Clinical research conduct

Medical Affairs departments design valuable and often extremely creative trials that provide important later phase information about clinical research conducted with soon-to-be-marketed or already marketed drugs in regard to their relative efficacy compared to others of its class, new information concerning efficacy in related indications and additional safety and efficacy data that supplement the core data which led to original approval. Because the type of research conducted in this later phase is often in response to residual questions about safety as part of phase IV commitments agreed to upon original approval,... 

There are other possible explanations as well. First, the data are consistent with an increasingly global marketplace for pharmaceuticals. If firms have over time tried to market new drugs in more countries, one would expect to see an increase in the number of foreign trials, because foreign governments often expect marketing applications will be supported at least partly by clinical research conducted in their countries. 

The development of the macrolide immunosuppressants was the result of careful basic and clinical research conducted by the pharmaceutical industry in close collaboration with the medical and scientific communities from around the world. The resultant drugs that have been developed to date and those still on the horizon promise to continue to benefit patients and provide physicians with valuable and novel therapeutic choices. 

The greatest advantage of psychotherapy over medication is that it reduces the likelihood of relapse after having got better. In 2005 a group of Dutch researchers conducted a clinical trial in which they examined the effect of adding cognitive therapy to treatment as usual in a group of patients with a history of... 

Sponsor companies use quality assurance units independent of the clinical research group to audit medical operations. Their role is to ensure that regulatory standards and company policies and procedures for clinical research are being followed in all countries where research is being conducted. 

During the conduct of the trial, constant communication between sponsor, vendor, inveshgator and investigahon teams is critical. There is real value in this process, particularly if all parties uhlize a Clinical Trial Management Software System (CTMS) that coordinates all trial activities involving the Clinical Research Coordinator (CRC) at the site and the project managers at the sponsor and CRO locations. 

Understands that being a respected clinician does not mean being a good researcher and is open to learning about the conduct of clinical research Is prompt in the turnaround on documentation... 

Although IRB members can and should come from a variety of backgrounds, all board members should know the basic elements of clinical research and should stay focused on their role in the ethical review process. Any board member who does not have a research background should take the time to learn the basics of the industry. Books, such as this one, can introduce the language, regulations, and ethical issues in the conduct of research with humans. 

Epidemiologic and laboratory methods can help identify food and toxins associated with a particular disease outbreak. However, very little clinical research has been conducted to determine effective treatments for these... 

The principles of medical research are based on the Declaration of Helsinki. The general assemblies of the World Medical Association (WMA) have, since 1964, made recommendations for guiding physicians in clinical research involving human subjects. Although not legally binding, the Declaration forms the foundation of all other significant international documents on the ethical conduct of biomedical research. 

In October 2000, the latest revision of the Declaration of Helsinki was approved by the WMA (see Appendix 1). The new version is very different from previous versions, with more detail on how clinical trials should be conducted. It requires that study subjects should have access to the best treatment identified by the study once the study has been completed. It also recommends that local participants in a study should be able to benefit from the study results, whether they are positive or negative. These principles were approved to avoid the exploitation of economically poor countries. In addition, the Declaration requires greater transparency regarding economic incentives involved in clinical research. 

Poor adherence to the schedule of taking the study medication will obviously confound interpretation of the efficacy and safety of the drug. There is usually good compliance in clinical pharmacology studies, especially those conducted in units where drugs are administered by the staff. However, in clinical research trials adherence to medication may be poorer. 

In more recent years, in an attempt to overcome these problems, it has become fashionable to include more centres than what may be necessary in a study on the basis that some will be successful at recruiting whereas others will not. All, of course, have to be assessed to ensure that they can operate within the principles of GCP. It is important to be realistic in estimating the speed at which recruitment will occur and even in common disease areas, it is often unreasonable to expect centres to recruit at the rate of more than 1-2 patients per month. Nevertheless, the geographical distribution of clinical research is of major commercial concern because involvement of influential clinicians in the evaluation of a product is vital. It necessarily follows that involvement of influential clinicians in potentially large markets is of prime importance. Studies should, therefore, be conducted in these areas as first choice. However, this mandates willingness on behalf of the investigator to participate in pivotal studies and to meet development deadlines, which, of course, assumes the existence of an appropriate patient population and facilities for the conduct of the study. 

In recent years, an increasing proportion of early clinical research involving healthy volunteers (Phase 1), and falling under the responsibility of the clinical pharmacologist, is conducted in clinical research units as part of the contract research sector working with, but outside, the pharmaceutical companies. 

The conduct of clinical research in humans raises numerous legal and ethical issues of significant importance. After a lengthy process of gestation, the European Commission has now officially... 

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