Clinical research studies are an incredibly important part of the overall healthcare system. However, there are a lot of misconceptions about clinical research and the role it plays in drug development. One such misconception is that clinical research operates as an extension of pharmaceutical companies.
What Clinical Research Studies Do
A clinical research organization (CRO) is an independent research firm that takes the lead in clinical research study management. CROs are not a part of the pharmaceutical companies that will package and sell the drug. Rather, their goal is to test the drug’s effectiveness and identify any side effects.
Safety and well-being of both case study participants and the public at large is always priority number one. Oftentimes, medical, and pharmaceutical companies will reach out to CROs to broaden and expedite the research and testing of a drug in development.
The benefits for pharmaceutical companies working with CROs essentially comes down to three factors: cost, time, and technology. CROs have resources, medical equipment, staffing, and procedural knowledge that drug companies often lack.
How Clinical Research Studies Protect the Public
There are many factors that determine whether a drug or device will become broadly available. These factors are what CROs seek to test in clinical studies.
Most important of these factors are the following:
- Is the drug or device effective in treating the condition it’s meant to treat?
- Is the drug or device safe?
- What can a person expect to experience while taking the drug or using the device?
While medical and pharmaceutical companies depend on clinical research to help advance the drugs, devices, and products they develop, failure is not uncommon at any stage.
Getting to the clinical research stage of any drug or device is a big deal. Any investigational drugs/devices that fail earlier phases of development or safety studies will not advance to human studies.
Yet even of the drugs/devices that do advance to clinical studies, 90% of these end up failing.
The reasons for the failure are numerous. Some drugs/devices simply aren’t effective in treating the condition for which they were developed. Others have side-effects that outweigh any potential benefit.
CROs and research studies help prevent subpar drugs/devices from becoming broadly available.
Phase 1 clinics like QPS help answer the question about dosage and side-effects before drugs/devices can advance for further studies. Altogether, CROs seek to ensure that the people who need care aren’t getting a useless drug or device, and that the side-effects are manageable.
Ethics in Clinical Research
Because of the sensitive nature of clinical research, and how many lives it stands to impact, there is a large emphasis on ethics in all approaches.
The ethical FDA regulated standards put in place around each study have several functions, the most important of which being the protection and welfare of the participants.
All proposed clinical trials must be approved by an institutional review board, according to government regulations. Among other things, the review board seeks to verify that the trial is ethical and that the participants are protected.
There are several formal documents that stipulate the ethical framework clinical researchers must follow, as well as core principles. Of the core principles, the validity of the results is one of the most significant. It represents the commitment CROs like QPS upholds to the local and global community.
Finding the right drugs or devices to treat chronic conditions or illness is a responsibility that clinical researchers do not take lightly. The goal is always to promote the best tested, proven advancements, even if that means having to tell pharmaceutical companies that their drugs or devices failed the clinical trial.
It is essential to remember that despite the high failure rates of clinical research studies, they are an important part of drug development. The drugs and devices that are available now all went through clinical trials like the ones conducted at QPS.
If you’re interested in being a part of one of our clinical research studies, don’t hesitate to reach out or sign up. Your participation may help advance research and ultimately improve lives not just in our community, but potentially worldwide.