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Newsletter October Issue
- 1. October Edition │Issue3 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 │Issue3 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 │Issue3 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 │Issue3 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 │Issue3 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 1902, Seahomes, Sector 36, Karave, Nerul. Navi Mumbai 400706. 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!