Factors that influence and motivate parents consenting to trials
Research type
Research Study
Full title
A pilot study of factors that influence and motivate parents of children with bleeding disorders to participate in clinical trials of new recombinant factor concentrates.
IRAS ID
151527
Contact name
Professor Nicola Crichton
Contact email
Sponsor organisation
London South Bank University
Duration of Study in the UK
0 years, 5 months, 15 days
Research summary
Inherited bleeding disorders comprise a varied series of conditions, namely von Willebrand Disease (vWD) (type 1, type 2 and type 3), Haemophilia A and B, Glanzmann Thrombasthenia (GT), Factor V, VII, X, XI, XIII deficiencies and platelet function abnormalities, with most having their first clinical presentation in childhood. In the past children with haemophilia and other bleeding disorders were treated with infusions of factor concentrates obtained from donor blood, which were discovered later to transmit blood-borne viruses. Presently, advanced research in specific clotting factors have led to pure and safer factor concentrates been used in the treatment of these bleeding disorders. This has come as a result of many years of research, including the participation of the affected children in clinical trials.
As bleeding disorders are rare, the numbers of competing trials in bleeding disorders make it a challenge to enrol target patient numbers in the clinical trials.
This complexity can lead to poor enrolment with delayed trial completion, resulting in delayed knowledge and delivery of new factor treatment. Moreover, most of the children in the UK are already receiving recombinant factor concentrate infusions, as part of their standard care, without any bleeding problems or complications related to their factor concentrates.
This study is designed to investigate the factors that influence and motivate parents to consent for their children to participate in these clinical trials. We wish to find out what key positive experiences and negative aspects from taking part in these trials are encountered by these parents who chose to let them participate. The views of those who decline for their children to participate in these trials will also be sought.
This is mix-method study and will last for approximately 7 months and participation in the study will involve completion of a questionnaire and a semi-structured interview.REC name
East of Scotland Research Ethics Service REC 1
REC reference
14/ES/1111
Date of REC Opinion
10 Dec 2014
REC opinion
Favourable Opinion