It’s unfortunate that every time in media we see negative aspect of clinical trials. Lay public in India are guided by what the media portrays and unfortunately the negative publicity in recent past leads them to equate medical research with experimenting on guinea pigs. This is unfair because you have had bad apples in all profession. Just like you have bad engineers, bad lawyers and bad accountant, you have bad medical researchers. Unfortunately, the problem created by small proportion of bad researchers is amplified and projected onto the whole profession.
The Indian clinical trial industry is going through a tough time. Once slated to be the world’s favorite destination for outsourcing drug trials, it seems to be losing ground fast, with even domestic companies preferring other countries over their own to speed up the process. Each drug moving through the drug development pipeline is rigorously scrutinized for its safety and efficacy.
So, why is this industry, which seems to be a very important part of our lives, not known to us? How many people really understand the process? Where is India on the global clinical research map?
Throughout history India has made notable contribution to the fields of science and technology. Less than two percent of the global clinical trials happen in India. In contrast, the disease burden in India is growing at an alarming rate. As per the latest prevalence data, cumulatively 150 million patients in India are suffering from diabetes, cardiovascular or respiratory diseases. Additionally, another two million patients are reported to have been diagnosed with cancer. The incidence rate of these diseases is also increasing much faster than developed countries due to changes in lifestyle and risk factors such as tobacco use, obesity and stress. However, since pharma R&D is highly risky, indigenous companies tend to shy away from the massive investment required. This is evident from the fact that filings in the pharma sector annually in US is more than 20 times than that of India despite having a comparable disease burden . We therefore, need to rely on western medication to tackle our healthcare needs. In many instances this is detrimental as the innovator company may launch the drug in India anywhere between two to 14 years after other markets, thereby denying best-in-class treatments to patients. Therefore, it can be argued that India has a moral obligation to participate in clinical research. By actively participating in clinical research India can make a positive contribution in the furtherance of the pharma sciences. Additionally, during the course of a clinical trial the subjects not only get access to cutting edge medication but also to advanced healthcare modalities which they would not have otherwise got access to.
Conducting trials in India meant better patient reach for global trials and access to cutting- edge life saving drugs for patient in India. Increased patient population for a trial results in quicker enrolment and eventually leads to the drug coming to the needed patient much earlier. The trials were extended to Asia in order to increase the gene pool and bring data from different parts of the world, thus presenting better results of drug efficacy.
The drugs we use to treat any condition- from an innocuous cough to a life threatening cancer- are the outcome of painstaking human clinical trials. These trials are the only way to credibly determine the safety and efficacy of drugs. Without trials there is no way pharmaceutical research can advance to improve disease management and the very quality of life.
Drugs go through several stages of development prior to human trials. The trials themselves are approved and regulated by government agencies and undertaken only after animal experiments prove their safety beyond any evidentiary doubt. Even then, the safety and efficacy of a drug on human needs to be proven before it can go to market. Unpredictable outcomes are but natural in this process – no wonder then that they are known as ‘trials’! The successful outcomes are of vital significance- for they not only help the patients involved in the trial but also transform the lives of hundreds of thousands who benefit from the commercial launch of such experimental drugs. Take some recent life- changing cancer drugs which have helped overcome what was thought to be an incurable condition- two such that readily come to mind are Herceptin for the treatment of breast cancer and Gleevec for the treatment of Leukemia.
Instead of dismissing clinical trials, we need to adopt a rational perspective of clinical trials- understand how they are run, realize their criticality to patients, and address issues objectively.
If we curtail clinical trials and global pharma companies move to China, South Korea and other East and South Asian countries – as they are doing – we will only end up hurting Indian patients.
Benefits of Clinical Research:
Benefits of participating in clinical research/ trials:
- Gaining access to innovative treatments before they become widely available.
- Access to cutting edge life saving drugs.
- Clinical research subjects are treated with more personal attention.
- Helping others by contributing to advancement in medical research.
- Governed by a well defined protocol.
- Operate on science mode.
- Strict inclusion – exclusion criteria.
- Personal involment of Research team members.
The most aggravating thing about the situation is that in the developed countries like US and UK medical research is being driven by lay public. They are demanding that their government spend more on medical research. In fact the war against cancer in the US came into being because of public pressure on federal government to increase funding for cancer research. In many cases public charity groups are actually funding trials. That is the way it should be. On the other hand in India you have the press as well as general public up in arms. So forget about being a positive push, there negative publicity about clinical research is becoming deterrent to medical research.
I strongly feel that the general public has to be more proactive when it comes to clinical trials. We all want better medical treatment for ourselves. Can we treat humans with drugs that have been never tested on them but on horses and animals? How can better treatment be ever discovered if we humans don’t participate in medical research? I feel it is a moral imperative for all of us to participate in medical research. Every pill that we pop today for a headache, for high blood pressure, for cancer is available to us only because someone somewhere in the west has participated in a clinical trial to prove that the pill works How we are justified in expecting better treatment if we don’t participate in research ourselves.
India in pharmacy world is more known as “copy cat” ,we were simply by reverse engineering blindly followed what has been discovered in the west. Innovation is hardly what we do. Also drug to be made available in human has to be tested for ultimately for safety and efficacy in humans. Mere study in animals won’t do good. Secondly what happens in a trial is that there are so many safety mechanism put into process that we would not miss out on a drug that is not working for too long nor would we miss out on important side effects for too long. And typically in most of the trials as an cancer trial,new treatment is usually tried as add on to the current standard line of treatment to maximize better outcome in a situation where the patient has already exhausted all available option.
Yes, I do also think the medical professionals needs to change for better as far as research goes like strictly sticking to international norms of Good Clinical Research Practices (GCP). As clinical research requires a specific skills set for carrying out various activities, a need of training exists at the level of individual stakeholder in clinical drug trials. No doctors should be involved in clinical trials till they have undergone training on GCP to do ethical clinical research.
Safety of participating subject is of utmost importance and “do no harm” is a rule of thumb in clinical drug trials. Institutional Ethics Committee need to be stringent and should keep hawk’s eye to monitor clinical research in their institutions. Ethical clinical research trial are must to try and find new better and safe drugs to treat many incurably diseases and must be done in more diligent and safe ways. What would possibly happen if all the drugs and vaccines are removed altogether from our world?
Quite intimidating. All diseases, Aids, Swine flu—— all will feed voraciously on the human population. To stop them we need medicines; good and improved medicines. But how could we do that? Significance of medical research and clinical trials should be seen under this perspective. We cannot progress on path of better Health without good research. I believe we need to address the issue of clinical trials not with blind emotion but with a rational understanding of the benefits and with greater compassion for those suffering for want of effective medicine.
(Dr. Rajesh Swarnakar is a Consultant Pulmonologist & Director, Getwell Hospital besides Principal of Academy for Ethical Clinical Research Training, the only Government approved training centre for clinical research in Nagpur)