All medications that are available on the market have gone through extensive testing period, starting with phase 1 clinical trials with health volunteers. These studies try to identify the efficacy and safety of the drug. Normally they are looking for 50 to 200 participants and represent the very early step to determine if the drug will be well-tolerated by the patients in future research.
Although phase 1 studies may sound straightforward they have their challenges like all other clinical trials and their success depends not only on the medication but also on volunteers` compliance.
What are the main challenges with early stage research?
1) Although it is rare there are some cases of phase 1 clinical trials where volunteers were hospitalized with complications. That kind of accidents could increase the precautions and reduce the interest in phase 1 clinical research. Regulatory agencies have increased the scrutiny on phase 1 studies to avoid any future accidents.
2) Sometimes even these early stage protocols can be quite complex and challenging to follow. Too many blood tests or visits could be the turning point of the clinical trial and significantly affect compliance. We should not forget that these are healthy volunteers and if they feel the study interferes with their daily life, they are likely to withdraw.
3) Lack of understating from the volunteers about the purpose of the research and compliance requirements.
4) Lack of experience in the research team.
What could be done to improve phase 1 clinical trials?
- Educate your volunteers – Provide your volunteers with information regarding the benefits and risks of clinical research. Explain them the purpose of the study and the significance of compliance.
- Evaluate compliance risks – Try to establish if the volunteer will be able to complete the study. Understanding volunteers’ life situation is the best way to assess if they will be able to comply with the protocol – Is the participant likely to go on holiday during the study or move house? Does the participant plan to have kids? Are they looking after a relative?
- Provide feedback to sponsors if any procedures or tests could result is low compliance. It is important for the sponsors to understand any protocol design complications.
- Sponsors have to provide support to research teams who are not very experienced in clinical trials and assure that all required safety information is captured. Often sponsors underestimate the support required for early stage research and it is important agreements to be made at the beginning of the study to assure that the sponsor will support the team if needed. It is common research teams who work on early stage research not to have the extensive experience that their colleagues have and they may need more support and guidance. The best approach is never to presume that they know everything.
Author: Olga Peycheva
Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe.
Originally published on 1 Oct 2014