- The Supreme Court of India
Allow the Review and Approval Process for Clinical Trial Applications to Resume
The recent decisions made in the Democratic Republic of India, leading to the suspension of the review and approval process for any new domestic and global clinical trial applications is a catastrophic mistake. The decision directly and negatively impacts the lives of millions of Indian’s across the country, under the false premise that the actions taken will protect those individuals. Logical, fact-based and statistically supported thinking and decision making has been sidelined in favor of embellishment, made-for-media headlines, sound bites and raw unchecked passion. When combined with court decisions made during the past 18 months, the result has been a nearly two year shut down of what was one of the fastest growing and most promising enterprises India has seen since the dawn of the new millennium. Furthermore, data from Frost and Sullivan, Boston Consulting Group, Price Waterhouse Coopers, Ernst and Young and PRTM forecasted that the future could only have been brighter. Most importantly, the vital flow of innovative new and potentially life improving treatments has come to a complete stop.
Therefore, the People for the Advancement of Clinical Research – India (PACRI) has launched this petition to urge the Supreme Court of India to allow the relevant government bodies to again begin reviewing and approving clinical trials. Through this petition we would also like to bring to the front the facts concerning clinical research that are being smudged in this very public media trial. We recognize that the process is not perfect and that changes must be committed to, measured and made in order to meet Court expectations – but a complete stop is a shortsighted and unacceptable solution. PACRI is comprised of ordinary individuals from the following groups: ordinary healthy citizens; patients; government officials; health enterprise professionals; educators; patient advocacy groups and more.
Below is a list of relevant facts and findings regarding the importance of clinical research to the physical and economic health of the people of India. Readers of this petition will find that many of these facts lay in stark contrast to the often vague data points being put forward by the small- yet-loud groups, who have stood in the way of any progress in an effort to create progress void of risk. The groups fail to recognize that their often emotive and misinformed statements are only turning out to be more detrimental to the cause they espouse – protection of the research participant. The very nature of clinical research and of any innovative enterprise, is that progress is often fraught with risk. More than law, it is the individuals who have to ensure that the risk is balanced with the benefit any process will provide to people and society. If we are realistic, we must recognize that mankind has never advanced without it.
FACT: New treatments cannot be brought to market and become available at your local pharmacy without first undergoing a rigorous testing process in the lab, in animals and then in humans in the clinic, known as Clinical Research or Clinical Trials
FACT: Clinical research when properly conducted has a great potential to help us understand the prevalence of various diseases and help us to more effectively prevent, diagnose, treat and rehabilitate the affected population
FACT: Clinical research has been occurring in India for decades and the conduct of global clinical trials has been occurring since 2005
FACT: There is no such thing as a clinical trial without risk for the volunteers who participate. The very nature of a clinical trial is that it is a test to determine whether an investigational product can be proven to be a safe and effective treatment.
FACT: The very individuals who want an excessive amount of safe guards imposed, have very much benefitted from the clinical research process and the efforts of volunteers anytime they take a medicine or receive treatment from their physician.
FACT: There is no statistical evidence to support that Indian citizens are being used as the world’s guinea pigs, as is often proposed by the press and uninformed advocacy organizations. In fact, India’s stake in the conduct of global clinical trials is still very small: The number of clinical trials DCGI approved in India from 2010-2012 is 1,065, while globally, during the same period 43,325 trials were registered officially in the US; about 2.5% of all registered studies. The opposite case is more likely, given that most of the marketed medicines available in India were innovated and tested elsewhere.
FACT: A statistic widely reported in the press, often not explained fully, has led to a massive wave of condemnation and public discourse. Specifically, the data that 2,868 people died during clinical trials of 475 new drugs between 2005 and 2012 is very misleading – and purposely so – it sells newspaper and attracts website visitors. The fact is, out of the estimated 451,000 people who participated in clinical trials between 2005 and 2012, 89 died of trial related causes. All other cases of death reported, represent individuals who died of something else while participating in the trial. If those people were injured or became ill during the trial – for example, a person in a cancer trial falls in an accident at home and dies – they are recorded as a Serious Adverse Event (SAE) – and officially tracked and reported as part of the data package associated with a new drug application. Therefore, 2,868 of the people reported in the news to have died during a clinical trial – died from something that was determined NOT to be caused by the study drug or trial related procedures. India has 1.2B people, more than 15% of the world’s population, while burdened with >22% of cases of disease. So, statistics prove that during a 7 year span, 89 people out of 1.2B died from their participation in research - research meant to advance treatments designed to improve or save lives. While ANY loss of life is regrettable and steps should be taken to prevent such loss, there is by no means a greater risk of safety issues occurring in India, than there is any other part of world where the human race is working to advance science and save lives. The deaths in clinical trials are not unique to India. The trials in which India participated had SAE’s and deaths reported from other parts of the world.
FACT: In all of 2013, 9 global clinical trials were approved for conduct in India. Essentially, there has been no advancement of treatments toward approval in India for nearly a year due to widespread overreaction and fear. Have people been saved or are we actually losing thousands of lives as a result of this stoppage?
FACT: India’s Good Clinical Practice standards – which outline the processes for the conduct of clinical trials are more stringent than those followed by the international community, including leading clinical research countries in the North America, Western Europe, Japan, Australia and elsewhere titled – called the International Conference on Harmonization – Good Clinical Practice or ICH-GCP.
FACT: Recent legislation requires compensation paid to clinical trial volunteers who do not receive the intended therapeutic effect of the investigational drug, or who receive a placebo (sugar pill) instead of the investigational drug. These two requirements are exotic, cannot be found in any other part of the world where clinical research exists, and strike right at the heart of the very point of conducting clinical trials. First, clinical trials are tests of investigational medicines so the very point of the trial is to see if the treatment has the intended effect. Second, to determine whether the treatment is actually working or if it’s simple the perception of the patient, a placebo is often used. The use of a placebo is a proven mechanism to help ensure the validity of the treatment group results. Volunteers are explained these things as part of the informed consent process before they even agree to participate in the study.
FACT: The Supreme Court is mandating the use of audio and visual recordings of the consent process that each clinical trial volunteer must go through when deciding to participate in the trial. This is another unprecedented step not found in normal Good Clinical Practice anywhere in the world, whether established or emerging market. The time, costs and logistics of implementing such a measure will further slow the clinical research process and create unnecessary delays in the advancement of potential new treatments to the patient population of India. The recommended process also does not take into account the two major ground realities of medical care in India.
FACT: The patient-doctor relationship in India is very strongly based on “faith”. This A-V process will introduce an element of distrust and discomfort in that relationship. Instead of encouraging real discussion on health and treatment between the doctor and the patient, it will only disengage the two parties.
FACT: A major proportion of the Indian population culturally still protects the female gender in a ‘purdah’ system. How will we deal with this cultural issue in the light of the ease of electronic transmission of data in this technological age. Who will protect their privacy?
FACT: The review process that new clinical trial applications go through in India is as rigorous, if not more rigorous than, most other countries across the world, even those that have been conducting trials for many decades. The past 5 years have seen the implementation of a number of new regulations and strict requirements aimed at tightening the review process after some earlier incidents. The resulting two step process which has been in place for nearly two years now, ensures that all new trial applications not only undergo the scrutiny of the office of the Drugs Controller General India - but due to legislative changes in 2010 - also now undergo an in-depth evaluation by a panel of 10 objective physicians, who have extensive expertise in the therapeutic area/disease being targeted by the clinical trial. Only after passing successfully through these two layers and then being approved by independent ethics committees located at each research center, can the trial actually proceed.
Other Truths about Clinical Research
- Clinical trials in India are regulated by a set of rules that are in conformity with – and in some cases surpass - global standards
- The implementation of present set of rules must be closely monitored before moving the goal post
- Clinical research when properly conducted has a great potential to help us understand the prevalence of various diseases and help us to more effectively prevent, diagnose, treat and rehabilitate the affected population
- Clinical research has provided medical access to thousands of patients since the policy change in 2005
- Since 2005, clinical research has generated employment to thousands of professionals and has the capacity to generate employment to a few hundred thousands of such professionals
- Clinical research has contributed significantly to the growth of laboratories, imaging, logistical support and other services
- The Supreme Court of India
Allow the Review and Approval Process for Clinical Trial Applications to Resume
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