In November 1985, the National Institute of Neurological Disorders and Strokes began a clinical trial studying the impact of Botulinum Toxin on involuntary movements, a trial that is still ongoing today. While some clinical trials like this are carried out over several years to capture long-term effects, others just get delayed. Here, Leah Shifra Price, freelance biostatistician at freelance platform for scientists Kolabtree, discusses how a flexible workforce can speed up trials and remove delays.
Clinical research
Whether you’re developing a drug to treat back pain or Alzheimer’s disease, clinical research is never a quick process and it’s frustrating when you face any delay. For instance, you may struggle to get the right number of participants or people may drop out halfway through. Around 85% of clinical trials experience some kind of delay, with 94% of these being delayed by over a month, that is according to global medical supply company MESM.
The challenges of recruitment
There are many reasons why your trial might not work out ─ whether it’s securing funding, accessing a physical location or obtaining statistical significance in a study. Clinical trials also rely on direct recruitment, and this is one of the biggest challenges you can face. “Difficulties with recruitment are very, very common, and some trials are just kicked into touch because they cannot recruit,” explained Shaun Treweek, senior lecturer at the University of Dundee and assistant director of the Tayside Clinical Trials Unit.
It can be hard to recruit participants without the necessary incentives and you could also struggle to retain them if your study is longitudinal, since this requires people to remain in the study for months or even years. You may also have a problem accessing the experts that you need to help design your research.
On the one hand, you could find yourself facing stiff competition to fill certain roles, or you might not have the money or resources to take on full-time employees. It isn’t always practical to hire permanent specialists either, since you may only need their expertise for a certain part of the process. For instance, if you only need somebody to consult with on trial design, they’ll become superfluous by the time you’re submitting your data at the end of the study.
Broad and flexible
The role of outsourcing is continuing to grow in clinical research. The global market for clinical trial services is forecast to increase at 12% every year until 2021, that is according to a report by The British Research Company. When carrying out research, you may already work with a contract research organisation (CRO) that provides services including toxicology tests, biostatistical research and central laboratory and data management functions.
When you first design your trial, you can contract a CRO to manage the research and take the lead with other tasks. More companies are outsourcing their research, with CRO consumption in North America already worth $20.8 billion, according to the same report.
Working with these organisations allows you to recruit expertise without hiring full time employees, and you also save costs on running these trials in-house. CROs like Quintiles and HMR can even manage your site selection and patient enrollment stages.
While CROs can take the lead on a project and provide these essential services, freelancers also offer expertise and knowledge that can enhance your trials. For example, a freelance medical writer will draft your initial proposal, prepare the informed consent documents that are given to participants, and write up the final research report. Like CROs, freelancers can also reduce the costs of drug development by outsourcing your trial management and saving money on the overhead costs that come with in-house employees.
Designing your trial
The way you design your clinical trial and disseminate the results will depend on the funding you are working with and the research focus. The type of study is also important. For example, your research could involve a large randomised trial or a series of small site studies, including those that are involved when using Genomic Profiling to explore the genetic makeup of individual participants.
If your trial is studying the treatment for prostate cancer, you’ll need a precision medicine trial since this accounts for variations in genes and lifestyles of participants. For instance, umbrella trials assign people a particular treatment arm based on the molecular makeup of their cancer. Your trial may also use basket studies to test the effect that a drug has on a single mutation in different tumour types. With PhDs in medicine, biology, biochemistry and other similar fields, freelancers can also use their expertise and experience to complement your trial design process.
Managing your data
“Statistical analysis is one of the foundations of evidence-based clinical practice, a key in conducting new clinical research and in evaluating and applying prior research,” that is according to a report by Howard Barkan, a senior consulting statistician at the University of California. When you run your clinical trial, you create vast amounts of data, including information about individual participants and other data that comes from the case report forms (CRF).
Statistical analysis helps form accurate inferences from your research while minimising the potential for error. If you hire a freelance biostatistician that has specialist skills in data management and informatics, they can strengthen your skills and manage the various data inputs in your trials. These include source data and its entry, as well as quality controls and queries. They will be able to lock your database so that the information can be submitted to either the FDA or EMA. They can also develop different statistical methods and tests and transform your data and handle any outliers.
If you don’t want your trial to last 24 years like the research into Botulinum Toxin, it’s important to use the right skillset.