What are the different phases of clinical trials?

Monique Ellis our consultant managing the role
Posting date: 05/10/2016

If you’re considering a career in clinical research, it’s useful to know what’s involved in this exciting and varied line of work. Clinical trials provide some of the most important and rewarding career opportunities available to those who have a degree in, or a passion for, life sciences and clinical research. Pharmaceutical jobs give you the chance to be involved in creating new drugs which combat some of today’s most serious health issues such as cancer, HIV and Alzheimer’s disease. The development of drugs can dramatically improve the quality of life, and even save the lives, of thousands of people. How’s that for a fulfilling career path? If it sounds like your kind of thing, read on!

What are the different phases?

Clinical trials are split into four separate phases, all of which involve testing a newly developed drug on an increasing number of patients and/or volunteers:

Phase I: (20-100 people) This early phase is crucial in determining whether a drug is safe enough to proceed onto later phases. It determines a safe dosage range for humans and is the first opportunity to discover and evaluate any side-effects. Healthy volunteers largely participate.

Phase II: (100-300 people) The drug’s safety is further evaluated and any side-effects are closely monitored and analysed. This is the stage in which the drug’s effectiveness will really become apparent.

Phase III: (+20,000 people) This phase is carried out on a very large scale (often in over 24 countries) and patient populations can exceed 30,000. Surprisingly, the drug is most likely to fail during this phase. The effectiveness, safety and side-effects continue to be monitored. It’s also a chance to compare it to similar drugs already in the market.

Phase IV: This phase is carried out after the drug has entered the pharmaceutical market and involves real world data monitoring. Phase IV trials take place over an indefinite period in order to collect vital information about side-effects associated with long-term use.

What sort of jobs are available during each phase of clinical trials?

It may surprise you to discover that clinical trials require a diverse range of skillsets in order to be executed successfully from start to finish. The different phases may have varying and specific needs depending on the drug or treatment being tested. Yet, as each phase is essentially building on from the previous one, clinical research jobs are often closely linked.

A clinical research associate (CRA) is involved in phases I to VI of the clinical trial cycle. You would be responsible for running trials and could participate in anything from investigating trial sites and writing up the purpose/methodology of the trial, to monitoring and analysing data. CRA jobs often require a degree or postgraduate qualification in life sciences, nursing or medical/ biomedical sciences. Employers will look for candidates who are willing to travel to different trial sites and are flexible and adaptable workers. It is a very people-facing role so the ability to communicate well and skills in conflict resolution will serve you well as a CRA. There are also opportunities to progress to senior (SCRA) and managerial levels within this field.

Positions such as clinical data analyst or clinical research coordinator can be considered. As a data analyst, you’ll focus mainly on capturing and recording research data to be scientifically studied, so excellent attention to detail is an absolute must for this role. Clinical research coordinators are involved in the day-to-day running of trial activities, such as recruiting and checking research participants. Both of these positions require a life-science degree and/or several years of healthcare experience, preferably within clinical trials.

It’s important not to overlook those involved in the preclinical phase of clinical trials (sometimes known as phase 0). This is a crucial phase of extensive preliminary tests which gauge the safety and toxicity of a new drug, and if it’s worth being tested on human subjects. This phase is predominantly carried out by graduate clinical researchers, so if you’re interested in doing this vital work and would consider doing a PhD, this could be the right path for you.

What about management opportunities?

Because the resources available to clinical trials are often limited, efficient and competent management of a trial can be make or break. There is growing need for excellent management at every phase of a trial, from planning through to completion. Examples of these roles are clinical project manager, clinical study manager, clinical research manager and clinical operations director. If you have specialised in a particular field, positions such as an early development manager may interest you as your career progresses.

To be a successful manager in clinical trials, you must possess a strong head for numbers, excellent leadership skills and a strategic and innovative approach to management to effectively oversee the operation of a successful trial. Duties are dependent on the specific role but usually involve planning trials, organising and motivating others, managing accounts/budgets, and communicating with clients, patients and colleagues during each phase. Knowledge of life sciences or medical studies is usually needed for these positions, as well as several years of experience. Click here to learn more about the importance of trial management.

What if I don’t have a directly relevant degree?

For those without a qualification but still interested in clinical research, you can opt to become a clinical trial assistant (CTA). Duties include, but are not limited to, supporting CRAs on a daily basis, handling clinical documentation, reviewing studies, liaising with volunteers and assisting with the management of clinical and non-clinical supplies. If you are interested in being involved in clinical trials but would prefer an office-based, administrative position without having to travel to site (like CRAs), this may be the career path for you. In some cases, full training is given on the job and you can always choose to further your career to become a CRA by undertaking a relevant qualification or getting some internal work experience. Similar positions that may not require a degree but are significant in providing continuous support include clinical trial technicians or patient liaison, and for those with organisational flair: other administrative positions such as data coordinator and clinical trial administrator.

Interested? Have a look for current opportunities at Proclinical to take the first step towards a great career in clinical trials. When you’ve found the one for you, don’t forget to check out our blog post on how best to prepare for that all-important clinical research interview!

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