Clinical trials require participation of volunteers to test new therapies or drugs. This participation is completely voluntary. There are of course certain risks associated with testing any new treatments, but careful planning and evaluation can minimize these risks. Taking part in clinical trials provides benefits to the participating volunteers regarding several aspects. It is a basic right of the participant to raise questions on every aspect of the study.

There are several questions that can help a volunteer in deciding to take part in the clinical trials:

  • What is the study for?
  • Why is the drug or therapy being tested?
  • What is the scientific reasoning behind effectivity of treatment??
  • Under what conditions can the drug or treatment fail?
  • Is there any existing record of earlier trials or testing of the drug?
  • Are there any known side effects predicted from the composition or current knowledge?
  • What to do in case of side effects?
  • What would I receive during the trial if I happen to be in the control group?
  • What does the study design behind the trial look like?
  • Who oversees the trial?
  • Who can I address concerning trial related topics and issues during the trial?
  • Who will know what I receive?
  • Will the drug intervene or affect my existing treatment plan?
  • What is the frequency of visits to the trial center?
  • Will I have to do any additional travel apart from the visits to the trial center?
  • What are additional tests to be done?
  • What is the duration of the study?
  • Who sponsors my participation?
  • How will I be reimbursed for any additional expenses?
  • Are there any post-study follow-ups needed and for how long?
  • Can I receive the drug or treatment after trial too in case the results are positive?
  • Will I get the trial results and in what form?
  • How is my data protected during and after the trial?
  • Will my general physician be informed of the trial results?
  • How do I handle my regular medical care during trial participation?
  • What happens if I suffer an adverse reaction or am injured during the trials?
  • What is the content of informed consent?
  • Who is in the review or ethics committee?
  • How am I protected in case of violations of ethical rules, trial conditions and consent agreement?
  • What are my legal rights if I experience violations of any kind?
  • How is data shared across trial centers and between the members of the team?
  • If I decide to leave the trial, what is the necessary formality?

There are multiple resources available to understand and find out more information about clinical trials being conducted globally. Doing a background search and some groundwork can help in better preparation to raise correct questions with the trial conducting team and still being vigilant to any uncertainties concerning these trials.

The solutions developed by Healex focus on reducing the burden of clinical trials by smooth data sharing and management. The better outcomes of the clinical trials with the usage of these solutions ensure higher trust among the scientific and patients’ community with the host institutions.

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.