ipl-logo

Clinical Research Scope

818 Words4 Pages

Clinical Research And It's Scope in India

Clinical research is a current booming industry. It provides scientific analysis of the impact, risks, benefits and efficacy of medicines or a medicinal product. The trials are done before initiating the products in the market. The tests are performed at different stages and after-launch, surveys are held to supervise the safety and monitor the side effects if any. The Clinical Research Organisations (CRO) or pharmaceutical companies carry out the tests.

It is the best time to become part of this fast evolving industry. So how to enter this field? The prerequisite is an educational qualification in clinical research.

The term clinical research refers to the entire record of a drug/device/biologic, …show more content…

However, informed consent is not sufficient for ethical clinical research. Drawing on the basic philosophies underlying major codes, declarations, and other documents relevant to research with human subjects there are some requirements that systematically explain a logical framework for evaluating the ethics of clinical research studies. Values, scientific validities, fair subjects selection, favorable risk benefit ratio and informed consent are a few among them. These requirements are universal and they must be adapted to the various fields in which clinical research is …show more content…

Clinical data management assures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). The ultimate goal of CDM is to assure that data support conclusions drawn from research. Achieving this goal protects public health and confidence in marketed therapeutics.

Clinical Research Organisation
A CRO landscape is vast, with offerings from functional to full service CROs. Using a CRO’s expertise can maximize the efficiency of your clinical trials, but only if you choose the right one for the project at hand.
Typically, a CRO will organise and conduct clinical trials to test the new molecule in humans. As independent companies, they offer an objective assessment of a new drug in the clinical setting and because they partner with many companies, typically offer broader experience.
Before selecting a CRO to work with, a Pharma company or Biotech company will go through the long process of defining the key competencies a provider has to ensure it meets the required needs before drawing up of a

Show More
Related

  • BSN Portfolio

    1879 Words  | 8 Pages

    Not just any research can be trusted. Research needs to be very extensive so that the researcher can compile the data. During my evidenced based practice course, I learned the difference between facilities quality improvement goals versus research. This may include topics such as nosocomial infections. I also learned the difference between qualitative and quantitative research.

    Read More

  • Henrietta Lack

    1937 Words  | 8 Pages

    The job of the “Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles.” (The National Commission for the Protection of Human

    Read More

  • Henrietta Lacks Informed Consent Essay

    857 Words  | 4 Pages

    In the study “Assessing the quality of informed consent in a resource-limited setting: A cross-sectional study,” researchers investigated the process of obtaining informed consent in clinical and public health research. The method of the study utilized interviews, in which research participants were asked a series of questions after they had been through informed consent procedures. 600 participants were interviewed, and the results show that 5.9% believed that they were not given enough information before deciding to participate. Only 5.7% of the participants said that they had not signed a consent form before making the decision to participate. Interestingly, 33.7% reported that they were not aware of their power to withdraw from participation

    Read More

  • Henrietta Lacks Informed Consent

    1122 Words  | 5 Pages

    Informed consent involves the patient understanding “ all aspects of the trial, which are important for the participant to make a decision.... the participant voluntarily confirms his or her willingness to participate in a particular clinical trial and significance of the research for advancement of medical knowledge and social welfare”(Nijhawan 134). When provided informed consent, a patient might refuse to allow his or her doctor to take samples of what the medical professional believes is beneficial. Because of this refusal, the opportunity for potentially valuable research disappears. As a medical expert, you should take on the responsibility of deciding whether or not a patient’s condition becomes research. The research given by one person could become the breakthrough research that helps to save hundreds of lives.

    Read More

  • Limits Of The Humane Slaughter Act

    1640 Words  | 7 Pages

    This methods enables human volunteers to participate in research. It can provide information on the safety of a drug. Volunteers are given a small one-time dose of a drug that 's high enough to cause a cellular effect but low enough to affect the body. They use sophisticated imaging to monitor how the drug behaves in the body. With microdosing benefits include being able to safety test on humans and get more accurate results.

    Read More

  • Methodology During The Tuskegee Study

    1469 Words  | 6 Pages

    For instance, the practitioners are obligated to constantly inform the participants about plans that pertains to interventions (Reamer, 1987). In addition, it is essential for informed consent to include the following: “What is done, the reasons for doing it, clients must be capable of providing consent, they must have the right to refuse or withdraw consent, and their decisions must be based on adequate information” (Kirk & Wakefield, 1997, p. 275). One of the most dehumanizing incidents that occur is the researchers prohibit the participants’ self-determination. For example, the men were compliant with receiving treatment and to be examined by the physicians.

    Read More

  • Define Nursing Research And Evidence-Based Practice

    422 Words  | 2 Pages

    1. Define research, nursing research, and evidence-based practice, and describe the purposes of research in implementing an evidence-based practice. Research is investigating and studying of materials and sources to establish facts and reach new conclusions or to report knowledge about something. Research can also mean to validate something that already exists based on some kind of theory.

    Read More

  • A Scene In Hoop Dreams

    479 Words  | 2 Pages

    Can an image tell us everything we want to know about what happened? Why or why not? An image can not tell us everything we want to know about what happened. The images can be changed or altered by a editor during and after a person is having an interview for example or even a picture with photoshop.

    Read More

  • Using Driscoll's Model Of Reflection On Consent

    1024 Words  | 5 Pages

    Consent is patients’ rights because they have right to know what is happening to their life which is fundamental value in professional practice (Department of Health (DH), 2001). Dougherty and Lister (2015) state that consent is a patient’s rights to refuse or to accept a treatment. However, Dimond (2010) said that consent is a voluntarily decision which can be given orally, verbally, written or implied for example if you ask a patient to take their blood pressure and they offer their arm. Eyal (2012) also states that consent promote trust in medical procedures that people may seek and comply with medical advice and participate in medical research. Bok (2013) argues that there are problems with the trust-promoting as many patients give consent despite being to some extent distrustful.

    Read More

  • Advantages And Disadvantages Of Risk Based Monitoring

    998 Words  | 4 Pages

    Risk Based Monitoring (RBM) is becoming more popular and widely used in clinical trials in the past few years. The concept of the risk based monitoring is to transform the traditional 100 % source data verification (SDV) monitoring approach towards a new concept of monitoring that includes varies of centralised activities in critical data evaluation and process monitoring. RBM is a monitoring approach which combines risk assessment and risk management by utilising key data indicators, along with analytical tools to identify risk at study level, site level and subject level respectively. It also introduces the new term Source Data Review (SDR) to the industry. Source Data Verification which is known as SDV is defined as “the process by which

    Read More

  • Medical Office Procedures Research Paper

    440 Words  | 2 Pages

    AAS- Medical Office Procedures Week 2 Discussion Judy Potts Explain why pharmaceutical representatives leave samples of expensive medications with physicians. Pharmaceutical representatives, show the physicians the newest drugs on the market, to drum up business for the pharmaceutical companies. The representatives leave samples of the products, In hopes that the doctor will strat prescribing their new name brand products for his patients instead of generic drugs. Also, in some cases, the patients are not financially able to purchase a new drug not knowing if it will help with their disease. The clinic 's management staff will determine whether they will be except the newest medication samples from the representative.

    Read More

  • Promoting Urinary Incontinence

    1323 Words  | 6 Pages

    Any study that involves subjects concerning human beings should be approved first from the ethics committee before being effected (Chiarelli & Cockburn, 2002). Further, if the paper ever sought for ethical approval is not being mentioned in any section of the article concerning its ethical issues. This is one of the pitfalls noticed at the beginning of the

    Read More

  • The Pros And Cons Of Medical Research Experiment

    922 Words  | 4 Pages

    Medical Research has the potential to advance society and make life better for everyone in it. However, the ends cannot justify the means; the rights of the subjects of research cannot be violated no matter the possible benefit to mankind. Despite this, time and time again, it has been very easy for, at least allegedly well-meaning scientists to violate the rights of their research subjects because they wanted to help society as a whole. Such experiments were not performed in secret by a minority of scientists; they were often done “by respected investigators at leading medical institutions and were published in medical journals (Scandals and Tragedies 3). " It is vital that we understand the circumstances of these experiments and why they happened so

    Read More

  • Clinical Pharmacist Essay

    752 Words  | 4 Pages

    Topic: Need and importance of clinical pharmacists in healthcare system Clinical pharmacy is a health science discipline in which pharmacists provide patient care that optimizes medication therapy and promotes health, and disease prevention, according to American College of Clinical Pharmacy (ACCP). Patient-oriented care requires specialized knowledge, skill and experience to improve quality of life of patient. The development of clinical pharmacy began at the University of Michigan in the early 1960s. Instead of drug-oriented pharmacy, patient-oriented concept was initiated within short period of time.

    Read More

  • The Importance Of Science In Health Care

    1622 Words  | 7 Pages

    Without research, people will continue suffering from epidemics and diseases that are difficult to treat. The importance of science is that it creates an opportunity for scientists to seek further knowledge that can help them understand how diseases work. For example, the cure for HIV/AIDS can only be found, if scientists continue conducting research on how the virus operates and how it can be treated. It is of great importance that research efforts are well-funded and that researchers receive the support they need to ensure that research efforts are successful. The information collected from proper research is helpful to all health professionals in the provision of targeted and well-informed treatment plans that meet the needs of the

    Read More

More about Clinical Research Scope

Open Document