Let’s talk clinical trials – a TASK Academy series
It will be very interesting to see statistics on how the various clinical trial industry professionals began their career in clinical trials. What did they study? Was clinical trial research part of their curriculum? How did they land their first job in trials? What were their expectations, and were they accurate?
I take myself as an example. I studied Occupational Therapy (OT). During my years of studying, one of my subjects was statistics. In my final year we conducted a research project on “Any O.T. related topic of your choice”. I was awarded “The best research project 1997” – looking back I can honestly say this award did not add any value to my current profession in clinical research. I landed my first job in trials after an “over the hedge” conversation with my then physiotherapy neighbour late one Saturday afternoon, who had just been appointed as a clinical research associate (CRA) at a large contract research organization (CRO). Her job was to travel from “site to site” to evaluate if the clinical team was conducting the trial according to Good Clinical Practice (GCP) and the protocol. Nothing of what she said that day made any sense to me but, with job opportunities in Occupational Therapy in South Africa being scarce, the job sounded interesting. I apparently had the correct qualification, so I also applied and landed my first job as a trainee-CRA, with no idea of what that meant nor the road that lay ahead.
The doctors at TASK have similar stories to mine – a conversation with a colleague or a friend; accidently stumbling upon a vacancy for an investigator (not knowing what it entails); part of community service at a hospital that happened to conduct trials; or approached by a Professor doing trials at a University Hospital – without even being aware back then that trials are conducted in South Africa.
During your studies you may have been introduced to concepts of research and biostatistics, but I doubt that a thorough overview of what clinical trial research is about and how trials are conducted was included. It sounds to me that most of us working in the industry got to learn about clinical trials “by chance”.
10 Steps to become a clinical trial investigator
1. Learn about regulations: Each country has its own regulations. If you conduct trials in, for example the USA, or the sponsor is seeking approval by the U.S. Food and Drug Administration (FDA)yourself as the investigator and your team will need to be familiar with parts 11, 50, 54, 56, 312, 812 of the Code of Federal Regulations (CFR) Title 21 and parts 45 CFR part 46. However, to standardize the conduct of trials across countries a guidance book on GCP was written. Individuals who want to conduct trials should know about GCP, which refers to the principles and processes site staff involved in clinical research are expected to follow. Compliance with GCP ensures that the rights, well-being, and confidentiality of participants are protected. It also assures the collection of reliable data for submissions to regulatory agencies.
In South Africa it is compulsory to attend an accredited International Council for Harmonisation (ICH) and SA-GCP course for you as an investigator to be approved by the South African Health Products Regulatory Authority(SAHPRA) and an ethics committee to conduct an investigational clinical trial. This certificate needs to be renewed every three years by attending a refresher GCP course. All other members of your team need to have a current accredited GCP certificate before they can work on the trial. Contact task.org.za/gcp to arrange this training today.
2. Establish the needed time, infrastructure, and resources: Many physicians plan to integrate a clinical research space into their existing practices. To accommodate the conduct of clinical trials you will need to ensure a minimum of:
Space to store investigational product (IP) in a temperature-and-access controlled environment; space for pre-analytical sample processing (depending on the study); equipment – to be calibrated annually – to perform protocol specific procedures; lockable cupboards to keep all participant records and trial documentation safe and confidential; stable internet connection and unlimited Wi-Fi as most trial data is captured on electronic systems; archiving space as well as providing workspace for CRAs who regularly come to monitor your trial; emergency trolleys as stipulated in SAHPRA guidelines. Additionally, the practice will need at least a dedicated clinical research coordinator (CRC) on hand, who will handle the management and documentation of the trial. Time will need to be set aside for training on the study, various administrative duties, study documentation requirements and meetings with staff, CRA and sponsor.
3. Search for clinical trials: Many physicians browse helpful websites. I stumbled upon a very resourceful website CenterWatch.com that shows actively recruiting clinical trials in South Africa per city with the protocol title, indication and site contact details. Other websites that provide a searchable electronic database of planned trials are ClinicalTrials.gov and Pan African Clinical Trials Registry (PACTR) https://pactr.samrc.ac.za. As a doctor you can also contact pharmaceutical companies whose products you may prescribe. Many CROs recruit clinical trial investigators in this way.
4. Prepare for a pre-study visit: As part of the qualification process for a newly awarded study, each potential study site will be visited by a sponsor representative or a contracted CRA to evaluate the investigator’s experience, expertise, and interest, as well as his or her staff, the facility and potential participant population available for the trial. This visit is called a pre-study site visit / site selection visit or feasibility visit. There are also several other items the CRA might want to discuss during the visit, including whether the physician is involved in any competing studies at the same time.
5. Complete needed forms: Once a physician has been identified as a potential investigator, he or she is required to complete several forms and agreements. These forms are called “essential clinical trial documents” and will all form part of the “investigator site file”. A full list of these documents can be found in section 8 of ICH GCP Revision 2 (R2). To list a few: a signed confidentiality disclosure agreement (CDA); Form FDA 1572 – if the study has a United States (US) sponsor or a clinical trial agreement (CTA); a protocol signature page; an investigational drug brochure (IDB) signature page; a curriculum vitae for the principal investigator, sub-investigators and all other team members; supporting qualification documentation and registration certificates; an institutional review board (IRB)/independent ethics committee (IEC) approval letter; if your trial involves investigational product (IP) a regulatory authority approval letter (SAHPRA); laboratory certifications and normal ranges; and the principal investigator’s financial disclosure statement.
6. Receive approval: If you want to conduct investigational product (IP) trials in South Africa you will need approval from both the regulatory authority (SAHPRA) and an IEC before you can start the trial. Both these authorities have executive committees consisting of a group designated to protect the rights, safety and well-being of participants involved in a clinical trial by reviewing all aspects of the trial and approving the import of the IP and the study start-up. During the study you will report on the study progress at specific points to both authorities as they keep close tabs on the progress of the research throughout the trial.
7. Sign the contract and budget: Before the clinical trial starts, the investigator and the sponsor (or a CRO) need to sign a contract and budget. The contract usually outlines the investigator’s responsibilities, including the number of subjects he or she is expected to enrol, timelines for enrolment and the regulatory requirements involved in the clinical trial. It also includes the sponsor’s responsibilities. The budget shows how much the investigator will be paid for study tasks. It is imperative that the investigator scrutinise the protocol to ensure everything has been budgeted for.
8. Get ready for a site initiation visit: A CRA will conduct a site initiation visit (SIV) after the applicable approvals from authorities have been given, the contract/budget and all essential documents have been completed and the IP is on site. The purpose of this visit is to train the investigator and staff and to ensure that everything is in place for the investigator to begin enrolling participants.
9. Delegate your team: The responsibly to conduct the trial according to GCP and the protocol, ensuring participant safety and producing accurate, reliable data is ultimately the sole responsibility of the (principle) investigator. However, the principle investigator can maintain a list of qualified persons to whom he/she has delegated significant trial related duties. After a staff member has been approved/notified to authorities, trained, and delegated they can assist on the trial.
10. Enrol first participant: An investigator (or his or her delegated staff) is usually responsible for recruiting participants, scheduling their visits, retaining them, and making sure they are compliant with the protocol and GCP throughout the trial.
Some of the information included in this article is based on PPD website: become and investigator/process and the book “Becoming a Successful Clinical Research Investigator” by Dr David Ginsberg.
Maybe I just need to mention that a profession in clinical trials is not only a possibility for doctors and nurses – there are numerous other qualifications that can land you a job either as part of the support team or clinical research team at a site – but more about that later!
Head Quality Assurance and Regulatory, Founder TASK Academy
With years of hands-on experience and under the leadership of Karen Cloete, TASK Quality and Regulatory team ensures high-quality standard and GCP compliance of all trials conducted at TASK. They also offer a consulting services to sponsors and sites – feasibility assessments, site start up support, regulatory submission support and clinical trial auditing (GCP / GCLP and vendor audits). Through the academy training and capacity development services are also be provided