Tips for Writing for Patients in Clinical Trial

1. Tips for Writing for Patients in Clinical Trial Clinical trialswritten for patients conducted in clinical research is very challenging part. It is also called as protocol writing in scientific words.A protocol is assisted by a chief member of research team. The health of the patient will be regularly monitored by members of the research team to ultimately ensure the safety and effectiveness ofdrug. Following are some tips given for efficient writing for phases clinical trials conducted for the drugs in clinicalresearch. Proveyouknowyouraudience Put yourself in their place. Research their indication and understand the symptoms and most common treatments. Reach out to people you may know who are challenged with thedisease. There are also blogs, diaries, and personal essays available on the web. Each person’s experience is unique – but you will find common themes in how people feel and what their first thoughts were upondiagnosis. Haveasinglecalltoaction Why are you writing this piece? What do you want the audience to get outof it? Is your intent to inform or to persuade? Answering these questions before starting will keep you on track with your direction and purpose throughout the writing process. Pulling the reader in multiple directions will dilute your message and can leave your audience feeling confused. Your writing should engage the audience in that particular topic of clinicalresearch. Keep itsimple Use active voice statements: The study medication reduced blood pressure in patients reads better than the passive blood pressure was reduced by thestudy

2. medication in patients. Avoid industry or professional terms. Do your best to write to a fifth grade reading level? This doesn’tmean write in a condescending way to those you assume are less educated. Writing simply requires forethought and effort. There is value if the largest audience has the best chance of understanding your message. These efforts will ensure your message is clear andstraightforward. • Befair • Use balanced content and avoid inflammatory language. Do not make promises or infer thepatient will receive improvements or benefits by participating in a study. It should be clear the sponsor is still investigating whether the compound or deviceworks. • By considering these few points in clinical trialsconducted, you will be able to ensure your patient-facing materials are engaging andeffective. • EthicalConsiderations • The protocol prepared in clinical trial should be prepared by considering all the ethical issues. It should follow the Declarations of Helsinki. The study and research of the medicine should not start until approval from ethics committee. • The following points should be explained under thissection: • The benefits and risks for the subjects involved. The physical, social and psychological implications of theresearch. • Details of the information to be given to the study patients including alternativetreatments/approaches. • Information should be provided on the free informed consent ofthe • participants. Information form should contain: Justification for research, outline of study, risks, confidentiality, and voluntary participation should be told patients about the freedom to withdraw from the study whenever they wish to. Confidentiality indicates how the personal information obtained from the patient will be kept secret (Datasafety).

3. Annexure: The following annexes are to be attached at the end of the protocol written in the clinical trial: Informed consentform. Letters from ethicscommittees. Study questionnaire (copies of any questionnaires or draft questionnaires). Case Record Forms(CRFs). Budgetdetails. Curriculum Vitae (CV) of the chief investigator and co-investigator and their role in the study. It will ensure that the role of each investigator is welldefined. CommonMistakesshouldbeavoided Incorporating insufficient elements regarding proposed studies and inadequate explanation for the implication of the problem must be shunned as well as suggesting far more work than can be practically done during the study period. Furthermore, underpowered sample size should be justified, invalid or unreliable instrumentation should be tested and improper statistics should be adequately analyzed. These are some mistakes that should be avoided in clinicaltrials.