1) Choose the right CRO wisely
For many pharmaceutical and biotech companies, particularly the smaller ones engaged in clinical trials, outsourcing is not so much a choice as it is a necessity. Clinical trials are often very complex projects and it isn’t often feasible to conduct the whole process in-house, nor does it make sense from a financial perspective. Therefore it is very important to choose the right Contract Research Organization (CRO). It is important to choose partners that are not only capable of doing the work, but can work well as a team. There are several issues to keep in mind when choosing a CRO.
2) Selection/Qualification Criteria
Before work at a CRO is initiated, a research team composed of members with a wide range of expertise should be involved in selecting which CRO will be performing the selected work. This might also be called “qualifying” the CRO. It is generally recommended that a visit to the CRO’s facility as well as holding meetings with management, scientists and quality assurance personnel be part of the process.
When selecting a CRO, due diligence requires establishing a predetermined set of criteria against which the service provider will be judged. These criteria range from regulatory compliance, areas of capability, and location. There are several specific organizational and operational areas that should be evaluated during this process:
Policies and Procedures: Conduct a comprehensive review of the CRO’s organizational structure, accreditation status, facility and equipment maintenance, quality assurance procedures, and compliance with national and international guidelines
Personnel Management: Thoroughly review the company’s staffing levels, job descriptions, training records, and observations of personnel performing work. Discussions should include scientific experience, capabilities, and expertise.
Facilities: The physical structures should be inspected for quality and compliance. Required equipment should be well-maintained and meet the specifications of the outsourced work.
Security: The confidentiality of the research performed by a CRO is critical. In addition to validating procedures that protect the security of electronic data and correspondence, an inspection of facility security and its intrusion deterrence system should be examined.
Crisis Management: CROs should have an effective crisis management plan that covers all potential circumstances and ensures effective communication with Sponsors.
3) Review and Ongoing Evaluations
CROs should be audited on a regular basis. Annual visits should be performed, but most CROs expect sponsor visits once every two to three years. Additionally, many sponsors opt to schedule visits that coincide with important study milestones.
During these visits, expectations can be reviewed and CRO records evaluated. Specific subjects to address during this assessment include significant changes in CRO staff, quality of data and communication, as well as regulatory or accreditation compliance issues.
All in all, it can be said that selecting the right CRO for clinical trials is, among others, one of the most important steps for success.
4) Selecting the Right Investigator
A clinical trial must be supervised by a qualified person in accordance with applicable regulations and clinical guidelines. These qualifications may vary depending on the disease or therapeutic treatment under investigation, such as cancer research. One of the worst mistakes a sponsor can make is to hire someone who is not qualified to run the clinical trial. Such mistakes can be costly to the sponsor, participating patients and the clinical investigator.
Therefore, one of the utmost important factors crucial to the success of a clinical research trial lies amongst the selection and evaluation of a clinical investigator. Clinical investigators perform the actual research used to support applications for new drugs, biologics and medical devices. A clinical investigator may be a professional researcher operating out of a research institution such as a research hospital or university, or may be a practicing physician who also conducts clinical research.
The Clinical Trial Managers (CTMs) involved with the process of selecting and evaluating the clinical investigator must possess the skills and knowledge in the clinical research area in order to know what to look for.
So what really counts in the selection and evaluation of the clinical investigator?
Looking into different key areas and qualities in which a successful investigator candidate should possess can make a clinical trial run more smoothly. Proper selection of clinical investigators is perhaps the single most important factor in the success of a clinical trial. A highly desirable clinical investigator should have knowledge in the research area, possess positive research practices and ethics, and will be unbiased to the clinical trial.
5) Hosting an Investigator Meeting
An Investigator meeting is a meeting that should be attended by all the participating Lead Investigators, Sub- and Co-Investigators and study site personnel. The purpose of the investigator meeting is to inform all the Investigators and the site staff about the investigational medicinal product and the particularities of the clinical trial. There may also be some training in GCP and regulatory requirements. Investigator meetings are usually held just before the start of the trial but when the regulatory green light has been given (green light from national Competent Authority (CA) and from the Lead Ethics Committee).
During this meeting, background information should be provided explaining why the clinical trial is conducted, the clinical endpoints of the trial, the history of the study (if is not the first study), and the investigational medicinal product itself. This information is very important for the investigator and aids them in making decisions during the course of the clinical trial.
The investigator meeting should be very interactive meaning that all the participants have the chance to ask questions, give feedback and offer other suggestions.
The meeting itself should be held in a central and accessible location. Dedicated conference staff is essential. Someone from the sponsor or CRO should visit the venue prior to booking to ensure facilities are as described in the brochure or on the internet. It should be checked that the meeting room is large enough and that the hotel bedrooms are up to the required standard.
For pan-European studies it may be worth considering separate meetings in respective countries, or regional meetings as appropriate.
Dr. Volker Scherhammer
VS LifeScience Consulting, Munich-Germany