The rising global prevalence of coronavirus infection cases and deaths calls for a drastic approach in the current coronavirus clinical trials to develop treatments to stem the tide. According to the World Health Organisation, the global number of coronavirus cases was 3 267 184 and there were 229,971 deaths.
There are numerous coronavirus clinical trials taking place simultaneously for both drug and vaccine development. According to vaccine developers, vaccine clinical trials take approximately 12-18 months to carry out.
In view of this public health emergency, what are the options regulatory bodies can use to speed up clinical trials for the development of a drug or vaccine against the Covid-19 virus?
In this post, the various clinical trial phases would be discussed coupled with updates on some coronavirus clinical trials and options for accelerated approvals.
PHASES OF CLINICAL TRIALS
Before clinical trials are commenced, pre-clinical testing using human cell cultures and animal models is carried out in a laboratory to determine medication toxicity. Clinical trials in humans are initiated once laboratory tests confirm the safety and potential efficacy of a medication.
The clinical trials are done in phases and each phase is a successful progression of the preceding phase.
- PHASE 0: The researcher administers a small test dose of the medication to fewer than 15 people. The clinical trial progresses to the next phase if there are no adverse reactions. However, the researcher subjects the mediation to further pre-clinical testing if there are adverse drug reactions.
- PHASE 1: The aim here is to determine the safety, ideal dosage, and route of administration of a drug in a larger set of healthy humans. The investigator monitors and evaluates these humans for months.
- PHASE 2: The investigator tests the medication on a larger group of ill people with the disease of interest. They are clinically assessed for unusual reactions and efficacy for a protracted period.
- PHASE 3: The researcher uses thousands of humans living with the disease to ascertain efficacy and safety. The scientist randomizes the human subjects used.
- PHASE 4: At this stage, a regulatory body would have approved the medication. This is the post-approval phase. This entails public safety monitoring and reporting of serious adverse events associated with using the medication.
CURRENT LISTS OF DRUGS AND VACCINES UNDERGOING CLINICAL TRIALS
- REMDESIVIR: This antiviral drug has shown promising benefits in being a potential drug for the treatment of the Covid-19 virus. It is progressing towards phase 3 of clinical trials.
- HYDROXYCHLOROQUINE/CHLOROQUINE: Although chloroquine has lots of lethal side effects like cardiac arrhythmias, researchers are still evaluating its potential efficacy in coronavirus treatment.
- IVERMECTIN: Clinical trials are still in progress for its therapeutic benefits in coronavirus treatment.
- mRNA VACCINE: Multiple pharmaceutical companies have started collaborations and partnerships to expedite the development of a vaccine within a short time. Companies like Moderna and Pfizer are carrying out clinical trials for an mRNA vaccine.
- Sanofi and G.S.K are also developing a novel vaccine for which clinical trials will commence soon.
LICENSING OPTIONS TO SPEED UP CLINICAL TRIALS
There might be an urgent need to bypass the traditional regulatory or licensing procedures for approving drugs or vaccines if the coronavirus mortality continues to spike.
What are the options?
- ACCELERATED APPROVAL
The F.D.A. instituted this rule in 1992. Under this rule, a drug or vaccine can be approved using clinical measurements or criteria to evaluate clinical trial data. This clinical measurement provides an index of the clinical outcome or efficacy if using the drug. For instance, the clinical measurement for a novel anticancer drug would be evidence of tumor shrinkage during clinical trial studies. This tumor shrinkage indicates a possible therapeutic benefit for cancer patients whom the drug is being developed for.
However, accelerated approval is reserved for dire public health emergencies.
For instance, the FDA under emergency use authorization, recently approved REMDISVIR because of its efficacy against the virus as indicated in the clinical trials.
- ANIMAL RULE
This involves approving drugs based on the therapeutic outcomes of several controlled animal studies of a specific human disease. This rule is chosen when it is either unethical to carry out clinical trials in humans or impossible to be done in humans.
In conclusion, clinical trials require time because of lots of monitoring and evaluation required.
A Medication or vaccine has to be safe and efficacious before being approved for human use.
Accelerated approval might be the last resort if there is no much progress in clinical trials.
What do you think? Kindly leave your comments below.