Academic journal article Ethics & Medicine

Informed Consent Documentation in Pharmaceutical Industry-Sponsored Clinical Trials

Academic journal article Ethics & Medicine

Informed Consent Documentation in Pharmaceutical Industry-Sponsored Clinical Trials

Article excerpt

Rationale

Demand for new therapies and medicines is only increasing as the population in developed countries ages. The average life expectancy of 48 in the mid-20th century rose to 65.6 in 2005, and is predicted to rise to 85 for females in 2030.' This has led to rapid growth in the pharmaceutical industry in recent decades. However, with many companies present on the market, the competition in developing new drugs is enormous. Drug patents expire after only 20 years, and the time needed to perform appropriate tests in vivo and in vitro is reaching up to 11 years, with staggering costs of up to $802 million per drug. Currently, only 1 in 5 compounds will be marketed as safe and efficient. Recent industry's experiences with the FDA (Food and Drug Agency) and EMA (European Medicines Agency) show that the requests for safety data grow with time, as does the cost and time needed to introduce a new drug to patients.2

Pharmaceutical companies know that they constantly have to work on new products, not only to improve the healthcare of patients, but also to ensure the survival of a company when its patents expire. As the patents for drugs expire, other companies get to market generic versions of these drugs. This is why a pharmaceutical company must invest so heavily in research (i.e. Pfizer has spent $7.945 billion on R&D in 2008, 16% of its annual income).3

With the growing demand for new drugs and new therapies and the need to plan for the long term financial stability of the pharmaceutical companies, it is important to remember that behind every clinical trial there are doctors, their patients, and a multitude of health care employees and research scientists. For this reason, there are certain laws and regulations which apply in order to protect all the stakeholders in the industry. The first guideline for the conduct of clinical trials and patient protection was issued in 1964 with the Declaration of Helsinki, which clearly outlined the need for patient protection and the importance of putting a patient's well-being above all other interests. It also drew attention to informed consent, patient's dignity, and the right to self-determination.4 Some years later, a stronger fundament of the clinical trial participant's protection was issued, the Belmont Report, which has three ethical principles in mind:5

* Respect for persons, aiming to protect the autonomy of each individual and give them the right to informed consent

* Beneficence, the "do no harm" rule, minimizing risks while maximizing the research benefit

* Justice, justifying reasonable and fair distribution of the procedures and benefits for the research subjects

In the early 1980s, the European Economic Community (now the European Union) together with Japan and the USA formed the International Conference of Harmonization (ICH) to create a common standard of conduct for clinical trials as a set of guidelines of Good Clinical Practice (GCP). Their principles were as follows:6 ethical conduct of the trial; research described in the protocol; risk identification; benefit-risk assessment; review by IRB/EC; protocol compliance; informed consent, ongoing review/risk-benefit assessment; investigator/staff qualifications; records integrity; confidentiality; good manufacturing practice; and quality systems.

These standards are the current set of rules for performing clinical trials, and are applied by all medicinal regulatory agencies including the EMA and FDA (implemented in the Code of Federal Regulations, CFR). From all the above-mentioned principles of GCP, this text focuses on Informed Consent and ways of documenting a subject's approval for clinical trial participation. It should be noted, however, that all of the principles are related to one another, so some of the others will also be discussed. The aim of the paper is to discuss current standards applied to Informed Consent Form preparation. This work will present an alternative to the currently used format, as well as propose additional actions which could be implemented to increase the readability of the form for the benefit of the patient. …

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