CROs begin videographing trial process to improve their public image

In order to make the clinical trials more transparent and also to improve the public image about the clinical trial activities, the Clinical Trial Organizations (CROs) in the country have started videographing the entire trial process right from subject recruitment to dosing of the drugs.

According to sources, several CROs have already started this new system of videographing as part of the Association of Contract Research Organizations (ACRO)'s efforts to self regulate the entire gamut of clinical trial process to counter the malpractices among the peers. ACRO is the umbrella organisation of hundreds of clinical trial companies spread across the country. Other members of the ACRO are also expected to follow suit to make the system more transparent, sources said.

Industry leaders said that there are a lot of misconceptions and propaganda about the working of the CROs in the country which are affecting the image of the industry in a big way. Even though millions of people are benefited because of clinical trial, without which no drugs can be marketed, the clinical trial companies are painted, both by media and common people, in poor light as that of perpetrators of unethical practices.

There are also misconceptions about the recruitment of volunteers and their consent for the participation in the trials. Even though the volunteers are recruited after counseling and they are provided free medicines and taken care of well during and after the trial, the CROs are blamed for unethical practices, sources said and added that it is to allay this impression that the CROs have decided to begin videographing the entire process.

The CROs in the country have been under pressure for the last some months as the authorities had tightened the noose around the neck of these CROs after the eruption of a couple of negative news reports about the alleged unethical practices in the trial. It all started with the controversy surrounding the Hyderabad-based CRO Axis Clinicals in which the company was alleged to have conducted clinical trials of a breast cancer drug on nearly 30 illiterate agriculture labourers after luring them with Rs.10,000 each. The incident created such a hue and cry in the country over the illegal activities of the CROs that the DCGI ordered auditing of all the CROs in the country.

Ever since the eruption of controversies, the authorities virtually stopped giving clearance to clinical trials including the BA/BE studies. Now, by initiating some self regulatory mechanisms like videographing, the CROs wanted to improve the image of the working these companies.

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Hospital to conduct clinical trials with DC therapy for cancer

There is a new ray of hope for cancer patients as a city hospital is in the process of conducting clinical trials with Dendritic Cell (DC) therapy, an FDA approved mode of treatment for prostate cancer.

Clinical trials will be conducted for use of this therapy for treatment of other cancers too as it relieves from the accepted modalities of cancer treatment including chemotherapy, radiation and surgery.

DCT is Food and Drug Administration approved and has been effective in treating prostate cancer, Dr Ashok Vaid, chairman, department of medical oncology and haematology of Medanta Hospital said.

"We are in the process of conducting clinical trials with help from dendritic cells for all types of cancer. If it is effective for treatment of prostate cancer then why not find its effectiveness for other cancers too. DCT is based on immunotherapy which is an autologous therapy and enhances the immune system of a patient naturally and helps combat the cancer cells," he said.

Dendritic cells are present in every person's tissues. They function as an immune cell but are present in small numbers. They identify cancer cells and process them into bits and jump start the immune response by bringing the foreign substance to the attention of the rest of the immune system.

However, he said, "In a cancer patient when dendritic cells are not formed in a natural manner they are harvested outside in large numbers from the patient's own blood cells. The blood cells monocytes of a patient are separated from blood and cultured in the laboratory and matured into dendritic cells by exposing them to patient's own tumor cells.

"This is done mainly to ensure that the dendritic cells mature into DCs that are specific to the tumor type of the particular patient. These DCs are then administered to the patient intravenously at regular intervals to boost and fortify the immune system of the patient and provide the necessary impetus the body requires to fight back the cancer."

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Now, get your health results in 8 hours

Patients can heave a sigh of relief. A new diagnostic test kit can now detect symptoms of critical infections very quickly -- in seven to eight hours compared to the average 72 hours and more it takes in conventional tests, leading to quicker diagnosis and treatment of the infection. 

The kit will reduce exorbitant testing charges and extended hospital stay costs for patients. The kit has been invented by Bangalore-based molecular diagnostics company, XCyton, with Rs 6-crore assistance from Council of Scientific and Industrial Research and private investors, including Biocon chairperson Kiran Mazumdar-Shaw. 

The invention known as Syndrome Evaluation System (SES) has been described by American-based investors as the fastest, simplest, elegant and most cost-effective testing kit or tool in the world that can in just one test detect multiple bugs/organisms at work in critical infections. 

"There are many diagnostic kits that do the same thing across the world but we haven't yet come across one that does it as rapidly and inexpensively as this kit does. We come from the Massachussets area where a lot of inventions do happen and we have come to this inference based on substantial research," said Ketan Patel of Fidelity, which has invested $ 4.5 million in product development and commercialization. 

What infections 

The invention is targeted at speedier treatment of brain-related infections, sepsis, eye infections, cancer-related ailments, lung, joint, spine-related infections among others, which means people afflicted with these infections can expect faster test results, therapy and treatment now. 

Scientist BV Ravi Kumar, XCyton founder and CMD, told TOI, "The new testing tool will identify the work of multiple organisms - bacteria, virus, fungi and parasites - in just one sample - that were causing a particular infection." 

"Multiple tests to detect each of these organisms are no longer necessary. The test kit will show up all these different organisms at work in one test within seven to eight hours, as compared to the 3-7 days' time conventional tests take. One test in place of multiple tests will now reduce patients' bills," Kumar explained. 

Kiran Mazumdar-Shaw, CMD, Biocon who has invested in her private capacity said: "I can relate to XCyton the very same way I built Biocon. Success for a biotech enterprise is about going from failure to failure without giving up. To get the correct outcomes, it all starts with correct diagnostics. We are poor at diagnosis and rush to treat patients. We use antibiotics as one-size-fits-all approach. Very often it doesn't work and has disastrous effects. Everyone thinks it's easy to build a company in biotech, because they often confuse it with IT. Biotech has huge challenges. The whole basis of discovering things, and validating those findings and translating them into commercial success is a much-harder journey. There are regulatory and scientific challenges. XCyton represents the new innovative India." 

Shaw added that the biotech sector did not support the compulsory licensing recently accorded to Indian company for a cancer drug. "We felt this was not the cancer drug that needed compulsory licensing. It was only benefiting a minority segment, and by doing this, we are giving the wrong signals. We are frivolously giving away compulsory licensing. We are determined to innovate in biotech sector."

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