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.

Wide Range of Bioanalytical Laboratory Facilities & Services in India

Bioanalytical laboratory Services have range of techniques that plays important role in accelerate drug development and in the success of the drug. These techniques are used in regulate the quantity of active drugs and their metabolites in the human body. Bioanalytical laboratory services can also be used in re-energize some drugs that were deemed ineffective and deserted during the starting phases of development.

Over current years, continues innovation and advances in R & D activities for new drug development is speeding up the demand for bioanalytical laboratory services for that very reason market growth of these services increasing day by day. There are companies who have their owned bioanalytical laboratory services and there are companies who outsource the bioanalytical laboratory services which are provided by CRO’s in the industry. The exposer of new technologies and rapid growth in advancement like BABE and PK/PD are strengthening the growth of bioanalytical laboratory services in India.

Veeda Clinical Research Organization has successfully completed Department of Defence (DOD) check-up for multiple biodefense plans proving our deep sympathetic of regulatory guidelines, and representing quality and integrity of our nonclinical and clinical bioanalytical data. We have wide expertise in developing sensitive methods for LC-MS/MS – qualifying multiple-analysis, metabolites, prodrugs, and light- and temperature-sensitive compounds. Our finding team frequently supports fast PK, bioavailability, and early toxicology studies.

Veeda Clinical Research Experience Supporting:

•  Method Development, Feasibility, and Validation
• Nonclinical Toxicokinetic (TK) Studies
• Pharmacokinetic (PK) Studies
• Pre-Clinical and Clinical Sample Analysis and Reporting
• Immunogenicity / Anti-Drug Antibody (ADA) Assays
• PD Biomarkers
• Biosimilar

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.

Advances Research Programs Bioanalytical Laboratory Services

Bioanalytical Laboratory Services dedicated to supporting clinical studies and to helping clients advance their research programs by providing high quality, accurate results across all phases of pharmaceutical development and commercialization. As per regulatory requirement, Bioanalytical Laboratory Services provides a full range of LC/MS/MS bioanalytical services, from method development, method validation, sample analysis, and hormones and vitamin analysis, etc.

The Bioanalytical Laboratory Services has significant experience working with small molecules, biologics, vaccines, and biomarkers across a wide variety of technologies and therapeutic areas.

Bioanalytical Laboratory Services is usually equipped with certain instruments necessary for experimentation such as gas chromatography-mass spectrometry (GC-MS), liquid chromatography-mass spectrometry (LC-MS), high-performance liquid chromatography, ion chromatography, etc.

There are multiple analytical procedures are carried out during these stages of drug development: 

* Bioanalytical Testing.
* Stability Testing.
* Batch release Testing.
* Raw Material Testing.
* Method Development.
* Method Validation.
  
These Bioanalytical Laboratory Services are set to test the efficacy and safety of biopharmaceutical compounds in a specific manner. For instance, a drug product is tested for its safety related to its intended use. The drug product should not harm the individual and react expectedly to heal the underlying health issue.

Early Phase Clinical Trials

The early phase includes phase I trial which is the first step in testing new medicines developed in the lab. The people who take part in phase I trials amongst the first patients to be given a new treatment.

Phase I trials are the first step in testing a new treatment in humans. The major intent of Phase I studies is to initiate how a particular treatment will act and the protection limits of the treatment. In these studies, researchers look for the finest way to give a new treatment such as by mouth, or injection and how regularly it should be given. They also try to find out the best dose that can be considered safe.

Early Phase Trail Main Objectives/Aim Are: 

• The correct dose for new medicines.
• How often the drug should be given to ensure it remains effective.
• The effects the new medicines may have on your body, including side effects and toxicities.
• How your body absorbs, Circulates, changes and eliminates the new medicines.

In Phase I Clinical trials treatment is given to the small groups of patients. After dosage patient are carefully watched for side effects.

Different dosage is given to a different group of the patient i.e.: One group will receive one dosage, and another group will receive another dosage. This process continues in order to find out the highest dose that does not cause harmful side effects. In Phase I clinical trial patients may have lots of blood tests because the researchers look at how your body copes with and gets rid of the drug. They carefully record any side affects you may have and when you have them.

At the end of Phase I trials, it is generally known which doses are good to use and how best to way to carry out the treatment.