Developing new drugs
“New drugs must undergo clinical trials to test safety and effectiveness before being approved for sale.”
New drugs must undergo clinical trials to test safety and effectiveness before being approved for sale. Taking part in a trial is one way to gain access to a drug that is not yet generally available.
Patients interested in clinical trials should begin by talking to their doctors. However, not all doctors will be aware of all the options, so it is also worthwhile doing research. Many websites, such as clinicaltrials.gov in the USA, carry information about trials that are seeking participants.
Not everyone who wants to take part in a trial is able to do so. Eligibility may depend on previous treatment, health, age or gender, for example. The number of participants is usually limited, and most trials take place at a few clinics only.
In addition, not everyone who takes part in a trial will receive the drug being studied. Usually a new treatment is tested against an existing alternative, with patients randomly assigned to receive one or the other.
It is important to understand that trials carry risks as well as possible benefits. It may turn out that the new drug is less effective than the old one. There is also a chance that the new drug may have serious side effects not detected in earlier studies. Participating in a trial may be time consuming and inconvenient.
Patients should find out as much as they can about a trial before enrolling, to assess whether the benefits are likely to outweigh the risks.
Drugs undergoing clinical trials are known as investigational treatments. Patients who can’t take part in trials may be able to access an investigational treatment through an expanded access programme or compassionate release scheme. In America, for example, the Food and Drug Administration (FDA) allows three main options for people living with HIV:
- Treatment IND
- Single-patient IND (or compassionate use IND)
- Emergency use IND
A treatment IND (Investigational New Drug application) allows the makers of a new drug to run a programme supplying it to patients in need, provided the drug has already shown promise and proven safety, and no comparable or satisfactory alternative is available. Those interested in accessing a drug under a treatment IND should contact the organisers of the programme.
Not every investigational drug is available under a treatment IND. In this case a doctor may apply for a single-patient IND (also known as a compassionate use IND) to help a particular individual. For this to work the manufacturer must be willing to supply the drug and create a way to monitor the patient while on treatment.
If a patient’s life is in immediate danger then a doctor may seek an emergency IND, which allows a drug to be supplied more quickly, before completion of the formal approval process.
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