Are Phase 0 CRO Clinical Trials about the Drug or the Patient?

Clinical trial companies prefer to screen multiple drugs in the early stages of development, so they can evaluate whether volunteer patients respond to the drugs in a way that makes it safe to progress to the next phase of research.

Volunteer patients on the other hand are largely unaware of the purpose of Phase 0 CRO clinical trials. The patient community, understandably, is more interested in the clinical implications of the new drug which is being tested, rather than whether it modulates the biological target or not.

Clinical Trial Companies and pharmas would like to know whether the new drug has the potential for fast and targeted development. However, they are also concerned about volunteer patients weighing up opportunity costs between Phase 0 CRO Clinical Trials which offer no therapeutic potential and a Phase 1 clinical trial which could offer a minimal benefit.

The common question Clinical Trial Companies face is whether Phase 0 trials are about the new drug being tested or the volunteer patients.

Phase 0 CRO Clinical Trials Participation

Phase 0 CRO Clinical Trials play an important role in the development of new drugs even if there is no prospect of a direct benefit to volunteer patients.

Volunteer patients who clearly understand their situation are willing to participate as long as they are clearly informed of the risks and benefits involved in the trial.

They favour efforts to speed up the process of drug development, but need evidence to understand and support participation in  Phase 0  CRO Clinical Trials.

Creating Dialogues With Patient Advocacy Communities

While investigating new drugs, Phase 0 clinical trials can save time and money for drug development. Advocacy groups, however, may be unclear on how volunteer patients will benefit. This is why it is important to create dialogues with patient advocacy communities explaining how Phase 0 CRO Clinical Trials help with the biological and pharmacologic understanding of new drugs in the process of development and how this increases the likelihood of therapeutic success.

Such interaction and collaboration goes a long way in making patient advocate communities feel comfortable to assist investigators recruit volunteer patients to participate in Phase 0 CRO clinical trials.

The drug development process is confusing to many people in advocacy, and volunteer patient communities. Informative material clearly explaining the conceptual framework of a Phase 0 CRO clinical trial is important for creating a healthy dialogue which explains the advantages as well as challenges of this approach. At the least, Clinical Trial Companies must have standard operating procedures which can be shared with participants in the dialogue to assure them that Phase 0 tests are an important part of the development process for new drugs.

One of the ways Clinical Trial Companies can gain acceptance among advocacy groups is to  share results of Phase 0 CRO Clinical Trials in real-time as much as possible, especially during a trial’s end. Tools such as presentation slides, published content and other relevant information will ensure that volunteer patients and advocates see the value of Phase 0 trials and their contribution to clinical research. Some experts recommended calling Phase 0 trials exploratory research instead of a clinical trial to help in eliminating therapeutic misconceptions.

Volunteer Recruitment for Phase 0 CRO Clinical Trials

Recruiting patients for Phase 0 CRO Clinical Trials depends on patient philanthropy, relationship between physician and patient, as well as careful planning and proper implementation of communication procedures.

Phase 0 CRO Clinical Trials can be conducted and accurately completed in the agreed time-frame if the procedures carry minimal risk, the trial meets with volunteer expectations and the outcome will be valuable to patients.

When conducting Phase 0 trials, clinical trial companies need to ensure the special procedures should complement scientific opportunities and clearly explain the absence of therapeutic benefits. They should also be made fully aware of the objectives, procedures and risks involved if they choose to participate in the trial.

Very often volunteer patients find motivation in enrolling for trials because of their interest in maintaining relationships with the family doctor. Accordingly, Clinical Trial Companies must carefully explain the difference between therapeutic care and experimental research as objectively as possible using easy-to-understand diagrams, charts and statistical data.

Providing information in ways that is easy to understand enables prospective volunteers to make an informed decision on whether they should participate in the CRO Clinical Trial. In addition, it also reduces any misconceptions of therapeutic benefits resulting from a Phase 0 CRO Clinical Trial.

To ensure eligible Phase 0 volunteer patients have understood the information which has been provided early-phase studies should include a documentation of understanding. This will be important in the patient consent process.

 

 

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