Designing a clinical trial is a challenge, however, executing the trial is a complex yet the most vital step in getting patients access to new treatments or drugs. Clinical trials face various barriers and are part of many scientific and community discussions and debates. One of the key barriers for clinical trials until now is the low participation of volunteers. However, this is not the only challenge as a part of the complete process.

Few of the key barriers can be listed as

Volunteers

Generally, many volunteers are confronted with the psychological challenge of facing the unknown therapy or drug, which evokes a bigger fear in the mind. Traditionally some societies are also reluctant to participate in scientific experimentation due to social or religious issues. Age is another part of this barrier as a trials’ requirement of older participants makes it more difficult to recruit volunteers. Gender is also a factor with women being underrepresented in trials. Fake news and information circulating through various channels of media, the internet, and social media add to the trouble of finding volunteers. There can also be practical challenges such as remote locations of trial centers or transport issues. The biggest hurdle in this segment remains to get the psychological approval of a volunteer to trust the rationale and science behind the planned clinical study.

Communication from the study group

Communication between the study group and participating volunteers is critical. Yet not all principal investigators or clinical trial conducting groups are effective in explaining the study design and the benefit of the trial for the interested volunteers. Also, volunteers generally assess the motivation of the interacting team and the staff members. Low interest or inability to put all facts forward can lead to volunteers backing off from the study.

Funding

Clinical trials require large funds to execute and critically evaluate a novel treatment or drug. Any delay or funding cuts from the host institutions or universities can lead to barriers for the clinical trials. Delays in the execution of trials can also lead to a lack of funds.

Study Design

The very nature of the chosen study design can create barriers to the smooth execution of the trial. For example, restrictions regarding the type of volunteers or limitations to certain age groups or locations, but also long durations of clinical trials can lead to lengthy approval procedures that impact the volunteer recruitment or retaining them for the complete trial. Invasive treatment procedures as part of a study can automatically create hindrances for explaining the trial’s true impact on the participants.

Data Protection

There are stringent guidelines to protect clinical trial data. Yet, increasing cyber risks, inadequate data protection infrastructures, and policies can be a barrier to participating in a clinical trial. Many volunteers are also well-informed and run a background check about the trial conducting authorities. Any previous records of a lapse in data protection could form a substantial barrier for future clinical trials.

Healex provides a variety of solutions in making clinical trials process streamlined with standardized data. Our solutions allow quick, cross-location clinical studies and real-time data exchanges. The final beneficiaries of these solutions are patients with access to globally acceptable data qualities.

About Dr. Jubin Shah:

Dr Shah is responsible for Business development at Healex. He has more then 10 years of inter-disciplinary experience in the field of Bioinformatics, Life science and Healthcare across academia, several startups and non-profit sector.

About Healex:

Connecting and accelerating medical research and treatment – with this goal Healex develops solutions that support and fasten clinical work and networked research, especially in the current Corona crisis.

Healex enables the transfer of information from various clinical and research systems as well as secure and usable storage of health information. The data can be used for prevention, up-to-date anamnesis, care, and science.
This enables fast, cross-site clinical trials and real-time data exchange between clinical research and care.