5 extraordinary clinical trials

One of the most useful ways to envision the future of medicine is to pay attention to clinical trials in progress. Looking at the therapeutic drugs and treatments being assessed in clinical trials to treat human diseases can be inspiring and provide insights into new pharmaceuticals and other treatments that may soon be available.

Here are a few of the most exciting clinical trials in recent years.

1. A vaccine against cancer mutations

The vaccine being assessed in a clinical trial as a potential preventative measure against melanoma can be modified to each individual patient. Neo-epitopes are immunogenic proteins produced by tumors and are specific for the tumor. Using these molecules against the tumor that produced them causes destruction of tumor cells and T-cell responses to the tumor. Initial studies are promising for the development of a vaccine against cancers.

2. In this age of multiple drug-resistant bacteria, new antibiotics are needed

Plazomicin, an aminoglycoside, is showing good coverage for MDR Enterobacteriaceae. This includes Carbapenem-resistant Enterobacteriaceae, which has emerged as a major problem. A semi-synthetic antibiotic called Lefamulin is demonstrating good activity against Gram positive bacteria, especially MRSA. A third antibiotic that shows promise is Omadacycline, a tetracycline derivative that is being tested for activity against acute bacterial skin infections and community acquired bacterial pneumonia.

3. Stem cell dosing for nerve regeneration

AST-OPC1 is the designation of progenitor cells of oligodendrytes from embryonic stem cells. Doses of these cells are being given to people with recent spinal cord injuries to attempt some regeneration of neural function. Early trial results have been good with individuals at least partially regaining one motor level. One patient has gone from C5-6 level to C7-8.

4. Fighting bortezomib and dexamethasone for multiple myeloma

Daratumumab is a monoclonal antibody that is being added to the usual treatment of bortezomib and dexamethasone for multiple myeloma. Plasma cells, part of the immune system that produce antibodies, are affected in this cancer. Early results showed a 70% decrease in the progression of the cancer compared with the standard two-drug regimen. Daratumumab is the first anti-cancer drug that not only destroys cancer cells, but also stimulates the immune system to fight the cancer.

5. A solution for severe migraines?

For those who suffer migraines frequently, nothing could be more exciting than recent clinical trial results on Eptinezumab, a monoclonal antibody that was tested in clinical trials for the prevention of migraine headaches. Early evidence indicates that this new drug will be effective with a good safety profile, allowing users to lead a more normal life.

From antibiotics to cancer treatments to spinal cord injuries and migraines, there is hope on the horizon for new medications and new treatments for many conditions.

Trend: Remote or Decentralized Clinical Trials

A recent trend for clinical trials is that more organizations are conducting clinical research as remote or decentralized clinical trials (DCT) by offering trial volunteers the option to participate from home. Remote clinical trials typically involve sending remote sample collection kits to study volunteers at home. In the kits are portable blood microsampling devices like the Mitra^® device with VAMS^® technology or hemaPEN^® that enable finger-stick blood collection by anyone, anywhere, anytime. 

Volunteers can mail their blood samples back to the study lab in the provided packaging using standard mail. The lab processes the samples and the clinical trial coordinators follow up with volunteers using telehealth channels, such as phone, email, online chat and video conferencing.

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