The International Conference on Clinical Trials, which is going to be held during July 27-29, 2015 at Orlando-FL, USA. With target audience as Principle Investigators, Methodologists and CRO/Industry professionals, the conference will focus on prevailing approaches in various Clinical Trials and how to increase its efficiency during different phases of trials to develop low cost therapeutic approach with higher efficacy. OMICS International Organizes 300+ conferences, 500+workshops and 200+symposiums on Clinical, Medicine, Pharma and Science & Technology every year across USA, Europe, Asia, Middle East, Australia and UK with support from 1000 more scientific societies and Publishes 500 open access journals which contains over 30000 eminent personalities, reputed scientists as editorial board members.

Clinical Trials Management System has made enormous progress in past few years, and according to Transparency Market Research the estimated net worth is approximately US$844 million in 2013, while growing at a compound annual growth rate of 14% during the forecast period, the worldwide Clinical Trials Management System market is expected to acquire market value worth US$1,848.5 million by 2019.  United States is the major center in the field of Clinical Trials with Florida being one of its major contributing states. Florida is considered to be a hot spot for various investigation sites of different Pharmaceutical Industries and Medical devices. Florida, Orlando, Miami and Tampa are major cites which are focused for Clinical Trials and Research.

For more details, please visit: Clinical Trials Analysis Report
 

Pre-Clinical Research and Conducts of Clinical Trials

Pre-clinical research also named preclinical studies and nonclinical studies is a stage of research that begins before clinical trials, and during which important feasibility, iterative testing and drug safety data is collected. The main goals of pre-clinical studies are to determine the safe dose for First-in-man study and start to assess product's safety profile. Products may include new or iterated or like-kind medical devices, drugs, etc. A clinical trial is a type of clinical research that follows a pre-defined plan or protocol. Researchers design clinical trials (Clinical study designs) to answer specific research questions related to a medical product. Clinical study design is the formulation of trials and experiments, as well as observational studies in medical, clinical and other types of research involving human beings. Clinical trials are typically conducted in four phases, each phase is considered as separate trial and, after completion of a phase, investigators are required to submit their data for approval from the FDA before continuing to the next phase. By taking part in clinical trials, participants can not only play a more active role in their own health care, but they can also access new treatments and help others by contributing to medical research. More than 600 clinical research centers are there worldwide, and approximately 1500 universities in which pre-clinical and clinical researches are going on. Clinical research funded by government grants like National Science Foundation, the National Institutes of Health, etc., companies doing research and development, and non-profit foundations like the Breast Cancer Research Foundation.

According to Pharma Clinical Trial Services: World Market 2011-2021. Global revenues are expected to reach US$32.73 billion in 2015 and to exceed US$65 billion in 2021, with the top ten CRO’s then accounting for more than half of the overall market.

 

Risk Management and Data Outsourcing: Organizational Aspect

The process of identification, analysis and either acceptance or mitigation of uncertainty in investment decision-making  Essentially, risk management occurs anytime an investor or fund manager analyzes and attempts to quantify the potential for losses in an investment and then takes the appropriate action given their investment objectives and risk tolerance. Inadequate risk management can result in severe consequences for companies as well as individuals.

A practice used by different companies to reduce costs by transferring portions of work to outside suppliers rather than completing it internally is called Outsourcing. It is a very important tool for reducing cost and improving quality. If an organization does one or all its work by itself, its work may affect its production quality. So, an organization must realize some important areas, from which its cost is reduced and its products stay in high quality.

 

Innovation in Clinical Trials

Clinical trials for the development of a new drug are, for the most part, initiated and financed by industry. There are also many clinical trials initiated by academic clinical researchers. Whether initiated by industry or by academic clinical investigators, clinical research is often performed in national, European and worldwide consortia, which can sometimes be very large ones.

Clinical research raises profound ethical and safety questions. The protection of participants in a clinical trial is of paramount importance. As a consequence, clinical research is highly regulated. To facilitate collaborations across borders, many aspects of this regulation are harmonized at the European level but also worldwide.

 

Transforming Trials Methodologies: Clinical Studies

Clinical study design is the formulation of trials and experiments, as well as observational studies in medical, clinical and other types of research involving human beings. The goal of a clinical study is to assess the safety, efficacy, and/or the mechanism of action of an investigational medicinal product, or new drug or device that is in development, but potentially not yet approved by a health authority.

Design-based research is a type of research methodology commonly used by researchers in the learning sciences. Within design-based research methodology, interventions are conceptualized and then implemented iteratively in natural settings in order to test the ecological validity of dominant theory and to generate new theories and frameworks for conceptualizing learning, instruction, design processes, and educational reform.

Types of Study Designs Meta-Analysis, Systematic Review, Randomized Controlled Trial, Cohort Study, Comparative Study, Case-control Study, Cross-sectional study, Case Reports and Series, Animal Research Studies, Test-tube Lab Research

 

Molecularly Targeted Trials: Comparative Approach

Molecularly targeted therapy is one of the major modalities of medical treatment (pharmacotherapy) for cancer, others being hormonal therapy and cytotoxic chemotherapy. As a form of molecular medicine, targeted therapy blocks the growth of cancer cells by interfering with specific targeted molecules needed for carcinogenesis and tumor growth, rather than by simply interfering with all rapidly dividing cells. Because most agents for targeted therapy are biopharmaceuticals, the term biologic therapy is sometimes synonymous with targeted therapy when used in the context of cancer therapy (and thus distinguished from chemotherapy, that is, cytotoxic therapy). However, the modalities can be combined, antibody-drug conjugates combine biologic and cytotoxic mechanisms into one targeted therapy.

Here are some targeted trials done so far for breast cancer, multiple myeloma, lymphoma, prostate cancer, melanoma and other cancers.

 

Challenges and Advancement in Breast Cancer Trials: Case Study

Over the past 30 years, treatment of breast cancer has greatly improved due to lessons learned through clinical trials.  Clinical trials test the safety and benefits of new treatments, diagnostic methods and screening tests. People volunteer to take part in these research studies. Whether a new therapy or test becomes part of standard treatment (or diagnosis or screening) for breast cancer depends largely on clinical trial results. For example, clinical trials showed the benefit of hormone therapies and trastuzumab (Herceptin) in breast cancer treatment and these drugs are now part of standard care. Large randomized clinical trials are viewed as the best basis for making treatment guidelines. Clinical trials take place around the world in many types of medical centers and hospitals. Often, trials are funded by a agencies like the National Cancer Institute.

 

Adaptive and Randomized Trials: CRO and Sponsors Partnership

Adaptive designs for clinical trials are being used increasingly in many areas of medical research. An adaptive design differs from a traditional design in that it uses accumulating results in the trial to modify the trial's course, a characteristic that makes the Bayesian approach an ideal tool for building adaptive designs. The most common adaptations used in modern clinical trials are the following, listed roughly in order of their prevalence across all diseases: stopping early (or late, that is, extending accrual) with a conclusion of either superiority, noninferiority, or futility, possibly after additional follow-up; dose finding; dropping arms or doses; multiple phases of development that are included seamlessly in a single trial; changing randomization proportion; responder population finding; and changing accrual rate. All adaptations should be completely specified in advance of the trial, at the design stage, so that operating characteristics such as the type I error rate can be calculated.

 

Future of Clinical Trials

With the increasing challenges associated with bringing a medical product to market, and skyrocketing R&D costs, there has been a shift in biopharmaceutical commercialization and clinical trial strategies in order to minimize risk and maximize success.  It is estimated that bringing medical products to market costs $1.3 billion and 1 out of every 5000 experimental compounds achieve FDA approval. Moreover, market saturation in many disease modalities is also forcing biopharmaceutical enterprises to focus their efforts on accessing patients with orphan/rare diseases.

The future of clinical trials illustrated as follows. Access and engage the patient online – Attract patients to the trial – Consent patients & convert to subjects – Remotely manage subjects & collect data. The sponsor plans to engage the patient through social media, such as Facebook, and regular e-mail updates in order to attract the patient to the trial, and once the patient agrees to learn more about the trial, the sponsor mails the patient a package containing mobile health devices, which collect medical diagnostic data and sends that data to the sponsor.  The patient turns on the tablet, which contains an electronic consent and a video of a physician explaining the clinical trial in detail. Humanization in digital media is believed to be an effective tool that is used to communicate with patients. During the clinical trial, the subject is able to access live physicians either virtually or through nearby medical community centers. Remote nurses visit the subject at their homes to collect samples.  In addition, the patient uses the mobile health device to automatically upload study data directly to the sponsor's EDC database.