Oncology Clinical Trials in India Challenges and Benefits

Oncology clinical trials in India in the last ten years has been a phenomenal increase and emerged as one of the major global destinations for clinical trials. Changed intellectual property regimen after WTO has been the principal mover of the occurrence, and maximizing profits rather than serving any considerate motives forms the main ideology of the rise of oncology clinical trial in India.

Challenges:

Regulation:

The complexity of the guidelines in heavily regulated clinical industry, addition of new rules and variations between different regulatory bodies causes constraints and predictable concern among professionals in this field. Increasingly emerging markets of clinical trials in new countries requires thorough understanding of whole new sets of requirements.

Infrastructure:

One of the major reasons for not being able to implement screening programmer in India has been lack of workforce - physicians, health workers, technical staff and pathologist to review pathological material.

Clinical Research:

There is a need to develop proper clinical research environment. This includes exposing graduate and postgraduate medical students, community physicians and medical college teachers about translation clinical research, and developing adequate infrastructure.

Spiralling Costs:

Tight timelines and increasing complexity results in cost of trials to be all-time high and puts more pressure on the resources required to implement and control every step.

Delay in Diagnosis:

Late presentation which in turn is due to low level of awareness in the population and among community physicians, lack of screening programs, lack of diagnostic facilities locally and vast distances to travel to reach a major tertiary cancer center, financial constraints and stigma associated with the diagnosis.

Benefits:

• Opportunity to access new drugs/treatments.
• Free treatment of cancer.
• Close supervision during treatment.
• Chance to participate in advancement of medical science.

Phase 1 Clinical Trials: Is The Treatment Safe?

Phase 1 Clinical trials are course of action to test new methods of treating, diagnosing or preventing health conditions of the patients. The goal is to govern whether the drug going to publicize are safe and effective with minimal or no adverse effect. Variety of things evaluated through clinical trials like medications, medication combinations and medical devices.

 

Phase 1 Clinical Trials: Is Treatment Safe?

Phase I studies of a new drug are regularly the first that include people. Phase I studies are done to find the maximum dose of the new treatment that can be given safely without affecting severe side effects. Although the treatment has been verified in lab and animal studies, the side effects in people can’t be identified for sure. These studies also benefit to resolve on the best way to give the new treatment.

Key Points of Phase 1 Clinical Trials:-

• In phase 1 clinical trials researchers aim to find best dose of the drug with minimal side effects, tested on small group of 15-30 patients.

• It starts by giving very low doses of the drug to few patients and higher doses to the other patients until side effects become severe or acceptable effect is seen of the dosed drug.

• The main thing in lime light in phase 1 clinical trial is to observe how the drug effects the body and what acceptance of drug to the body.

• Placebos (sham or inactive treatments) is not part of phase I trials.

• These studies generally include a minor number of people (typically up to a few dozen).

• Often, people with different types of cancer can take portion in the similar phase I study.

• These studies are frequently done in major cancer centres.

• These studies are not planned to find out if the new treatment workings against cancer.

Observer keeps very close eye on the people as the main concern is the safety and to watch for any serious side effects because in phase 1 studies rare side effects may not be seen until late. These studies generally done in major cancer centres and people with different types of cancer can take part in the same phase 1 study.

Overall, phase I trials are the ones with the likely greater risk. But phase I studies help some patients with life-threatening illnesses.

Opportunities and Challenges of Oncology Clinical Trials in India

Oncology Clinical trials are research studies that call for people. Through Oncology clinical trials, doctors find new methods to ameliorate treatments, quality and value of life for people with disease.

Researchers design oncology clinical trials to investigate new ways to:

• Treat cancer
• Find and diagnose cancer
• Prevent cancer
• Manage symptoms of cancer and side effects from its treatment

Oncology clinical trials are the full and final step in a long method that begins with research in a laboratory.

With well-developed medical education and a long-standing experience, a rock-hard information technology infrastructure, the presence of numerous institutions and laboratories with state-of-the-art equipment, India is a great platform for global market to conduct oncology clinical trials and to offer cheaper, safer, and effective treatment options to its afflicted population. Country like India having increased cancer load, have started considering clinical trials as a treatment alternative to the patient pools. With colloquy between the regulators, experts and stakeholders from industry, the regulatory environment has significantly improved in last few years.

Increasing cancer burden throughout the world and appreciable research spending in targeted cancer therapies, Oncology clinical trials undertaken in this therapeutic area has increased remarkably. Countries like India with its improved regulatory environment investigators and infrastructure offers opportunities to pharma companies to conduct their clinical trials in India in a cost-effective way. 

Why Are Oncology Clinical Trials Important?

Today, people are long lasting from effective cancer treatments that are the results of previous oncology clinical trials. Over the oncology clinical trials, doctors’ control whether innovative treatments are safe and effective and work better than current treatments. Oncology clinical trials also support us to innovative ways to prevent and detect cancer. And they help us progress the excellence of life for people during and after treatment.

When you take part in an oncology clinical trial, you add to our information about cancer and support recover cancer care for future patients. Oncology clinical trials are the key to making development against cancer.