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   2011| January-March  | Volume 2 | Issue 1  
    Online since January 29, 2011

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Quality assurance: Importance of systems and standard operating procedures
Kishu Manghani
January-March 2011, 2(1):34-37
It is mandatory for sponsors of clinical trials and contract research organizations alike to establish, manage and monitor their quality control and quality assurance systems and their integral standard operating procedures and other quality documents to provide high-quality products and services to fully satisfy customer needs and expectations. Quality control and quality assurance systems together constitute the key quality systems. Quality control and quality assurance are parts of quality management. Quality control is focused on fulfilling quality requirements, whereas quality assurance is focused on providing confidence that quality requirements are fulfilled. The quality systems must be commensurate with the Company business objectives and business model. Top management commitment and its active involvement are critical in order to ensure at all times the adequacy, suitability, effectiveness and efficiency of the quality systems. Effective and efficient quality systems can promote timely registration of drugs by eliminating waste and the need for rework with overall financial and social benefits to the Company.
  17,616 3,713 -
Phase 0 clinical trials in oncology new drug development
Umesh Chandra Gupta, Sandeep Bhatia, Amit Garg, Amit Sharma, Vaibhav Choudhary
January-March 2011, 2(1):13-22
DOI:10.4103/2229-3485.76285  PMID:21584177
Research focus of pharmaceutical industry has expanded to a larger extent in last few decades putting many more new molecules, particularly targeted agents, for the clinical development. On the other hand, researchers are facing serious challenges due to high failure rates of new molecules in clinical studies. The United States Food and Drug Administration (FDA) in combination with academia and industry experts identified many factors responsible for failures of new molecules, and with a vision of taking traditional drug development model toward an innovative paradigm shift, issued regulatory guidance on conduct of exploratory investigational new drug (exploratory IND) studies, often called as phase 0 clinical trials, requiring reduced preclinical testing, which has special relevance to life-threatening diseases such as cancer. Phase 0 trials, utilizing much lower drug doses, provide an opportunity to explore the clinical behavior of new molecules very early in the drug development pathway, helping to identify the promising candidates and eliminating non-promising molecules, thus improving the efficiency of overall drug development with significant savings of resources. Being non-therapeutic in nature, these studies, however, pose certain ethical challenges requiring careful study designing and informed consent process. This article reviews the insights and perspectives for the feasibility, utility, planning, designing and conduct of phase 0 clinical trials, in addition to ethical issues and industrial perspective focused at oncology new drug development.
  8,855 1,907 7
Adaptive designs in clinical trials
Suresh Bowalekar
January-March 2011, 2(1):23-27
DOI:10.4103/2229-3485.76286  PMID:21584178
In addition to the expensive and lengthy process of developing a new medicine, the attrition rate in clinical research was on the rise, resulting in stagnation in the development of new compounds. As a consequence to this, the US Food and Drug Administration released a critical path initiative document in 2004, highlighting the need for developing innovative trial designs. One of the innovations suggested the use of adaptive designs for clinical trials. Thus, post critical path initiative, there is a growing interest in using adaptive designs for the development of pharmaceutical products. Adaptive designs are expected to have great potential to reduce the number of patients and duration of trial and to have relatively less exposure to new drug. Adaptive designs are not new in the sense that the task of interim analysis (IA)/review of the accumulated data used in adaptive designs existed in the past too. However, such reviews/analyses of accumulated data were not necessarily planned at the stage of planning clinical trial and the methods used were not necessarily compliant with clinical trial process. The Bayesian approach commonly used in adaptive designs was developed by Thomas Bayes in the 18th century, about hundred years prior to the development of modern statistical methods by the father of modern statistics, Sir Ronald A. Fisher, but the complexity involved in Bayesian approach prevented its use in real life practice. The advances in the field of computer and information technology over the last three to four decades has changed the scenario and the Bayesian techniques are being used in adaptive designs in addition to other sequential methods used in IA. This paper attempts to describe the various adaptive designs in clinical trial and views of stakeholders about feasibility of using them, without going into mathematical complexities.
  5,355 1,068 11
Electronic data capture - Narrowing the gap between clinical and data management
Deven Babre
January-March 2011, 2(1):1-3
DOI:10.4103/2229-3485.76282  PMID:21584174
  4,944 855 8
Integrated monitoring: Setting new standards for the next decade of clinical trial practice
Kamala Rai
January-March 2011, 2(1):28-33
DOI:10.4103/2229-3485.76287  PMID:21584179
The new age clinical research professional is now geared toward an "integrated monitoring" approach. A number of critical activities at the site level and at the sponsor's organization need convergence to harness rich dividends in early study start and quick close of the study. The field monitor needs full integration to ensure standard of care, train the site in protocol, select the right site, ensure regulatory support, ensure excellent project management skills, coach, support the logistics team, manage the vendor, ensure good documentation practices, develop patient recruitment and retention, lean the applicable process, as well as ensure effective site management amongst the myriad activities assigned toward developing the drug in the clinic.
  5,134 643 2
Patient advocacy groups: Need and opportunity in India
Kunal Shah, Sunil Garg
January-March 2011, 2(1):4-7
DOI:10.4103/2229-3485.76283  PMID:21584175
With an increasing number of corporate hospitals, healthcare related issues, research trials and undue attention by media in India, there is a need to focus more on patient's rights and protection. In India, multiple agencies like regulatory bodies, scientific review committees, ethics committees, NGOs, etc. work toward patient rights and protection. However, these agencies are inadequate to cater to the general issues related to patient's rights. There's a need to have a separate group of people who provide advocacy to the patient, or simply, a patient advocacy group which will work explicitly in these areas to increase transparency and credibility of healthcare system in India. This group will provide special attention to patient care and protection of rights from the planning stage rather than at the troubleshooting stage.
  5,109 611 2
Use, abuse and misuse of notes to file
Aditi Hazra
January-March 2011, 2(1):38-40
DOI:10.4103/2229-3485.76289  PMID:21584181
A quick and easy solution to the absence of adequate documentation during clinical trial conduct is the use of notes to file. Over the years, the use of notes to file has evolved from a last resort solution to a common working practice amongst clinical teams, bordering on misuse and abuse of this tool. This article explores this evolution from the perspective of an independent observer.
  4,464 769 2
Challenges in conducting psychiatry studies in India
Saifuddin Kharawala, Jeroze Dalal
January-March 2011, 2(1):8-12
DOI:10.4103/2229-3485.76284  PMID:21584176
A large number of psychiatry studies are conducted in India. Psychiatry studies are complex and present unique challenges in the Indian setting. Ethical issues pertaining to the risk of worsening of illness, use of placebo and validity of informed consents are commonly faced. Site selection can be difficult due to the relative paucity of ICH-GCP (International Conference on Harmonisation - Good Clinical Practice) trained psychiatry investigators in India. Recruitment can be challenging due to issues such as strict eligibility criteria, (lack of) availability of caregiver, illness-related considerations, etc. Assessment of the consent capacity of patients is not simple, while structured assessments are not commonly employed. As the illness fluctuates, the consent capacity may change, thus requiring continued assessment of consent capacity. Study patients run the risk of worsening of illness and suicide due to exposure to inactive treatments; this risk is counterbalanced by use of appropriate study designs, as well as the indirect psychotherapeutic support received. Psychiatry studies are associated with a high placebo response. This necessitates conduct of placebo-controlled studies despite the attendant difficulties. Also, the high placebo response is often the cause of failed trials. Rating scales are essential for assessment of drug response. Some rating instruments as well as some rater training procedures may not be suitable for the Indian setting. Technological advancements may increase the procedural complexity but improve the quality of ratings. Psychiatry studies present monitors and auditors with unique scenarios too. Utilization of psychiatry specific training and expertise is recommended to ensure successful conduct of these studies in India.
  4,412 598 2
International regulatory agencies: Indian clinical trials
Arun Bhatt
January-March 2011, 2(1):41-41
DOI:10.4103/2229-3485.76290  PMID:21584182
  2,513 469 -