Preclinical and Clinical Trial Requirements
A brief overview of the situation regarding preclinical and clinical trial requirements in United Kingdom. Prepared in association with Clyde & Co, a leading law firm in United Kingdom, this is an extract from The Pharma Legal Handbook: United Kingdom, available to purchase here for USD 99.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
There is no requirement to conduct clinical trials locally to receive marketing approval. The steps that have to be complied with in order to obtain authorisation to develop, test and market a product are dealt with in the answer to Regulatory, Pricing and Reimbursement Overview, Question 3.
2. How are clinical trials funded?
Clinical trials in the UK are funded by a variety of different public and private organisations:
- charities (normally focused on a particular disease);
- UK government through organisations such as the National Institute for Health Research (NIHR) or the Medical Research Council (MRC);
- pharmaceutical companies; and
- international organisations.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
As a first step, preclinical studies are carried out to evaluate the safety of a drug and its potential applications. These studies provide important information, including about the toxicity of a drug. If the studies are promising, then the next step is to prepare a clinical trial protocol which is required to obtain the necessary authorisation to carry out a clinical trial in humans.
A clinical trial protocol should set out how the trial will run and needs to be approved by various groups of people before a clinical trial can commence. This includes:
- peer review; and
- ethical approval by a Research Ethics Committee or REC.
In addition, all clinical trials need to be authorised by the MHRA.
If a trial is taking part in an NHS hospital, each hospital will need to get approval from their NHS Research and Development department.
4. What are the requirements for consent by participants in clinical trials?
Participants must give their informed consent in writing before being entered into a clinical trial.
For each trial, specific consent documentation must be developed and approved by the ethics committee. This should consist of a participant information sheet and consent form so that a participant is clear about the objectives, nature and risks of the trial.
Participants in clinical trials are encouraged to ask questions before providing their consent to participate. As a result of case law, informed consent must be focused on the individual participant and based on a genuine two-way dialogue.
Throughout the trial, the subject’s willingness to continue participating in a trial should be checked and reaffirmed periodically.
If new developments come to light during the trial, which could affect consent, these must be brought to the attention of participants.
5. May participants in clinical trials be compensated?
Yes, participants can receive a fee for participation in a trial in addition to expenses. Fees vary depending on the type and extent of the trial.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
All clinical trials must be conducted in accordance with the principles of good clinical practice to protect the safety of the clinical trial participants.
Participants in clinical trials in the UK are protected because of substantial regulation imposed and enforced by the MHRA. Companies engaging in clinical trials are legally bound to comply with legislation in order to protect patient safety and government bodies, such as the MHRA, carry out regular inspections to ensure compliance.
In addition, before patients can be enrolled on a trial, a medical ethics committee must approve the ethicality of a trial.
The sponsor of the clinical trial is required to maintain indemnity insurance to protect against the risk of harm to clinical trials participants.
Where a contract research organisation (CRO) is involved, it is typical that a clinical trial agreement is put in place which sets out the rights and responsibilities of the CRO and also ensures that the sponsor fulfils their legal obligations.
The clinical trial agreement sets out the indemnification procedure. This information is provided to participants. In addition individual clinicians involved in the clinical trial would be personally liable in the event of any negligence on their part, either through NHS indemnity or through a private insurance company.