Glossary

Attrition is the loss of participants during a clinical trial it is also known as the 'drop-out rate'. The opposite of attrition is 'retention'.

Attrition can cause bias in study results if more participants drop out of one study arm than another, or if there is a difference between the participants who drop out and those who continue. Attrition can affect how applicable the results of a study are (external validity), or the statistical power of a study.

Research suggests that using a combination of strategies can improve the retention of participants in trials. Many different methods may be appropriate, for example providing incentives for taking part, giving personal reminders of appointments, and involving patients and/or their carers throughout the trial-design process.

Audits (independent evaluations of activities, processes and product quality) are an element of quality management in industry, finance, commerce and public service. They are typically performed by an independent auditing service, but may also be conducted as an internal audit (self-inspection) by the company through a specific audit department usually directly reporting to the board.

In medicines development, two audit types are routine and required:

1) Good Manufacturing Practice (GMP) audits (self-inspections) to monitor the implementation and compliance with good manufacturing practice principles (required as per Directive 2003/94/EC) and other quality standards like ICH Q10 and to propose necessary corrective measures.

2) Good Clinical Practice (GCP) audits, a systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data was recorded, analysed and accurately reported according to the protocol, sponsor™s standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s) (ICH E6 Directive 75/318/EEC as amended

Autologous tissue or cells are tissue or cells derived from the same individual. For example, skin transferred from one part of the body to another is autologous tissue in advanced therapies, stem cells are removed, stored, and later given back to the same person. Autologous transplants are used to treat a number of different blood cancers. Autologous stem cell transplantation is distinguished from allogeneic stem cell transplantation, where the donor and the recipient of the transplanted stem cells are different people.

Portuguese National Competent Authority. http://www.infarmed.pt"

A subdivision of microbiology that involves the identification, classification, and characterisation of bacteria.

Baseline assessments are carried out with participants as they enter a trial and before they receive any treatment.

These assessments may take the form of interviews, questionnaires, physical examinations, laboratory tests, or other procedures. Baseline assessments include demographics (such as age, gender), patient characteristics (such as height, weight, blood pressure), and measurements specific to the study (such as disease characteristics or previous treatment).

Baseline data provide information about participants as they enter a trial and before they receive any treatment.

Baseline data collection may take the form of interviews, questionnaires, physical examinations, laboratory tests, or other procedures. Baseline data include demographics (such as age, gender), patient characteristics (such as height, weight, blood pressure), and measurements specific to the study (such as disease characteristics or previous treatment).

Beneficence is a concept in research ethics that states that researchers should have the welfare of the research participant as a goal in any clinical trial or other research study. In public health, beneficence implies acting in the best interest of the population or society as a whole.

Medicines almost always carry risks as well as benefits, so practising beneficence in clinical trials is not straight forward. An analysis of the risks as well as the benefits is required in each case.

Benefit is a positive outcome (such as the relief of symptoms, cure, or prevention) from using a treatment or taking part in a study. The benefits of taking part in research may include helping others by participating in medical research, close monitoring by health professionals and experts, or getting access to an effective treatment before it is made available to the wider patient population.

In medicines R&ampD, benefit-risk assessment is the continuous examination of the favourable and unfavourable results of a specific treatment to determine whether its benefits outweigh its risks in a -specific condition. It takes into account the evidence on safety and efficacy, as well as other factors like the nature and severity of the condition the medicine is intended to treat or prevent.