Business Line : Opinion : Why clinical trials evoke suspicion

Business Line : Opinion : Why clinical trials evoke suspicion.

Source : THE HINDU Business Line – Sep 5, 2012

Harvard University’s online free course on ‘Clinical & Public Health Research’

Ex-DCGI asks medical community to pursue Harvard University’s online free course on ‘Clinical & Public Health Research’

September 04, 2012, 0800 IST  – Source : Pharmabiz News

Anticipating big scope for opportunities for clinical trials in India in the coming years, former Drug Controller General of India (DCGI) Dr Surinder Singh has suggested to the medical community to pursue the Harvard University’s online free course on ‘Clinical and Public Health Research’. He has made the request through an online discussion forum of doctors and health professionals, and forwarded a letter, sent to him by the vice-president of Piramal Enterprises, Dr Swati Piramal who was recently elected to the Harvard Board of Overseers, a 350-year old governing board of the Harvard University in Boston in USA. By persuading the medical community to pursue the course, Dr Singh opines that the Indian pharmaceutical industry has the potential to become ‘Pharmacy of the World” in another one decade. He declares that there is big scope for clinical trials in the near future in India, so the course will help the medical professionals in a big way. His email to the forum members says that recently there has been a paradigm shift in the Indian pharma industry’s thrust from production of generics to innovation, i.e. drug discovery & development which entails an increase in conduct of clinical trials, especially the ones which require high degree of domain expertise i.e. micro-dosing studies (phase 0), phase I & phase II clinical trials. “Having been the former Drug Controller General of India till November 2011, I can appreciate the importance of this course for the medical fraternity and bring it to your notice, so that you may like to avail this opportunity to enhance your skills to become top professionals in clinical research or investigator for conduct of clinical trials,” he said in his email to the members. According to him drugs from India are exported to more than 200 countries and vaccines to about 150 countries across the world. Currently Dr Surinder Singh is the director–in-charge at the National Institute of Biologicals, Noida. Dr Swati Piramal’s letter to Dr Singh clarifies that the course, “Quantitative Methods in Clinical and Public Health Research’ is the online adaptation of material from the Harvard School of Public Health’s classes in epidemiology and biostatics. This course will address the need by covering the principles of biostatics and epidemiology used for public health and clinical research.

CDSCO notifies draft rules on inspection of clinical trial sites

CDSCO notifies draft rules on inspection of clinical trial sites
August 09, 2012, 0800 IST – Source Pharmabiz News

In a move to further streamline the clinical trials in the country, the Central Drugs Standard Control Organisation (CDSCO) has finalized and issued draft rules regarding the inspection of premises of clinical trial sites by the regulatory officials with or without prior notice.

“The premises of sponsor/clinical research organization and clinical trials shall be open to inspection by the officer of the CDSCO, who may be accompanied by an officer of the concerned state drug control authority to verify compliance to the requirements of Schedule Y, good clinical practices and other applicable regulation,” according to the notification seeking to change the Drugs and Cosmetics Act (D&C Act).

“The sponsor/CRO, investigators shall allow CDSCO officer who may be accompanied by an officer of the concerned State Drug Control Authority to enter, with or without prior notice, any premises of sponsor/CRO and clinical trial site to inspect, search, seize any record, data, document, books, investigational drugs etc. related to clinical trials and provide adequate replies to any queries raised by the inspecting authority in relation to the conduct of the trial,” the document said.

The rules, already approved by the DTAB, will be the third amendment to the Drugs and Cosmetics Rules, 2012 and will be implemented after final notification, the notification said, while seeking inputs and suggestions from the stakeholders.

The rules, to be incorporated in Part X-A after Rule 122 DAB, in detail lays down mandatory procedures for getting permissions, approval of the ethics committee, registration with Clinical Trials Registry-India, reporting of injuries and death, and procedures for submitting replies if notices were issued by the CDSCO on the lapses.

If any company fails to comply with any of the conditions, the licensing authority, may after giving an opportunity, will take proceed to take actions, as required. The can be warning letter on the deficiency found during the inspection, recommendation for rejecting the study, suspension or cancellation of the trial permission and restriction of the investigator/CRO from conducting studies, the draft rules said.

Registration of Ethics Committees becomes mandatory for clinical trials

Registration of Ethics Committees becomes mandatory for clinical trials

August 07, 2012, 0800 IST – Source : Pharmabiz.com

Registration of Ethics Committees attached with the Clinical Trial Organisations (CROs) for conducting clinical trials has been made mandatory in the country by the Drugs Controller General of India (DCGI).

A draft notification, issued by the Central Drugs Standard Control Organisation (CDSCO), said, “No ethics committee shall review and accord its approval to a clinical trial protocol without prior registration of the committee with the licensing authority as defined in clause (b) of rule 21”.

Earlier in October last year, the Drugs Technical Advisory Board (DTAB), the highest decision-making body under the Union health ministry on technical matters, had taken the decision to make registration of Ethics Committees mandatory in the country for clinical trials. The DTAB’s decision came in the wake of widespread complaints that the Ethics Committees at most of the clinical trial sites are not independent and also not active with no monitoring of the trials by the authorities.

So far, only the registration of clinical trials with the drugs controller general of India (DCGI) is mandatory in the country. Independent ethics committees are constituted by the individual companies and its registration is not mandatory. For starting any clinical trial, the approval of the ethics committee is crucial as without which the DCGI will not provide his sanction for beginning the study in the country.

As per the notification, an application for registration of ethics committee shall be made to the licensing authority in accordance with the requirements prescribed in Schedule Y-I. The licensing authority after being satisfied that the requirements of the rules have been complied with and the conditions of the registration will be observed, may grant registration subject to the condition stated therein.

The ethics committee will review and accord its approval to a clinical trial as per Schedule Y, the Good Clinical Practice Guidelines for Clinical Trials in India and other applicable regulatory requirements for safeguarding rights, safety and well being of the trial subjects.

The ethics committee shall allow inspectors/officials of CDSCO to enter the premises of the committee to inspect any record, data, document etc. related to clinical trial and provide adequate replies to any queries raised by the inspecting authority in relation to the conduct of clinical trial. The registration, unless it is sooner suspended or cancelled, shall be valid for a period of five years from the date of issue.

If the licensing authority is not satisfied, he shall reject the application and shall inform the applicant of the reasons for such rejection and the conditions which must be satisfied before the registration can be granted. If the ethics committee fails to comply with any of the conditions of registration, the licensing authority may after giving an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefore, suspended or cancel the registration of the ethics committee for such period considered necessary.

The ethics committee whose registration has been suspended or cancelled by the licensing authority may within ninety days of the receipt of the copy of the order by him prefer an appeal to the central Government and the central Government may, after giving an opportunity of being heard, confirm, reverse or modify such order, the draft notification said.

State drug control officials not empowered to monitor clinical trials

State drug control officials not empowered to monitor clinical trials: Dr Jagashetty

June 12, 2012, 0800 IST – Source : Pharmabiz News

State drugs control departments have no powers to keep tabs on the clinical trials conducted in their states unless they are empowered as per the Drugs & Cosmetics Act & Rules, according to Dr BR Jagashetty, drugs controller, government of Karnataka.

The department’s team of inspectors has no authority to enter the premises of the clinical trial organizations, said Dr Jagashetty following the recent statement by the Drugs Controller General of India (DCGI), Dr G N Singh who said that the state DCs were required to keep a close vigil on the illegal human studies.

Without empowerment under the D&C Act & Rules, there is no question of inspection and even the clinical trial companies will not permit the inspectorate teams to enter the premises for the inspection, he added.

Further state drugs control departments have no information on clinical trial or clinical research organizations. There is also no mention of human studies in the D&C Act. So far no state drugs control departments have been involved in conducting inspections on clinical trial companies.

A key focus of a clinical trial is to assess the safety of the drug and efficacy. There has been several initiatives to look at pharmacovigilance, a adverse drug monitoring activity, from the government side. “There is definitely need for an audit and a dedicated team of inspectors to be in place to carry out the inspections of all clinical trials,” said Karnataka drugs regulator, said Dr Jagashetty.

India has around 40 clinical research organizations (CROs) including domestic and multinational companies. Out of these, there are around 20 leading companies and Karnataka is home to at least 15 of these CROs. The notable names are Ecron Acunova, Clinigene which is part of Biocon Limited, Lotus Labs. Omnicare, Vaatsalya, Treista Life Sciences which is part of Health Care Global Enterprises (HCG), St. John’s Medical College Clinical Trial Centre, Synchron, D2L, SMO India and Infinitus which are the homegrown companies.

In addition the state also has a presence of global majors include Quintiles, PharmaNet, PharmaOlam and ClinTech International to name a few. Besides this, there are corporate and government hospitals engaged in clinical trials. These cover Manipal Hospital, Fortis, Columbia Asia, Ramaiah Memorial Hospital where international pharma majors identify a principal clinical investigator to carry out the human studies.

Health ministry tightens norms on clinical trials, action on two violations

January 25, 2012, 0800 IST – Source : PharmaBizNews

The Union health ministry has tightened the norms on clinical trials after amending necessary rules regarding obtaining informed consent from the trial subjects and extending financial assistance to the victims, and has found two cases of violations in trials in the recent past.

The two cases came to the notice of the Drug Controller General of India (DCGI) were about the trial of drug Tadalafil in a hospital at Indore and the trial of an anti-cancer drug by Axis Clinical Research, Hyderabad, prompting the authorities to take action, sources said.

The DCGI initiated action following report t in respect of allegedly flouting of clinical trial norms at Maharaja Yashwant Rao Hospital and Mahatma Gandhi Memorial College, Indore where the drug Tadalafil was used for clinical trial for Pulmonary Arterial Hypertension (PAH).

“The office of DCG(I) directed CDSCO (WZ) on 12-07-11 to carry out a investigation to ascertain the facts. Accordingly an investigation was carried out by the office of CDSCO(WZ) and State Drugs Controlling Authority on 10-08-11 in respect of clinical trials conducted at M G M Medical college and associated M Y Hospital in Indore. As per the investigation report, a trial was conducted by Dr Anil Bharani and Dr Ashish Patel with tadalafil in patients with group-1 pulmonary hypertension without permission from DCG(I),” sources said.

“The study with Tadalafil was initiated on 18-09-05 when the drug was not approved for the said indication in the country. However, the drug was approved in the country for another indication – male erectile dysfunction on 10.06.2003. In view of above, vide letter dated 02-11-11 directed both the doctors namely Dr Anil Bharani and Dr Ashish Patel to stop the clinical trial of Tadalafil in Pulmonary Arterial Hypertension and restricted them to conduct any clinical trial for a period of six months,” sources said.

Another case that attracted action from the authorities was the trial of an anti-cancer drug by Axis Clinical Research, on poor people without proper informed consent. The investigations revealed that the firm conducted bioequivalence study on an already approved anticancer drug and there were certain irregularities with respect to informed consent process, review and decision making process of Ethics Committee.

“The permission granted to the firm for conducting bioequivalence and bioavailability study was suspended on 22.06.2011. Consequent to this, the firm, on 04.07.2011, has submitted corrective actions being taken by them including revised Standard Operative Procedures (SOP’s) for subject recruitment process, informed consent process, review and decision making process of the Ethics Committee. Based on further investigations and verifications, Axis Clinical Research, Hyderabad was granted ‘NOC’ to conduct Bio-equivalence study  subject to fulfillment of various condition regarding Informed Consent Process including documentation of the Informed consent process through Audio-Video means, functioning of Ethics Committee and investigators,” sources said.

In order to strengthen the regulations relating to clinical trials, following proposals  for amendments in Drugs and Cosmetics Rules, 1945 have been  approved by Drug Technical Advisory Board (DTAB) and a draft notification was published some time back to incorporate effective provisions for providing financial compensation to the trial subjects in case of trial related injury or death.

Another step in this regard was enhancement of responsibilities of Ethics Committee, Sponsor & Investigator to ensure that financial compensation as well as medical care is provided to the trial subjects who suffer trial related injury or deaths. Amendment was also made on the format for obtaining informed consent of trial subjects to include the details of address, occupation, annual income of the subject so as to have information regarding socio-economic status of the trial subjects.

Informed consent and compensation to victims set to drive more volunteers and patients for clinical trials

 January 28, 2012, 0800 IST – Source : PharmaBizNews

The Union government’s stringent regulations on seeking informed consent and providing compensation to clinical trial victims would increase the number of volunteers and patients going for a trial in India, according to experts.

According to Dr Bhanu Priya, director and head, clinical research, G7 Synergon Life Sciences Consulting, the clause of compensation has now been insisted and therefore it is an assurance for the patients and for clinical research organizations to participate in human study and carry out the trial respectively.

Although Schedule Y of the Drugs and Cosmetics Act (D&C Act) called for compensation, Clinical Research Organizations (CROs) took up insurance policies to protect the patient in the wake of an adversity. But now with the amendment in the Act, the compensation cannot be ignored. There have been several insurance players who have chipped in to support the CROs with a dedicated policy. These include National Insurance, Oriental Insurance and  Metflife, to name a few.

There is no doubt that both informed consent and compensation to victims are the two key factors which are giving the Indian volunteers and patients the confidence of participating in a clinical trial. While the former helps the volunteer or patient to understand the risks of the human study, the latter provides the much needed financial and medical support if the medicine turns fatal or reports an adverse drug reaction.

These two features will not just benefit the patients, but both informed consent and compensation for the clinical trial participants give them the option to even withdraw from a human study, Prof. SP Thyagarajan, Pro Vice Chancellor, Sri Ramachandra University, Chennai told Pharmabiz.

But Dr Krathish Bopanna, president & executive director, Semler Research Centre, begs to differ and stated that the move on compensation is a threat to the clinical  research companies and we need to challenge this aspect of the law. This is primarily because there is no basis on which the compensation could be based because there are two aspects to the issue on whether it could be the test or the reference drug. Patients in a double blinded study could receive a placebo drug. We need clear cut guidelines and self regulatory norms.

Illiterate women lured secretly by clinical trial firms in Andhra Pradesh

February 03, 2012, 0800 IST  – Source : Pharmabiz News

A 55-year old illiterate woman, Sabavath Chilkamma, who volunteered as a clinical trial subject from Bhavanikunta tanda of Wardhannapeta mandal in Warangal district of Andhra Pradesh, had lost her life due to multiple organ failure. The unknown clinical trial company had offered to pay her Rs. 10,000 for volunteering as their subject for the drug trial. According to sources, it is believed that 20 people from Bhavanikunta thanda of Wardhannapet mandal have volunteered for drug trials together with Chilkamma. All of the volunteers were offered a sum of Rs. 10,000 per each person by an unknown clinical trial company to participate in the drug trial. When contacted and asked how many companies in the district are carrying out clinical trials in the district, the district medical and health officer Dr P Sambasiva Rao told Pharmabiz that he has no records of the number of companies carrying out drug trials or of those enrolled for clinical trials in the district. He said, “The clinical trial companies work secretly and target poor illiterate people by luring them with money to undergo drug trials.” In spite of such incidents by the clinical trial companies, the government has taken no concrete action against any clinical trial organizations in the state, because of which these companies are not mending their ways to comply with ethics of clinical trials and taking illiterate poor women for their drug trials, said a source from the Lambada Hakkula Porata Samiti. Meanwhile, Telangana Tribals joint action committee has demanded stringent action against those responsible for the death of Sabavath Chilkamma. As a precautionary measure the district health administration is planning to conduct a health camp to find out any medical abnormality in the four tribal hamlets of Wardhannapet mandal to avoid any further deaths. It is believed that since restrictions on drug trials were relaxed in 2005, the clinical trial industry in India has grown hugely and today more than 150,000 people are involved in at least 1,600 clinical trials, by various firms in India on behalf of leading foreign pharma companies like AstraZeneca, Pfizer, Merck, etc. Though there are no available official records, some estimates suggest the clinical industry may be worth as much as above Rs. 1400 crore in India. Regulators have struggled to keep pace with the explosion. Between 2007 and 2010, at least 1,730 people have died in India while, or after, participating in such trials.

Human rights panel seeks report on Clinical Trial deaths

Business Standard Joe C Mathew / New Delhi August 31, 2011, 0:47 IST

The National Human Rights Commission (NHRC) has sought a detailed report from apex health research body Indian Council of Medical Research (ICMR) and top drug regulator Drugs Controller General of India (DCGI) on clinical trials being conducted in India. The notices to ICMR and DCGI were sent last week. The commission took suo motu action following media reports highlighting instances of deaths during clinical trials. According to health ministry statistics, 671 persons had died during clinical trials last year. However, the ministry did not link majority of the deaths to the adverse effect of the experimental drugs because many volunteers participating in trials were critical and terminally ill patients. Click here to visit SME Buzz Also Read Related Stories News Now – SC asks NHRC to submit rehabilitation report on Kandhamal riot – ICMR sanctions multi disciplinary research unit in Amritsar college – NIF extends its tie-up with ICMR – Decision on endosulfan after ICMR report: Govt – GM strike enters 6th day; production remains hit – ‘Drafters of N-Bill ignored ILO recommendations’ Also Read Related Stories News Now – Sensex ends up 288 pts – China yuan could challenge dollar role in a decade – Obama urged to lay out bold approach on jobs – US consumer confidence crumbles to 2-year low – Gold falls 0.5% after rallying on sluggish data More Officials said they are in the process of responding to the NHRC query. There are rising demands for having proper regulations to monitor and control clinical trials from various sections of the society. The Allahabad High Court is expected to hear a public interest litigation calling for a ban on all clinical trials until laws to govern and regulate trials are in place. Civil society groups alleged that clinical trial monitoring is not mandated under the 70-year-old Drugs and Cosmetics Act 1940, which governs medicine regulation in the country. “Clinical trials are governed through subordinate rules, and not mandated under the Act. Legally speaking, these regulations can be questioned in the court of law as it does not have legislative backing under the Act,” an official said. According to a submission by the Union Health Minister before the Parliament, 22 deaths were reported due to serious adverse effects of experimental drugs during the clinical trials in 2010. The minister also informed that in all cases the companies had compensated for the deaths. The health ministry had asked pharmaceutical companies to compensate clinical trial victims after a probe carried out by the ministry under the instructions of the Parliamentary Committee on Government Assurances headed by Bharatiya Janata Party MP Maneka Gandhi revealed that pharmaceutical majors conducting clinical trials in India have not compensated majority of volunteers who died during the trials. Of the 671 deaths that were reported in 2010, the ministry had evidence of just three cases of compensation. According to the minister, initially only 25 deaths related to adverse effects of study drugs were reported in 2010 involving nine companies. “Subsequently, it was revealed that in two cases the deaths were reported twice for the same patients. Further, in one case, the ethics committee and the investigator later on clarified that the death was not related to the clinical trial.” However, civil society groups and medical experts have different views on the ministry claim. “One needs to dispel this myth that there were only 22 deaths among hundreds of deaths that happened during clinical trials just because companies agreed to pay compensation in 22 cases.” said C M Gulhati, a Delhi-based medical expert. According to Gulhati, it is normal for companies to understate the quantum of adverse reactions as it would decrease their compensation load. He also said medical practitioners who conduct the trials and the ethics committee who oversee the trials are also interested parties because they are looking for long-term association with pharmaceutical companies. “The regulator should be able to assess the situation. There has to be proper procedures for arbitration in case of trial related deaths. Independent audits are necessary.” The Drugs and Cosmetics Act calls for life imprisonment and Rs 10 lakh fine (or three times the value of the drug) in case of a death related to consumption of spurious drugs. However, there is no clause in the Act that covers clinical trials, experts said. According to industry insiders, clinical trials are complicated because it involves not just one person — like the spurious drug manufacturer in the case of spurious drug-related deaths — but several players, including the sponsors of the trial, investigators who conduct the trial, the ethics committees that monitor it and drug regulators who approve the trial. Y K Gupta, national scientific coordinator of Pharmacovigilance Programme of India, a government initiative to track side effects of approved medicines in the country, said concerns over clinical trials are being addressed in a new bill, which once enacted, will replace the current drug law.

Source : http://www.business-standard.com/india/news/human-rights-panel-seeks-reportclinical-trial-deaths/447641/

Wipro’s cloud-based portal to speed up collaboration for clinical trials, decreasing cycle time by 20-30%

July 30, 2011, 0800 IST – Source : Pharmabiz News

Wipro Technologies has developed a secure cloud-based solution ‘Clinical Collaboration Portal’, to help its customer base of Drug Development Owners (Sponsors), CROs (Clinical Research Organizations), clinical sites and regulators to significantly improve collaboration capabilities for multi-region clinical trials.

Clinical trials for global studies require close collaboration between partners and regulators across multiple regions to conduct multi-region clinical trials effectively and rapidly. The portal platform will reduce the clinical trial cycle time by 20-30% by speeding up communication and document exchanges between all the stakeholders who are the  sponsor organization, CRO staff along with clinical site coordinators and principal investigators. The portal platform can be leveraged as an enterprise level solution to increase efficiency and lower the cost of clinical operations.

There is an intensifying need in the market for a platform that can centralize information, manage financing, facilitate accurate reporting, automatic scheduling and provide the ease of patient recruitment. This need for increased collaboration in clinical trial operation elements, coupled with the need to cater to different styles of recruiting patients, for different therapeutic areas and identifying the best clinical sites that can perform clinical studies, in adherence with the local regulations, has opened up a potential market for a collaboration portal.

This Wipro portal has the capability to better manage all the data required to conduct a clinical trial that makes up the trial master file – which, in the existing clinical trial model, is dominantly paper based in combination with shared folders across geographies.

By enforcing a common Standard Operating Procedures across the groups which are involved in clinical trials, the Wipro Clinical Collaboration portal helps them to better adhere to regulatory frameworks such as Good Clinical Practice (GCP) guidelines to avoid any oversight in the trial management process.

“The Wipro Clinical Collaboration ‘cloud’ based portal is supported by Wipro’s Rapid Trial framework and very well integrated with leading market products for Electronic Data Capture (EDC), Interactive Voice Recording System (IVRS), Safety, electronic Trial Master File, document management systems and Clinical Trial Management System (CTMS) solutions with a zero CAPEX in a highly compliant, best-in-class system,” said R Srinivas Rao, vice president and Vertical Head – Life Sciences Solutions, Wipro Technologies.

“A platform which enables the exchange of documents and communication seamlessly and in compliance with global standards i.e. CFR (Code of Federal Regulations) part 11, while performing the clinical trials really relieves our customers from worrying about the compliance and validation of any solution used in the clinical trial space and helps them focus better on core trial conduct and efficiency,” he added.