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What is the authorisation procedure for conducting clinical trials in your jurisdiction?
Authorisation applicants must be sponsors of the trial or its legal representative (if the sponsor is not established in the European Union). Submissions must be made to the Medicines and Healthcare products Regulatory Agency (MHRA).
Sponsors must have a positive opinion from an ethics committee before the start of the trial, which can be obtained at the same time or after submission to the MHRA.
Clinical trials have four phases and a product can pass to the next phase only if it has passed the safety and effectiveness tests of the previous phase.
Following the submission of a valid request, the MHRA conducts an initial assessment within 30 days (on average within 14 days for a Phase I trial) and either:
- accepts the request for the clinical trial authorisation;
- accepts the request subject to conditions (eg, the sponsor can submit an amended request within 14 days and the MHRA will assess within 60 days of the original request); or
- denies the request and provides reasons for its decision.
How robust are the standard good clinical practices followed in your jurisdiction?
Very robust. The United Kingdom adheres to a set of internationally recognised good clinical practice requirements that must be followed when designing, conducting, recording and reporting clinical trials. To ensure good clinical practice compliance, the MHRA carries out inspections and must be notified if serious breaches of good clinical practice or the trial protocol are uncovered.
If critical findings are identified, these are referred to the Good Clinical Practice Inspection Action Group (IAG) – a cross-agency group that oversees all critical findings and decides on the actions to be taken, in addition to reviewing the corrective and preventative action report for the critical finding.
The IAG may consider a number of possible non-routine post-inspection actions depending on the critical finding and its impact on public safety and data integrity, including:
- quarterly reporting;
- early re-inspections;
- referrals to relevant stakeholders (eg, other regulators or agencies, the Health Research Authority (HRA), the General Medical Council or the Care Quality Commission;
- suspending calls to action;
- serving infringement notices; or
Reporting, disclosure and consent
What are the reporting and disclosure requirements for the results of clinical trials?
All UK relevant suspected unexpected serious adverse reactions (SUSARs) which occur during a trial must be reported to the MHRA. Fatal or life-threatening SUSARs must be reported as soon as possible, but no later than seven days after becoming aware of the reaction. Any additional relevant information must be sent within eight days of the report. Non-fatal or non-life-threatening SUSARs must also be reported as soon as possible, but no later than 15 days after first becoming aware of the reaction.
The MHRA’s definition of ‘UK relevant’ includes SUSARs originating in the United Kingdom or SUSARs originating outside the United Kingdom where the sponsor has an ongoing UK trial involving the same product.
Detailed records of all adverse reactions must be kept. The MHRA may require copies of records if there is an investigation. There is also a requirement to submit development safety update reports (DSURs) accounting for all new available safety information received during the reporting period.
A declaration of the end of a clinical trial should be sent to the MHRA within 90 days of the global end of the trial. Any trial activities (eg, follow-ups and visits) should be completed before submitting the end of trial declaration form. Trial amendments may not be submitted once the declaration form has been received.
The sponsor is responsible for uploading the end of trial summary results within six months of the end of paediatric clinical trials or within one year of the end of trial for non-paediatric clinical trials.
What are the informed consent obligations with respect to clinical trial subjects?
Clinical trial subjects must give informed consent to participate in a trial. Before subjects give consent, the sponsor must give them full details of the trial’s nature, significance, implications and risks. Subjects must also be interviewed by the investigating team. Consent must be evidenced in writing, usually by signing a consent form. An ethics committee will consider the wording and information in the consent form. Throughout the trial, the subject’s willingness to continue participation should be reaffirmed periodically – particularly following any significant new information becoming available.
What are the insurance requirements for clinical trials?
Under the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended), a clinical trial may be undertaken only if insurance or indemnity provisions have been made to cover the liability of the sponsor and investigator (this is also a good clinical practice requirement). Sponsors must have clinical trial insurance cover in place before trial approval is given. Ethics committees usually request separate insurance cover, rather than allowing a sponsor to self-insure.
In addition, sponsors usually agree to compensate patients for injuries under the relevant Association of the British Pharmaceutical Industry Compensation Guidelines.
What data protection issues should be considered when conducting clinical trials?
Clinical research is highly regulated with many processes and procedures in place to ensure that the principles of data protection are upheld, including:
- Research Ethics Committee approval;
- Health Research Authority (HRA) assessment; and
- good clinical practice.
Further, the General Data Protection Regulation (GDPR) requires organisations to process personal data in a lawful, fair and transparent way. When conducting trials, the following data protection measures should be considered:
- Safeguarding – the GDPR highlights the need for organisations to have processes in place to ensure that data is processed securely, accurately and in accordance with legal and ethical responsibilities. In addition, study-specific methods to safeguard participants’ data are also required – for example:
- stringent arrangements for securing and storing data;
- anonymising or pseudonymising data wherever possible;
- only collecting data that is needed (data minimisation); and
- minimising the number of participants recruited.
- Consent – the GDPR has strengthened the conditions for consent and assent. Informed, voluntary consent in clinical research is fundamental in protecting participants’ health and welfare, and is already a requirement of good clinical practice. In line with the GDPR, the consent and assent process in clinical research should ensure that organisations treat study participants in a fair and transparent way, providing information about:
- what their data will be used for;
- who will process it; and
- how it will be stored.
Clinical research organisations must also ensure that study participants have access to data protection and privacy policies.
- Research exemptions – the processing of special categories of data (including health data) is permitted under Article 9(2)(j) of the GDPR where:
[The] processing is necessary for… scientific… research purposes or statistical purposes in accordance with Article 89(1)… is proportionate to the aim pursued, respects the essence of the right to data protection and provides for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.
Article 89(1) of the GDPR outlines certain safeguards that are likely to be present in most clinical research.
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