The ins and outs of clinical trials

 So what does it cost to run a clinical trial, anyway?

Performing a clinical trial requires a great deal of resources. Namely, time, money, and people. The cost of running a clinical trial depends on a variety of factors including:

  • Disease type
  • Trial design
  • Trial operations.

Some trials are longer than others, require different numbers of participants and trial sites, collect different types of samples and data, and involve varying numbers of patient visits. Depending on where these numbers fall, the cost to conduct a trial can go up to millions of dollars. That number increases as the number of years, people, sites, and visits increase.

Carrying out a clinical trial requires facilities, equipment and staff. Factors to consider when budgeting for a clinical trial include:

  • Costs associated with regulatory and ethics approvals
  • Patient recruitment, personnel (physicians, nurses, clinical trial coordinators, technicians, and administrative staff)
  • Data collection and analysis

The cost to conduct clinical trial will also depend on the type of clinical trial; a phase I clinical trial involves less people and is often shorter in duration. They are therefore less expensive than a phase II clinical trial.  Phase III clinical trials usually include up to thousands of patients and multiple treatment arms, and are the most expensive to run.

Increasing demands

Today’s clinical research landscape has become more complex than ever before. Clinical trials are increasing in their complexity in terms of design and operations. Researchers must conduct even larger clinical trials in order to demonstrate the improved safety and efficacy of newer treatments over existing ones. This of course raises costs. Regulatory bodies such as Health Canada also require increasing amounts of clinical trial data , which influences trial duration and cost. Finally, trials involving new MS treatments are often longer, more complex, and require multiple measures like clinical, imaging, biomarkers, and patient-reported outcomes.  This helps them to understand if a treatment is beneficial and safe for a chronic disease.

Clinical trials aren’t simple, straightforward research studies. They require a tremendous amount of time and resources. Nevertheless, a clinical trial is a vital step to making effective treatments available for people with MS and other diseases. Clinical trials inform everyday health decisions made by clinicians, patients, their families, and health care policy makers. They make us aware of side effects, unexpected benefits, and the appropriate patients who would benefit most from such treatments.

How do clinical trials impact people living with MS?

An important breakthrough in MS research was announced this spring when Dr. Luanne Metz’s study was published in the New England Journal of Medicine. The promising results show that minocycline – a drug that’s been around for decades – has the potential to reduce the risk of developing MS in individuals with early signs of the disease.

An MS neurologist and professor at the University of Calgary, Dr. Metz began her work with minocycline in 2008 when she launched a phase III, double-blinded, randomized, placebo-controlled clinical trial. She received funding from the Multiple Sclerosis Scientific Research Foundation (MSSRF). The candidate drug? Minocycline – an antibiotic that’s most commonly known for treating bacterial infections such as acne. Early discovery research done by Dr. Metz’s University of Calgary colleague, Dr. Wee Young, showed that minocycline had anti-inflammatory and neuroprotective properties. This work, also funded by the MSSRF, eventually propelled Dr. Metz into leading a clinical trial to see if minocycline could reduce the chance that people who experienced symptoms suggestive of MS (clinically isolated syndrome) would progress to a diagnosis of MS.

Participating in a clinical trial

The clinical trial consisted of 142 participants from 12 Canadian MS clinics, who were randomly selected to receive either 100mg of minocycline twice a day or placebo for up to 24 months. Jill, a participant from Calgary, shares her experience and results from participating in the trial,

“From the time I started taking minocycline seven years ago, I haven’t had any other MS-related symptoms. I feel that this drug has really helped me from progressing to a MS diagnosis.” She continues, “The rate of people going from CIS (clinically isolated syndrome) to MS is very high, and I’m so fortunate that this drug seems to have stopped any further progression in its tracks. I’m still undiagnosed and I strongly believe that it’s because of this drug.”

Results of the minocycline trial

The exciting results of this clinical trial show that minocycline reduces the risk of developing MS in individuals with early signs of the disease. It also shows that treating MS or early events predictive of MS as early as possible with a readily available, affordable treatment like minocycline, is essential. In Canada, the generic form of minocycline costs around $1 per dose. Based on two doses a day, this works out to around $500-600/year, which is considerably cheaper compared to other treatments available.

The results from the trial are very encouraging and position minocycline as a viable treatment option for people with early signs of MS given its availability, established safety profile and cost. In addition, the study will help inform decisions made by neurologists and people with MS around early treatment and whether minocycline can be considered as part of one’s treatment plan.

The journey of minocycline is a successful example of “bench to bedside”, where researchers translate findings from early laboratory studies into clinical applications. The results of these efforts will help to mobilize more options for people living with MS, and contribute to the growing movement to treat as early in the disease as possible.

Remain informed on all things MS research at mssociety.ca/msupdates

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  1. Pingback: Minocycline and MS: How Jill is living symptom free

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