Medical research is an area that has many different perspectives and questions about it’s value to patients. Over the next few months I’m going to be hosting a few interviews with various people who have been involved in medical research work. The best answers to the questions that are raised will always come from those who have experienced it, either as a researcher or as a participant. My first guest is Doctor/Researcher, Jim Bush, Associate Medical Director at Covance Covance Clinical Research.
What are your responsibilities when it comes to clinical trials?
As Principal Investigator I assume responsibility for the proper conduct of clinical trials. It is my job to ensure that all trial staff have been adequately trained and are competent to perform the procedures on the trial. It is my responsibility to make decisions regarding the medical care of volunteers or patients taking part in clinical trials and to ensure that trials are run in the safest possible way so as to minimise the risk to people taking part. I am involved with reviewing the study protocols, discussing studies with the Ethics committees, checking the medical histories of potential volunteers and making sure that they meet the criteria required for entry into a trial, performing medical procedures during trials, and reviewing data and the final report when the trial has finished.
What regulations and guidelines affect clinical trial work?
The main regulations that affect clinical trial work are the EU Clinical Trials Directive, the EU Good Clinical Practice Directive both of which have been transposed into UK law by the Medicines for Human Use (Clinical Trials) Regulations 2004 (Statutory Instrument 2004/1031). We also adhere to the Good Clinical Practice guidelines issued by the Internation Conference on Harmonisation (ICH GCP).
How do these affect your role?
Everything that we do is affected by European and UK laws and International guidelines. We are regularly inspected by the UK drug regulators, the MHRA, to make sure that our procedures are in line with these laws and guidelines. We are also audited by the companies that we run clinical trials for and by our own internal auditors. If we did not pass our regulatory inspections our unit could be closed down.
What processes do you have in place to manage risk in clinical trials?
We have many processes in place to reduce risk in clinical trials. Protocols are written after reviewing the information from all previous studies that have been performed with the drug involved, whether those studies were in animals or humans. All protocols have inclusion and exclusion criteria to make sure that the people taking part in the trial do not have any medical conditions, past or present, that may put them at risk. Protocols generally have “stopping criteria” and “withdrawal criteria”. These are conditions that, if met, would mean that the trial was stopped or a particular person was taken off the trial.
Who are you ultimately responsible to?
I am ultimately responsible to the Medical Director and in turn the Executive Medical Director and Chief Medical Officer of Covance. I am also registered with the General Medical Council of the UK as a Specialist in Pharmaceutical Medicine (the equivalent of a Hospital Consultant) and have a License to Practice in the UK.
How would you define ‘compliance’ in this area?
Compliance has several meanings in clinical trials. For me it means working in accordance with the relevant laws and guidelines related to clinical trials. For volunteers or patients taking part in clinical trials it means taking medication and allowing trail procedures to be performed as required by the trial protocol.
Confidentiality of all your data.
All personal and medical information is handled in a confidential manner. All data that we collect is used and disclosed in accordance with the Data Protection Act and a Data Privacy Statement signed by all clinical trial participants before they start a trial. Your name will not appear on any study related documents, we will only use your date of birth, sometimes your initials, and a study number which is given to you when you are entered onto the trial.