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Regulating clinical trials

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A month-old news report from ET talks of the promise of a new industry, and the crying need for regulations:

According to a recent Frost & Sullivan report, the domestic clinical research organization (CRO) market was worth $ 485 million in 2011, but is set to cross $ 1-billion-mark by the turn of 2016.

The report says that the large, easy-to-access, treatment-naive population, high degree of available cost arbitrage of up to 30-50 percent over the US, and an improved regulatory environment is driving the domestic CRO market, which is growing at 11-13 percent.

As many as 438 lives were lost in 2011 during clinical trials, however only 16 deaths due to the serious adverse events (SAEs) of the drugs being used were recorded, according to information given by Union Health Minister Ghulam Nabi Azad last week. Average compensation paid in 2011 was a paltry Rs 2.2 lakh.

On the same day My Health Bowl gave more details from the health minister’s reply to a question in the parliament:

The known number of deaths occurred by clinical trials were 668 and 438 respectively in the year 2010 and 2011 and the known deaths occurred due to serious side effects stood at 22 and 16 in the same years.

Clinical trial deaths accounted for 211 up to June in the year 2012 and the actual cause of death by clinical trials are under scrutiny and still not finalized.

The compensation rules are yet to be framed in India and using this situation the drug companies doing human clinical trials pay low as compensation to each of the life lost.

BS reported the Ministry’s thinking a couple of days later:

With 11 persons dying every week in clinical trials in India, Government is all set to strengthen rules regulating the sector by mooting independent auditing of fatalities during such tests.

So far, investigations into death of people who participate in drug trials are done by investigators hired by firms holding such trials.

Though these hired investigators are part of the Ethics Committees which the sponsor companies conducting trials set up as part of standard protocols for conducting clinical trials, objections have been raised on their fairness and objectivity due to their conflict of interest.

The Ministry of Health and Family Welfare, which is in the process of amending the existing rules to ensure the safety of people participating in the drug trials, has now agreed in principle that every drug trial death must be independently audited.

The potential for growth is clear from the number of courses sprouting across the country which train biotechnology and life sciences graduates in the methodology of clinical trials. The finance market in India grew when clear rules and procedures were put in place after a series of scams. Clear rules and structures need to be put into place for this segment of the pharma industry to grow.

This need is also felt by workers in the field, as the following report from Pharma Biz illustrates:

The Pune-based Jehangir Clinical Development Centre Pvt. Ltd (JCDC) has now been accredited by the Association for the Accreditation of Human Research Protection Programs, Inc. JCDC by earning AAHRPP accreditation, has taken the lead in demonstrating a commitment to safe and ethical research,” said Dr. Marjorie A. Speers, president and CEO, AAHRPP.

“Like its AAHRPP-accredited peers in the United States and India, JCDC has earned a place among some of the world research organizations. In fact, to attain AAHRPP accreditation, JCDC had to show compliance with both India’s requirements for research protections and US regulations. Even before attaining AAHRPP accreditation, JCDC had taken steps to differentiate itself from other entities in India,” he added.

The accreditations are the latest indication that organizations are adhering to AAHRPP’s goal of one set of standards worldwide for CROs, independent institutional review boards, research intensive universities, medical colleges, hospitals, and other entities engaged in research involving human participants, according to the release issued by AAHRPP

India is among the fastest growing markets for clinical trials. But growth has also brought calls for stronger research protections and greater emphasis on research quality. In US, organizations increasingly are seeking AAHRPP accreditation, stated the release.

The always-business-friendly ET takes an extreme stance by terming all criticism of practices as scaremongering, but makes a valid point nevertheless:

The recent controversy over clinical trials in India is worrisome. A series of articles in newspapers apparently aimed at tarnishing the entire clinical trials sector and some NGOs going to court with public interest litigations seem to be fuelling it. These individuals and entities are whipping up emotions by portraying only the darker side — showing how some terminally-ill patients didn’t survive a clinical trial. As the Indian Society for Clinical Research ( ISCR) has said, those participating in trials are already afflicted.

Their death, therefore, was not due to the drug. If they were terminally ill, the drug perhaps was not as effective as was anticipated.

It is important to note that many trials in India are Phase-III trials which are global trials with a stringent common protocol for already well-tested drugs. Hence, the risks to patients are minimal. In any case, without a trial it is impossible to determine if and how a drug works.

India is seen to be an attractive hub for drug innovation based on our cost and skill base. Assocham had predicted that India would garner 15% of the global clinical trials opportunity. However, out of over 1,00,000 human trials being conducted in 178 countries, less than 2,000 (2%) are being done in India compared to over 9,000 (9%) in China.

SciDevNet reported the point of view taken by some of the NGOs:

Amulya Nidhi of the Swasthya Adhikar Manch, a civil society organisation which has petitioned the Supreme Court for rectification of gaps in existing laws on injury and compensation and in the regulation of contract research organisations (CROs), says only parliamentary legislation can ensure fairness to people undergoing clinical trials.

Nidhi told SciDev.Net said that ethics committees set up to monitor the trials and CROs need to be made answerable to regulatory bodies.

The clinical trials registry, where every trial is registered for approval, does not have papers on the outcome of trials. The 22 deaths attributed to trials were paid a total compensation of just US$ 90,000, says Nidhi – making a case for changing the guidelines.

“We are not asking for a stoppage of the trials but there should be laws in place to ensure that CROs function in an ethical manner,” he said.

All that was done by September 12. Now, on October 9 Livemin reported the Supreme Court’s order on the public interest litigation:

The Supreme Court may stop clinical trials in the country unless the health ministry provides it information within a month on deaths, compensation and general practices when new drugs are tested on Indians.

“We can even issue a one-line direction that all these clinical trials which affect many people must stop forthwith,” judges R.M. Lodha and A.R. Dave said on Monday.

In an unprecedented move, the apex court made all state governments and union territories parties to a public interest litigation, directing them to submit information on clinical trials in their jurisdictions.

The Union health ministry and Central Drugs Standards Control Organization have four weeks to furnish data and the provincial authorities have eight weeks to comply.

The court was hearing a lawsuit filed by non-profit Swasthya Adhikar Manch (SAM) in February 2012, which alleges wide abuse of people who participated in clinical trials in Madhya Pradesh by many international drug companies.

The court is taking the matter “very seriously”, the judges told additional solicitor general Siddharth Luthra, PTI reported.

The petitioner had moved interim applications seeking information on experimental drugs being tested in India, between January 2005 and 30th June 2012. Nearly 217 clinical trials of new chemical entities not approved as drugs for human use anywhere in the world are currently underway in various states across the country, the petitioner said.

“We have moved two interim applications till date on new chemical entities or experimental drugs introduced in India since January 2012. While it is not a complete list, we provide a list of drugs which are being tested but have no use for Indian patients,” said Amulya Nidhi, an health activist at SAM.

The hardened and adversarial stance is surprising. Certainly human deaths are, and must remain, a matter of great concern to courts, but one wonders whether the harsh words by the court were a response to stonewalling by ministry officials. The widened scope of the review is actually promising, since it might result in uniformity of standards.

Another matter of concern is the statement by Amulya Nidhi, which seems to indicate a stance that only drugs which immediately benefit Indians should be tested in India. One could perhaps understand this if phase III trials were extremely hazardous and highly unregulated. However, with hard regulations in place, such a stance may not be very fruitful.

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Written by Arhopala Bazaloides

October 9, 2012 at 5:09 am

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