European Medicine Agency has started reviewing the GCP guide with the idea to adopt it to the changes in the modern world, including new technologies, changes in business models, new concepts of data collection and access.
How these changes will affect the hospitals working on clinical trials?
1) The investigator is responsible for supervising any individual or party to whom the investigator delegates study tasks conducted at the trial site. If the investigator/institution retains the services of any party to perform study tasks they should ensure this party is qualified to perform those study tasks and should implement procedures to ensure the integrity of the study tasks performed and any data generated.
This amendment would give the investigators more responsibility in managing the clinical trial locally buy requesting them to supervise satellite sites, recruitment centres, outsourced facilities (labs, radiology, etc). This undoubtedly will reflect on investigators time commitment to clinical trials and the level of their involvement. However, increased responsibilities in supervising third parties may not be every investigator’ cup of coffee, considering their high workload and the limited time they can spend with their patients.
2) The sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials. The flexibility in the extent and nature of monitoring described in this section is intended to permit varied approaches that improve the effectiveness and efficiency of monitoring. A combination of on site and centralized monitoring activities may be appropriate. The sponsor should document the rationale for the chosen monitoring strategy (e.g. in the monitoring plan).
The implementation of risk-based monitoring is coming shortly after FDA guidance for risk-based approach in clinical trials and it is not surprising. However, this would mean that hospitals running clinical trials will need to allocate more resources to assure data integrity and quality. The positive aspect is that this approach will reduce unnecessary monitoring visits for studies in follow up with no patients on treatment and give more time to the site staff to concentrate on recruiting studies.
3) When significant noncompliance is discovered, the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions. If required by applicable law or regulation the sponsor should inform the regulatory authority(ies) when the noncompliance is a serious breach of the trial protocol or GCP.
UK was one of the first countries to implement serious breaches reporting. Serious breach is a protocol violation which could affect patients’ safety, study data quality and integrity. In UK serious breaches are reported to MHRA within 7 days. Now EMA is implementing serious breaches to all clinical trials, which means that any prolonged noncompliance or serious issues at the site will be reported to regulatory agencies and could trigger more frequent inspections.
What is not included in the current GCP update?
Electronic informed consent process guidance – Unfortunately electronic consent process is not discussed in the GCP amendment. With the implementation of new technologies there are varies mobile applications (like Apple’s Research Kit), which offer electronic consent process and a guidance from EMA on this topic would be very helpful. Electronic consent process could give more flexibility to the sites to discuss studies and consent patients without face to face appointment. This form of consent will be also welcome by the patients and may improve participation rates.
GCP guide is still under development and EMA is accepting feedback from general public. Maybe this is the chance to all hospitals in Europe to get more involved in the next GCP guideline, which will affect them directly.
Author: Olga Peycheva
Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe.
Originally published on 16 Feb 2016
