards.
OIG has recently completed a study of OCR's HIPAA audit program and published the following recommendations:
(1) OCR should fully implement a permanent audit program
(2) OCR should maintain complete documentation of corrective action
(3) OCR should develop an efficient method in its case-tracking system to search for and track covered entities
(4) OCR should develop a policy requiring OCR staff to check whether covered entities have been previously investigated
(5) OCR should continue to expand outreach and education efforts to covered entities. OCR concurred with all five recommendations and described its activities to address them.
OCR's chief Jocelyn Samuels has concurred with all the recommendations of OIG.
For the complete report please visit our slideshare page:
Full description of the regulatory process for the medical devices registration in South Korea. It contains information about: classification, substantial equivalence, product license, testing, Korean Good Manufacturing Practice (KGMP)...
Find more on: http://kobridgeconsulting.com/?p=767
An institutional review board, or IRB, is a group of experts who are appointed to monitor and review biomedical research involving human subjects at a facility. An IRB plays an important role for medical device manufacturers as they will oversee any clinical research activities in order to protect the rights of the human research subjects...
Medical device as per india and usa special reference with 510(k)vikash vyas
1. medical device as per usa:
a) classification
b) 510(k)
c) 510(k) submission process
d) pre market approval(PMA)
2. medical device as per india
a) definition
b) organization of medical device reviewer
c) registration process
d) document required for the registration of medical device as per cdsco
Nowadays, health is given much priority in all aspects. The present
generation is very much conscious about having periodic checkups
and maintaining a good health. This awareness has given an upper
hand to the medical equipment business. The healthcare industry is
booming like no other field and because of this, Medical Device
Regulation India has also become equally complicated. Unlike
previous years, nowadays most medical devices are required to be
registered and need approval for business
Guidance for Industry Electronic Source Data in Clinical InvestigationsCRF Health
This guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations.2 In an effort to streamline and modernize clinical investigations this guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission.
Office of Inspector General Study on OCR's HIPAA audit programdata brackets
Office of Inspector General: OCR should strengthen its oversight of covered entities' compliance with the HIPAA privacy standards.
OIG has recently completed a study of OCR's HIPAA audit program and published the following recommendations:
(1) OCR should fully implement a permanent audit program
(2) OCR should maintain complete documentation of corrective action
(3) OCR should develop an efficient method in its case-tracking system to search for and track covered entities
(4) OCR should develop a policy requiring OCR staff to check whether covered entities have been previously investigated
(5) OCR should continue to expand outreach and education efforts to covered entities. OCR concurred with all five recommendations and described its activities to address them.
OCR's chief Jocelyn Samuels has concurred with all the recommendations of OIG.
For the complete report please visit our slideshare page:
Full description of the regulatory process for the medical devices registration in South Korea. It contains information about: classification, substantial equivalence, product license, testing, Korean Good Manufacturing Practice (KGMP)...
Find more on: http://kobridgeconsulting.com/?p=767
An institutional review board, or IRB, is a group of experts who are appointed to monitor and review biomedical research involving human subjects at a facility. An IRB plays an important role for medical device manufacturers as they will oversee any clinical research activities in order to protect the rights of the human research subjects...
Medical device as per india and usa special reference with 510(k)vikash vyas
1. medical device as per usa:
a) classification
b) 510(k)
c) 510(k) submission process
d) pre market approval(PMA)
2. medical device as per india
a) definition
b) organization of medical device reviewer
c) registration process
d) document required for the registration of medical device as per cdsco
Nowadays, health is given much priority in all aspects. The present
generation is very much conscious about having periodic checkups
and maintaining a good health. This awareness has given an upper
hand to the medical equipment business. The healthcare industry is
booming like no other field and because of this, Medical Device
Regulation India has also become equally complicated. Unlike
previous years, nowadays most medical devices are required to be
registered and need approval for business
The mission of the Clinical Trials Registry-India (CTRI) is to ensure that all clinical trials conducted in India are prospectively registered, i.e. before the enrolment of the first participant. Additionally, post-marketing surveillance studies, BA/BE studies as well as clinical studies as part of PG thesis are also expected to be registered in the CTRI. The vision of the CTRI is to ensure that every clinical trial conducted in the region is prospectively registered with full disclosure of the trial data set items. While this register is meant primarily for trials conducted in India, the CTRI will also accept registration of trials conducted in other countries in the region, which do not have a Primary Registry of its own, provided ethics approval (in English) is available and the study has not begun enrolling. The Clinical Trials Registry- India (CTRI), hosted at the ICMR's National Institute of Medical Statistics (http://icmr-nims.nic.in), is a free and online public record system for registration of clinical trials being conducted in India that was launched on 20th July 2007 (www.ctri.nic.in). Initiated as a voluntary measure, since 15th June 2009, trial registration in the CTRI has been made mandatory by the Drugs Controller General (India) (DCGI) (www.cdsco.nic.in). Moreover, Editors of Biomedical Journals of 11 major journals of India declared that only registered trials would be considered for publication1, 2.
Today, any researcher who plans to conduct a trial involving human participants, of any intervention such as drugs, surgical procedures, preventive measures, lifestyle modifications, devices, educational or behavioral treatment, rehabilitation strategies as well as trials being conducted in the purview of the Department of AYUSH (http://indianmedicine.nic.in/) is expected to register the trial in the CTRI before enrollment of the first participant. Trial registration involves public declaration and identification of trial investigators, sponsors, interventions, patient population etc before the enrollment of the first patient. Submission of Ethics approval and DCGI approval (if applicable) is essential for trial registration in the CTRI. Multi-country trials, where India is a participating country, which have been registered in an international registry, are also expected to be registered in the CTRI. In the CTRI, details of Indian investigators, trial sites, Indian target sample size and date of enrollment are captured. After a trial is registered, trialists are expected to regularly update the trial status or other aspects as the case may be. After a trial is registered, all updates and changes will be recorded and available for public display.
Siro Clinical Research Institute
Post Graduate Diploma in Clinical Research
www.siroinstitute.com
www.siroclinpharm.com
To recap the August 2015 month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 18 has been released with the following content.
News Uptoday
New Guidance
Audit Findings
483 Observations
- 483 of PharMEDium Services, LLC (Outsourcing facility)
- 483 of "Walgreens Home Care, Inc. dba Walgreens Infusion Services
EU Non Compliance Report
- EU Non-Compliance Report: TXCELL - BESANCON, France Warning Letters
- Warning letter : Sipra Labs Limited, Hyderabad
- Warning letter : Mylan Laboratories Limited, India
Health Canada Non Compliance Report
- Procter & Gamble Inc., Canada.
Regulations of the Month
- Sec. 211.28 Personnel responsibilities (b) & (c)
- Sec. 211.42 Design and construction features (a) & (b)
Keeping with its promises, Association of the British Pharmaceutical Industry has launched a clinical-trial disclosure toolkit to help its member businesses observe with transparency needs for information from or about clinical trials.
Keeping with its promises, Association of the British Pharmaceutical Industry has launched a clinical-trial disclosure toolkit to help its member businesses observe with transparency needs for information from or about clinical trials.
NASSCOM CoE IoT spearheaded a high-level industry roundtable to discuss firsthand the challenges & opportunities in India’s clinical trial industry and how technology can accelerate development
1. October Edition │Issue 3
Page 1 of 5
Foreword
We thank you for your continued support and guidance. I am glad to share that we were always
known for our quality and commitment in GMP services, now, with your wishes, we are on our way
to become a leading and reliable partner for GCP Services. Some encouraging statistics, as on this
date, there are 1014 registered Ethics Committees in India, numbers are increasing every month, as
in August we were at 859 and September 958 ( www.cdsco.nic.in) . Now, in these ECs, how many
comply with Schedule Y and GCP requirements, abide by SOPs, modified their SOPs as per latest
regulatory amendments, refreshed their training requirements, regularly meet as per SOP etc. is
worth investigating. Last quarter, majority of our time was spent in training and audits at Sites and
Ethics Committee. Positive news is that for each site/EC we dealt with, patient safety is of
paramount importance and there is a deep desire to work within the ambit of law however need
institution’s support (both mind-set as well as finances) for constant oversight and training activities.
Unless “QUALITY” becomes a part of Site’s DNA, it would always remain at superficial level.
We are confident that we have better than before and do hope you enjoy reading this edition.
Thank you and best wishes!
Team Harrisons.
In this Issue
Worldwide/India: Clinical Trial Data
Let's Talk in Numbers..
Empowering Sites with Data
Important Indian Clinical Trials Regulatory Milestones
RegUpdate
FDA Approves Merck's Keytruda for NLC Lung Cancer
TrialMatch aims to ease the Pain of Clinical Trials
Recruitment
Fast Facts
Worldwide/India: Clinical Trial Data
Area-wise distribution of Clinical trials registered on Clinicaltrials.gov
Total 200,004 trials have been registered till October 06, 2015.
2. October Edition │Issue 3
Page 2 of 5
Let's Talk in Numbers..
This table represents the number of trials registered
on Clinicaltrials.gov (as of 06 October, 2015)
Open refers to: Recruiting
Not yet recruiting or
Available for Expanded access
Total Number of trials conducted in India that
are registered on Clinicaltrials.gov
Empowering Sites with Data
(Article in press)
Deepti Goel, Executive Director, Harrisons Tech Consultants,
Mumbai
Abstract:
Site is an epicenter of clinical research, as the core
action of clinical research happens here. Time and
again sponsor and Clinical Research Organization
(CROs) have tried and used various parameters to
assess a site. These parameters have been subjective,
objective and pragmatic. With effect from year 2013,
Schedule Y has enhanced the role of Investigators
and Institution’s watch dog i.e. Ethics Committee,
which in turn has made a “site” more accountable. It
is evident that the key stakeholders e.g. sponsors,
CROs and regulators are looking for objective data to
support decisions like which sites are the best and
serve as long term partners. After all, relationship
between a drug manufacturer and site/investigator if
turns out be a win-win, goes a long way. It is
imperative that site identifies its core action points,
monitor its performance and continuously improve.
Through this article, author has attempted to lay
down some important top metrics (data points) site
should focus on as part of their own continuous
improvement initiatives.
Indication-wise Market Share in India
(Source: Clinicaltrials.gov)
3. October Edition │Issue 3
Page 3 of 5
Important Indian Clinical Trials Regulatory Milestones
(Data compiled from www.cdsco.nic.in)
Here is a chronological year wise update for us to follow the regulatory scenario in India from year 2009 onwards..
June 2009: Registration of clinical trials in the Indian Council of Medical Research (ICMR) registry becomes mandatory.
March 2011: Twelve New Drug Advisory Committees are constituted to evaluate applications for approval of clinical trials, excluding
investigational new drugs (INDs). Applications for INDs are evaluated by a separate committee.
February 2012: Indore and Pune based health activist group, Swasthya Adhikar Manch, files Public Interest Litigation seeking
justice for “drug trial victims throughout nation”.
January 2013: Amendments to the Drugs and Cosmetics Rules specify procedures to analyse the reports of serious adverse events
occurring during clinical trials and procedures for payment of compensation in case of trial-related injury or death.
February 2013: Amendments to the Drugs and Cosmetics Rules specify various conditions for conduct of clinical trials, authority for
conducting clinical trial inspections and actions in case of non-compliance. Further amendments specify requirements and guidelines
for mandatory registration of ethics committees.
March 2013: The Drugs Controller General of India (DCGI) constitutes an expert committee to examine reports of deaths in clinical
trials.
July 2013: The Ranjit Roy Chaudhury panel — established to advise on policy guidelines for approval of new drugs, clinical trials and
banning of drugs — publishes a report suggesting major changes, including that clinical trials should be held only at centres that are
accredited for the purpose, and that the existing 12 drug advisory committees should be replaced by a single broad expertise-based
Technical Review Committee to ensure speedy clearance of applications.
July 2013: The US National Institutes of Health announces it is suspending 40 clinical trials in India because of the uncertainties
posed by the new requirements.
August 2013: Drugs and Cosmetics (Amendment) Bill 2013 introduced in Parliament, which contains penal provisions for violations
of clinical trial procedures, and provisions for payment of compensation and ethics committees.
August 2013: The DCGI makes it mandatory for the sponsor or his representatives to furnish the details of the contract between
the sponsor and the investigator with regard to financial support, fees, honorarium, and payments in kind to be paid to the
investigator.
September 2013: India’s Supreme Court suspends all clinical trials of new drugs in the country.
November 2013: The DCGI issues a directive that an audiovisual recording of the process of obtaining written informed consent is
required for each trial subject.
December 2014: DCGI amends the Schedule Y with respect to Compensation guidelines, along with the changes in SAE (Serious
Adverse Event) reporting timelines.
January 2015: The health ministry proposes pre-submission meetings in a bid to enable technical deliberations between
stakeholders and the drug regulator before clinical trial applications are submitted.
July 2015: DCGI mandates that an audio-video recording of the informed consent process in case of vulnerable subjects in Clinical
trials of New Chemical Entity including procedure of providing information to the subject and his understanding on such content shall
be maintained by the investigator for record.
September 2015: CDSCO takes initiative to create an IT enabled system OCTAMS (Online Clinical Trials Application and Monitoring
System) for online submission and processing of application as well as monitoring of clinical trials in the country.
RegUpdate
Here are some Important updates regarding Academic studies, Ethics Committee Membership and Amendments
which we found worth sharing. (Source: F2F Clarification at DCGI Office)
Can EC Chairperson at one EC act as a Chairperson for another?
Response: No, EC Chairperson can NOT act as a Chairperson for another EC! Similarly other EC members can NOT act
as members for another EC. When the EC applies for re-registration/accreditation, and regulatory agency notices such
issues, they may disqualify both the ECs. Two main questions arising are:
(1) How do the chairperson/EC members ensure that there is no conflict of interest when they serve on 2 ECs?
(2) How do they give enough time to 2 ECs to participate in the EC review, approval and post-approval oversight?
Is AV consenting mandatory for investigator-driven academic clinical trial on already approved vaccines in infants?
Response: Yes, AV consenting in this situation is compulsory. The new GSR 611(E) requires that an audio-visual
recording of the informed consent in case of vulnerable subjects in clinical trial of new chemical entity or new molecule
entity shall be maintained by the investigator for record.
4. October Edition │Issue 3
Page 4 of 5
As per ICH GCP definition vulnerable subjects include:
Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether
justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a
hierarchy in case of refusal to participate.
Vulnerable subjects include, but are not limited to: patients with incurable diseases, persons in nursing homes,
unemployed or impoverished persons, and patients in emergency situations, ethnic minority groups, homeless persons,
nomads, refugees, minors, and those incapable of giving consent.
If the local company address of a CRO/Sponsor has changed, re-approval of the investigational product label has to
be taken from the Licensing authority?
Response: As per Drugs & Cosmetics Act any change in the process of manufacture, method of testing, labeling,
packaging, designing of the sale pack, medical literature and documentation is to be intimated to the licensing authority
forthwith and permission to be obtained within 30 days time period.
Buzz Around Us...
FDA Approves Merck's Keytruda for NLC Lung Cancer
The U.S. Food and Drug Administration granted accelerated approval for Keytruda (pembrolizumab) on October 2,
2015 to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) with tumors that express a
protein called PD-L1. Keytruda works by blocking the cellular pathway known as PD-1/PD-L1 (proteins found on the
body’s immune cells & some cancer cells) and helps the body’s immune system fight the cancer cells.
According to the National Cancer Institute, lung cancer is the leading cause of cancer death in the United States, with
an estimated 221,200 new diagnoses and 158,040 deaths in 2015, with NSCLC being the most common type of lung
cancer.
(Source: www.fda.gov)
TrialMatch aims to ease the Pain of Clinical Trials Recruitment
In Clinical Trials, the biggest challenge for the researchers is signing the right people up to studies with very specific
inclusion and exclusion criteria for participants. Co-founder Brian Clark has been working on TrialMatch, for around 6
months which targets this recruitment problem. Clark points to clinical trials being a $260 billion a year industry —
with $20 billion spent “just on recruiting patients” — so the size of the opportunity is clear.
He has built an interface that pulls in the 200,000 clinical trials on ClinicalTrials.gov, cleans up the data to establish
clear inclusive/exclusion criteria, and lets potential trialists create a profile on TrialMatch to be automatically matched
to trials that match their personal criteria. The system then sends an email when a potential match is established.
Click here to read more. (Source: Medical News Today)
5. October Edition │Issue 3
Keep up With Us…
Website Refresh
We have refreshed our Public Website! Did you
Notice? Visit our Website now!!
Harrison’s Tech Consultants
We would appreciate your feedback regarding this Newsletter!
We have refreshed our Public Website! Did you
Harrison’s Tech Consultants
HTC Core Services
Fast Facts
October is Breast Cancer Awareness month!
Breast cancer is the most common invasive cancer in females
worldwide. It accounts for 18.2% of all cancer deaths
worldwide.
It is a leading cause of Death among Females.
Of Cancers in females, 1 in 3 is Breast Cancer
About 1% of the Breast Cancers occur in Men!
appreciate your feedback regarding this Newsletter!
Our Mailing Address is:
Harrison’s Tech Consultants
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Karave, Nerul.
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Page 5 of 5
Awareness month!
Breast cancer is the most common invasive cancer in females
of all cancer deaths
It is a leading cause of Death among Females.
Breast Cancer.
st Cancers occur in Men!